YY/T 1985-2025 Tissue engineered medical devices—Collagen
YY/T 1985-2025 Tissue engineered medical devices—Collagen
Basic Information
Scope
This document specifies the requirements for process control, testing indicators, and biological evaluation of collagen extracted from tissues, and describes the corresponding testing methods.
This document is applicable to the characterization and quality evaluation of collagen used in tissue engineering medical devices.
Note 1: The testing indicators and requirements listed in this document are primarily based on purified Type I collagen and may not necessarily apply to all collagen types.
Note 2: For the characterization and quality evaluation of collagen used in other medical devices, please refer to this document.
Note 3: For collagen extracted from cultured cells, the characterization of collagen should be conducted in accordance with this document, and quality control should be based on risk analysis.