YY/T 0523-2009Dentistry - Guidelines for developing dental implants (English PDF)
牙科学 牙种植体开发指南
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0523-2009 is the English-translated version of 牙科学 牙种植体开发指南.
Guidelines for the development of dental implants are the content of YY/T 0523-2009, a recommended standard of the Chinese medical device and pharmaceutical industry.
It provides general guidelines, principles and concepts for the production of a given type of dental implant product, rather than acceptance figures for a finished item.
The material is organised into technical aspects and biological aspects, treated in two separate clauses of the document. The standards it quotes are GB/T 9937.1-2008, GB/T 16886.1-2001, YY/T 0268-2008, YY/T 0287-2006 and YY/T 0524-2009. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0523-2009
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 0523-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 9937.1-2008
GB/T 16886.1-2001
YY/T 0268-2008
YY/T 0287-2006
YY/T 0524-2009
......
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
Normative references
- GB/T 16886.1-2001Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0268-2008Dentistry - Biological evaluation of medical devices used in dentistry - Unit 1: Evaluation and testing
- YY/T 0287-2006Medical devices-Quality management systems- Requirements for regulatory purposes
- YY/T 0524-2009Dentistry - Dental implant systems - Contents of a technical file
GB/T 9937.1-2008
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Related Standards
YY/T 0268-2008 — Dentistry - Biological evaluation of medical devices used in dentistry - Unit 1: Evaluation and testing
YY/T 0524-2009 — Dentistry - Dental implant systems - Contents of a technical file
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 0523-2009
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