GB 8662-1988
Replaced
YY/T 1897-2023
Active
Industry standards-Medicine
YY/T 1897-2023 Biological evaluation of nanomaterial medical devices—Test for genotoxicity—In vitro mammalian cell micronucleus test
YY/T 1897-2023 Biological evaluation of nanomaterial medical devices—Test for genotoxicity—In vitro mammalian cell micronucleus test
Basic Information
Standard Code:
YY/T 1897-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2023-06-20
Implement Date:
2024-07-01
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纳米医疗器械生物学评价分技术委员会(SAC/TC 248/SC 1)
Pages:
12 pages
Scope
本文件给出了评价纳米医疗器械或用于医疗器械的纳米材料的体外哺乳动物细胞微核试验方法，通过测定细胞暴露于纳米医疗器械或用于医疗器械的纳米材料供试液后的含微核细胞数，评价其是否具有潜在遗传毒性风险。
本文件适用于采用永生化细胞胞质分裂阻断法微核试验评价纳米医疗器械或用于医疗器械的纳米材料的遗传毒性。
注： 其他，如人外周血原代细胞培养法等可参考本方法，但宜进行方法学验证。
Development Information
Drafting Units:
中国食品药品检定研究院、四川大学(四川医疗器械生物材料和制品检验中心有限公司)、国家纳米科学中心
Drafting Persons:
文海若、袁暾、张潇、杨颖、王小蕾、纪英露、李秋、吴美玉、徐丽明、耿兴超、刘颖、梁洁
Referenced Standards
YY/T 0870.6-2019 Test for genotoxicity of medical devices—Part 6:In vitro mammalian cell micronucleus test
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
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced