ASTM F763-04(2016)
Standard Practice for Short-Term Screening of Implant Materials
- Standard No.
- ASTM F763-04(2016)
- Release Date
- 2004
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F763-22
- Latest
- ASTM F763-22
- Scope
5.1 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.
5.2 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.
5.3 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.
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.
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 and health practices and determine the applicability of regulatory limitations prior to use.
ASTM F763-04(2016) Referenced Document
- ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
- ASTM F138 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- ASTM F562 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
- ASTM F563 Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)
- ASTM F603 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application
- ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
- ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
- ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
- ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
- ASTM F90 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
- ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
ASTM F763-04(2016) history
- 2022 ASTM F763-22 Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
- 2004 ASTM F763-04(2016) Standard Practice for Short-Term Screening of Implant Materials
- 2004 ASTM F763-04(2010) Standard Practice for Short-Term Screening of Implant Materials
- 2004 ASTM F763-04 Standard Practice for Short-Term Screening of Implant Materials
- 2003 ASTM F763-99(2003) Standard Practice for Short-Term Screening of Implant Materials
- 1999 ASTM F763-99 Standard Practice for Short-Term Screening of Implant Materials
