F04.21 - Osteosynthesis

ABSTRACT
This specification covers the material requirements and functional dimensions for fixation pins and wires. Factors such as bending strength, fatigue strength, break strength (Knowles type only), torsion strength, and ductility are considered important but the values and associated test methods for which have not been established yet.
SCOPE
1.1 This specification covers functional dimensions for fixation pins and wires.  
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1-3.
FIG. 1 Fixation Pins and Wires
Note 1: Pins and wires may be smooth shank or threaded.
Note 2: Point angle and helix angle, where applicable, is as specified by the manufacturer.
Note 3: On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins larger than 3.2 mm may be reduced.
Note 4: Optional designs, both ends pointed or point with suture hole.
FIG. 2 Fixation Pin—Knowles Type
Note 1: Shall be made of one piece of material; that is, not an assembly of two or more pieces.
Note 2: Thread major diameter may be the same or larger than the shaft diameter.
Note 3: Thread length shall be optional to suit the intended medical application.
Note 4: Optional marking in this location.
FIG. 3 Fixation Pin—Hagie Type
Note 1: Thread major diameter may be the same or larger than the shaft diameter.
Note 2: Thread length shall be optional to suit the intended medical application.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 Due to the variety of small bone fractures, plates used for the fixation of these fractures come in a variety of shapes and configurations. Table 1 categorizes the plate types for each anatomical area. Flat plates are the simplest; see Fig. 2 for an example of a basic flat plate. Many other plates have features to accommodate specific anatomies, such as condylar, complex (such as cuneiform), pre-contoured (such as metatarsophalangeal joint (MPJ)), step, orbital, orthognathic step, and wedge plates. Other plates, such as mesh-based and burr hole plates, are generally flat but are designed to be used in specific anatomical regions, so their designs are not the same as conventional straight plates. If test data is used from one type of plate for justification of the mechanical properties of another type of plate, this justification shall be described in the final report.  
4.2 Most of the testing described herein is focused on a “functional unit,” which can be described as a single-line fracture being spanned by a plate with one screw hole on each side of the fracture. This configuration allows for the simplest determination of worst-case size if the strut geometry is the determining factor for the worst case. If a worst-case size cannot be isolated to a functional unit/strut geometry, perhaps due to irregular screw hole patterns or the shape of the plate, it is understandable that some tests would need to be modified, or possibly removed from test consideration, to accommodate the shape of the plate or the screw hole. Any test modifications or omissions shall be described in the final report with a rationale related to the plate’s anatomical use, indications, and functional requirements.
SCOPE
1.1 This standard is intended to provide guidance for the static testing of small bone metallic plates used for fracture fixation. Small bone plates referred to in this standard would be used in minimally load-bearing anatomical areas of the far extremities, such as the fingers and toes, and in the cranium and upper face. Lower face/mandible, wrist, and ankle fixation plates would generally be larger and carry a substantial amount of load and should not be evaluated under this standard.  
1.2 ASTM Specification F382 and ISO 9585 are currently available for the testing of metallic bone plates as well, so the user can choose to use any of the tests in these standards for small bone plates. However, due to plate size, Specification F382 and ISO 9585 test setup and execution difficulty can be increased for small bone plates. Thus, this standard offers alternative test methods that are more appropriate for metallic bone plates used in small bone fracture fixation.  
1.3 This standard is not intended to address the mechanical performance of the plating construct or accessory components (for example, screws and wires).  
1.4 This standard is intended to provide a basis for the mechanical comparison of small bone plates. Due to the complex and varying biomechanics found in the areas of the body where these plates are used, this standard should only be used to compare the in vitro mechanical performance of small bone plates and not used to infer in vivo performance characteristics.  
1.5 This standard describes static tests by specifying load types and specific methods of applying these loads. Tests for evaluating and characterizing these loads include the following: static torsion, static cantilever beam bending, static lateral bending, and static three-point bending.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 Multiple tests are cited in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design.  
1.8 This standard does not purport to address all of th...

ABSTRACT
This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments. Many implants are wrapped in special sterilizable or pre-sterilized packages, envelopes, or other containers. These wrappings should not be removed by the receiving personnel. Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or instrument. Store implants or instruments prior to use in such a manner as to maintain the device’s surface finish or configuration, or both. Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of mixing during surgery. Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and implants. Dispose of orthopedic implants that exhibit surface or configuration damage. Avoid the reimplantation of previously implanted orthopedic implants.
SCOPE
1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments.  
1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage to orthopedic implants and instruments.  
1.3 This practice does not cover producer level handling and packaging procedures.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification covers the acceptable material and dimensional requirements, and tolerances for bits of screwdrivers used for inserting and removing metal screws applied in surgical implants. The medical screwdrivers are available in the following types: Type I—single-slot bit; Type II—cruciate-slot bit; Type III—cross-slot (modified Phillips) bit; Type IV—hexagonal bit; Type V—square bit; Type VI—hexalobe bit. The bit and shaft portion should be fabricated from either martensitic stainless steel or cold worked cobalt-chromium-tungsten-nickel alloy, as specified. The portions should also meet specified values of Rockwell hardness.
SCOPE
1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants.  
