This document specifies the requirements and methods for characterization and evaluation of recombinant collagen as starting material for implants, including requirements for quality assessment and quality control, test items and corresponding methods, packaging and storage.
This document is intended to be used for the quality assessment and quality control of recombinant collagen.
This document is not applied for recombinant collagen which will be used as medicine for the treatment of collagen related genetic diseases, such like recombinant collagen VII for the treatment of Epidermolysis bullosa.
Registration number (WIID)
94085
Scope
This document specifies the requirements and methods for characterization and evaluation of recombinant collagen as starting material for implants, including requirements for quality assessment and quality control, test items and corresponding methods, packaging and storage.
This document is intended to be used for the quality assessment and quality control of recombinant collagen.
This document is not applied for recombinant collagen which will be used as medicine for the treatment of collagen related genetic diseases, such like recombinant collagen VII for the treatment of Epidermolysis bullosa.
