ASTM F763-22
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials

Standard No.

ASTM F763-22

Release Date

2022

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F763-22

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.

ASTM F763-22 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 F763-22 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