YY/T 0771.3-2009Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (English PDF)
动物源医疗器械 第3部分：病毒和传播性海绵状脑病（TSE）因子去除与灭活的确认
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0771.3-2009 is the English-translated version of 动物源医疗器械 第3部分：病毒和传播性海绵状脑病（TSE）因子去除与灭活的确认.
YY/T 0771.3-2009 is Part 3 of the Chinese medical device series on devices made using animal tissues and their derivatives, and it covers validation of the elimination or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents.
It applies to devices manufactured from animal tissue or from tissue-derived products, in vitro diagnostic devices excepted, where that material is non-viable or has been rendered non-viable.
The risk management process set out in YY/T 0771.1 applies to this part, and YY/T 0771.2 is cited as well. It does not deal with the transmission of other agents, nor with the effect a removal or inactivation method may have on a device's suitability.
The text is identical to ISO 22442-3-2007. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0771.3-2009
National Standard of the People's Republic of China
- ICS
- 11.100.20
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 0771.3-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
YY/T 0771.1
YY/T 0771.2
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
Cited by
- YY/T 1985-2025Tissue engineered medical devices - Collagen
- YY/T 1950-2024Tissue engineering medical device - Silk fibroin
- YY/T 1876-2023Tissue engineered medical products - Quantification of remnant DNA in animal-derived biomaterials - Fluorescent staining method
- YY/T 0988.3-2021Coatings of surgical implants - Part 3: Mussel adhesive proteins
- YY/T 0771.1-2020Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- YY/T 0771.2-2020Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
Similar standards
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Related Standards
YY/T 0771.1-2009 — Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
YY/T 0771.1-2020 — Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
YY/T 0771.2-2009 — Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
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YY/T 0771.3-2009
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