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YY/T 0940-2014: Medical Endoscopes - Endotherapy Device - Grasping 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 0940-2014: Medical Endoscopes - Endotherapy Device - Grasping 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/YYT0940-2014YY PHARMACEUTICAL INDUSTRY STANDARD OF THEPEOPLE’S REPUBLIC OF CHINA ICS 11.040.99 C 40 Medical Endoscopes - Endotherapy Device - Grasping 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... 5 4 Requirements... 5 5 Test Methods... 10 6 Inspection Rules... 14ForewordThis Standard was drafted as per the rules specified in GB/T 1.1-2009. Please note some contents of this document may involve the patents. The issuing agency of this document shall not assume the responsibility to identify these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Subcommittee for Standardization of Medical Optics and Instruments (SAC/TC 103/SC 1). Drafting organizations of this Standard. Zhejiang Institute for the Control of Medical Device; and Medical Device Supervising and Testing Center of Hangzhou, State Food and Drug Administration. Chief drafting staffs of this Standard. Qi Weiming, Zhang Qinyuan, Jia Xiaohang, and Yan Qinglai. Medical Endoscopes - Endotherapy Device - Grasping Forceps1 ScopeThis Standard specifies the scope, terms and definitions, requirements, and test methods of grasping forceps. This Standard is applicable to grasping forceps used in endoscopic surgery.2 Normative ReferencesThe following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document. 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 9706.4 Medical Electrical Equipment - Part 2-2.Particular Requirements for the Safety of High Frequency Surgical Equipment GB 9706.19 Medical Electrical Equipment - Part 2.Particular Requirements for the Safety of Endoscopic Equipment GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipment for Medical Use - Part 1.Chemical Analysis Methods3 Terms and DefinitionsFor the purpose of this document, the following terms and definitions apply. 3.1 Grasping forceps An endotherapy device that is used in conjunction with a designated endoscope, which is mainly composed of a handle, a clamp rod, and a clamp head; and is used to grasp and obtain human tissue. 3.3 Maximum insertion portion width The maximum outer width of the insertion portion 3.4 Working length The maximum length of the insertion portion of the grasping forceps. 3.5 Endotherapy device In endoscopic surgery, for the purposes of inspection, diagnosis or treatment, it is a medical device that enters the human body's natural orifice or surgical incision through the same or different channel as the endoscope.4 Requirements4.1 Materials used in contact with the patient 4.1.1 Requirements for chemical composition The part of material that is used in contact with the patient shall be clearly stated 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; and the chemical composition of the metal material shall be verified through tests. 4.1.3 Dissolved and precipitated products of polymer materials in contact with patients 4.1.3.1 Appearance (turbidity, color). colorless and transparent; no foreign matter can be seen by visual inspection. 4.1.3.5 Evaporation residue. The total dry residue of the dissolution solution shall be less than 2.0mg. 4.1.4 Hardness The clamp head shall meet the hardness requirements specified by the manufacturer. 4.1.5 The manufacturer shall claim that the surface part of the device that uses metal materials shall be consistent with the internal material. If it is really necessary to coat the surface of the device, the manufacturer shall provide the corresponding coating requirements and test methods. 4.2 Appearance 4.2.1 Under the field of view of the endoscope, the visible tip of the surgical instrument shall be processed to eliminate possible directional reflection. 4.2.2 Except for special purposes, there shall be no possible damage such as burrs on the outer surface. 4.3 Dimensions 4.3.1 Maximum insertion portion width The manufacturer shall give the nominal value of the maximum insertion portion width in the instruction manual. 4.4 Use performance 4.4.1 Opening and closing performance The opening and closing of the clamp head shall be smooth, and the clamp rod shall not be shaken that interferes with the user's usage when opening and closing. 4.4.2 Clamping force There shall be a certain clamping force. The manufacturer shall give the meshing force of the clamp head in the locking state; and its actual meshing force shall not exceed 20% of the manufacturer's stated value. 4.4.6 Closing force transmission coefficient The force transmission coefficient between the force applied by the handle and the closing force of the clamp head shall comply with the manufacturer's provisions. 4.4.7 Tooth shape of the clamp head The arrangement of the tooth shape of the grasping forceps head shall meet the design requirements, and the tooth shape shall be clear, accurate, and in place. 