GB/T 16886.11-1997
Replaced
YY/T 0870.2-2019
Active
Industry standards-Medicine
YY/T 0870.2-2019 Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test
YY/T 0870.2-2019 Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test
Basic Information
Standard Code:
YY/T 0870.2-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2019-05-31
Implement Date:
2020-06-01
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:
16 pages
Scope
YY/T 0870的本部分规定了医疗器械/材料体外哺乳动物细胞染色体畸变试验方法。
本部分适用于通过对处于有丝分裂中期的动物细胞的染色体畸变情况进行分析，来评价试验样品潜在的致畸变性的试验方法。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心、四川大学(四川医疗器械生物材料和制品检验中心)
Drafting Persons:
王鸾鸾、盖潇潇、袁暾、梁洁、詹杨
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