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YY 0672.2-2011: Endoscopy instruments. Part 2: Laparoscopy scissors
Status: Obsolete
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Endoscopy instruments. Part 2: Laparoscopy scissors
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YY 0672.2-2011
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Basic data | Standard ID | YY 0672.2-2011 (YY0672.2-2011) | | Description (Translated English) | Endoscopy instruments. Part 2: Laparoscopy scissors | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,117 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 1220; GB/T 2828.1; GB/T 2829; GB/T 4340.1; GB 9706.4-2009; GB/T 16886.5-2003; GB/T 16886.10-2005; YY/T 0149-2006; YY/T 1052 | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the classification of laparoscopic scissors, requirements, test methods, inspection rules and signs to, the use of brochures, packaging, transportation, storage and other requirements. This standard applies to laparoscopic scissors (hereinafter referred to as scissors), for laparoscopic surgery, endovascular tissue was cut. | YY 0672.2-2011: Endoscopy instruments. Part 2: Laparoscopy scissors---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.
Endoscopy instruments.Part 2. Laparoscopy scissors
ICS 11.040.30
C31
People's Republic of China pharmaceutical industry standards
Endoscopic equipment - Part 2. laparoscopic scissors
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
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.
This part of the surgical instrument by the National Standardization Technical Committee (SAC/TC94) and focal points.
This section is drafted. Tonglu Medical Optical Instruments Factory, Shanghai Medical Device Testing, Shanghai Medical Devices (Group) have
Limited surgical instruments factory, Shanghai Institute of Electronic Technology Co., Ltd. Jinbao Long fiber.
The main drafters of this section. Yan Liping, Wang Wei, Huang Lili, Zheng will be music, Shen Tu Yuhua, Chen Da rights.
Endoscopic equipment - Part 2. laparoscopic scissors
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. by acceptance quality limit (AQL) retrieval batch inspection sampling plan
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. requirements for the safety of high frequency surgical equipment
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. irritation and delayed-type hypersensitivity test
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.
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