iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM F799-99

(Specification)

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

SCOPE
1.1 This specification covers the material requirements of cobalt-28chromium-6molybdenum alloy high-strength forgings for the manufacture of surgical implants. Material conforming to this specification has been evaluated for biocompatibility and corrosion resistance and has been found to be comparable to material conforming to Specification F 75. The properties specified in this document specifically apply to finished or semifinished parts that receive no subsequent metallurgical processing.  
1.2 The values stated in inch-pound units are to be regarded as the standard. The metric equivalents of the inch-pound units may be approximate.  
1.3 Wrought material to be used as forging stock in the manufacture of forgings conforming to this specification, typically hot worked and unannealed with a surface finish suitable for forging, shall be fabricated and supplied in accordance with F 1537.

General Information

Status
Historical
Publication Date
09-Jun-1999
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.12 - Metallurgical Materials
Current Stage
Ref Project

Relations

Replaced By
ASTM F799-02 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Effective Date
10-Apr-2002
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
10-Jun-1999
Referred By
ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
Effective Date
10-Jun-1999
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
10-Jun-1999
Referred By
ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
Effective Date
10-Jun-1999
Referred By
ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
Effective Date
10-Jun-1999
Referred By
ASTM F1537-20 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Effective Date
10-Jun-1999
Referred By
ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
Effective Date
10-Jun-1999
Referred By
ASTM F1672-14(2019) - Standard Specification for Resurfacing Patellar Prosthesis (Withdrawn 2023)
Effective Date
10-Jun-1999
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
10-Jun-1999
Referred By
ASTM F2091-15 - Standard Specification for Acetabular Prostheses (Withdrawn 2023)
Effective Date
10-Jun-1999
Referred By
ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
Effective Date
10-Jun-1999
Referred By
ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
Effective Date
10-Jun-1999
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
10-Jun-1999
Referred By
ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
Effective Date
10-Jun-1999

Buy Standard

ASTM F799-99 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)ASTM F799-99 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
PreviousNext
Technical specification
ASTM F799-99 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
English language
3 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)


NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 799 – 99
Standard Specification for
Cobalt-28Chromium-6Molybdenum Alloy Forgings for
Surgical Implants (UNS R31537, R31538, R31539)
This standard is issued under the fixed designation F 799; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope F 981 Practice for Assessment of Compatibility of Bioma-
terials (Non-porous) for Surgical Implants with Respect to
1.1 This specification covers requirements of cobalt-
Effect of Materials on Muscle and Bone
28chromium-6molybdenum alloy (UNS R31537, R31538,
F 1537 Specification for Wrought Cobalt-28 Chromium-6
R31539) high-strength forgings for the manufacture of surgical
Molybdenum Alloy for Surgical Implants
implants. Material conforming to this specification has been
2.2 American Society for Quality Standard:
evaluated for biocompatibility and corrosion resistance and
ASQ C1 Specification of General Requirements for a Qual-
has been found to be comparable to material conforming to
ity Program
Specification F 75. The properties specified in this document
specifically apply to finished or semifinished parts that receive
3. Significance and Use
no subsequent metallurgical processing.
3.1 The purpose of this specification is to characterize the
1.2 The values stated in inch-pound units are to be regarded
properties of currently available cobalt-28chromium-
as the standard. The metric equivalents of the inch-pound units
6molybdenum forgings.
may be approximate.
1.3 Wrought material to be used as forging stock in the
4. Ordering Information
manufacture of forgings conforming to this specification,
4.1 Inquiries and orders for material under this specification
typically hot worked and unannealed with a surface finish
shall include the following information:
suitable for forging, shall be fabricated and supplied in
4.1.1 Quantity,
accordance with F 1537.
4.1.2 ASTM designation and date of issue,
4.1.3 Mechanical properties,
2. Referenced Documents
4.1.4 Form (semifinished parts, part No.),
2.1 ASTM Standards:
3 4.1.5 Applicable dimensions or print number,
E 8 Test Methods for Tension Testing of Metallic Materials
4.1.6 Condition (forged, heat treated, annealed),
E 18 Test Methods for Rockwell Hardness and Rockwell
3 4.1.7 Special tests, and
Superficial Hardness of Metallic Materials
4.1.8 Other requirements.
E 112 Test Methods for Determining the Average Grain
Size
5. Condition
E 165 Test Method for Liquid Penetrant Examination
5.1 The material shall be forged by hammering, pressing,
E 930 Test Methods for Estimating the Largest Grain Ob-
3 rolling, extruding, or upsetting, and shall be processed, if
served in a Metallographic Section (ALA Grain Size)
practicable, so as to cause metal flow during the hot-working
F 75 Specification for Cast Cobalt-Chromium-Molybdenum
5 operation in the direction most favorable for resisting stresses
Alloy for Surgical Implant Applications
encountered in service, as may be indicated by the implant
F 601 Practice for Fluorescent Penetrant Inspection of Me-
5 manufacturer.
tallic Surgical Implants
5.2 Forgings shall be free of splits, scale, cracks, flaws, and
other imperfections not consistent with good commercial
practice.
This specification is under the jurisdiction of ASTM Committee F-4 on Medical
5.3 Optional indentification marks, including the manufac-
and Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials. turer’s logo, material designation, heat code number, and
Current edition approved June 10, 1999. Published September 1999. Originally
impression number, may be placed upon each forging, the
published as F 799 – 82. Last previous edition F 799 – 96.
Supporting data are available from ASTM Headquarters, 100 Barr Harbor Dr.,
West Conshohocken, PA 19428.
Annual Book of ASTM Standards, Vol 03.01.
4 6
Annual Book of ASTM Standards, Vol 03.03. Available from American Society for Quality, 161 W. Wisconsin Ave.,
Annual Book of ASTM Standards, Vol 13.01. Milwaukee, WI 53203.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 799
method and location of which shall be as specified by the or small size. In lieu of mechanical testing, these parts shall
purchaser. exhibit hardness of HRC 35 to 45 when tested in accordance
with Test Methods E 18.
6. Chemical Compostion
7.2 Hardness—Finished or semifinished parts conforming
6.1 The chemical composition of forgings shall meet the
to this specification shall have a minimum Rockwell C
chemical requirements of F 1537
hardness of 35 HRC. The hardness determination shall be
performed in accordance with Test Methods E 18.
7. Mechanical Requirements
8. Special Tests
7.1 Tensile Properties:
7.1.1 Tensile properties shall be determined in accordance
8.1 The grain size of forgings shall be five or finer when
with Test Methods E 8.
tested in accordance with Test Methods E 112. In forgings it
7.1.2 The mechanical properties of test specimens prepared
may not be possible to fully recrystallize the entire microstruc-
from finished or semifinished parts shall conform to the
ture to a fine grain size. Duplex microstructures exhibiting
requirements in Table 1.
areas of unrecrystallized grains as large as ASTM No. 2 (or
7.1.3 Tension specimens shall be produced from finished or
ALA No. 2, as applicable, see E 930) shall be acceptab
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM F2267-24(Test Method)
Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

SIGNIFICANCE AND USE
5.1 Intervertebral body fusion devices are generally simple geometric-shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment.  
5.2 This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since this is a potential clinical failure mode. These tests are conducted in vitro in order to simplify the comparison of simulated vertebral body subsidence induced by the intervertebral body fusion devices.  
5.3 The static axial compressive loads that will be applied to the intervertebral body fusion devices and test blocks will differ from the complex loading seen in vivo, and therefore, the results from this test method may not be used to directly predict in vivo performance. The results, however, can be used to compare the varying degrees of subsidence between different intervertebral body fusion device designs for a given density of simulated bone.  
5.4 The location within the simulated vertebral bodies and position of the intervertebral body fusion device with respect to the loading axis will be dependent upon the design and manufacturer's recommendation for implant placement.
SCOPE
1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.  
1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.  
1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test method is designed to allow for the comparative evaluation of intervertebral body fusion devices.  
1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.  
1.5 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.  
1.6 Units—The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.  
1.7 The use of this standard may involve the operation of potentially hazardous 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.  
1.8 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.

