ISO/PWI 25405.2

Tissue-engineered medical products-General requirement of bio-derived scaffold material for peripheral nerve repair

Scope

This document specifies the general requirements for bio-derived peripheral nerve repair scaffold material, including performance and corresponding test methods, safety of raw material, biological evaluations, label, packing, shipping, and storage.
This document is intended to be used for quality assessments of bio-derived peripheral nerve repair scaffold material as surgical implants.
This document is not applicable for peripheral nerve implants of non-biological origins.