This document specifies the requirements for characterization and evaluation, including test items and corresponding test methods, marking, packaging, transportation, and storage requirements of silk fibroin as starting material for tissue engineered medical products (TEMPs) or other surgical implants.
This document is intended to be used for the quality assessment and quality control of silk fibroin as starting material.
This document is not applied for silk fibroin obtained by genetic engineering or transgene.
Registration number (WIID)
90236
Scope
This document specifies the requirements for characterization and evaluation, including test items and corresponding test methods, marking, packaging, transportation, and storage requirements of silk fibroin as starting material for tissue engineered medical products (TEMPs) or other surgical implants.
This document is intended to be used for the quality assessment and quality control of silk fibroin as starting material.
This document is not applied for silk fibroin obtained by genetic engineering or transgene.