1.2 This specification is based, in part, upon ISO 8319-1, ISO 8319-2, and ISO 10664.  
1.3 The screwdrivers with the bits described in this specification are suitable for use with screws described in Specification F543, ISO 5835, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for implantation into the human body. All materials should conform to the specified quality of appearance, dimensional stability, and composition, and values of void content, compressive strength, compressive modulus, shear strength, shear modulus, and screw pullout.
SIGNIFICANCE AND USE
5.1 This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments.  
5.2 This foam described in this specification is not intended to replicate the mechanical properties of human or animal bone. The requirements of this specification are intended to provide a consistent and uniform material with properties on the order of human cancellous bone to use as a test medium when testing various orthopaedic devices, such as bone screws.
SCOPE
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.  
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.  
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1, Rationale, for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.  
1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.  
1.5 This specification provides qualification criteria for vendor or end user processes and acceptance criteria for individual material lots.  
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone. Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered. In general, intramedullary reamers consist of two types: one-piece reamer—a design where the reamer shaft and cutting head are permanently attached to each other; and Modular Reamer—a design where the reamer shaft and cutting head are two separate components, fixed to each other temporarily at the time of use via a geometric connection, for example, dovetail joint.
SCOPE
1.1 This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone.  
1.2 Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFDs). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This practice covers recommendations on permanent marking of metallic and nonmetallic orthopaedic implant components. The practical amounts of information that should be included in the marking are specified. Where implant size and shape allow, it is recommended that the following standard information be included in the permanent marking: (1) manufacturer, (2) material, (3) implant component catalog number or model number, and (4) implant component serial number or lot number. For smaller implants, it is recommended that the following minimum information be included in the permanent marking: symbols or letters selected by the manufacturer which identify (1) the manufacturer and (2) the material from which the component is made. The system of symbols or letters shall be described in the manufacturer’s product literature. Optional information may be included in the permanent marking, such as implant size and whether an implant is intended for right limb or left limb reconstruction.
SCOPE
1.1 It is common practice for orthopaedic implant manufacturers to apply permanent identification to implant components. In this regard, Practice F86 describes recommended locations and methods of marking for metallic implants.  
1.2 The purpose of this practice is to (1) recommend that orthopaedic implants be permanently marked, and (2) recommend practical amounts of information that should be included in the marking. It is recognized, however, that marking is not practical in some cases (see 4.1).  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
4.1 Absorbable devices are intended to degrade and absorb over time once they are implanted into the body. This makes a removal operation unnecessary, which is especially advantageous for pediatric patients.  
4.2 While the polymer degrades due to hydrolytic reaction with the environment, the mechanical performance of the device also deteriorates. The key to developing mechanically effective fracture fixation systems based on absorbable devices is to provide an adequate level of fixation strength and stiffness for a time frame that exceeds that expected for fracture healing. Once the fracture is healed, the device can be completely absorbed by the body. The biological performance of the device, particularly for application at a bony site, may be enhanced by incorporation of bioactive fillers in the polymer.  
4.3 Absorbable devices will be tested using test methods that are similar to those used to evaluate conventional metallic devices. The pre-test conditioning requirements, handling requirements, and time-dependent mechanical property evaluations for absorbable devices shall be considered.  
4.4 This specification and accompanying test methods are intended to complement the more general considerations for the assessment of absorbable polymeric implants that are described within Guide F2902.
FIG. 1 Screw Parameters
SCOPE
1.1 This specification and test methods cover the mechanical characterization of plates and screws for orthopedic internal fixation. Covered devices are fabricated from one or more hydrolytically degradable polymer (from this point on referred to as “absorbable”) resins or resin composites.  
1.2 This specification establishes a common terminology to describe the size and other physical characteristics of absorbable implants and performance definitions related to the performance of absorbable devices.  
1.3 This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of absorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed.  
1.4 This specification may not be appropriate for all absorbable devices, especially those that possess limited hydrolytic susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of the particular absorbable device and its potential application.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. Different test methods shall be performed in order to determine the following mechanical properties of metallic bone staples: bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending.
SIGNIFICANCE AND USE
A1.3 Significance and Use
A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances.
A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories.
A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application.
SCOPE
1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.  
1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:  
1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples—Annex A1.  
1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples—Annex A2.  
1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples—Annex A3.  
1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples—Annex A4.  
1.3 The values stated in SI units are to be regarded as standard. Any other units of measurement included in this standard are shown for reference only.  
1.4 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
A1.4 Significance and Use
A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed.
SCOPE
1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs.  
1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in-vivo performance of the device.  
1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows:  
1.3.1 Classification of External Fixators—Annex A1.  
1.3.2 Test Method for External Skeletal Fixator Connectors—Annex A2.  
1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements—Annex A3.  
1.3.4 Test Method for External Skeletal Fixator Joints—Annex A4.  
1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements—Annex A5.  
1.3.6 Test Method for External Skeletal Fixator Subassemblies—Annex A6.  
1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies—Annex A7.  
1.4 A rationale is given in Appendix X1.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods  
1.7 The following safety hazards caveat pertains only to the test method portions (Annex A2 – Annex A6):  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification and test method establishes the consistent methods for classifying, and defining the geometric and performance characteristics of five types (cloverleaf, cobra head, reconstruction, straight, and tubular) of metallic bone plates used in the surgical internal fixation of the skeletal system. Also presented here are catalogs of standard specifications for material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical (single cycle bend and bend fatigue) characteristics determined to be important to the in vivo performance of bone plates. This neither defines the levels of performance or case-specific clinical performance for bone plates, nor describes specific designs for bone plates.
