YY/T 1788-2021 English PDF

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YY/T 1788-2021: (Surgical living things General requirements for animal-derived patch products)
Status: Valid

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Basic data

Standard ID: YY/T 1788-2021 (YY/T1788-2021)
Description (Translated English): (Surgical living things General requirements for animal-derived patch products)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Word Count Estimation: 13,197
Issuing agency(ies): State Drug Administration

YY/T 1788-2021: (Surgical living things General requirements for animal-derived patch products)

---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.
(Surgical living things General requirements for animal-derived patch products) ICS 110.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical implants animal-derived patch products common enquiries Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration directory Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 5 Inspection method 4 Appendix A (Normative Appendix) Selection of Donor Animals and Requirements for Raw Materials 7 Reference 8

foreword

This standard is written in accordance with the rules given in GB/T 1.1-2009. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This standard was drafted by. China National Institute for Food and Drug Control, Shenzhen Institute for Drug Control (Shenzhen Medical Device Testing Center), Sichuan University (Sichuan Medical Device Biomaterials and Products Inspection Center), Zhejiang Huazhen Medical Device Co., Ltd., Beijing Galaxy Bama Biotechnology Technology Co., Ltd., Guanhao Biotechnology Co., Ltd., Beijing Ruijian High-tech Biotechnology Co., Ltd., Sichuan University Biomaterials Engineering Co., Ltd. Cheng Research Center, Yantai Zhenghai Biotechnology Co., Ltd. The main drafters of this standard. Wang Jian, Wang Chunren, Yang Zhaopeng, Wang Shuhan, Shi Qi, Zhang Yanqin, Zhang Wei, Zhang Kai, Sun Wenquan, Yuan Tun, Lin Hai, Li Cen, Zhong Xingxia, Zhang Donggang, Liu Qisheng. Surgical implants animal-derived patch products common enquiries

1 Scope

This standard specifies the terms and definitions, technical requirements and test methods of animal-derived patch products. This standard applies to patch products prepared from animal-derived tissues and their derivatives through specific processing techniques.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 13078 Feed Hygiene Standard GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment - Part 1.Chemical analysis methods GB/T 16886 (all parts) Biological evaluation of medical devices YY/T 0606.12-2007 Tissue engineered medical products-Part 12.Guidelines for the processing of cells, tissues and organs YY/T 0771.1 Medical Devices of Animal Origin Part 1.Application of Risk Management YY/T 0771.2 Medical Devices of Animal Origin Part 2.Control of Source, Collection and Disposal NY/T 388 Environmental Quality Standard for Livestock and Poultry Farms NY5027 Pollution-free food, livestock and poultry drinking water quality NY5031 Guidelines for Veterinary Epidemic Prevention of Pollution-Free Food Pig Feeding NY5032 Guidelines for the use of pollution-free food, livestock and poultry feed and feed additives NY/T 5033 Pollution-free food pig breeding management guidelines "Pharmacopoeia of the People's Republic of China" 2020 Edition

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 materialofanimal-derived material Substances made in whole or in part from animal tissues or derived from animal tissues, derivatives of animal tissues or naturally obtained from the animal body. 3.2 animal-derived patch Made in whole or in part from animal tissue or derived from animal tissue, derivatives of animal tissue or from substances naturally obtained from the animal body A patch that can be implanted to support a tissue or organ. Note. The animal-derived material can be the main component, coating or impregnating agent that constitutes the patch, or it can be an auxiliary material used in the production process. 3.3 acellular matrix decelularmatrix Using physical, chemical and biological techniques, the decellularized tissue obtained by decellularization basically retains the extracellular matrix of the original tissue, Scaffolding materials that maintain the biological activity and/or structural integrity of the extracellular matrix. ......

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