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YY/T 1794-2021 English PDF

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YY/T 1794-2021: General technical requirements for dental collagen membrane
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PDF similar to YY/T 1794-2021


Standard similar to YY/T 1794-2021

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Basic data

Standard ID YY/T 1794-2021 (YY/T1794-2021)
Description (Translated English) General technical requirements for dental collagen membrane
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Word Count Estimation 10,171
Issuing agency(ies) State Drug Administration

YY/T 1794-2021: General technical requirements for dental collagen membrane

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
General technical requirements for dental collagen membrane ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standards General technical requirements for oral collagen membrane Released on 2021-03-10 2022-04-01 implementation Issued by the National Medical Products Administration

Table of contents

Foreword Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Category 2 5 Requirements 2 6 Test method 4

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee for Dental Materials and Devices (SAC/TC99). Drafting organizations of this standard. Peking University School of Stomatology Dental Medical Device Inspection Center, Yantai Zhenghai Biotechnology Co., Ltd., Institute of Process Engineering, Chinese Academy of Sciences, Guestley Trading (Beijing) Co., Ltd., China Institute for Food and Drug Control. The main drafters of this standard. Han Jianmin, Lin Hong, Zhang Dianyun, Sun Xianchang, Zhang Guifeng, Gao Jianping, Wang Qiu, Mu Ruihong. General technical requirements for oral collagen membrane

1 Scope

This standard specifies the terms and definitions, classification, requirements and test methods of oral collagen membrane materials. This standard is applicable to the repair of oral soft and hard tissue defects caused by various reasons, which can guide, isolate, repair, fix, reduce tension, replace, etc. It is a membrane material with collagen as the main component.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 528-2009 Determination of tensile stress and strain properties of vulcanized rubber or thermoplastic rubber GB/T 1040.3-2006 Determination of tensile properties of plastics Part 3.Test conditions for films and sheets GB 5009.6-2016 National Food Safety Standard Determination of Fat in Food GB/T 6682-2008 Analytical laboratory water specifications and test methods GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods GB/T 14233.2-2005 Medical transfusion, blood transfusion, injection equipment inspection methods Part 2.Biological test methods GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management GB/T 16886.3 Biological Evaluation of Medical Devices Part 3.Genetic Toxicity, Carcinogenicity and Reproductive Toxicity Test GB/T 16886.4 Biological Evaluation of Medical Devices Part 4.Test Selection for Interaction with Blood GB/T 16886.5 Biological Evaluation of Medical Devices Part 5.In Vitro Cytotoxicity Test GB/T 16886.6 Biological evaluation of medical devices Part 6.Local reaction test after implantation GB/T 16886.7 Biological Evaluation of Medical Devices Part 7.Residues of Ethylene Oxide Sterilization GB/T 16886.10 Biological Evaluation of Medical Devices Part 10.Irritation and Skin Sensitization Test GB/T 16886.11 Biological Evaluation of Medical Devices Part 11.Systemic Toxicity Test GB/T 16886.12 Biological Evaluation of Medical Devices Part 12.Sample Preparation and Reference Materials GB/T 16886.20 Biological Evaluation of Medical Devices Part 20.Principles and Methods of Immunotoxicology Tests for Medical Devices YY/T 0127.2 Biological Evaluation of Oral Medical Devices Unit 2.Test Method Acute Systemic Toxicity Test. Intravenous Route YY/T 0127.4 Biological Evaluation of Dental Medical Devices Unit 2.Test Method Bone Implantation Test YY/T 0127.8 Biological Evaluation of Dental Materials Unit 2.Biological Test Methods of Dental Materials Subcutaneous Implantation Test YY/T 0127.10 Biological Evaluation of Dental Medical Devices Unit 2.Test Method Salmonella Typhimurium Reversion Test Test (Ames test) YY/T 0268 Biological Evaluation of Dental Medical Devices in Dentistry Unit 1.Evaluation and Testing YY/T 0606.25-2014 Tissue engineered medical products Part 25.Determination of DNA residues in biological materials of animal origin. Fluorescence staining method YY 0954-2015 Passive surgical implants Type I collagen implants YY/T 1511-2017 Collagen sponge Pharmacopoeia of the People's Republic of China (2020 edition)

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