SIGNIFICANCE AND USE
A2.5 Significance and Use
A2.5.1 This test method establishes a uniform four-point bending fatigue test to characterize and compare the fatigue performance of different bone plate designs. This test method may be used to determine a fatigue life of the bone plate at either a specific maximum bending moment or over a range of maximum bending moment conditions. Alternatively, the test method may be used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles.
A2.5.2 This test method utilizes a simplified bone plate load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the  in vivo performance of the bone plate being tested. The data generated from this test method can be used to conduct relative comparisons of different bone plate designs.
A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.
A2.5.4 This test method assumes that the bone plate is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior.
A2.5.5 This test method is restricted to the testing of bone plates within the lnear-elastic range of the material. . Therefore, the test method is not applicable for testing bone plates under conditions that would approach or exceed the bending strength of the bone plate being tested.
SCOPE
1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates.  
1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system.  
1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application.  
1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics:  
1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates—Annex A1, and  
1.4...

ABSTRACT
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. Cabling constructions shall be 7×7 and 7×19 cable. Mechanical requirements include ultimate tensile strength and minimum breaking force. Strand or cable shall have no welds or splices, free of imperfections, and shall conform to dimensions, surface finish, and tolerances indicated in this specification.
SCOPE
1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables.  
1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly appropriate for high load bearing applications. It is not intended however, to address all of the possible variations in construction, material, or properties.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
A2.5 Significance and Use
A2.5.1 The test method establishes a uniform cantilever bending fatigue test to characterize and compare the fatigue performance of different angled device designs. This test method may be used to determine the fatigue life of an angled device at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate the fatigue strength of an angled device for a specified number of fatigue cycles.
A2.5.2 The test method utilizes a simplified angled device cantilever bending load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in-vivo performance of the angled device being tested. The data generated from this test method can be used to conduct relative comparisons of different angled device designs.
A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.
A2.5.4 This test method assumes that the angled device is manufactured from a material that exhibits linear-elastic material behavior; therefore, this test method is not applicable for testing angled devices made from materials that exhibit nonlinear elastic behavior.
A2.5.5 This test method is restricted to the testing of angled devices within the linear-elastic range of the material; therefore, this test method is not applicable for testing angled devices under conditions that would approach or exceed the bending strength of the angled device being tested.
SCOPE
1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of angled devices.  
1.2 It is not the intention of this standard to define levels of performance or case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system.  
1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application.
Note 1: This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate.  
1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:  
1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1).  
1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see Annex A2).  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
Note 2: There is currently no ISO standard that is either similar to equivalent to this standard.  
1.6 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only se...

SIGNIFICANCE AND USE
A1.4 Significance and Use
A1.4.1 This test method describes a static bending test to determine the bending stiffness and bending strength of the central and uniform portions of an IMFD.
A1.4.2 This test method may not be appropriate for all types of implant applications (that is, in proximal or distal extremity of an IMFD where screw holes exist). The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential applications.
SCOPE
1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs.  
1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.  
1.3 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.  
1.4 This specification includes four standard test methods:  
1.4.1 Static Four-Point Bend Test Method—Annex A1 and  
1.4.2 Static Torsion Test Method—Annex A2.  
1.4.3 Bending Fatigue Test Method—Annex A3.  
1.4.4 Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.  
1.5 A rationale is given in Appendix X1.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ABSTRACT
This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments. Many implants are wrapped in special sterilizable or pre-sterilized packages, envelopes, or other containers. These wrappings should not be removed by the receiving personnel. Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or instrument. Store implants or instruments prior to use in such a manner as to maintain the device’s surface finish or configuration, or both. Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of mixing during surgery. Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and implants. Dispose of orthopedic implants that exhibit surface or configuration damage. Avoid the reimplantation of previously implanted orthopedic implants.
SCOPE
1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments.  
1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage to orthopedic implants and instruments.  
1.3 This practice does not cover producer level handling and packaging procedures.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone. Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered. In general, intramedullary reamers consist of two types: one-piece reamer—a design where the reamer shaft and cutting head are permanently attached to each other; and Modular Reamer—a design where the reamer shaft and cutting head are two separate components, fixed to each other temporarily at the time of use via a geometric connection, for example, dovetail joint.
SCOPE
1.1 This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone.  
1.2 Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification covers the material requirements and functional dimensions for fixation pins and wires. Factors such as bending strength, fatigue strength, break strength (Knowles type only), torsion strength, and ductility are considered important but the values and associated test methods for which have not been established yet.
SCOPE
1.1 This specification covers functional dimensions for fixation pins and wires.  
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1-3.
FIG. 1 Fixation Pins and Wires  
Note 1: Pins and wires may be smooth shank or threaded.  
Note 2: Point angle and helix angle, where applicable, is as specified by the manufacturer.  
Note 3: On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins larger than 3.2 mm may be reduced.  
Note 4: Optional designs, both ends pointed or point with suture hole.  
FIG. 2 Fixation Pin-Knowles Type  
Note 1: Shall be made of one piece of material; that is, not an assembly of two or more pieces.  
Note 2: Thread major diameter may be the same or larger than the shaft diameter.  
Note 3: Thread length shall be optional to suit the intended medical application.  
Note 4: Optional marking in this location.  
