YY/T 0526-2009 PDF English
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Basic data
| Standard ID | YY/T 0526-2009 (YY/T0526-2009) |
| Description (Translated English) | Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C33 |
| Classification of International Standard | 11.060.10 |
| Word Count Estimation | 11,154 |
| Date of Issue | 2009-12-30 |
| Date of Implementation | 2011-06-01 |
| Quoted Standard | 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 16886.7; GB 18278; GB 18279; GB 18280; GB/T 19633; GB/T 19974; YY/T 0297; YY/T 0316; YY 0466 |
| Adopted Standard | ISO 22803-2004, IDT |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This standard specifies the evaluation can be absorbed, partly absorbed or non-absorbable membrane material of chemical, physical, mechanical, biological and clinical performance and the performance of the technical documentation requirements. Membrane materials can be used: Oral and Maxillofacial Surgery in guided tissue regeneration to correct defects or abnormal morphology, with teeth and (or) dental implant exposure, prevent periodontal surgery caused by epithelial migration, for dental implants increased before bone surgery, and (or) used to stabilize the growth of bone dental prosthesis surgery. This standard does not include primarily for drug release, autograft and allograft, or by pharmacological, immunological or metabolic means a material which functions. |