YY/T 0522-2009Dentistry - Preclinical evaluation of dental implant systems - Animal test methods (English PDF)
牙科学 牙种植体系统临床前评价 动物试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0522-2009 is the English-translated version of 牙科学 牙种植体系统临床前评价 动物试验方法.
YY/T 0522-2009 is a recommended Chinese medical device standard describing the animal test methods used in the preclinical evaluation of dental implant systems.
It sets out how macroscopic and microscopic parameters are applied in order to assess the functional state of an implant system. Its use is limited to the situation where a risk analysis shows that the additional information required can be obtained only through animal testing.
Two documents are quoted, GB/T 9937.5 and GB/T 16886.2, the second belonging to the biological evaluation series. The standard is classified C33 in the Chinese system and 11.060.10 internationally. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0522-2009
National Standard of the People's Republic of China
- ICS
- 11.060.10
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 2 Normative references
2 Normative references
YY/T 0522-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 9937.5
GB/T 16886.2
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 16886.2-2011 — Biological evaluation of medical devices -- Part 2: Animal welfare requirements
GB/T 16886.2-2026 — Biological evaluation of medical devices - Part 2: Animal welfare requirements
GB/T 9937.5-2008 — Dental vocabulary -- Part 5: Terms associated with testing
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YY/T 0522-2009
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