FIG. 3 Fixation Pin-Hagie Type  
Note 1: Thread major diameter may be the same or larger than the shaft diameter.  
Note 2: Thread length shall be optional to suit the intended medical application.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ABSTRACT
This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for implantation into the human body. All materials should conform to the specified quality of appearance, dimensional stability, and composition, and values of void content, compressive strength, compressive modulus, shear strength, shear modulus, and screw pullout.
SIGNIFICANCE AND USE
5.1 This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments.  
5.2 This foam described in this specification is not intended to replicate the mechanical properties of human or animal bone. The requirements of this specification are intended to provide a consistent and uniform material with properties on the order of human cancellous bone to use as a test medium when testing various orthopaedic devices, such as bone screws.
SCOPE
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.  
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.  
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1, Rationale, for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.  
1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.  
1.5 This specification provides qualification criteria for vendor or end-user processes and acceptance criteria for individual material lots.  
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification covers the acceptable material and dimensional requirements, and tolerances for bits of screwdrivers used for inserting and removing metal screws applied in surgical implants. The medical screwdrivers are available in the following types: Type I—single-slot bit; Type II—cruciate-slot bit; Type III—cross-slot (modified Phillips) bit; Type IV—hexagonal bit; Type V—square bit; Type VI—hexalobe bit. The bit and shaft portion should be fabricated from either martensitic stainless steel or cold worked cobalt-chromium-tungsten-nickel alloy, as specified. The portions should also meet specified values of Rockwell hardness.
SCOPE
1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants.  
1.2 This specification is based, in part, upon ISO 8319–1, ISO 8319–2, and ISO 10664.  
1.3 The screwdrivers with the bits described in this specification are suitable for use with screws described in Specification F543, ISO 5835, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
A1.4 Significance and Use
A1.4.1 This test method describes a static bending test to determine the bending stiffness and bending strength of the central and uniform portions of an IMFD.
A1.4.2 This test method may not be appropriate for all types of implant applications (i.e., in proximal or distal extremity of an IMFD where screw holes exist). The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential applications.
SCOPE
1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs.  
1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.  
1.3 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.  
1.4 This specification includes four standard test methods:  
1.4.1 Static Four-Point Bend Test Method—Annex A1 and  
1.4.2 Static Torsion Test Method—Annex A2.  
1.4.3 Bending Fatigue Test Method—Annex A3.  
1.4.4 Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.  
1.5 A rationale is given in Appendix X1.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ABSTRACT
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. Cabling constructions shall be 7×7 and 7×19 cable. Mechanical requirements include ultimate tensile strength and minimum breaking force. Strand or cable shall have no welds or splices, free of imperfections, and shall conform to dimensions, surface finish, and tolerances indicated in this specification.
SCOPE
1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables.  
1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly appropriate for high load bearing applications. It is not intended however, to address all of the possible variations in construction, material, or properties.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

SIGNIFICANCE AND USE
A1.4 Significance and Use
A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed.
SCOPE
1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs.  
1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in-vivo performance of the device.  
1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows:  
1.3.1 Classification of External Fixators—Annex A1.  
1.3.2 Test Method for External Skeletal Fixator Connectors—Annex A2.  
1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements—Annex A3.  
1.3.4 Test Method for External Skeletal Fixator Joints—Annex A4.  
1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements—Annex A5.  
1.3.6 Test Method for External Skeletal Fixator Subassemblies—Annex A6.  
1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies—Annex A7.  
1.4 A rationale is given in Appendix X1.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 The following safety hazards caveat pertains only to the test method portions (Annex A2 – Annex A6):  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification covers the material requirements and functional dimensions for fixation pins and wires. Factors such as bending strength, fatigue strength, break strength (Knowles type only), torsion strength, and ductility are considered important but the values and associated test methods for which have not been established yet.
SCOPE
1.1 This specification covers functional dimensions for fixation pins and wires.  
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1-3.  
Note 1: Thread major diameter may be the same or larger than the shaft diameter.  
Note 2: Thread length shall be optional to suit intended medical application.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ABSTRACT
This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. Different test methods shall be performed in order to determine the following mechanical properties of metallic bone staples: bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending.
SIGNIFICANCE AND USE
A1.3 Significance and Use
A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances.
A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories.
A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application.
SCOPE
1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.  
1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:  
1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples—Annex A1.  
1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples—Annex A2.  
1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples—Annex A3.  
1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples—Annex A4.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification and test method establishes the consistent methods for classifying, and defining the geometric and performance characteristics of five types (cloverleaf, cobra head, reconstruction, straight, and tubular) of metallic bone plates used in the surgical internal fixation of the skeletal system. Also presented here are catalogs of standard specifications for material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical (single cycle bend and bend fatigue) characteristics determined to be important to the in vivo performance of bone plates. This neither defines the levels of performance or case-specific clinical performance for bone plates, nor describes specific designs for bone plates.
SIGNIFICANCE AND USE
A2.5 Significance and Use
A2.5.1 This test method establishes a uniform four-point bending fatigue test to characterize and compare the fatigue performance of different bone plate designs. This test method may be used to determine a fatigue life of the bone plate at either a specific maximum bending moment or over a range of maximum bending moment conditions. Alternatively, the test method may be used to estimate a bone plate's fatigue strength for a specified number of fatigue cycles.
