This document specifies the requirements for characterization and evaluation of silk fibroin used for manufacturing surgical implants, including test items and corresponding test methods, labeling, packaging, shipping, and storage.
This document is intended to be used for the quality assessment and quality control of silk fibroin.
This document does not apply for silk fibroin obtained by genetic engineering or transgenic technologies.
Registration number (WIID)
94086
Scope
This document specifies the requirements for characterization and evaluation of silk fibroin used for manufacturing surgical implants, including test items and corresponding test methods, labeling, packaging, shipping, and storage.
This document is intended to be used for the quality assessment and quality control of silk fibroin.
This document does not apply for silk fibroin obtained by genetic engineering or transgenic technologies.
