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www.ChineseStandard.net Database: 189760 (25 Oct 2025)

YY/T 1816-2022 English PDF

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YY/T 1816-2022: Implants for surgery - Synthetic non-absorbable patch - Dura patch
Status: Valid
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YY/T 1816-2022English259 Add to Cart 3 days [Need to translate] Implants for surgery - Synthetic non-absorbable patch - Dura patch Valid YY/T 1816-2022

PDF similar to YY/T 1816-2022


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Basic data

Standard ID YY/T 1816-2022 (YY/T1816-2022)
Description (Translated English) Implants for surgery - Synthetic non-absorbable patch - Dura patch
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Word Count Estimation 12,119
Issuing agency(ies) State Drug Administration

YY/T 1816-2022: Implants for surgery - Synthetic non-absorbable patch - Dura patch

---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.
Implants for surgery - Synthestic non-absorbable patch - Dura patch ICS 110.040.40 CCSC35 People's Republic of China Pharmaceutical Industry Standard Synthetic Nonabsorbable Patches for Surgical Implants Dura (spinal) patch Published on 2022-05-18 2023-06-01 Implementation Released by the State Drug Administration directory Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 1 5 Inspection method 3 6 Identification requirements6 7 Packaging, transport and storage 6 Appendix A (Informative) Infrared Spectrum Figure 7 Appendix B (informative) Particular requirements for PTFE and expanded PTFE dura (spinal) membrane patches 8 Reference 9

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. Please note that some content of this document may involve patents, and the issuing authority of this document does not assume responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document is drafted by. China National Institute for Food and Drug Control. The main drafters of this document. Wang Jian, Liu Li, Feng Xiaoming, Shi Qi, Wang Chunren. Synthetic Nonabsorbable Patches for Surgical Implants Dura (spinal) patch

1 Scope

This document specifies the terms and definitions, technical requirements, test methods, marking, packaging, storage and transportation requirements of dura mater. This document is applicable to the processing of synthetic non-absorbable materials such as polyvinylidene fluoride, polytetrafluoroethylene or expanded polytetrafluoroethylene. Dura (spinal) patch.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB/T 528-2009 Determination of tensile stress-strain properties of vulcanized or thermoplastic rubber GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment - Part 1.Chemical analysis methods GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process GB/T 16886.7 Biological Evaluation of Medical Devices Part 7.Ethylene Oxide Sterilization Residues YY/T 0313 Requirements for medical polymer product packaging and information provided by manufacturers YY/T 0500-2021 Cardiovascular Implants, Vascular Prostheses, Tubular Vascular Grafts and Vascular Patches 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 Dura (spinal) membrane duramater There are three layers of connective tissue membranes on the surface of the brain and spinal cord, the meninges that wrap the brain and the meninges that wrap the spinal cord. Membrane, arachnoid and pia mater (spinal) membrane composed of three layers. The outermost layer of the dura (spinal) membrane, which is called the dura mater in the brain and the dura mater in the spinal cord, Both are composed of dense connective tissue, thick and tough, and have protective and supportive effects on the brain and spinal cord. 3.2 non-absorbablematerial After implantation into the human body, materials that are not absorbed by the human body (currently commonly used clinically polyvinylidene fluoride, polytetrafluoroethylene or expanded polytetrafluoroethylene) alkene materials, etc.).

4 Requirements

4.1 Physical Properties 4.1.1 Appearance There should be no stains or foreign objects, and the same surface should be uniform, free of scratches, abrasions, and particles.

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