A2.5.2 This test method utilizes a simplified bone plate load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the  in vivo performance of the bone plate being tested. The data generated from this test method can be used to conduct relative comparisons of different bone plate designs.
A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.
A2.5.4 This test method assumes that the bone plate is manufactured from a material that exhibits linear-elastic material behavior. Therefore, the method is not applicable for testing bone plates made from materials that exhibit non-linear elastic behavior.
A2.5.5 This test method is restricted to the testing of bone plates within the lnear-elastic range of the material. . Therefore, the test method is not applicable for testing bone plates under conditions that would approach or exceed the bending strength of the bone plate being tested.
SCOPE
1.1 This specification and test method is intended to provide a comprehensive reference for bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone plates. The standard also presents a catalog of standard specifications that specify material; labeling and handling requirements; and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of bone plates.  
1.2 It is not the intention of the standard to define levels of performance or case-specific clinical performance for bone plates, as insufficient knowledge is available to predict the consequences or their use in individual patients for specific activities of daily living. Futhermore, it is not the intention of the standard to describe or specify specific designs for bone plates used in the surgical internal fixation of the skeletal system.  
1.3 This document may not be appropriate for all types of bone plates. The user is cautioned to consider the appropriateness of the standard in view of a particular bone plate and its potential application.  
1.4 This document includes the following test methods used in determining the following bone plate mechanical performance characteristics:  
1.4.1 Standard Test Method for Single Cycle Bend Testing of Metallic Bone Plates—Annex A1, and  
1.4...

SIGNIFICANCE AND USE
A1.4 Significance and Use
A1.4.1 This test method describes a static bending test to determine the bending stiffness and bending strength of the central and uniform portions of an IMFD.
A1.4.2 This test method may not be appropriate for all types of implant applications (i.e., in proximal or distal extremity of an IMFD where screw holes exist). The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential applications.
SCOPE
1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs.  
1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.  
1.3 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.  
1.4 This specification includes four standard test methods:  
1.4.1 Static Four-Point Bend Test Method—Annex A1 and  
1.4.2 Static Torsion Test Method—Annex A2.  
1.4.3 Bending Fatigue Test Method—Annex A3.  
1.4.4 Test Method for Bending Fatigue of IMFD Locking Screws—Annex A4.  
1.5 A rationale is given in Appendix X1.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ABSTRACT
This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone. Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered. In general, intramedullary reamers consist of two types: one-piece reamer—a design where the reamer shaft and cutting head are permanently attached to each other; and Modular Reamer—a design where the reamer shaft and cutting head are two separate components, fixed to each other temporarily at the time of use via a geometric connection, for example, dovetail joint.
SCOPE
1.1 This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone.  
1.2 Intramedullary reamers are commonly used to prepare the medullary canal for the insertion of intramedullary fixation devices (IMFD). As such, the relationship between the intramedullary reamer diameter and the IMFD's diameter are considered.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ABSTRACT
This practice covers recommendations on permanent marking of metallic and nonmetallic orthopaedic implant components. The practical amounts of information that should be included in the marking are specified. Where implant size and shape allow, it is recommended that the following standard information be included in the permanent marking: (1) manufacturer, (2) material, (3) implant component catalog number or model number, and (4) implant component serial number or lot number. For smaller implants, it is recommended that the following minimum information be included in the permanent marking: symbols or letters selected by the manufacturer which identify (1) the manufacturer and (2) the material from which the component is made. The system of symbols or letters shall be described in the manufacturer�s product literature. Optional information may be included in the permanent marking, such as implant size and whether an implant is intended for right limb or left limb reconstruction.
SCOPE
1.1 It is common practice for orthopaedic implant manufacturers to apply permanent identification to implant components. In this regard, Practice F86 describes recommended locations and methods of marking for metallic implants.  
1.2 The purpose of this practice is to (1) recommend that orthopaedic implants be permanently marked, and (2) recommend practical amounts of information that should be included in the marking. It is recognized, however, that marking is not practical in some cases (see 4.1).  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments. Many implants are wrapped in special sterilizable or pre-sterilized packages, envelopes, or other containers. These wrappings should not be removed by the receiving personnel. Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or instrument. Store implants or instruments prior to use in such a manner as to maintain the device�s surface finish or configuration, or both. Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of mixing during surgery. Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and implants. Dispose of orthopedic implants that exhibit surface or configuration damage. Avoid the reimplantation of previously implanted orthopedic implants.
SCOPE
1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments.  
1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage to orthopedic implants and instruments.  
1.3 This practice does not cover producer level handling and packaging procedures.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1. Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1. Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for implantation into the human body. All materials should conform to the specified quality of appearance, dimensional stability, and composition, and values of void content, compressive strength, compressive modulus, shear strength, shear modulus, and screw pullout.
SIGNIFICANCE AND USE
5.1 This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments.  
5.2 This foam described in this specification is not intended to replicate the mechanical properties of human or animal bone. The requirements of this specification are intended to provide a consistent and uniform material with properties on the order of human cancellous bone to use as a test medium when testing various orthopaedic devices, such as bone screws.
SCOPE
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.  
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.  
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1, Rationale, for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.  
1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.  
1.5 This specification provides qualification criteria for vendor or end-user processes and acceptance criteria for individual material lots.  
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for implantation into the human body. All materials should conform to the specified quality of appearance, dimensional stability, and composition, and values of void content, compressive strength, compressive modulus, shear strength, shear modulus, and screw pullout.
SIGNIFICANCE AND USE
5.1 This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments.  
5.2 This foam described in this specification is not intended to replicate the mechanical properties of human or animal bone. The requirements of this specification are intended to provide a consistent and uniform material with properties on the order of human cancellous bone to use as a test medium when testing various orthopaedic devices, such as bone screws.
SCOPE
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.  
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.  
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1, Rationale, for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.  
1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.  
1.5 This specification provides qualification criteria for vendor or end-user processes and acceptance criteria for individual material lots.  
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification covers the acceptable material and dimensional requirements, and tolerances for bits of screwdrivers used for inserting and removing metal screws applied in surgical implants. The medical screwdrivers are available in the following types: Type I—single-slot bit; Type II—cruciate-slot bit; Type III—cross-slot (modified Phillips) bit; Type IV—hexagonal bit; Type V—square bit; Type VI—hexalobe bit. The bit and shaft portion should be fabricated from either martensitic stainless steel or cold worked cobalt-chromium-tungsten-nickel alloy, as specified. The portions should also meet specified values of Rockwell hardness.
SCOPE
1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants.  
1.2 This specification is based, in part, upon ISO 8319–1, ISO 8319–2, and ISO 10664.  
1.3 The screwdrivers with the bits described in this specification are suitable for use with screws described in Specification F543, ISO 5835, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
A2.5.1 The test method establishes a uniform cantilever bending fatigue test to characterize and compare the fatigue performance of different angled device designs. This test method may be used to determine the fatigue life of an angled device at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate the fatigue strength of an angled device for a specified number of fatigue cycles.
A2.5.2 The test method utilizes a simplified angled device cantilever bending load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in-vivo performance of the angled device being tested. The data generated from this test method can be used to conduct relative comparisons of different angled device designs.
A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.
A2.5.4 This test method assumes that the angled device is manufactured from a material that exhibits linear-elastic material behavior; therefore, this test method is not applicable for testing angled devices made from materials that exhibit nonlinear elastic behavior.
A2.5.5 This test method is restricted to the testing of angled devices within the linear-elastic range of the material; therefore, this test method is not applicable for testing angled devices under conditions that would approach or exceed the bending strength of the angled device being tested.
SCOPE
1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of angled devices.
1.2 It is not the intention of this standard to define levels of performance or case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system.
1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application.  
Note 1—This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate.
1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:  
1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1).
1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see Annex A2).
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
Note 2—There is currently no ISO standard that is either similar to equivalent to this standard.

SIGNIFICANCE AND USE
A2.4.1 This test method describes a static torsional test to determine the torsional stiffness of the central and uniform portion of an intramedullary fixation device.
A2.4.2 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.
SCOPE
1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs.
1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.
1.3 This specification includes four standard test methods:
1.3.1 Static Four-Point Bend Test MethodAnnex A1 and
1.3.2 Static Torsion Test MethodAnnex A2.
1.3.3 Bending Fatigue Test MethodAnnex A3.
1.3.4 Test Method for Bending Fatigue of IMFD Locking ScrewsAnnex A4.
1.4 A rationale is given in Appendix X1.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

SIGNIFICANCE AND USE
A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed.
SCOPE
1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs.
1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in-vivo performance of the device.
1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows:
1.3.1 Classification of External Fixators—Annex A1.
1.3.2 Test Method for External Skeletal Fixator Connectors—Annex A2.
1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements—Annex A3.
1.3.4 Test Method for External Skeletal Fixator Joints—Annex A4.
1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements—Annex A5.
1.3.6 Test Method for External Skeletal Fixator Subassemblies—Annex A6.
1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies—Annex A7.
1.4 A rationale is given in Appendix X1.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 The following safety hazards caveat pertains only to the test method portions (Annex A2-Annex A6):
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.  
A1.1.1 This classification covers the definitions of basic terms and considerations for external skeletal fixation devices (ESFDs) and the mechanical analyses thereof.
A1.1.2 It is not the intent of this classification to define levels of acceptable performance or to make recommendations concerning the appropriate or preferred clinical usage of these devices.
A1.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.  
A2.1.1 This test method covers the procedures for determining the stiffness and strength of connecting elements (clamps) of external skeletal fixators under axial loads and bending moments. Depending on the design of the connector and its use in the overall construct, the connector needs to transmit one or more components of loading (tension, compression, torsion, or bending, or a combination thereof) between the elements it grips (anchorage elements or bridge elements), without itself undergoing either permanent deformation or excessive elasti...

ABSTRACT
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. Cabling constructions shall be 7×7 and 7×19 cable. Mechanical requirements include ultimate tensile strength and minimum breaking force. Strand or cable shall have no welds or splices, free of imperfections, and shall conform to dimensions, surface finish, and tolerances indicated in this specification.
SCOPE
1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables.
1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly appropriate for high load bearing applications. It is not intended however, to address all of the possible variations in construction, material, or properties.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ABSTRACT
This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. Materials shall be manufactured using equivalent size wires in the cold-worked and stress-relieved or annealed condition. Standard strand constructions shall be 1×3, 1×7, and 1×19 strand. Cabling constructions shall be 7×7 and 7×19 cable. Mechanical requirements include ultimate tensile strength and minimum breaking force. Strand or cable shall have no welds or splices, free of imperfections, and shall conform to dimensions, surface finish, and tolerances indicated in this specification.
