YY/T 1985-2025 Pending Industry standards-Medicine

YY/T 1985-2025 Tissue engineered medical devices—Collagen

YY/T 1985-2025 Tissue engineered medical devices—Collagen

Publish Date: 2025-09-15 Implement Date: 2026-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
Price: $ 76.00
Out of stock

Basic Information

Standard Code: YY/T 1985-2025
Standard Type: Industry standards
Standard Status: Pending
is_force_gb: no
CCS Name: Medical devices
ICS Name: -
Publish Date: 2025-09-15
Implement Date: 2026-10-01
Pages: 48 pages

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.

Development Information

Word Count: 71 Thousand words Pages: 48 pages

Referenced Standards

GB/T 5009.6-2003 Determination of fat in foods GB 5009.6-2016 The National Standard of Food Safety: Determination of Fat in Foods GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/T 44353.1-2024 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management GB/T 44353.2-2024 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling YY/T 0771.3-2009 Animal-derived medical devices - Part 3: Verification of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors YY/T 0771.4-2015 Medical devices utilizing animal tissues and their derivatives—Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes YY/T 1511-2017 Collagen sponge YY/T 1805.2-2021 Tissue engineering medical device products—Collagen protein—Part 2:Determination of molecular weight of type Ⅰ collagen—Sodium dodecyl sulfate polyacrylamide gel electrophoresis YY/T 1805.3-2022 Tissue engineering medical device products—Collagen protein—Part 3:Quantification of collagen based on marker peptide detection—Liquid chromatography-mass spectrometry YY/T 1849-2022 Recombinant collagen protein YY/T 1955-2025 Tissue engineering medical device—Collagen—Terminology 中华人民共和国药典 GB 5009.6-2025 National Standards for Food Safety - Determination of Fat in Foods

Related Standards

Contact Us