  • Standard
    8 pages
    English language
    sale 15% off
  • Standard
    8 pages
    English language
    sale 15% off
ASTM
ASTM F1538-24(Specification)
Standard Specification for Glass and Glass-Ceramic Biomaterials for Implantation

ABSTRACT
This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. Glass and glass-ceramic biomaterials should be evaluated thoroughly for biocompatibility before human use. Tests shall be performed to determine the properties of the biomaterials, in accordance with the following test methods: bulk composition; density; flexural strength; Young's modulus; hardness; surface area; bond strength of glass or glass ceramic coating; crystallinity; thermal expansion; and particle size.
SCOPE
1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems.  
1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1-12)2 and laboratory studies (13-17).  
1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite.  
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.  
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.

  • Technical specification
    4 pages
    English language
    sale 15% off
  • Technical specification
    4 pages
    English language
    sale 15% off
ASTM
ASTM F1350-24(Specification)
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

ABSTRACT
This specification covers UNS S31673 chromium-nickel-molybdenum wrought annealed stainless steel surgical fixation wires. The wires should conform to the required values of tensile strength and elongation. Wire surfaces should be processed to minimize tool marks, nicks, scratches, cracks, cavities, spurs, and other imperfections that would impair wire serviceability.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for the manufacture of wrought 18chromium-14nickel-2.5molybdenum stainless steel in the form of surgical fixation wire.  
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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.

  • Technical specification
    4 pages
    English language
    sale 15% off
  • Technical specification
    4 pages
    English language
    sale 15% off
ASTM
ASTM F1295-24(Specification)
Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)

ABSTRACT
This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold worked, or hot rolled titanium-6aluminum-7niobium alloy (UNS R56700) bar and wire to be used in the manufacture of surgical implants. Titanium mill products covered in this specification shall be formed with the conventional forging and rolling equipment found in primary ferrous and nonferrous plants, and may be furnished as descaled or pickled, sandblasted, chemically milled, ground, machined, peeled, polished, or cold drawn. The alloy shall be multiple melted in arc furnaces (including furnaces such as plasma arc and electron beam) of a type conventionally used for reactive metals. Heat analysis shall conform to the chemical composition requirements prescribed for aluminum, niobium, tantalum, iron, oxygen, carbon, nitrogen, hydrogen, and titanium. The material shall conform to the specified requirements for mechanical properties such as ultimate tensile strength, yield strength, and elongation. A minimum of two tension tests from each lot shall be performed. Special requirements for the microstructure are detailed as well.
SCOPE
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed, cold-worked, or hot-worked titanium-6aluminum-7niobium alloy bar, wire, sheet, strip, and plate to be used in the manufacture of surgical implants (1-7).2  
1.2 The SI units in this standard are the primary units. The values stated in either primary SI units or secondary inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
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.

  • Technical specification
    6 pages
    English language
    sale 15% off
  • Technical specification
    6 pages
    English language
    sale 15% off
ASTM
ASTM F2914-12(2024)(Guide)
Standard Guide for Identification of Shelf-Life Test Attributes for Endovascular Devices

SIGNIFICANCE AND USE
3.1 The purpose of this guide is to provide a procedure for determining the appropriate attributes to evaluate in a shelf-life study for an endovascular device.
SCOPE
1.1 This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example, drug devices, biologic devices, or drug biologics) may require additional considerations, depending on their nature.  
1.2 This guide does not directly provide any test methods for conducting shelf-life testing.  
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.

