YY/T 0524-2009Dentistry - Dental implant systems - Contents of a technical file (English PDF)
牙科学 牙种植体系统技术文件内容
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0524-2009 is the English-translated version of 牙科学 牙种植体系统技术文件内容.
YY/T 0524-2009 belongs to the recommended medical device standards of China and states what the technical file of a dental implant system has to contain. It applies to dental implants and prefabricated components that remain in the mouth after surgery, and it lists the documentation needed to show that such products meet the regulatory requirements.
Instruments and other parts of an implant system that are not retained in the mouth lie outside its field, although the documents describing them still form part of the overall technical file.
The standard draws on GB/T 7408, GB/T 9937.1, GB/T 16886.1, YY/T 0268 and YY/T 0316. It carries the Chinese classification C31 and the international classification 11.060.10. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0524-2009
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 0524-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 7408
GB/T 9937.1
GB/T 16886.1
YY/T 0268
YY/T 0316
......
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 7408Date and time - Representations for information interchange - Part 1: Basic rules
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0268Dentistry - Biological evaluation of medical devices used in dentistry - Unit 1: Evaluation and testing
- YY/T 0316Medical devices-Application of risk management to medical devices
GB/T 9937.1
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 7408.1-2023 — Date and time - Representations for information interchange - Part 1: Basic rules
GB/T 7408.2-2025 — Date and time - Representation for information interchange - Part 2: Extensions
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