YY/T 0943-2014 PDF EnglishUS$170.00 · In stock · Download in 9 seconds
YY/T 0943-2014: Medical endoscopes - Endotherapy device - Needle forceps Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
YY/T 0943-2014: Medical endoscopes - Endotherapy device - Needle forceps---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/YYT0943-2014YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.99 C 40 Medical endoscopes - Endotherapy device - Needle forceps Issued on. JUNE 17, 2014 Implemented on. JULY 01, 2015 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative references... 4 3 Terms and definitions... 4 4 Requirements... 5 5 Test methods... 9 6 Inspection rules... 13ForewordThis Standard was drafted in accordance with the rules given in GB/T 1.1-2009. Attention is drawn to the possibility that some of the elements of this Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of Sub-technical Committee of National Technical Committee on Medical Optics and Instruments of Standardization Administration of China (SAC/TC 103/SC 1). The drafting organizations of this Standard. Zhejiang Medical Device Inspection Institute, State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center. Main drafters of this Standard. Jia Xiaohang, Zhang Qinyuan, Yan Qinglai. Medical endoscopes - Endotherapy device - Needle forceps1 ScopeThis Standard specifies the scope, terms and definitions, requirements, test methods for needle forceps. This Standard applies to needle forceps used in endoscopic surgery.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 1962 (all parts), Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment GB/T 4340.1-2009, Metallic materials - Vickers hardness test - Part 1.Test method GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for medical use - Part 1.Chemical analysis methods3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply. 3.1 needle forceps An endoscopic instrument for use with a designated endoscope. It is mainly composed of handle, forceps rod, forceps head. It is used to hold suture needles. 3.2 insertion portion A part of needle forceps. This portion can be inserted into the natural orifice of the human body or the surgical incision, or into the instrument channel of the endoscope, or the instrument channel of the endoscope accessory, or the instrument channel of the endoscope instrument. 3.5 endotherapy device In endoscopic surgery, for the purpose of examination, diagnosis or treatment, a medical device that enters the natural orifice or surgical incision of the human body through the same or different channel as the endoscope.4 Requirements4.1 Materials used in patient contact parts 4.1.1 Requirements for chemical composition The material used in the parts in contact with the patient shall be indicated by the manufacturer in any possible form. Among them, the metal material shall be marked with the designation and (or) code and the chemical composition requirements of the material. The chemical composition of metallic materials shall be verified by tests. 4.1.3 Dissolution extracts of polymeric materials in patient contact parts 4.1.3.1 Appearance (turbidity, color). Colorless and transparent. No foreign matter can be seen by visual inspection. 4.1.3.2 pH. Compared with the blank control solution of the same batch, the pH difference shall be less than 2.0. 4.1.4 Hardness The forceps head shall meet the hardness requirements specified by the manufacturer. 4.1.5 Surface and internal material consistency The manufacturer shall claim that the surface of the part of the device made of metal material is consistent with the internal material. If it is really necessary to coat the surface of the device, the manufacturer shall give the corresponding coating requirements and test methods. 4.2 Appearance 4.2.1 Under the endoscopic field of view, the visible tip portion of the surgical instrument shall be treated, so as to eliminate possible directional reflections. 4.2.2 Except for special purposes, the outer surface shall not have burrs and other defects that may cause injury. 4.2.3 The locking teeth on the locking mechanism of the needle forceps shall be complete. 4.3 Size 4.3.1 Maximum insertion portion width The manufacturer shall give the nominal value of the maximum insertion portion width in the instructions for use. 4.4 Use performance 4.4.1 Opening-closing performance The forceps heads shall open and close smoothly. When the forceps rods are opened and closed, there shall be no shaking that interferes with the user's use. 4.4.2 Clamping force There shall be a certain clamping force. 4.4.5 Rotation performance (for needle forceps with rotation function) Rotation shall be smooth. When the forceps rods are rotated, there must be no shaking that interferes with the user's use. 4.4.6 Hold the needle forceps in the maximum locking state, and there shall be no damage or deformation. 