ASTM F763-22
(Practice)Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
SIGNIFICANCE AND USE
4.1 The use of in vivo implantation techniques for characterizing the biocompatibility of implantable materials to be utilized in various medical applications enables the assessment of such materials not achieved by other procedures. Physical characteristics (that is, form, density, hardness, surface finish) can influence the type and severity of the tissue response to the test materials.
4.2 This practice is intended as a short-term screening procedure for determining the acceptability of candidate materials. It may be utilized prior to using the long-term tests described in Practice F981. It is recommended that for some applications, additional tests, including long-term implantation studies, may be required to assess the final suitability of the candidate materials.
4.3 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
SCOPE
1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the local effects of the material that is implanted intramuscularly. This method may not be applicable for absorbable materials, depending on the absorption profile of the test material. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials. This is a short-term (less than 30 days) screening procedure for determining acceptability of candidate materials.
1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests), may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.
1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, or mutagenicity of the material since other standards address these issues.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 provides guidance for the selection of appropriate methods for testing materials for a specific application.
1.5 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.
1.6 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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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: F763 − 22
Standard Practice for
Short-Term Intramuscular Screening of Implantable Medical
1
Device Materials
ThisstandardisissuedunderthefixeddesignationF763;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 Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
1.1 This practice provides guidelines for short-term testing
Barriers to Trade (TBT) Committee.
or screening of candidate materials, both porous and dense, as
to the local effects of the material that is implanted intramus-
2. Referenced Documents
cularly. This method may not be applicable for absorbable
2
2.1 ASTM Standards:
materials, depending on the absorption profile of the test
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
material. The tissue reactions will be evaluated in comparison
Alloy Castings and Casting Alloy for Surgical Implants
to those evoked by control materials that are accepted as
(UNS R30075)
clinical implant materials. This is a short-term (less than 30
F86 Practice for Surface Preparation and Marking of Metal-
days) screening procedure for determining acceptability of
lic Surgical Implants
candidate materials.
F90 Specification for Wrought Cobalt-20Chromium-
1.2 This practice, along with other appropriate biological
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
tests (including other appropriateASTM tests), may be used in
tions (UNS R30605)
the biocompatibility assessment of the candidate materials for
F136 Specification for Wrought Titanium-6Aluminum-
use in the fabrication of devices for clinical application.
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.3 This experimental protocol is not designed to provide a
Implant Applications (UNS R56401)
comprehensive assessment of the systemic toxicity,
F138 Specification for Wrought 18Chromium-14Nickel-
carcinogenicity, or mutagenicity of the material since other
2.5Molybdenum Stainless Steel Bar andWire for Surgical
standards address these issues.
Implants (UNS S31673)
F562 Specification for Wrought 35Cobalt-35Nickel-
1.4 This practice is one of several developed for the
20Chromium-10Molybdenum Alloy for Surgical Implant
assessment of the biocompatibility of materials. Practice F748
Applications (UNS R30035)
provides guidance for the selection of appropriate methods for
F563 Specification for Wrought Cobalt-20Nickel-
testing materials for a specific application.
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
1.5 The values stated in SI units, including units officially
for Surgical Implant Applications (UNS R30563) (With-
accepted for use with SI, are to be regarded as standard. No
3
drawn 2005)
other systems of measurement are included in this standard.
F603 Specification for High-Purity Dense Aluminum Oxide
1.6 This standard does not purport to address all of the
for Medical Application
safety concerns, if any, associated with its use. It is the
F648 Specification for Ultra-High-Molecular-Weight Poly-
responsibility of the user of this standard to establish appro-
ethylene Powder and Fabricated Form for Surgical Im-
priate safety, health, and environmental practices and deter-
plants
mine the applicability of regulatory limitations prior to use.
F748 PracticeforSelectingGenericBiologicalTestMethods
1.7 This international standard was developed in accor-
for Materials and Devices
dance with internationally recognized principles on standard-
F981 Practice for Assessment of Compatibility of Biomate-
ization established in the Decision on Principles for the
rials for Surgical Implants with Respect to Effect of
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 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, 2022. Published September 2022. Originally the ASTM website.
3
approved in 1982. Last previous edition approved in 2016 as F763 – 04 (2016). The last approved version of this historical standard is referenced on
DOI: 10.1520/F0763-22. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
-----------------
...
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: F763 − 04 (Reapproved 2016) F763 − 22
Standard Practice for
Short-Term Intramuscular Screening of Implant Implantable
1
Medical Device Materials
This standard is issued under the fixed designation F763; 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 guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the
local effects of the material on animal tissue in which it is implanted. that is implanted intramuscularly. This method may not be
applicable for absorbable materials, depending on the absorption profile of the test material. The tissue reactions will be evaluated
in comparison to those evoked by control materials that are accepted as clinical implant materials. This is a rapid short-term (less
than 30 days) screening procedure for determining acceptability of candidate materials.
1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests)tests), may be used in the
biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.
1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity,
teratogenicity, or mutagenicity of the material since other standards deal with address these issues.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 provides
guidance for the selection of appropriate methods for testing materials for a specific application.
1.5 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.
1.6 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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
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, 2022. Published June 2016September 2022. Originally approved in 1982. Last previous edition approved in 20102016 as
F763 – 04 (2010).(2016). DOI: 10.1520/F0763-04R16.10.1520/F0763-22.
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 ----------------------
F763 − 22
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)
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F648 Specificat
...
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