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YY/T 1816-2022Implants for surgery-Synthetic non-absorbable patch-Dura patch (English PDF)

外科植入物合成不可吸收补片硬脑（脊）膜补片

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 18, 2022

Implementation date

June 1, 2023

Scope

YY/T 1816-2022 is the English-translated version of 外科植入物合成不可吸收补片硬脑（脊）膜补片.

YY/T 1816-2022 is the Chinese pharmaceutical industry standard for the synthetic non-absorbable patch used to repair the dura mater, the membrane covering the brain and the spinal cord.

It gives the terms and definitions, the technical requirements, the test methods and the rules for marking, packaging, storage and transport, covering the identification of the polymer, the thickness and areal density, the tensile and suture retention strength, the water tightness of the repair, sterility and biological evaluation.

It applies to dural and spinal patches made of synthetic non-absorbable materials such as polyvinylidene fluoride, polytetrafluoroethylene and expanded polytetrafluoroethylene. Issued on 18 May 2022, it has applied since 1 June 2023.

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Document preview — YY/T 1816-2022

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

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirement
5 Inspection method
6 Identification requirements
7 Packaging, transport and storage
Appendix A (Informative) Infrared Spectrum Figure
Appendix B (informative) Particular requirements for PTFE and expanded PTFE dura (spinal) membrane patches
Reference

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.

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

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