If you have difficulty in submitting comments on draft standards you can use a commenting template and email it to admin.start@bsigroup.com. The commenting template can be found here.
Standards Development
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.
A large number of bio-derived peripheral nerve repair implants have been developed and clinically applied as an in-situ tissue engineering way to repair peripheral nerve defects, meanwhile preventing local adhesion at the injury sites or the formation of neuroma. Diverse bio-derived peripheral nerve repair implants are now commercially available, as examples are: Avance Nerve Graft, Axoguard Nerve Connector, Axoguard Nerve Protecto and Axoguard Nerve Cap (AxoGen, Alachua, FL, USA), NeuraWrap and NeuraGen (Integra Lifesciences, Plainsboro, NJ, USA), NeuroMatrix, NeuroFlex and NeuroMend (Collagen Matrix,Oakland, NJ, USA), GEM Neurotube (Synovis, Birmingham, AL, USA), Shen Qiao (ZDMED, Guangzhou Zhongda Medical Equipment Co., Guangdong, China), NervElite (Tech Thinkful, Beijing, China), NRep (Junxiu, Shandong, China), and Peripheral nerve graft (Eton, Jiangsu, China). These bio-derived peripheral nerve repair implants help to overcome bottlenecks in problems of nerve tissue hardly regeneration. And these implants share a set of common requirements about components, structure, safety, as well as physical, chemical, or biological properties. Several international documents are available to characterize and assessment the production of tissue engineering medical devices, “General requirements of tissue-engineered medical products” (ISO/TS 21560), American Society for Testing and Materials has also published tissue engineering medical device product–related standardized documents which focused on raw materials (or starting materials), such as standard guide for raw materials (ASTM F2027-16), chitosan salts (F2103-18), polymeric scaffolds (F2450-18), and Type I collagen (ASTM F2212-20 and ASTM F3089). However, there are no standards or guidelines for the quality evaluation of nerve repair and regenerative implantation products, which limits their wide clinical application. Therefore, it is necessary to develop an international standard of the general requirements of bio-derived peripheral nerve repair implants, contributes to supporting research and application.
You are now following this standard. Weekly digest emails will be sent to update you on the following activities:
You can manage your follow preferences from your Account. Please check your mailbox junk folder if you don't receive the weekly email.
You have successfully unsubscribed from weekly updates for this standard.
Comment on proposal
Required form fields are indicated by an asterisk (*) character.