ASTM F981-04(2016)

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone

SIGNIFICANCE AND USE
4.1 This practice covers a test protocol for comparing the local tissue response evoked by biomaterials, from which medical implantable devices might ultimately be fabricated, with the local tissue response elicited by control materials currently accepted for the fabrication of surgical devices. The materials may include metals (and metal alloys), dense aluminum oxide, and polyethylene that are standardized on the basis of acceptable, well recognized, long-term response. The controls consistently produce cellular reaction and wound healing to a degree that has been found to be acceptable to the host.
SCOPE
1.1 This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. 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 these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. It is recommended that short-term assays, according to Practice F763, first be performed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys in Specifications 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.  
1.3 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.

General Information

• Status: Historical
• Publication Date: 31-Mar-2016
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

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: F981 − 04 (Reapproved 2016)
Standard Practice for
Assessment of Compatibility of Biomaterials for Surgical
Implants with Respect to Effect of Materials on Muscle and
1
Insertion into Bone
ThisstandardisissuedunderthefixeddesignationF981;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 Thispracticeprovidesaseriesofexperimentalprotocols
F67 Specification for Unalloyed Titanium, for Surgical Im-
for biological assays of tissue reaction to nonabsorbable
plant Applications (UNS R50250, UNS R50400, UNS
biomaterials for surgical implants. It assesses the effects of the
R50550, UNS R50700)
material on animal tissue in which it is implanted. The
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
experimental protocol is not designed to provide a comprehen-
Alloy Castings and Casting Alloy for Surgical Implants
sive assessment of the systemic toxicity, immune response,
(UNS R30075)
carcinogenicity, teratogenicity, or mutagenicity of the material
F86 Practice for Surface Preparation and Marking of Metal-
since other standards deal with these issues. It applies only to
lic Surgical Implants
materials with projected applications in humans where the
F90 Specification for Wrought Cobalt-20Chromium-
materials will reside in bone or soft tissue in excess of 30 days
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
and will remain unabsorbed. It is recommended that short-term
tions (UNS R30605)
assays, according to Practice F763, first be performed. Appli-
F136 Specification for Wrought Titanium-6Aluminum-
cations in other organ systems or tissues may be inappropriate
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
and are therefore excluded. Control materials will consist of
Implant Applications (UNS R56401)
any one of the metal alloys in Specifications F67, F75, F90,
F138 Specification for Wrought 18Chromium-14Nickel-
F136, F138,or F562, high purity dense aluminum oxide as
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
described in Specification F603, ultra high molecular weight
Implants (UNS S31673)
polyethylene as stated in Specification F648 or USP polyeth-
F361 Practice for Assessment of Compatibility of Metallic
ylene negative control.
Materials for Surgical Implants with Respect to Effect of
3
1.2 This practice is a combination of Practice F361 and
Materials on Tissue (Withdrawn 1987)
Practice F469. The purpose, basic procedure, and method of
F469 Practice for Assessment of Compatibility of Nonpo-
evaluation of each type of material are similar; therefore, they
rous Polymeric Materials for Surgical Implants with
have been combined.
Regard to Effect of Materials on Tissue (Withdrawn
3
1986)
1.3 The values stated in SI units are to be regarded as
F562 Specification for Wrought 35Cobalt-35Nickel-
standard. No other units of measurement are included in this
20Chromium-10Molybdenum Alloy for Surgical Implant
standard.
Applications (UNS R30035)
1.4 This standard does not purport to address all of the
F603 Specification for High-Purity Dense Aluminum Oxide
safety concerns, if any, associated with its use. It is the
for Medical Application
responsibility of the user of this standard to establish appro-
F648 Specification for Ultra-High-Molecular-Weight Poly-
priate safety and health practices and determine the applica-
ethylene Powder and Fabricated Form for Surgical Im-
bility of regulatory limitations prior to use.
plants
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland 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 [e-mail]. 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 April 1, 2016. Published June 2016. Originally the ASTM website.
3
approvedin1986.Lastpreviouseditionapprovedin2010asF981 – 04(2010).DOI: The last approved version of this historical standard is referenced on
10.1520/F0981-04R16. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F981 − 04 (2016)
F763 Practice for Short-Term Screening of Implant Materi- Specifications F67, F75, F90, F138,or F562, ceramic 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: F981 − 04 (Reapproved 2016)
Standard Practice for
Assessment of Compatibility of Biomaterials for Surgical
Implants with Respect to Effect of Materials on Muscle and
1
Insertion into Bone
