YY/T 1951-2024 Tissue engineering medical device products—Generic requirement for bio-derived peripheral nerve repair implant
YY/T 1951-2024 Tissue engineering medical device products—Generic requirement for bio-derived peripheral nerve repair implant
Basic Information
Scope
This document specifies the performance indicators, packaging markings, and general requirements for storage and transportation of bio-based peripheral nerve implants used in peripheral nerve repair, and describes the corresponding testing methods. This document is applicable to bio-based peripheral nerve repair implants.
This document is not applicable to non-bio-based peripheral nerve implants.
Note: Peripheral nerve repair implants mainly include: peripheral nerve implants used for repairing peripheral nerve defects of different degrees; peripheral nerve suture tubes used to provide a microenvironment for nerve growth and guide the selective growth of nerve fibers (chemotactic induction) by the small-gap suture method; and peripheral nerve implants used to prevent adhesions or the formation of neuromas at the site of peripheral nerve injury.