YY/T 1985-2025Tissue engineered medical devices - Collagen (English PDF)

1 Scope

This document specifies the requirements for process control, detection indicators, and biological evaluation of collagen extracted from tissues, and describes the corresponding detection methods.

method.

This document applies to the characterization and quality evaluation of collagen for tissue-engineered medical devices.

Note 1.The detection indicators and requirements listed in this document are mainly based on purified type I collagen and may not be applicable to all collagen types.

Note 2.This document provides reference for the characterization and quality evaluation of collagen for other medical devices.

Note 3.Collagen extracted from cultured cells should be characterized in accordance with this document, and quality control should be based on risk analysis.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.

For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.

This document.

GB 5009.6 National Food Safety Standard - Determination of Fat in Food

GB/T 6682 Specifications and test methods for water used in analytical laboratories

GB/T 16886.1 Biological evaluation of medical devices – Part 1.Evaluation and testing in the risk management process

GB/T 16886.10 Biological evaluation of medical devices – Part 10.Irritation and skin sensitization tests

GB/T 16886.20 Biological evaluation of medical devices - Part 20.Principles and methods for immunotoxicological testing of medical devices

GB/T 44353.1 Animal-derived medical devices – Part 1.Risk management applications

GB/T 44353.2 Animal-derived medical devices – Part 2.Control of source, collection and disposal

YY/T 0771.3 Animal-derived medical devices – Part 3.Removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors confirm

YY/T 0771.4 Animal-derived medical devices – Part 4.Removal and/or inactivation of factors contributing to transmissible spongiform encephalopathy (TSE) and their effects

Principles of process validation analysis

YY/T 1511-2017 Collagen Sponge

YY/T 1805.2 Collagen for Tissue Engineering Medical Devices - Part 2.Determination of Molecular Weight of Type I Collagen (XII)

Sodium alkyl sulfate polyacrylamide gel electrophoresis

YY/T 1805.3 Collagen in Tissue-Engineered Medical Devices - Part 3.Collagen Content Based on Characteristic Peptide Determination

Quantitative detection liquid chromatography-mass spectrometry

YY/T 1849-2022 Recombinant Collagen

YY/T 1955 Terminology for Collagen in Tissue-Enhanced Medical Devices

Pharmacopoeia of the People's Republic of China

3 Terms and Definitions

The terms and definitions defined in YY/T 1955 and the following terms and definitions apply to this document.