YY/T 1783-2021 PDF EnglishUS$230.00 · In stock · Download in 9 seconds
YY/T 1783-2021: Endoscopic surgical instruments - Reusable abdominal trocar Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/T 1783-2021: Endoscopic surgical instruments - Reusable abdominal trocar---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1783-2021YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.30 CCS C 36 Replacing YY 0672.1-2008 Endoscopic surgical instruments - Reusable abdominal trocar Issued on. MARCH 09, 2021 Implemented on. APRIL 01, 2022 Issued by. National Medical Products Administration Table of ContentsForeword... 3 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 5 4 Structure and materials... 6 5 Requirements... 9 6 Test methods... 11 7 Type inspection... 13 8 Label, instructions... 13 9 Packaging, transportation and storage... 15 Appendix A (Normative) Test methods for gas barrier property and sealing property16 Appendix B (Informative) Test method for puncture property evaluation... 17 Appendix C (Informative) Test method for insertion/pullout property evaluation... 19ForewordThis document was drafted in accordance with the rules given in GB/T 1.1-2020, Directives for standardization - Part 1.Rules for the structure and drafting of standardizing documents. This document replaces YY 0672.1-2008, Endoscopic instruments - Part 1.Trocars for laparoscope use. The main technical changes, except editorial changes, are as follows. -- Add trocar with skin cutting (see 4.1.1); -- Change the requirements for materials (see 4.2; 3.2 of 2008 edition); -- Change the requirements for the trocar appearance (see 5.1; 4.2 of 2008 edition); -- Change the requirements for surface roughness (see 5.3; 4.7 of 2008 edition); -- Add the property of trocar with skin cutting (see 5.4.2); -- Change the requirements for gas barrier and sealing property (see 5.6; 4.5 of 2008 edition); -- Change the hardness requirements (see 5.7; 4.6 of 2008 edition); -- Add the requirements for the gas injection valve interface (see 5.8); -- Add the evaluation requirements for puncture and insertion performance (see 5.9); -- Change the requirements for corrosion resistance (see 5.10; 4.8 of 2008 edition); -- Add the requirements for reusability (see 5.11); -- Add the requirements for sealing property of the converter (see 5.12); -- Add the requirements for connection firmness (see 5.13); -- Add the requirements for packaging, marking and instructions (see 5.14); -- Add the test method for the property of trocar with skin cutting (see 6.4.2); -- Change the test method for fitting performance (see 6.5.2; 5.4.2 of 2008 edition); -- Change the test method for gas barrier and sealing property (see 6.6; 5.5 of 2008 edition); -- Add the test method for puncture and insertion performance (see 6.9); -- Add the test method for reusability (see 6.11); -- Add the test method for sealing property of the converter (see 6.12); -- Add the test method for connection firmness (see 6.13); -- Add the test method for packaging, marking and instructions (see 6.14). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This document was proposed by National Medical Products Administration. This document shall be under the jurisdiction of National Technical Committee 94 on Chirurgicum Apparatus of Standardization Administration of China (SAC/TC 94). Drafting organizations of this document. Shanghai Medical Device Testing Institute, Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd., Hangzhou Kangji Medical Instrument Co., Ltd., Beijing Institute of Medical Device Testing and Hangzhou Tonglu Medical Optical Instrument Co., Ltd. Chief drafting staffs of this document. Huang Shuze, Xu Shengyuan, Zhong Ming, Hu Guangyong, Wang Caijuan, Zhang Lihua, Gui Chengkui, Tang Wenpeng, Geng Xin, Huang Jiajin. The previous version of this document is. -- YY 0672.1-2008. Endoscopic surgical instruments - Reusable abdominal trocar1 ScopeThis document specifies the structure, materials, requirements, test methods, type inspection, labels, instructions, packaging, transportation and storage of reusable abdominal trocar. This document applies to the reusable abdominal trocar (hereinafter referred to as trocar) for puncturing human abdominal tissue to establish artificial pneumoperitoneum and operating surgical instrument channels during endoscopic surgery.2 Normative referencesThe following documents are normatively referenced in this document and are indispensable for its application. For dated references, only the version corresponding to that date is applicable to this document; for undated references, the latest version (including all amendments) is applicable to this document. GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2.Lock fittings GB/T 4340.1-2009, Metallic materials - Vickers hardness test - Part 1.Test method GB/T 16886 (all parts), Biological evaluation of medical devices YY/T 0149-2006, Medical instruments of stainless steel - Test methods of corrosion resistance3 Terms and definitionsThe following terms and definitions are applicable to this document. 3.1 Gas barrier property The gas resistance of the trocar after the puncture needle is pulled out of the puncture sleeve. 3.3 Puncture force The maximum force required for the trocar to pierce the test material at a certain speed. 3.4 Insertion force/ pullout force The maximum force required for the puncture needle to be inserted into/pulled out from the trocar sleeve.4 Structure and materials4.1 Structure and identification 4.1.1 The trocar is mainly composed of a puncture sleeve and a puncture needle, and can be equipped with a converter. The main parts of the puncture sleeve are composed of a cannula, a gas injection valve, a cannula seat, a sheath cap (including a seal) and a gas blocking valve, and the surface of the cannula can be threaded; the main parts of the puncture needle consist of a needle head, a needle shaft and a needle handle, and the needle head can be equipped with a skin-cutting or non-skin-cutting puncture knife. 4.2 Materials Puncture sleeve, puncture needle head, puncture needle shaft. shall be made of stainless steel and other materials specified in YY/T 0294.1-2016.5 Requirements5.1 Appearance 5.1.1 The outer surface of the trocar shall be smooth and clean, and there shall be no defects such as burrs, air bubbles, impurities, cracks, pores, grooves, sintered objects, and rust on the surface. 5.1.2 There shall be no visible accumulation of lubricant on the trocar surface. 5.2 Dimensions The inner diameter ϕ of the puncture sleeve and the working length L of the puncture sleeve shall meet the requirements in Table 1. 5.3 Surface roughness The surface of the trocar can be treated to be bright or dull, and the maximum surface roughness Ra of the metal parts shall not be greater than 0.4 μm for bright and not greater than 0.8 μm for dull. 5.4 Flexibility 5.4.1 The gas injection valve of the trocar shall be opened and closed flexibly, and there shall be no blockage or stagnation. 5.4.2 If the needle head of the puncture needle is equipped with a puncture knife, the puncture knife shall be able to retract flexibly, and there shall be no blockage or stagnation. 5.5 Fitting performance 5.6 Gas barrier property and sealing property 5.6.1 The trocar shall have a good gas barrier property, and the number of air bubbles shall be less than 20 under the pressure of 4 kPa. 5.6.2 The trocar shall have a good sealing property, and there shall be no leakage under the pressure of 4 kPa. 5.7 Hardness The hardness of the puncture needle head shall be ≥210 HV0.2. 5.8 Gas injection valve interface The gas injection valve shall be equipped with a Luer lock connector, in line with the provisions of GB/T 1962.2. 5.9 Puncture, insertion and pullout properties The puncture property and insertion/pullout property of the trocar shall be evaluated, which shall comply with the manufacturer’s regulations. 5.10 Corrosion resistance The corrosion resistance of trocar parts made of stainless steel shall not be lower than the requirements of grade b in 5.4 of YY/T 0149-2006. 5.12 Converter sealing property A converter, if equipped and used with the trocar, shall have good sealing property, and there shall be no leakage when subjected to 4 kPa air pressure. 5.13 Connection firmness 5.13.1 If the sheath cap is detachable, it shall be firmly connected with the puncture cannula seat, and there shall be no disengagement at the connection. 5.13.2 The connection of the puncture sleeve shall be firm, and the cannula and cannula seat shall not be separated. 5.14 Packaging, marking and instructions 5.14.1 The single package of trocar shall have a marking that meets the requirements of 4.1.2. 5.15 Biological evaluation The trocar shall be biologically evaluated according to the provisions of the GB/T 16886 series standards, and there shall be no biocompatibility hazards.6 Test methods6.1 Appearance Check by visual observation – normal or corrected vision – and hand touch under the illumination of 300 lx ~ 750 lx. 6.2 Dimensions Use a general or special measuring tool for measurement. 6.3 Surface roughness Check with surface roughness comparison samples. 6.4 Flexibility 6.5 Fitting performance 6.5.1 Imitate the operation, insert and pull out the puncture needle in the puncture sleeve 3 times. 6.6 Gas barrier and sealing property Follow the method specified in Appendix A. 6.7 Hardness According to the method specified in GB/T 4340.1-2009, calculate the average value of the three measurement points. 6.8 Gas injection valve interface The Luer lock joint of the gas injection valve shall be tested according to the method specified in GB/T 1962.2. 6.9 Puncture, insertion and pullout properties See Appendix B and Appendix C for the test methods for the evaluation of puncture property and insertion/pullout property. 6.11 Reusability According to the cleaning, disinfection and sterilization methods specified by the manufacturer, test the trocar repeatedly for 20 times. 6.12 Converter sealing property Assemble the converter with the trocar; use the puncture needle of the converter’s matching specifications; follow the test method for sealing property in Appendix A. 6.13 Connection firmness 6.13.1 At the connection between the detachable sheath cap and the puncture sleeve seat, apply an axial static tension force of 50 N to any part for 10 s. 6.13.2 Imitate the operation; fix the cannula; rotate and pull the cannula seat. 6.14 Packaging, marking and instructions Observe visually. 6.15 Biological evaluation The trocar shall be subjected to biological evaluation according to the provisions of GB/T 16886.7 Type inspectionDuring type inspection, unless otherwise specified, the inspection items shall be 5.1 ~ 5.14.8 Label, instructions8.1 Label The label of trocar shall at least have the following contents or symbols. 8.2 Instructions The instructions for trocar shall at least include the following.9 Packaging, transportation and storage9.1 Packaging The trocar package (the smallest sales unit) shall be accompanied by instructions for use and qualification certificates. 9.2 Transportation and storage ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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