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ASTM F2068-15

(Specification)

Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)

Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)

ABSTRACT
This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads. Femoral prostheses presented are defined as follows: type IA - single-piece (mono-block), metallic femoral total hip or hemi-arthroplasty hip prosthesis with an integral stem, neck and head, type IB - single-piece (mono-block), metallic, femoral total hip or hemi- arthroplasty hip prostheses with an integral stem, neck, and head, type IIA - modular metallic femoral hip prostheses that could include a modular (type II) head or other modular components, or both, and type IIB - Modular metallic femoral hip prosthesis that could include a modular (type II) head or other modular components, or both. Femoral prostheses shall be capable of withstanding normal static and dynamic loading in the physiological range without overload fracture, plastic deformation, or fatigue fracture. Shear strength, tensile strength, and abrasion resistance of plasma spray thermal coatings shall be tested to meet the requirements prescribed.
SCOPE
1.1 This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses may have integral femoral heads or cones designed to accept modular heads.  
1.2 Modular femoral heads, which may be affixed to cones on implants covered by this specification, are not covered by this specification. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integral implants are covered by this specification.  
1.3 Femoral prostheses included within the scope of this specification are intended for fixation by press fit between the prosthesis and host bone, the use of bone cement, or through the ingrowth of host bone into a porous coating.  
1.4 Custom femoral prostheses, designed explicitly for a single patient, are not covered within the scope of this specification.  
1.5 Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, or porous-polymer coatings, are specifically excluded from the scope of this specification.  
1.6 The requirements for modular connections of multicomponent modular femoral hip prostheses are not covered by this specification.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
WITHDRAWN RATIONALE
This specification covered metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in December 2023. This standard is being withdrawn without replacement due to its limited use by industry.

General Information

Status
Withdrawn
Publication Date
14-Mar-2015
Withdrawal Date
03-Dec-2023
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.22 - Arthroplasty
Current Stage
Ref Project

Relations

Replaces
ASTM F2068-09 - Standard Specification for Femoral Prostheses—Metallic Implants
Effective Date
15-Mar-2015
Refers
ASTM F2996-20 - Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
Effective Date
15-Jun-2020
Refers
ASTM F1537-20 - Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
Effective Date
01-Mar-2020
Refers
ASTM F620-20 - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
Effective Date
01-Feb-2020
Refers
ASTM F138-19 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Effective Date
01-Dec-2019
Refers
ASTM F799-19 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
Effective Date
15-May-2019
Refers
ASTM F1580-18 - Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
Effective Date
15-Nov-2018
Refers
ASTM F983-86(2018) - Standard Practice for Permanent Marking of Orthopaedic Implant Components
Effective Date
01-Feb-2018
Refers
ASTM F1044-05(2017)e1 - Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
Effective Date
01-Dec-2017
Refers
ASTM F1978-17 - Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
Effective Date
01-Sep-2017
Refers
ASTM F67-13(2017) - Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
Effective Date
01-Mar-2017
Refers
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Effective Date
01-Apr-2016
Refers
ASTM F620-11(2015) - Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
Effective Date
01-Dec-2015
Refers
ASTM F1854-15 - Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
Effective Date
15-Mar-2015
Refers
ASTM F138-13a - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Effective Date
01-Oct-2013

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ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic ImplantsASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants
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REDLINE ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic ImplantsREDLINE ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants
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ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
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ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
English language
6 pages
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Standards Content (Sample)

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.
Designation: F2068 −15
Standard Specification for
1
Femoral Prostheses—Metallic Implants
This standard is issued under the fixed designation F2068; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This specification covers metallic stemmed femoral 2.1 ASTM Standards:
prostheses used to replace the natural hip joint by means of F67 Specification for Unalloyed Titanium, for Surgical Im-
hemi-arthroplasty or total hip surgical procedures. Prostheses plant Applications (UNS R50250, UNS R50400, UNS
for hemi-arthroplasty are intended to articulate with the natural R50550, UNS R50700)
acetabulum of the patient. Prostheses for total hip replacement F75 Specification for Cobalt-28 Chromium-6 Molybdenum
are intended to articulate with prosthetic acetabular cups. Alloy Castings and Casting Alloy for Surgical Implants
Prostheses may have integral femoral heads or cones designed (UNS R30075)
to accept modular heads. F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
1.2 Modular femoral heads, which may be affixed to cones
F90 Specification for Wrought Cobalt-20Chromium-
on implants covered by this specification, are not covered by
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
this specification. The mechanical strength, corrosion
tions (UNS R30605)
resistance, and biocompatibility of the head portions of one-
F136 Specification for Wrought Titanium-6Aluminum-
piece integral implants are covered by this specification.
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.3 Femoral prostheses included within the scope of this
Implant Applications (UNS R56401)
specification are intended for fixation by press fit between the
F138 Specification for Wrought 18Chromium-14Nickel-
prosthesis and host bone, the use of bone cement, or through
2.5Molybdenum Stainless Steel Bar andWire for Surgical
the ingrowth of host bone into a porous coating.
Implants (UNS S31673)
F562 Specification for Wrought 35Cobalt-35Nickel-
1.4 Custom femoral prostheses, designed explicitly for a
20Chromium-10Molybdenum Alloy for Surgical Implant
single patient, are not covered within the scope of this
specification. Applications (UNS R30035)
F620 Specification for TitaniumAlloy Forgings for Surgical
1.5 Prostheses incorporating nonmetallic (for example,
Implants in the Alpha Plus Beta Condition
polymer composite) implants, nonporous bioactive ceramic
F746 Test Method for Pitting or Crevice Corrosion of
coatings,orporous-polymercoatings,arespecificallyexcluded
Metallic Surgical Implant Materials
from the scope of this specification.
F748 PracticeforSelectingGenericBiologicalTestMethods
1.6 Therequirementsformodularconnectionsofmulticom-
for Materials and Devices
ponent modular femoral hip prostheses are not covered by this
F799 Specification for Cobalt-28Chromium-6Molybdenum
specification.
Alloy Forgings for Surgical Implants (UNS R31537,
R31538, R31539)
1.7 The values stated in SI units are to be regarded as
F981 Practice for Assessment of Compatibility of Biomate-
standard. No other units of measurement are included in this
rials for Surgical Implants with Respect to Effect of
standard.
Materials on Muscle and Bone
F983 Practice for Permanent Marking of Orthopaedic Im-
plant Components
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.22 on Arthroplasty. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved March 15, 2015. Published May 2015. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2000. Last previous edition approved in 2009 as F2068 – 09. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2068-15. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2068 − 15
F1044 Test Method for Shear Testing of Calcium Phosphate HipJointProstheses—Part4:DeterminationofEndurance
Coatings and Metallic Coatings Properties and Performance of Stemmed Femoral Com-
F1108 Specification for Titanium-6Aluminum-4Vanadium ponents
Alloy Castings for Surgical Implants (UNS R56406) ISO 7206-7 Implants for Surgery—Partial and Total Hip
F1147 Test Method for Tensio
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2068 − 09 F2068 − 15
Standard Specification for
1
Femoral Prostheses—Metallic Implants
This standard is issued under the fixed designation F2068; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of
hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural
acetabulum of the patient. Prostheses for total hip replacement are intended to articulate with prosthetic acetabular cups. Prostheses
may have integral femoral heads or cones designed to accept modular heads.
1.2 Modular femoral heads, which may be affixed to cones on implants covered by this specification, are not covered by this
specification. The mechanical strength, corrosion resistance, and biocompatibility of the head portions of one-piece integral
implants are covered by this specification.
1.3 Femoral prostheses included within the scope of this specification are intended for fixation by press fit between the
prosthesis and host bone, the use of bone cement, or through the ingrowth of host bone into a porous coating.
1.4 Custom femoral prostheses, designed explicitly for a single patient, are not covered within the scope of this specification.
1.5 Prostheses incorporating nonmetallic (for example, polymer composite) implants, nonporous bioactive ceramic coatings, or
porous-polymer coatings, are specifically excluded from the scope of this specification.
1.6 The requirements for modular connections of multicomponent modular femoral hip prostheses are not covered by this
specification.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
2. Referenced Documents
2
2.1 ASTM Standards:
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant
3
Applications (UNS R30563) (Withdrawn 2005)
F620 Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved Sept. 1, 2009March 15, 2015. Published September 2009May 2015. Originally approved in 2000. Last previous edition approved in 20032009
as F2068 – 03.F2068 – 09. DOI: 10.1520/F2068-09.10.1520/F2068-15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2068 − 15
F745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical
3
Implant Applications (Withdrawn 2012)
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical I
...

