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YY/T 1867-2023 English PDF

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YY/T 1867-2023: (Sports Medicine Implants Wired Anchor)
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1867-2023	English	299	Add to Cart	3 days [Need to translate]	(Sports Medicine Implants Wired Anchor)	Valid	YY/T 1867-2023

Standard similar to YY/T 1867-2023

Basic data

Standard ID	YY/T 1867-2023 (YY/T1867-2023)
Description (Translated English)	(Sports Medicine Implants Wired Anchor)
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of International Standard	11.040.40
Word Count Estimation	14,148
Date of Issue	2023-01-13
Date of Implementation	2024-01-15
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the performance requirements of anchors with wires for sports medicine implant devices (hereinafter referred to as anchors with wires), specifies the corresponding test methods, and specifies the requirements for manufacturing, sterilization, biological safety evaluation, packaging and manufacturer's provision information, etc. This standard applies to the test and evaluation of anchors with wires for the fixation of soft tissue and bone joints in sports medicine surgery. This standard also applies to the test and evaluation of non-preset suture anchors and full suture anchors.

YY/T 1867-2023: (Sports Medicine Implants Wired Anchor)

---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.
ICS 11.040.40 CCSC35 Pharmaceutical Industry Standard of the People's Republic of China Sports Medicine Implantable Anchor with Wire Released on 2023-01-13 2024-01-15 Implementation Released by the State Drug Administration

Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 5 Test method 5 6 Manufacturing 8 7 Sterilization 8 8 Biological Safety Evaluation 8 9 packs 8 10 Information provided by the manufacturer9 Appendix A (Informative) Basic Principles 10 Reference 11

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 for Standardization Documents" drafting. Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee on Surgical Implants and Orthopedic Devices (SAC/TC110). This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, State Drug Administration Medical Device Technical Review Center, Beijing Medical Device Evaluation and Inspection Center, Stryker (Beijing) Medical Devices Co., Ltd., Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., Beijing Natong Technology Group Co., Ltd., Beijing Deyidamei Medical Technology Co., Ltd., Beijing Fule Technology Development Co., Ltd. The main drafters of this document. Li Wenjiao, Dong Shuangpeng, Zhang Shu, Ma Chunbao, Yuan Bo, Guo Xiaolei, Zhen Zhen, Guo Xu, Gao Chunyu, Chen Ruikai, Zhao Wenwen, Kong Qingjun and Li Hongyan. Sports Medicine Implantable Anchor with Wire

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 sutureanchor 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 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).

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