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Database: 189759 (12 Oct 2025)
YY/T 0526-2009 English PDF
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YY/T 0526-2009
: Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
Status: Valid
Standard ID
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Standard Title (Description)
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YY/T 0526-2009
English
214
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Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
Valid
YY/T 0526-2009
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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.