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2068 − 15
Standard Specification for
1
Femoral Prostheses—Metallic Implants
This standard is issued under the fixed designation F2068; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This specification covers metallic stemmed femoral 2.1 ASTM Standards:
prostheses used to replace the natural hip joint by means of F67 Specification for Unalloyed Titanium, for Surgical Im-
hemi-arthroplasty or total hip surgical procedures. Prostheses plant Applications (UNS R50250, UNS R50400, UNS
for hemi-arthroplasty are intended to articulate with the natural R50550, UNS R50700)
acetabulum of the patient. Prostheses for total hip replacement F75 Specification for Cobalt-28 Chromium-6 Molybdenum
are intended to articulate with prosthetic acetabular cups. Alloy Castings and Casting Alloy for Surgical Implants
Prostheses may have integral femoral heads or cones designed (UNS R30075)
to accept modular heads. F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
1.2 Modular femoral heads, which may be affixed to cones
F90 Specification for Wrought Cobalt-20Chromium-
on implants covered by this specification, are not covered by
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
this specification. The mechanical strength, corrosion
tions (UNS R30605)
resistance, and biocompatibility of the head portions of one-
F136 Specification for Wrought Titanium-6Aluminum-
piece integral implants are covered by this specification.
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
1.3 Femoral prostheses included within the scope of this
Implant Applications (UNS R56401)
specification are intended for fixation by press fit between the
F138 Specification for Wrought 18Chromium-14Nickel-
prosthesis and host bone, the use of bone cement, or through
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
the ingrowth of host bone into a porous coating.
Implants (UNS S31673)
1.4 Custom femoral prostheses, designed explicitly for a F562 Specification for Wrought 35Cobalt-35Nickel-
single patient, are not covered within the scope of this 20Chromium-10Molybdenum Alloy for Surgical Implant
Applications (UNS R30035)
specification.
F620 Specification for Titanium Alloy Forgings for Surgical
1.5 Prostheses incorporating nonmetallic (for example,
Implants in the Alpha Plus Beta Condition
polymer composite) implants, nonporous bioactive ceramic
F746 Test Method for Pitting or Crevice Corrosion of
coatings, or porous-polymer coatings, are specifically excluded
Metallic Surgical Implant Materials
from the scope of this specification.
F748 Practice for Selecting Generic Biological Test Methods
1.6 The requirements for modular connections of multicom-
for Materials and Devices
ponent modular femoral hip prostheses are not covered by this
F799 Specification for Cobalt-28Chromium-6Molybdenum
specification.
Alloy Forgings for Surgical Implants (UNS R31537,
R31538, R31539)
1.7 The values stated in SI units are to be regarded as
F981 Practice for Assessment of Compatibility of Biomate-
standard. No other units of measurement are included in this
rials for Surgical Implants with Respect to Effect of
standard.
Materials on Muscle and Bone
F983 Practice for Permanent Marking of Orthopaedic Im-
plant Components
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.22 on Arthroplasty. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved March 15, 2015. Published May 2015. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2000. Last previous edition approved in 2009 as F2068 – 09. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2068-15. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2068 − 15
F1044 Test Method for Shear Testing of Calcium Phosphate Hip Joint Prostheses—Part 4: Determination of Endurance
Coatings and Metallic Coatings Properties and Performance of Stemmed Femoral Com-
F1108 Specification for Titanium-6Aluminum-4Vanadium ponents
Alloy Castings for Surgical Implants (UNS R56406) ISO 7206-7 Implants for Surgery—Partial and Total Hip
F1147 Test Method for Tension Testing of Calcium Phos- Join Prostheses—Part 7: Endurance Performance of
phate and Metallic Coatings
...

