GB/T 16886.11-1997
Replaced
YY/T 0870.3-2019
Active
Industry standards-Medicine
YY/T 0870.3-2019 Test for genotoxicity of medical devices—Part 3:TK gene mutation test using mouse lymphoma cells
YY/T 0870.3-2019 Test for genotoxicity of medical devices—Part 3:TK gene mutation test using mouse lymphoma cells
Basic Information
Standard Code:
YY/T 0870.3-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2019-07-24
Implement Date:
2020-08-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
Pages:
20 pages
Scope
YY/T 0870的本部分规定了使用小鼠淋巴瘤细胞系（L5178Y TK+/-3.7.2C）进行医疗器械/材料体外哺乳动物细胞基因突变试验的方法。本部分适用于采用微孔板法，使用小鼠淋巴瘤细胞系（L5178Y TK+/-3.7.2C）进行TK基因突变试验，采用相对存活率（RS）和相对总生长（RTG）两种指标来评估细胞毒性的方法。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心、中国食品药品检定研究院
Drafting Persons:
孙令骁、王国伟、韩倩倩、史建峰
Same series standard
Replace the following standards
Referenced Standards
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 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced