YY/T 0456.1-2003
Replaced
GB/T 16886.11-2021
Active
National standards
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
Basic Information
Standard Code:
GB/T 16886.11-2021
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Laboratory medicine
Publish Date:
2021-11-26
Implement Date:
2022-12-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
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:
33 pages
Scope
本文件规定了评价医疗器械材料导致潜在不良全身反应时的要求，给出了试验步骤指南。
本文件适用于医疗器械或材料的全身毒性研究。
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:
王昕、孙立魁、韩倩倩、王涵、褚祥宇、许晶
Same series standard
Replace the following standards
Referenced Standards
ISO 10993-1
ISO 10993-2
Adopt standards
ISO 10993-11:2017
Related Standards
YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active