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 a series of experimental protocols
F67 Specification for Unalloyed Titanium, for Surgical Im-
for biological assays of tissue reaction to nonabsorbable
plant Applications (UNS R50250, UNS R50400, UNS
biomaterials for surgical implants. It assesses the effects of the
R50550, UNS R50700)
material on animal tissue in which it is implanted. The
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
experimental protocol is not designed to provide a comprehen-
Alloy Castings and Casting Alloy for Surgical Implants
sive assessment of the systemic toxicity, immune response,
(UNS R30075)
carcinogenicity, teratogenicity, or mutagenicity of the material
F86 Practice for Surface Preparation and Marking of Metal-
since other standards deal with these issues. It applies only to
lic Surgical Implants
materials with projected applications in humans where the
F90 Specification for Wrought Cobalt-20Chromium-
materials will reside in bone or soft tissue in excess of 30 days
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
and will remain unabsorbed. It is recommended that short-term
tions (UNS R30605)
assays, according to Practice F763, first be performed. Appli-
F136 Specification for Wrought Titanium-6Aluminum-
cations in other organ systems or tissues may be inappropriate
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
and are therefore excluded. Control materials will consist of
Implant Applications (UNS R56401)
any one of the metal alloys in Specifications F67, F75, F90,
F138 Specification for Wrought 18Chromium-14Nickel-
F136, F138, or F562, high purity dense aluminum oxide as
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
described in Specification F603, ultra high molecular weight
Implants (UNS S31673)
polyethylene as stated in Specification F648 or USP polyeth-
F361 Practice for Assessment of Compatibility of Metallic
ylene negative control.
Materials for Surgical Implants with Respect to Effect of
3
1.2 This practice is a combination of Practice F361 and
Materials on Tissue (Withdrawn 1987)
Practice F469. The purpose, basic procedure, and method of
F469 Practice for Assessment of Compatibility of Nonpo-
evaluation of each type of material are similar; therefore, they
rous Polymeric Materials for Surgical Implants with
have been combined.
Regard to Effect of Materials on Tissue (Withdrawn
3
1986)
1.3 The values stated in SI units are to be regarded as
F562 Specification for Wrought 35Cobalt-35Nickel-
standard. No other units of measurement are included in this
20Chromium-10Molybdenum Alloy for Surgical Implant
standard.
Applications (UNS R30035)
1.4 This standard does not purport to address all of the
F603 Specification for High-Purity Dense Aluminum Oxide
safety concerns, if any, associated with its use. It is the
for Medical Application
responsibility of the user of this standard to establish appro-
F648 Specification for Ultra-High-Molecular-Weight Poly-
priate safety and health practices and determine the applica-
ethylene Powder and Fabricated Form for Surgical Im-
bility of regulatory limitations prior to use.
plants
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 [e-mail]. 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 April 1, 2016. Published June 2016. Originally the ASTM website.
3
approved in 1986. Last previous edition approved in 2010 as F981 – 04(2010). DOI: The last approved version of this historical standard is referenced on
10.1520/F0981-04R16. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F981 − 04 (2016)
F763 Practice for Short-Term Screening of Implant Materi- Specifications F67, F75, F90, F138, or F562, ceramic in
als Specification F603, or polymers such as in Specification F648
polyethylene or U
...

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 2010) F981 − 04 (Reapproved 2016)
Standard Practice for
Assessment of Compatibility of Biomaterials for Surgical
Implants with Respect to Effect of Materials on Muscle and
1
Insertion into Bone
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 implants. It assesses the effects of the material on animal tissue in which it is implanted. 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 these issues. It applies only to materials with
projected applications in humans where the materials will reside in bone or soft tissue in excess of 30 days and will remain
unabsorbed. It is recommended that short-term assays, according to Practice F763, first be performed. Applications in other organ
systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys
in Specifications 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.
1.3 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.
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 Surgical Implants with Respect to Effect of Materials
3
on Tissue (Withdrawn 1987)
F469 Practice for Assessment of Compatibility of Nonporous Polymeric Materials for Surgical Implants with Regard to Effect
3
of Materials on Tissue (Withdrawn 1986)
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 June 1, 2010April 1, 2016. Published September 2010June 2016. Originally approved in 1986. Last previous edition approved in 20042010 as
F981 – 04.F981 – 04(2010). DOI: 10.1520/F0981-04R10. 10.1520/F0981-04R16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
The last approved version of this historical standard is referenced on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F981 − 04 (2016)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F603 Specification for High-Purity Dense Aluminum Oxide for
...