Standardization News

ASTM International’s committee on medical and surgical materials and devices (F04) is developing a standardized guide for pre-clinical testing considerations for materials used to regenerate muscle.

This guide (WK64460) will provide scientifically-based information concerning repairing and regenerating muscle when defects are caused by trauma, such as blast injuries.

“These types of injuries can range widely, from relatively small to those that require entire muscles to be removed,” says ASTM International member Barbara Boyan, dean of the engineering college at Virginia Commonwealth University.

The guide will present the strengths and weaknesses of animal models used to demonstrate effectiveness.

Boyan noted that by creating this guide, the committee hopes that scientists in industry and academia will have a better structure to inform their approach to develop products for muscle regeneration. Labs and manufacturers, she says, could use the standard as a roadmap to determine approaches with higher success. Regulatory bodies and consumers could also find this guide useful in determining effectiveness of materials.

ASTM welcomes participation in the development of its standards. Become a member at www.astm.org/JOIN. The next meeting of ASTM International committee on medical and surgical materials and devices is November 6-9 at the Washington Hilton; Washington, DC, USA.