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4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.
SCOPE
1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648, or USP polyethylene negative control.  
1.2 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this 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.

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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.

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ASTM
ASTM F3495-23(Test Method)
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components

SIGNIFICANCE AND USE
5.1 These test methods are intended to determine the ultimate failure load of a ceramic femoral knee component. This information can be used for evaluation of different ceramic component designs or different ceramic materials, or for series production control.  
5.2 Although the test methodology described attempts to identify physiologically relevant intraoperative and in vivo loading conditions, the interpretation of results is limited to an in vitro comparison between ceramic femoral component designs and materials regarding their static ultimate failure load under the stated test conditions.
SCOPE
1.1 The test methods included in this standard cover two procedures for static burst testing of a ceramic femoral component used in total knee replacement (TKR). The two procedures are used to determine the static ultimate failure load of a ceramic femoral knee component. Both procedures are simulating in vivo loading conditions. One of the procedures additionally simulates intraoperative loading conditions. The standard applies to cruciate retaining (CR) femoral components which cover both the medial and lateral condyles and the patellar surface of the femur. These test methods may require modifications to accommodate other femoral component designs.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

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ASTM
ASTM F1609-23(Specification)
Standard Specification for Calcium Phosphate Coatings for Implantable Materials

ABSTRACT
This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response and laboratory characterization. This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, and applied by methods including, but not limited to, the following: mechanical capture, plasma spray deposition, dipping/sintering, electrophoretic deposition, porcelainizing, and sputtering. Substrates may include smooth, porous, textured, and other implantable topographical forms. This specification excludes organic coatings that may contain calcium and phosphate ionic species. Materials shall be tested and the individual grades shall conform to chemical requirements such as elemental analysis for calcium and phosphates, and intentional additions, trace element analysis for hydroxylapatite and beta tricalcium phosphate; crystallographic characterization such as Fourier Transform infrared spectroscopy, and environmental stability; physical characterization such as coverage of substrate, thickness, porosity, color, surface topography, and density; and mechanical characterization such as tensile bond strength, shear strength, and fatigue strength. The test specimen fabrication and contact with calcium phosphate coatings are also detailed.
SCOPE
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.  
1.2 In particulate and monolithic form, the calcium phosphate materials system has been well characterized regarding biological response (1, 2)2 and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems.  
1.3 This specification covers hydroxylapatite coatings, other calcium phosphate (for example, octacalcium calcium phosphate, amorphous calcium phosphate, dicalcium phosphate dihydrate) coatings, or a coating containing a combination of two or more calcium phosphate phases, with or without intentional minor additions of other elements or compounds (for example, fluorine, manganese, magnesium, carbonate),3 and applied by methods including, but not limited to, the following: (1) plasma spray deposition, (2) solution precipitation, (3) dipping/sintering, (4) electrophoretic deposition, and (5) sputtering.  
1.4 For a coating containing two or more calcium phosphate phases, one or more of which will be a major phase or major phases in the coating, while the other phase(s) may occur as a second or minor phases, the phase composition(s) of the coating should be determined against each corresponding crystalline phase, respectively. See X1.2.  
1.5 Substrates may include smooth, porous, textured, and other implantable topographical forms.  
1.6 This specification excludes organic coatings that may contain calcium and phosphate ionic species.  
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.

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ASTM
ASTM F3141-23(Guide)
Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
SCOPE
1.1 Motion path, load history, and loading modalities all contribute to the wear, degradation, and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and descent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning, and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions, which have the ability to cause damage and modes of failure other than normal wear (8-10).  
1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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ASTM
ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
SCOPE
1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the 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.

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ASTM
ASTM F543-23(Specification)
Standard Specification and Test Methods for Metallic Medical Bone Screws

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.

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