YY/T 1788-2021Implants for surgery-General requirements for animal-derived patch products (English PDF)
外科植入物 动物源性补片类产品通用要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 1788-2021 is the English-translated version of 外科植入物 动物源性补片类产品通用要求.
YY/T 1788-2021 is the Chinese pharmaceutical industry standard that sets the general requirements for animal-derived patch products used as surgical implants, the patches made from animal tissue and its derivatives by a defined process.
It gives the terms and definitions, the technical requirements and the test methods, covering the source and traceability of the tissue and the control of viral and TSE agents, the removal of cells and of residual DNA and protein, the crosslinking where used and its residues, the mechanical properties of the patch, the sterility and the biological evaluation. Issued on 6 September 2021, it has applied since 1 September 2022.
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Document preview — YY/T 1788-2021
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 5 Inspection method
- Appendix A (Normative Appendix) Selection of Donor Animals and Requirements for Raw Materials
- Reference
Foreword
This standard is written in accordance with the rules given in GB/T 1.1-2009.
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 document. 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
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
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 13078Hygienical standard for feeds
- GB/T 14233.1Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- YY/T 0606.12-2007Tissue engineered medical products - Part 12: Guide for processing cells, tissues and organs
- YY/T 0771.1Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- YY/T 0771.2Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- NY/T 5033Guidelines for the management of pollution-free food hog
GB/T 16886 · NY/T 388
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Related Standards
GB 13078-2017 — Hygienical standard for feeds
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.1-2022 — Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
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YY/T 1788-2021
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