4.5 Tolerance (applicable to non-disposable products) 4.5.1 High-temperature and high-pressure resistance The grasping forceps marked as being able to withstand high-temperature and high- pressure shall still meet the requirements of 4.4 after 20 high-temperature and high- pressure tests. 4.6 Sterilization requirements (applicable to disposable products) 4.6.1 The grasping forceps shall be sterile. 4.6.2 Residual ethylene oxide (applicable to products using ethylene oxide sterilization method), and residual concentration of ethylene oxide. 10μg/g below. 4.7 Luer connector (applicable to the grasping forceps with the filling port) It shall meet the relevant requirements of GB/T 1962 (all parts). 4.8 Product instruction manual 4.8.1 It should contain a clear description of the endoscope and its accessories that can be used in conjunction with the grasping forceps; so that the user can select the appropriate endoscope and its accessories according to this guide. 4.8.8 Operation, transportation and storage environmental restrictions. the allowable environmental conditions for operation, transportation and storage shall be specified. 4.9 Marking and labels The product shall have a clearly identifiable and permanently affixed marks, the name and/or trademark of the manufacturer or supplier. 4.11 Water/air flow performance (applicable to grasping forceps with filling ports) The manufacturer shall give requirements and test methods for the water or air flow of the injection channel.5 Test Methods5.1 Material test 5.1.1 Chemical composition test The chemical composition analysis test of metal materials is carried out with the method whose accuracy reaches or is better than 1/3 of the tolerance or limit. 5.1.3.4 Potassium permanganate reducing substances. it shall be carried out according to the method specified in 5.2 of GB/T 14233.1-2008. 5.1.3.5 Steaming residues. it shall be carried out according to the method specified in 5.5 of GB/T 14233.1-2008. 5.1.4 Hardness test It shall be carried out according to the method specified in GB/T 4340.1-2009; measure 3 points on each of the 2 pieces of clamp head; and take the arithmetic average of every 3 points. 5.2 Appearance 5.2.1 Imitate actual operation and take visual inspection. 5.2.2 Defects such as burrs. feel it, and take visual inspection. 5.3 Dimensions 5.3.1 Inspection of the maximum insertion portion width Use universal measuring tools to test. 5.4 Use performance test 5.4.1 Opening and closing test Imitate actual operation and take visual inspection. 5.4.2 Clamping force test Clamp a No. 7 type-Ⅰ suture thread specified by YY 0167-2005 at the front 1/3 of the head of the grasping forceps; the grasping forceps are completely closed; and apply the manufacturer's specified pulling force to the suture thread in a direction parallel to the main axis of the clamp rod. The suture thread must not slip off. 5.4.5 Locking-meshing force The locking-meshing force is tested in a simulated application state. The slightly open state of the clamp head is given by the manufacturer; and is expressed by the open height at the 1/3 front of the head. Put the handle of the grasping forceps in the locking state; and measure the meshing force value at the1/3 front of the head in this state, which is the locking-meshing force. 5.4.6 Closing force transmission coefficient The test is performed in a simulated application state. The slightly open state of the clamp head is given by the manufacturer. It is expressed by the open height at the 1/3 front of the head. The force fi on the handle is within the range of 5N~20N; and the sampling interval is no greater than 3N. Record the closing force value fo perpendicular to the bisector of the opening angle of the clamp head at the 1/3 front of the head; and fit the collected data through the least squares method to get the value of fo/fi, which is the closing force transmission coefficient. 5.4.7 Tooth type test of clamp head Use a 10x magnifier to observe the alignment. 5.5 Tolerance test 5.5.1 High-temperature and high-pressure resistance test After repeating the test for 20 times in accordance with the manufacturer's high- temperature and high-pressure test method, the test shall be carried out according to the method of 5.4. 5.6 Sterilization requirement test 5.6.1 It shall be carried out according to the method specified in GB/T 14233.2; thereof, the preparation method of the test solution can be specified by the manufacturer, if it is not applicable. 5.6.2 It shall be carried out in accordance with the gas chromatography method specified in Clause 9 of GB/T 14233.1-2008. 5.7 Luer connector test It shall be carried out according to related tests of GB/T 1962. 5.8 Inspection of product instruction manual Check the contents of the product instruction manual provided by the manufacturer. 5.9 Inspection of marking and label Visually inspect the contents of the marking and label on the product. 5.10 Electrical safety test methods It shall be carried out according to the method in GB 9706.4 and GB 9706.19. 5.11 Water/air flow performance It shall be carried 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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