This document specifies the quality control requirements, testing indexes and testing methods for recombinant collagen protein. This document applies to the quality control of recombinant collagen protein used as a raw material for medical devices. NOTE. given the current state of technological development, the recombinant collagen protein in this document primarily refers to products based on the collagen protein gene recombination of human beings. Recombinant collagen protein or collagen-like products based on non-human collagen protein genes can refer to this document, but quality control needs to be implemented in accordance with specific product characteristics and production processes.
Basic Data
Standard ID
YY/T 1849-2022 (YY/T1849-2022)
Description (Translated English)
Recombinant collagen protein
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
