YY/T 1950-2024 Active

This document specifies the performance requirements for silk fibroin used in tissue engineering medical device products, as well as requirements for labeling, packaging, transportation, and storage, and describes the corresponding test methods.
This document applies to silk fibroin used in the preparation of tissue engineering medical device products.
Note 1: The silk fibroin referred to in this document is a product obtained from the cocoon layer or raw silk of natural silkworms, which is processed by degumming (i.e., natural silk fibroin fibers) or by dissolving and regenerating after degumming (i.e., regenerated silk fibroin). It does not include silk fibroin obtained through genetic engineering or transgenic methods.
Note 2: For other products such as surgical implants or dressings, refer to this document for the use of silk fibroin.