YY/T 0525-2009Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (English PDF)
牙科学 口腔颌面外科用骨填充及骨增加植入性材料 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 0525-2009 is the English-translated version of 牙科学 口腔颌面外科用骨填充及骨增加植入性材料 技术文件内容.
Bone filling and augmentation materials implanted in oral and maxillofacial surgery are the subject of YY/T 0525-2009, a recommended standard of the Chinese medical device and pharmaceutical industry.
It takes in both absorbable and non-absorbable implantable materials, and covers their physical and chemical, mechanical, biological and clinical performance together with the way that performance is evaluated and set down in a technical file.
Products made mainly of pure hydroxyapatite, above 90 percent, are excluded from it. Autografts and allografts, membrane materials and items intended chiefly for drug delivery are also outside its field.
The document cites GB/T 16886.1, GB/T 19633, GB/T 19974, YY/T 0316 and YY/T 0567.1. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0525-2009
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 0525-2009 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB/T 9937.1
GB/T 9937.2
GB/T 9937.3
GB/T 9937.4
GB/T 9937.5
GB/T 16886.1
GB/T 16886.17
GB 18278
GB 18279
GB 18280
GB/T 19633
GB/T 19974
YY/T 0297
YY/T 0316
YY 0466.1
YY/T 0567.1
......
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 9937.2Dental vocabulary -- Part 2: Dental materials
- GB/T 9937.5Dental vocabulary -- Part 5: Terms associated with testing
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 16886.17Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
- GB 18279Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
- GB/T 19974Sterilization of health care products -- General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
GB/T 9937.1 · GB/T 9937.3 · GB/T 9937.4 · GB 18278 · GB 18280 · GB/T 19633 · YY 0466.1
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Related Standards
GB 18278.1-2015 — Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 — Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18279-2023 — Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
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