DZ/T 0101.12-1994
Active
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
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
Publisher:
国家药品监督管理局
Technical Committee:
全国外科植入物和矫形器械标准化技术委员会组织工程医疗器械产品分技术委员会 (SAC/TC 110/SC 3)
Pages:
48 pages
Scope
本文件规定了组织提取胶原蛋白的工艺控制、检测指标、生物学评价等要求,描述了相应的检测方法。
本文件适用于组织工程医疗器械用胶原蛋白的表征和质量评价。
注1:本文件所列出的检测指标和要求主要基于纯化的Ⅰ型胶原蛋白考虑,并不一定适用于全部胶原类型。
注2:其他医疗器械用胶原蛋白的表征和质量评价参考本文件。
注3:由培养细胞提取的胶原蛋白参考本文件进行胶原蛋白的表征,宜基于风险分析进行质量控制。
Development Information
Drafting Units:
中国食品药品检定研究院、中国科学院过程工程研究所、四川省药品检验研究院(四川省医疗器械检测中心)、广州创尔生物技术股份有限公司、河北考力森生物科技有限公司、无锡贝迪生物工程股份有限公司、中国科学院遗传与发育生物学研究所、中国科学院理化技术研究所、中国医学科学院生物医学工程研究所、四川大学轻工科学与工程学院、浙江珂瑞康生物医疗科技有限公司
Drafting Persons:
陈亮、柯林楠、张贵锋、刘兴兰、李国英、邵明非、赵燕南、张其清、叶春婷、程咏梅、刘国保、徐松成、付步芳、黄元礼、高建萍、邢芳毓、王晓亮、兰婉玲、罗思施、李奕恒、陆金婷、陈丽媛、戴建武、郭燕川、徐丽明
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
JJG 204-1980
Active
JJG 204-1980 Meteorological Ventilation Psychrometer
SC 53-1980
Active
SC 53-1980 Transfer blade hydraulic steering gear repair quality standard
DZ 4-1981
Replaced
DZ 4-1981
SC 69-1982
Active
SC 69-1982 ZSS-12 Flash-type seawater desalination production device technical specifications
SC 72-1982
Active