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YY/T 1867-2023Implants for sports medicine - Suture anchor (English PDF)

运动医学植入器械带线锚钉

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 13, 2023

Implementation date

January 15, 2024

Scope

YY/T 1867-2023 is the English-translated version of 运动医学植入器械带线锚钉.

YY/T 1867-2023 is the Chinese standard "Implants for sports medicine - Suture anchor".

Its scope clause reads: This document specifies the performance requirements of anchors with wires (hereinafter referred to as "anchors with wires") for implantable sports medicine devices, and gives the corresponding test The method specifies the content of manufacturing, sterilization, biological safety evaluation, packaging and information provided by the manufacturer.

Note. Appendix A gives the rationale for this document. This document applies to the test and evaluation of anchors with wires for the fixation of soft tissue and bone joints in sports medicine surgery.

This document also applies to the test evaluation of non-preset suture anchors and full suture anchors. Its clauses include terms and definitions.

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Document preview — YY/T 1867-2023

National Standard of the People's Republic of China

ICS: 11.040.40

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirements
5 Test method
6 Manufacturing
7 Sterilization
8 Biological Safety Evaluation
9 packs
10 Information provided by the manufacturer
Appendix A (Informative) Basic Principles

1 Scope

This document specifies the performance requirements of anchors with wires (hereinafter referred to as "anchors with wires") for implantable sports medicine devices, and gives the corresponding test

The method specifies the content of manufacturing, sterilization, biological safety evaluation, packaging and information provided by the manufacturer.

Note. Appendix A gives the rationale for this document.

This document applies to the test and evaluation of anchors with wires for the fixation of soft tissue and bone joints in sports medicine surgery.

This document also applies to the test evaluation of non-preset suture anchors and full suture anchors.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 4340.1 Vickers hardness test for metallic materials - Part 1.Test method

GB/T 10610 Product Geometric Specifications (GPS) Surface Structure Profiling Method for Assessing Surface Structure Rules and Methods

GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods

GB/T 14233.2 Test methods for medical infusion, blood transfusion and injection equipment Part 2.Biological test methods

GB/T 16886 (all parts) Biological evaluation of medical devices

YY/T 0043 Medical Suture Needles

YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical devices

YY 0167 Non-absorbable surgical suture

YY/T 0343 Liquid Penetrant Testing of Surgical Metal Implants

YY/T 0640 General requirements for passive surgical implants

YY/T 1832 Suture Tensile Test Method for Sports Medicine Implantable Devices

Pharmacopoeia of the People's Republic of China (four volumes)

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Anchor with wire

It is a medical device that refixes soft tissues such as tendons and ligaments to human bones through specific surgical techniques.

NOTE. Usually consists of implants and accessories. The implant includes anchors, sutures (with or without needles), and auxiliary parts include inserters, thread device etc.

3.2 insertion force

The maximum pressure required to fully insert an anchor implanted into the body by percussion into the test block.

Note. The unit is Newton (N).

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 16886

Similar standards

HJ 1198|GJB 1763

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