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YY/T 1906-2023 English PDF

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YY/T 1906-2023: Sterile ligation clips for single use
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1906-2023239 Add to Cart 3 days Sterile ligation clips for single use Valid

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Basic data

Standard ID: YY/T 1906-2023 (YY/T1906-2023)
Description (Translated English): Sterile ligation clips for single use
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.30
Word Count Estimation: 12,168
Date of Issue: 2023-09-05
Date of Implementation: 2024-09-15
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the structure and materials, requirements, labels, and instructions for single-use sterile closure clips (hereinafter referred to as closure clips), and describes the corresponding test methods. This standard is applicable to closure clips used to clamp blood vessels or close tubular tissues (including small and medium-sized arteries and veins, bile ducts, etc., but not applicable to large arteries and veins) during surgical operations. This document does not apply to metal clips, absorbable closure clips, continuous closure clips, and closure clips that temporarily clamp tissue or blood vessels during surgery and are removed after surgery.

YY/T 1906-2023: Sterile ligation clips for single use

---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 11.040.30 CCSC31 Pharmaceutical Industry Standards of the People's Republic of China Disposable sterile closure clips Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. Release of this document The Agency assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Surgical Instruments Standardization Technical Committee (SAC/TC94). This document was drafted by. Hangzhou Kangji Medical Devices Co., Ltd., Shanghai Medical Device Inspection Institute, Beijing Medical Device Inspection Research Institute (Beijing Medical Biological Protective Equipment Inspection and Research Center), Shandong Weirui Surgical Medical Products Co., Ltd., Jiangsu Provincial Drug Supervision and Administration Administration Review Center, Anhui Institute of Food and Drug Inspection, Hangzhou Guangdian Medical Devices Co., Ltd., Jiangsu Sanlian Xinghai Medical Devices Co., Ltd. Company, Changzhou Kandi Medical Stapler Co., Ltd. The main drafters of this document. Tang Wenpeng, Qi Xia, Hu Guangyong, Wang Zewei, Yu Qi, Ding Fang, Xu Juan, Zhang Daojun, Xie Tanyi, Ma Xiaojian, Geng Xin, Tang Wen, Wei Sheng, Cheng Da, Huang Baohua, Yue Jiqiang, Zhao Ning, Ma Gang, Xue Yu, Yang Huibing. Disposable sterile closure clips

1 Scope

This document specifies the structure and materials, requirements, labels, and instructions for single-use sterile closure clips (hereinafter referred to as closure clips), and describes Corresponding test methods. This document is suitable for clamping blood vessels or closing tubular tissues (including small and medium-sized arteries and veins, bile ducts, etc.) during surgical operations. It is not suitable for large arteries and large arteries. large veins). This document does not apply to metal clips, absorbable closure clips, consecutive closure clips, and closures that temporarily clip tissue or blood vessels during surgery or remove them after surgery. Close folder.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 6682 Specifications and test methods for water used in analytical laboratories GB/T 14233.1-2022 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods YY 0167 non-absorbable surgical suture Pharmacopoeia of the People's Republic of China (2020 edition, four volumes)

3 Terms and definitions

There are no terms or definitions to be defined in this document.

4 Structure and materials

4.1 Structure The closing clamp consists of a lock buckle and a clamp arm. It is usually installed in the base and fixed with a pressure plate (see Figure 1).
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