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YY 0672.2-2011Endoscopy instruments - Part 2: Laparoscopy scissors (English PDF)

内镜器械第2部分：腹腔镜用剪

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY 0672.2-2011 is the English-translated version of 内镜器械第2部分：腹腔镜用剪.

YY 0672.2-2011 is the Chinese pharmaceutical industry standard for laparoscopy scissors, the instrument with which tissue is cut inside the abdominal cavity.

It is the second part of the YY 0672 series on endoscopy instruments and specifies the classification, the requirements, the test methods, the inspection rules, the signs, the instructions and the requirements for packaging, transport and storage, covering the dimensions and the cutting edges, the cutting performance and its durability, the insulation where the instrument is used with electrosurgery, the hardness and corrosion resistance of the material and the ability of the instrument to be cleaned and sterilized. Issued on 31 December 2011, it has applied since 1 June 2013.

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Document preview — YY 0672.2-2011

National Standard of the People's Republic of China

ICS: 11.040.30
Classification: C 31

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Product Categories

Foreword

YY 0672 "endoscopic instrument", consists of the following components.

--- Part 1. laparoscopic puncture;

--- Part 2. laparoscopic scissors. This is Part 2 YY 0672 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

1 Scope

YY 0672 This section specifies the laparoscopic scissors classification, requirements, test methods, inspection rules and signs, instructions, package Equipment, transportation, storage and other requirements.

This section applies to laparoscopic scissors (hereinafter referred to as scissors), in time for laparoscopic surgery, with tissue cut cavity.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 1220 stainless steel rods

GB/T 2828.1 Sampling procedures for inspection - Part 1.

GB/T 2829 periodic inspection Sampling procedures and tables (suitable for process stability test)

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

GB 9706.4-2009 Medical electrical equipment - Part 2-2.

GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests

GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10.

YY/T 0149-2006 stainless steel medical equipment corrosion test methods

YY/T 1052 surgical instruments logo

3 Product Categories

3.1 Structure type (see Figure 1)

3.1.1 scissors structure mainly composed of blade, Arbor, handle, points overall and removable types.

3.1.2 scissors straight points by the shape of the tip scissors, curved scissors, cut the hook three types; by opening and closing the sub-way and single open double open two kinds; divided by the degree of insulation Insulated and non-insulated scissors cut categories.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

GB/T 46944-2025

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