GB/T 16886.11-1997
Replaced
YY/T 1770.1-2021
Active
Industry standards-Medicine
YY/T 1770.1-2021 Test method for thrombogenicity study—Part 1:Thrombogenicity study in dogs in vivo
YY/T 1770.1-2021 Test method for thrombogenicity study—Part 1:Thrombogenicity study in dogs in vivo
Basic Information
Standard Code:
YY/T 1770.1-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2021-03-09
Implement Date:
2022-04-01
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:
12 pages
Scope
YY/T 1770的本部分规定了在对医疗器械/材料血液相容性评价时，采用犬进行体内血栓形成试验的方法。
本部分适用于对医疗器械/材料是否引起体内血栓形成进行评价。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心、深圳市药品检验研究院(深圳市医疗器械检验中心)
Drafting Persons:
乔春霞、林振华、曹苹、徐炜区、董传俊、韩乃水
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 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
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