  • Guide
    6 pages
    English language
    sale 15% off
ASTM
ASTM F2527-24(Specification)
Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)

ABSTRACT
This specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms are addressed. This specification applies to straight length tubing of specified diameters and thickness. Seamless tubing shall be made from bar, hollow bar, rod, or hollow rod raw material forms through a prescribed process. Welded and drawn tubing shall be made from strip or sheet raw material forms that meet the specified chemical requirements. The tubing shall be subject to tensile testing.
SCOPE
1.1 This specification covers the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F90, F562, F688, F1058 or F1537, Alloy 1. This specification addresses those product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms covered in these specifications.  
1.2 This specification applies to straight length tubing with 6.3 mm [0.250 in.] and smaller nominal outside diameter (OD) and 0.76 mm [0.030 in.] and thinner nominal wall thickness.  
1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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.

  • Technical specification
    6 pages
    English language
    sale 15% off
  • Technical specification
    6 pages
    English language
    sale 15% off
ASTM
ASTM F601-23(Practice)
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

SIGNIFICANCE AND USE
3.1 This practice is intended to confirm the method of obtaining and evaluating the fluorescent penetrant indications on metallic surgical implants.
SCOPE
1.1 This practice is intended as a standard for fluorescent penetrant inspection of metallic surgical implants.  
1.2 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.  
1.3 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.

  • Standard
    2 pages
    English language
    sale 15% off
  • Standard
    2 pages
    English language
    sale 15% off
ASTM
ASTM F2777-23(Test Method)
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion

SIGNIFICANCE AND USE
4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue/cyclic creep performance of UHMWPE bearing components subject to substantial rotation in the transverse plane (relative to the tibial tray) for a relatively large number of cycles.  
4.2 The loading and kinematics of bearing component designs in vivo will, in general, differ from the loading and kinematics defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to enable comparisons between the fatigue performance of different bearing component designs when tested under similar conditions.  
4.3 The test described is applicable to any bicompartmental knee design, including mobile bearing knees that have mechanisms in the tibial articulating component to constrain the posterior movement of the femoral component and a built-in retention mechanism to keep the articulating component on the tibial plate.
SCOPE
1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
1.2 This test method is intended to simulate near posterior edge loading similar to the type of loading that would occur during high flexion motions such as squatting or kneeling.  
1.3 Although the methodology described attempts to identify physiological orientations and loading conditions, the interpretation of results is limited to an in vitro comparison between knee prosthesis designs and their ability to resist deformation and fracture under stated test conditions.  
1.4 This test method applies to bearing components manufactured from UHMWPE.  
1.5 This test method could be adapted to address unicompartmental total knee replacement (TKR) systems, provided that the designs of the unicompartmental systems have sufficient constraint to allow use of this test method. This test method does not include instructions for testing two unicompartmental knees as a bicompartmental system.  
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 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.  
1.8 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.

  • Standard
    8 pages
    English language
    sale 15% off
  • Standard
    8 pages
    English language
    sale 15% off
ASTM
ASTM F2886-17(2023)(Specification)
Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

ABSTRACT
This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for metal injection molded (MIM) cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants  
1.2 The MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing.  
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the 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.

  • Technical specification
    5 pages
    English language
    sale 15% off
ASTM
ASTM F3140-23(Test Method)
Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

SIGNIFICANCE AND USE
4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles.  
4.2 The loading of tibial tray designs in vivo will, in general, differ from the loading defined in this practice. The results obtained here cannot be used to directly predict in vivo performance. However, this practice is designed to allow for comparisons between the fatigue performance of different metallic tibial tray designs, when tested under similar conditions.  
4.3 In order for fatigue data on tibial trays to be comparable, reproducible, and capable of being correlated among laboratories, it is essential that uniform procedures be established.
SCOPE
1.1 This test method covers a procedure for the fatigue testing of metallic tibial trays used in partial knee joint replacements.  
1.2 This test method covers the procedures for the performance of fatigue tests on metallic tibial components using a cyclic, constant-amplitude force. It applies to tibial trays which cover either the medial or the lateral plateau of the tibia.  
1.3 This test method may require modifications to accommodate other tibial tray designs.  
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle.  
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.

  • Standard
    6 pages
    English language
    sale 15% off
  • Standard
    6 pages
    English language
    sale 15% off