GB/T 16886.11-1997
Replaced
YY/T 1649.2-2019
Active
Industry standards-Medicine
YY/T 1649.2-2019 Test method for interactions of medical devices with platelet—Part 2:In vitro platelet activation products(β-TG,PF4 and TxB2)assay
YY/T 1649.2-2019 Test method for interactions of medical devices with platelet—Part 2:In vitro platelet activation products(β-TG,PF4 and TxB2)assay
Basic Information
Standard Code:
YY/T 1649.2-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2019-10-23
Implement Date:
2020-10-01
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:
8 pages
Scope
YY/T 1649的本部分规定了在体外对医疗器械/材料进行血液相容性评价时，医疗器械/材料与血小板相互作用的体外血小板激活试验方法。本标准适用于医疗器械/材料表面血小板粘附性能和激活潜能的评价。
本部分中建立的试验体系适用于人血。若使用动物血液，可在论证其适宜性的基础上进行试验。
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:
乔春霞、王国伟、袁暾、梁洁、郑利萍
Same series standard
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
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