SCOPE
1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables.
1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly appropriate for high load bearing applications. It is not intended however, to address all of the possible variations in construction, material, or properties.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

SIGNIFICANCE AND USE
A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed.
SCOPE
1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs.
1.2 This specification describes ESFDs for surgical fixation of the skeletal system. It provides basic ESFD geometrical definitions, dimensions, classification, and terminology; material specifications; performance definitions; test methods; and characteristics determined to be important to the in-vivo performance of the device.
1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows:
1.3.1 Classification of External Fixators—Annex A1.
1.3.2 Test Method for External Skeletal Fixator Connectors—Annex A2.
1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements—Annex A3.
1.3.4 Test Method for External Skeletal Fixator Joints—Annex A4.
1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements—Annex A5.
1.3.6 Test Method for External Skeletal Fixator Subassemblies—Annex A6.
1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies—Annex A7.
1.4 A rationale is given in Appendix X1.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 The following safety hazards caveat pertains only to the test method portions (Annex A2-Annex A6):
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Absorbable devices are intended to degrade and absorb over time once they are implanted into the body. This makes a removal operation unnecessary, which is especially advantageous for pediatric patients.
While the polymer degrades due to hydrolytic reaction with the environment, the mechanical performance of the device also deteriorates. The key to developing mechanically effective fracture fixation systems based on absorbable devices is to provide an adequate level of fixation strength and stiffness for a time frame that exceeds that expected for fracture healing. Once the fracture is healed, the device can be completely absorbed by the body. The biological performance of the device, particularly for application at a bony site, may be enhanced by incorporation of bioactive fillers in the polymer.
Absorbable devices will be tested using test methods that are similar to those used to evaluate conventional metallic devices. The pre-test conditioning requirements, handling requirements, and time-dependent mechanical property evaluations for absorbable devices shall be considered.
SCOPE
1.1 This specification and test methods cover the mechanical characterization of plates and screws for orthopedic internal fixation. Covered devices are fabricated from one or more hydrolytically degradable polymer (from this point on referred to as “absorbable”) resins or resin composites.  
1.2 This specification establishes a common terminology to describe the size and other physical characteristics of absorbable implants and performance definitions related to the performance of absorbable devices.
1.3 This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of absorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed.
1.4 This specification may not be appropriate for all absorbable devices, especially those that possess limited hydrolytic susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of the particular absorbable device and its potential application.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
A2.5.1 The test method establishes a uniform cantilever bending fatigue test to characterize and compare the fatigue performance of different angled device designs. This test method may be used to determine an angled device's fatigue life at either a specific or over a range of maximum bending moment conditions. Additionally, this test method may be alternatively used to estimate an angled device's fatigue strength for a specified number of fatigue cycles.
A2.5.2 The test method utilizes a simplified angled device cantilever bending load model that may not be exactly representative of the in-situ loading configuration. The user should note that the test results generated by this test method can not be used to directly predict the in-vivo performance of the angled device being tested. The data generated from this test method can be used to conduct relative comparisons of different angled device designs.
A2.5.3 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.
A2.5.4 This test method assumes that the angled device is manufactured from a material that exhibits linear-elastic material behavior; therefore, this test method is not applicable for testing angled devices made from materials that exhibit nonlinear elastic behavior.
A2.5.5 This test method is restricted to the testing of angled devices within the material's linear-elastic range; therefore, this test method is not applicable for testing angled devices under conditions that would approach or exceed the bending strength of the angled device being tested.
SCOPE
1.1 These specifications and test methods provide a comprehensive reference for angled devices used in the surgical internal fixation of the skeletal system. This standard establishes consistent methods to classify and define the geometric and performance characteristics of angled devices. This standard also presents a catalog of standard specifications that specify material, labeling, and handling requirements, and standard test methods for measuring performance related mechanical characteristics determined to be important to the in vivo performance of angled devices.
1.2 It is not the intention of this standard to define levels of performance of case-specific clinical performance for angled devices, as insufficient knowledge is available to predict the consequences of their use in individual patients for specific activities of daily living. Futhermore, this standard does not describe or specify specific designs for angled devices used in the surgical internal fixation of the skeletal system.
1.3 This standard may not be appropriate for all types of angled devices. The user is cautioned to consider the appropriateness of this standard in view of a particular angled device and its potential application.  
Note 1—This standard is not intended to address intramedullary hip screw nails or other angled devices without a sideplate.
1.4 This standard includes the following test methods used in determining the following angled device mechanical performance characteristics:  
1.4.1 Standard test method for single cycle compression bend testing of metallic angled orthopedic fracture fixation devices (see Annex A1).
1.4.2 Standard test method for determining the bending fatigue properties of metallic angled orthopedic fracture fixation devices (see Annex A2).
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
Note 2—There is currently no ISO standard that is either similar to equivalent to this standard.

ABSTRACT
This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. Different test methods shall be performed in order to determine the following mechanical properties of metallic bone staples: bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending.
SIGNIFICANCE AND USE
A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances.
A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories.
A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application.
SCOPE
1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.
1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:
1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone StaplesAnnex A1.
1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone StaplesAnnex A2.
1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone StaplesAnnex A3.
