ASTM F3645-25
Standard Guide for Pre-clinical Testing of Materials Used to Regenerate Muscle Following Volumetric Muscle Loss Injuries
Standard number: | ASTM F3645-25 |
Released: | 01.04.2025 |
Status: | Active |
Pages: | 6 |
Section: | 13.02 |
Keywords: | muscle injury; muscle function; skeletal muscle; volumetric muscle loss; |
1.1 This guide covers general evaluation guidelines for assessment of skeletal muscle and measures that inform skeletal muscle function in animal models of injury, in particular volumetric muscle loss (VML) injury.
1.2 Guidelines include a description and rationale of various animal models utilizing a range of species such as mice, rats, dogs, sheep, and pigs. Outcome measures based on the functional capacity of skeletal muscle, proportional measures, or on histologic and biochemical analyses are briefly described and referenced. The user should refer to specific test methods for additional detail.
1.3 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of product(s). ASTM standards for these steps are available in Section 2.
1.4 This guide is not intended to identify a standard of functional recovery.
1.5 The values stated in SI units are to be regarded as the 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.