YY/T 0526-2009
Dentistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of a technical file (English Version)
- Standard No.
- YY/T 0526-2009
- Language
- Chinese, Available in English version
- Release Date
- 2009
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 0526-2009
- Scope
- This standard gives requirements for technical documentation to evaluate the chemical, physical, mechanical, biological and clinical properties and performance of absorbable, partially absorbable or non-absorbable membrane materials. Membrane materials can be used for: Oral and maxillofacial surgery to guide tissue regeneration to correct morphological defects or abnormalities; Contact with teeth and/or dental implants; Prevent epithelial migration caused by periodontal surgery; Used for bone augmentation before dental implant placement surgery; and/or bone augmentation for stabilizing dental restorations. This standard does not include materials that are used primarily for drug release, autografts and allografts, or that act through pharmacological, immunological, or metabolic means.
YY/T 0526-2009 Referenced Document
- GB 18278 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
- GB 18279 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization*， 2023-09-08 Update
- GB 18280 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
- GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
- GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals*， 2015-12-10 Update
- GB/T 19633 Packaging for terminally sterilized medical devices
- GB/T 19974 Sterilization 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*， 2018-05-14 Update
- GB/T 9937.1 Dental vocabulary.Part 1:General and clinical terms
- GB/T 9937.2 Dental vocabulary.Part 2:Dental materials
- GB/T 9937.3 Dental vocabulary.Part 3:Dental instruments
- GB/T 9937.4 Dental vocabulary-Part 4:Dental equipment
- GB/T 9937.5 Dental vocabulary.Part 5:Terms associated with testing
- YY 0466 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
- YY/T 0297 Clinical investigation of medical devices
- YY/T 0316 Medical devices.Application of risk management to medical devices*， 2016-01-26 Update
YY/T 0526-2009 history
- 2009 YY/T 0526-2009 Dentistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of a technical file