1.2.4 Test Method for Elastic Static Bending of Metallic Bone StaplesAnnex A4.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification covers the material requirements and functional dimensions for fixation pins and wires. Factors such as bending strength, fatigue strength, break strength (Knowles type only), torsion strength, and ductility are considered important but the values and associated test methods for which have not been established yet.
SCOPE
1.1 This specification covers functional dimensions for fixation pins and wires.
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1-3.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

ABSTRACT
This practice covers recommendations on permanent marking of metallic and nonmetallic orthopaedic implant components. The practical amounts of information that should be included in the marking are specified. Where implant size and shape allow, it is recommended that the following standard information be included in the permanent marking: (1) manufacturer, (2) material, (3) implant component catalog number or model number, and (4) implant component serial number or lot number. For smaller implants, it is recommended that the following minimum information be included in the permanent marking: symbols or letters selected by the manufacturer which identify (1) the manufacturer and (2) the material from which the component is made. The system of symbols or letters shall be described in the manufacturer's product literature. Optional information may be included in the permanent marking, such as implant size and whether an implant is intended for right limb or left limb reconstruction.
SCOPE
1.1 It is common practice for orthopaedic implant manufacturers to apply permanent identification to implant components. In this regard, Practice F 86 describes recommended locations and methods of marking for metallic implants.
1.2 The purpose of this practice is to (1) recommend that orthopaedic implants be permanently marked, and (2) recommend practical amounts of information that should be included in the marking. It is recognized, however, that marking is not practical in some cases (see 4.1).
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
Biodegradable devices are expected by intention to deteriorate over time once they are implanted into the body. This makes a removal operation unnecessary, which is especially advantageous especially for pediatric patients.
While the polymer degrades due to hydrolytic reaction with the environment, the mechanical performance of the device also deteriorates. The key to developing effective fracture fixation systems based on biodegradable devices is to provide an adequate level of fixation strength for a time frame that exceeds that expected for fracture healing. Once the fracture is healed, the device can be completely resorbed by the body.
Generally, biodegradable devices will be tested with test methods that are similar to those used to evaluate conventional metallic devices. In addition, one has to take into consideration the pre-test conditioning requirements, handling requirements, and time-dependent mechanical property evaluations for biodegradable devices.
SCOPE
1.1 This specification and test methods covers a mechanical characterization reference for hydrolytically degradable polymer resin (from this point on referenced as “bioabsorbable”) plates and screws for orthopedic internal fixation.  
1.2 This specification establishes a common terminology to describe the size and other physical characteristics of bioabsorbable implants and performance definitions related to the performance of bioabsorbable devices.
1.3 This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of bioabsorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed.
1.4 This specification may not be appropriate for all bioabsorbable devices. The user is cautioned to consider the appropriateness of the standard in view of the particular bioabsorbable device and its potential application.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

ABSTRACT
This specification covers the material requirements and functional dimensions for fixation pins and wires. Factors such as bending strength, fatigue strength, break strength (Knowles type only), torsion strength, and ductility are considered important but the values and associated test methods for which have not been established yet.
SCOPE
1.1 This specification covers functional dimensions for fixation pins and wires.
1.2 In recognition of many broad and varied uses of such pins and wires, many options are included. A variety, but not necessarily all, of the options are illustrated in Figs. 1-3.
1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
Note 1—Pins and wires may be smooth shank or threaded.
Note 2—Point angle and helix angle, where applicable, is as specified by manufacturer.
Note 3—On square or triangular shanks, flats are equal and corners are on the same circumference as the pin diameter. Shank diameters on pins larger than 1/8 in. (3.2 mm) may be reduced.
Note 4—Optional designs, both ends pointed or point with suture hole. FIG. 1 Fixation Pins and Wires
Note 1—Shall be made of one piece of material; that is, not an assembly of two or more pieces.
Note 2—Thread major diameter may be the same or larger than the shaft diameter.
Note 3—Thread length shall be optional to suit intended medical application.
Note 4—Optional marking in this location. FIG. 2 Fixation Pin-Knowles Type
Note 1—Thread major diameter may be the same or larger than the shaft diameter.
Note 2—Thread length shall be optional to suit intended medical application. FIG. 3 Fixation Pin-Hagie Type

ABSTRACT
This practice covers recommended procedures for the handling of orthopedic implants and instruments. Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments. Many implants are wrapped in special sterilizable or pre-sterilized packages, envelopes, or other containers. These wrappings should not be removed by the receiving personnel. Perform transport in a manner to preclude any damage or alteration to the received condition of the implant or instrument. Store implants or instruments prior to use in such a manner as to maintain the device's surface finish or configuration, or both. Maintain orthopedic implants and instruments of different metals separately to avoid the possibility of mixing during surgery. Prior to initial sterilization and promptly following each surgical procedure, thoroughly and carefully clean all instruments and implants. Dispose of orthopedic implants that exhibit surface or configuration damage. Avoid the reimplantation of previously implanted orthopedic implants.
SCOPE
1.1 This practice covers recommended procedures for the handling of orthopedic implants and instruments.
1.2 Hospital receiving personnel, central supply personnel, operating room personnel, surgeons, and occasionally other individuals will handle orthopedic implants and instruments. All personnel should be informed of recommended care and handling procedures to prevent damage of orthopedic implants and instruments.
1.3 This practice does not cover producer level handling and packaging procedures.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.