GB/T 803-1989
Replaced
YY/T 0771.2-2020
Active
Industry standards-Medicine
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling
Basic Information
Standard Code:
YY/T 0771.2-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Air quality
Publish Date:
2020-03-31
Implement Date:
2021-04-01
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:
17 pages
Scope
YY/T 0771的本部分规定了用动物源性材料制造的医疗器械的动物和组织的来源、收集和处置（包括贮存和运输）的控制要求，不包括体外诊断医疗器械。YY/T 0771.1-2020中给出的风险管理过程要求适用。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心
Drafting Persons:
王昕、范春光、朱福余
Same series standard
Replace the following standards
YY/T 0771.2-2009
Referenced Standards
YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management
YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes
YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes
YY/T 0771.4-2015 Medical devices utilizing animal tissues and their derivatives—Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes
YY/T 0771.3-2009 Animal-derived medical devices - Part 3: Verification of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors
Adopt standards
ISO 22442-2:2015
Related Standards
GB/T 8190.1-1999
Replaced
GB/T 8190.1-1999 Reciprocating internal combustion engines—Exhaust emission measurement—Part 1:Test-bed measurement of gaseous and particulate exhaust emissions
GB/T 8190.4-1999
Replaced
GB/T 8190.4-1999 Reciprocating internal combustion engines—Exhaust emission measurement—Part 4:Test cycles for different engine applications
GB/T 8188-2003
Replaced
GB/T 8188-2003 Internal combustion engine—Emissions terminology and nomenclature
GB/T 32155-2015
Active
GB/T 32155-2015 General technological specification for equipments of fabric filter dedusting system
GB/T 8188-2017
Active