ASTM F763-04(2010)
(Practice)Standard Practice for Short-Term Screening of Implant Materials
Standard Practice for Short-Term Screening of Implant Materials
SIGNIFICANCE AND USE
The use of in vivo implantation techniques for characterizing the biocompatibility of materials to be utilized in various medical applications provides a unique assessment of such materials not achieved by other procedures. Physical characteristics (that is, form, density, hardness, surface finish) can influence the character of the tissue response to the test materials.
This practice is intended as a rapid screening procedure for determining the acceptability of candidate materials. It would be invoked prior to using the long-term tests described in Practice F981. It is understood that for some applications additional tests, including long-term implantation studies, may be required to assess the final suitability of the candidate materials.
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 effects of the material on animal tissue in which it is implanted. This is a rapid 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, teratogenicity, or mutagenicity of the material since other standards deal with 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 are to be regarded as standard. No other units of measurement are included in this standard.
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Standards Content (Sample)
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Designation: F763 − 04(Reapproved 2010)
Standard Practice for
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Short-Term Screening of Implant 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 F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial)Alloy for Surgical
1.1 This practice provides guidelines for short-term testing
Implant Applications (UNS R56401)
or screening of candidate materials, both porous and dense, as
F138 Specification for Wrought 18Chromium-14Nickel-
to the effects of the material on animal tissue in which it is
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
implanted. This is a rapid screening procedure for determining
Implants (UNS S31673)
acceptability of candidate materials.
F562 Specification for Wrought 35Cobalt-35Nickel-
1.2 This practice, along with other appropriate biological
20Chromium-10Molybdenum Alloy for Surgical Implant
tests (including other appropriateASTM tests) may be used in
Applications (UNS R30035)
the biocompatibility assessment of the candidate materials for
F563 Specification for Wrought Cobalt-20Nickel-
use in the fabrication of devices for clinical application.
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
for Surgical Implant Applications (UNS R30563) (With-
1.3 This experimental protocol is not designed to provide a
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comprehensive assessment of the systemic toxicity, drawn 2005)
F603 Specification for High-Purity Dense Aluminum Oxide
carcinogenicity, teratogenicity, or mutagenicity of the material
since other standards deal with these issues. for Medical Application
F648 Specification for Ultra-High-Molecular-Weight Poly-
1.4 This practice is one of several developed for the
ethylene Powder and Fabricated Form for Surgical Im-
assessment of the biocompatibility of materials. Practice F748
plants
provides guidance for the selection of appropriate methods for
F748 PracticeforSelectingGenericBiologicalTestMethods
testing materials for a specific application.
for Materials and Devices
1.5 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
2. Referenced Documents 3. Terminology
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2.1 ASTM Standards: 3.1 Definitions of Terms Specific to This Standard:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum 3.1.1 biocompatibility assay—a comparison of the tissue
Alloy Castings and Casting Alloy for Surgical Implants response produced through the close association of the im-
(UNS R30075) planted candidate material to its implant site within the host
F86 Practice for Surface Preparation and Marking of Metal- animal to that tissue response recognized and established as
lic Surgical Implants suitable with control materials.
F90 Specification for Wrought Cobalt-20Chromium-
4. Summary of Practice
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
tions (UNS R30605)
4.1 Under aseptic conditions, test specimens of the candi-
date material and of controls are inserted into a muscle or
group of muscles of the animal host.After a period of time the
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animals are euthanized. The tissue reactions to implants of the
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
candidate material during the acute to subchronic time period
F04.16 on Biocompatibility Test Methods.
of healing are compared with tissue reactions to control
Current edition approved June 1, 2010. Published November 2010. Originally
materials which have a well characterized response. The
approved in 1982. Last previous edition approved in 2004 as F763 – 04. DOI:
implants are not subject to major stress while in situ.
10.1520/F0763-04R10.
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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
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Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
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F763 − 04 (2010)
5. Significance and Use application in humans. Dense metal implants should be fin-
ished in accordance with Practice F86. The size, shape, and
5.1 The use of in vivo implantation techniques for charac-
surface of te
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