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 (ε) 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 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.

2. Referenced Documents

2.1 ASTM Standards:²

2.2 ISO Standards:⁴

3. Summary of Practice

3.1

4. Significance and Use

4.1

4.2

4.3

5. Test Preparation

5.1

5.2 Animal Model and Implantation Sites:

5.3 Selection of Control Materials:

6. Test Articles

6.1 Fabrication

6.2

6.3 Implantation Period

7. Procedure

7.1 Implantation

7.2 Postoperative Care:

7.3 Euthanasia and Implant Retrieval:

7.4 Gross Evaluation, Acute Test (7 days), and Subacute Test (30 days):

7.5 Histopathological Evaluation, Acute Test (7 days), and Subacute Test (14 to 30 days):

7.6 Overall Evaluation

8. Report

8.1

8.2

8.3

9. Keywords

9.1

ASTM F763 - 22

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

Current

Published:

1 Sep 2022