4.4.7 The arrangement of the tooth pattern of the needle forceps head shall meet the design requirements. The tooth pattern shall be clear. The alignment shall be accurate. The meshing shall be in place. 4.5 Resistance (for non-single-use products) 4.5.1 High-temperature and high-pressure resistance After 20 high-temperature and high-pressure tests of needle forceps marked as high- temperature and high-pressure resistance, they shall still meet the requirements of 4.4. 4.6 Sterilization requirements (for single-use products) 4.6.1 Needle forceps shall be sterile. 4.6.2 Residual amount of ethylene oxide (applicable to products sterilized by ethylene oxide) Residual concentration of ethylene oxide. 10μg/g or less. 4.7 Luer connector (for needle forceps with injection port) It shall meet the relevant requirements of GB/T 1962. 4.8 Instructions for use 4.8.1 It shall contain clear instructions for the suture needles, endoscopes and 4.8.3 Product specifications shall be included. 4.8.4 A statement of the intended use of the product shall be included. 4.8.5 Instructions for preparation, inspection and operation when using the product shall be included. 4.8.7 If the needle forceps are not single-use products, the instructions for use shall include details on the methods of cleaning, disinfection or sterilization that can be used. Prescribe suitable disinfectants when necessary. List the temperature, pressure, humidity, and time limits to which these equipment components can withstand. 4.8.8 Operation, transportation and storage environmental restrictions. The allowable environmental conditions for operation, transportation and storage shall be specified. 4.9 Labelling There shall be clearly legible and permanently affixed formal marks, the name and/or trademark of the manufacturer or supplier on the product.5 Test methods5.1 Material test 5.1.1 Chemical composition test The chemical composition analysis test of metal materials shall be carried out by a method whose accuracy is equal to or better than 1/3 of the tolerance or limit value. 5.1.4 Hardness test Carry out the test according to the method specified in GB/T 4340.1-2009.Measure 3 points on each of the 2 pieces of the forceps head. Take the arithmetic mean of every 3 points. 5.1.5 Consistency inspection of surface and interior materials Visually inspect. For products with a coating on the surface of the device, follow the corresponding test method provided by the manufacturer. 5.2 Appearance 5.2.1 Imitate the actual operation. Visually inspect. 5.3 Size 5.3.1 Inspection of maximum insertion portion width Use a universal measuring tool to inspect. 5.3.2 Inspection of working length Use a universal measuring tool to inspect. 5.3.3 Inspection of maximum opening range of forceps head Use a universal measuring tool to inspect. 5.4 Use performance tests 5.4.1 Opening-closing test Imitate the actual operation. Visually inspect. 5.4.2 Clamping force test 5.4.6 Anti-deformation test Lock the needle forceps in the maximum lock state. Hold a straight round needle that complies with YY 0043-2005.Keep this state for 10min. The temperature is room temperature. Check whether the suture needle is damaged or deformed. 5.4.7 Forceps head tooth test Use a 10x magnifying glass to observe the alignment. 5.5 Resistance tests 5.5.1 High-temperature and high-pressure resistance test After repeating the test for 20 times according to the high-temperature and high- pressure resistance test method specified by the manufacturer, carry out the test according to the method of 5.4. 5.5.2 Corrosion resistance test The martensitic and austenitic stainless-steel materials are partly tested according to the boiling water test method in YY/T 0149-2006.The rest materials are sterilized once as specified by the manufacturer in the instructions for use. 5.6 Sterilization requirements test 5.6.1 Sterilization test Carry out according to the method specified in GB/T 14233.2.The test solution preparation method may be specified by the manufacturer if not applicable. 5.7 Luer joint test Carry out according to the relevant test in GB/T 1962. 5.8 Inspection of instructions for use Check the contents of the instructions for use provided by the manufacturer. 5.9 Inspection of marks and labels Visually inspect the mark and label on the product. 5.10 Water/ventilation performance Carry out according to the test method specified by the manufacturer.6 Inspection rulesThe inspection rules are determined by the manufacturer according to the product characteristics. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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