ASTM F981-23
(Practice)Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
SIGNIFICANCE AND USE
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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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: F981 − 23
Standard Practice for
Assessment of Muscle and Bone Tissue Responses to
1
Long-Term Implantable Materials Used in Medical Devices
This standard is issued under the fixed designation F981; 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
2.1 ASTM Standards:
1.1 This practice provides guidelines for biological assess-
F67 Specification for Unalloyed Titanium, for Surgical Im-
ment of tissue responses to nonabsorbable for medical device
plant Applications (UNS R50250, UNS R50400, UNS
implants. It assesses the effects of the material that is implanted
R50550, UNS R50700)
intramuscularly or intraosseously. The experimental protocol is
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
not designed to provide a comprehensive assessment of the
Alloy Castings and Casting Alloy for Surgical Implants
systemic toxicity, immune response, carcinogenicity, or muta-
(UNS R30075)
genicity of the material since other standards address these
F86 Practice for Surface Preparation and Marking of Metal-
issues. It applies only to materials with projected applications
lic Surgical Implants
in humans where the materials will reside in bone or skeletal
F90 Specification for Wrought Cobalt-20Chromium-
muscle tissue in excess of 30 days. Applications in other organ
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
systems or tissues may be inappropriate and are therefore
tions (UNS R30605)
excluded. Control materials are well recognized with a well-
F136 Specification for Wrought Titanium-6Aluminum-
characterized long-term response and can include metals and
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
any one of the metal alloys in Specification F67, F75, F90,
Implant Applications (UNS R56401)
F136, F138, or F562, high purity dense aluminum oxide as
F138 Specification for Wrought 18Chromium-14Nickel-
described in Specification F603, ultra high molecular weight
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
polyethylene as stated in Specification F648, or USP polyeth-
Implants (UNS S31673)
ylene negative control.
F562 Specification for Wrought 35Cobalt-35Nickel-
20Chromium-10Molybdenum Alloy for Surgical Implant
1.2 The values stated in SI units, including units officially
Applications (UNS R30035)
accepted for use with SI, are to be regarded as standard. No
F603 Specification for High-Purity Dense Aluminum Oxide
other systems of measurement are included in this standard.
for Medical Application
1.3 This standard does not purport to address all of the
F648 Specification for Ultra-High-Molecular-Weight Poly-
safety concerns, if any, associated with its use. It is the
ethylene Powder and Fabricated Form for Surgical Im-
responsibility of the user of this standard to establish appro-
plants
priate safety, health, and environmental practices and deter-
F763 Practice for Short-Term Intramuscular Screening of
mine the applicability of regulatory limitations prior to use. Implantable Medical Device Materials
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2.2 ISO Standard:
1.4 This international standard was developed in accor-
ISO 10993-6 Biological Evaluation of Medical Devices—
dance with internationally recognized principles on standard-
Part 6: Tests for Local Effects After Implantation
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
3. Summary of Practice
mendations issued by the World Trade Organization Technical
3.1 This practice describes the preparation of implants, the
Barriers to Trade (TBT) Committee.
number of implants and animal models, test sites, assessment
1 2
This practice is under the jurisdiction of ASTM Committee F04 on Medical and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.16 on Biocompatibility Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Sept. 1, 2023. Published September 2023. Originally the ASTM website.
3
approved in 1986. Last previous edition approved in 2016 as F981 – 04 (2016). Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
DOI: 10.1520/F0981-23. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700,
...
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: F981 − 04 (Reapproved 2016) F981 − 23
Standard Practice for
Assessment of Compatibility of Biomaterials for Surgical
Implants with Respect to Effect of Materials on Muscle and
Insertion into BoneMuscle and Bone Tissue Responses to
1
Long-Term Implantable Materials Used in Medical Devices
This standard is issued under the fixed designation F981; 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 practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials
for surgical guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the
effects of the material on animal tissue in which it is implanted. that is implanted intramuscularly or intraosseously. The
experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response,
carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with address these issues. It applies only
to materials with projected applications in humans where the materials will reside in bone or soft skeletal muscle tissue in excess
of 30 days and will remain unabsorbed. It is recommended that short-term assays, according to Practice days. F763, first be
performed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will
consist of are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys
in SpecificationsSpecification 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 This practice is a combination of Practice F361 and Practice F469. The purpose, basic procedure, and method of evaluation
of each type of material are similar; therefore, they have been combined.
1.2 The values stated in SI units units, including units officially accepted for use with SI, are to be regarded as standard. No other
unitssystems 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 and healthsafety, 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.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved April 1, 2016Sept. 1, 2023. Published June 2016September 2023. Originally approved in 1986. Last previous edition approved in 20102016 as
F981 – 04 (2016).(2010). DOI: 10.1520/F0981-04R16.10.1520/F0981-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F981 − 23
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)
F361 Practice for Assessment of Compatibility of Metallic Materials for
...
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