YY Translated English of Chinese Standard: YY NATIONAL STANDARD OF THE

Transcription

1 Translated English of Chinese Standard: YY NATIONAL STANDARD OF THE YY PEOPLE S REPUBLIC OF CHINA ICS C 40 YY Medical endoscopes - Endotherapy device Stone retrieval forceps 医用内窥镜内窥镜器械取石网篮 Issued on: December 31, 2011 Implemented on: June 1, 2013 Issued by: China Food and Drug Administration Page 1 of 12

2 Table of Contents Foreword Scope Normative references Terms and definitions Requirements Test methods Inspection rules Page 2 of 12

3 Foreword This Standard was drafted in accordance with the rules given in GB/T Please note that some content of this document may involve patents. The issuing agency of this document does not undertake the responsibility for the identification of these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of National Medical Optical Instrument Standardization Technical Committee (SAC/TC103/SC1). The drafting organizations of this Standard: Supervising and Testing Center of Hangzhou Zhejiang Institute of State Food and Drug Administration, and Zhejiang Institute for the Control of Medical Device. Main drafters of this Standard: Zhang Qinyuan, Jia Xiaohang, Yan Qinglai, He Tao and Qi Weiming. Page 3 of 12

4 Medical endoscopes - Endotherapy device Stone retrieval forceps 1 Scope This Standard specifies the scope, terms and definitions, requirements and test methods of stone retrieval forceps. This Standard is applicable to stone retrieval forceps that is used for endoscopic surgery as an independent product. 2 Normative references The 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 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement GB/T Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings GB Stainless steel for surgical implants GB/T Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods GB/T Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods GB/T Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process YY/T Medical instruments of stainless steel - Test methods of corrosion resistance YY Surgical instruments - Metallic materials - Part 1: Stainless steel Page 4 of 12

5 YY/T Marking requirements for surgical instruments 3 Terms and definitions The following terms and definitions are applicable to this document. 3.1 Wire basket A mesh basket that is used for taking stone, foreign matter or tissue sample. 3.2 Stone retrieval forceps An endotherapy device that works with designated endoscope, which is mainly composed of handle, slender guiding-rope and guiding-duct, and wire basket on the head. It traps the stone, foreign matter or tissue sample via wire basket s circle; and firmly catches the stone, foreign matter or tissue sample through contraction of wire basket. 3.3 Insertion portion A part of stone retrieval forceps which can be inserted into human nature orifice, surgical incision, endoscope s device channel or endotherapy device s channel. 3.4 Maximum insertion portion width The maximum external width of insertion portion. 3.5 Working length The maximum length of insertion portion of stone retrieval forceps. 3.6 Endotherapy device A medical device, which is used in endoscopic surgery, goes into human nature orifice or surgical incision through the same or different channel with endoscope, so as to realize examination, diagnosis or treatment. Note 1: Endotherapy device includes some devices that lead the endotherapy device to insert. It also includes some devices that are used under observation of endoscope and go from human opening which is different from the endoscope, for safety purpose. 4 Requirements 4.1 Material used in the part of contacting with patients Requirements for chemical composition Page 5 of 12

6 Material used in the part of contacting with patients shall be clearly indicated in any possible form by the manufacturer. Metal material shall be marked with trademark and/or code as well as the material s chemical composition requirements. Metal material s chemical composition shall be verified by experiment Biocompatibility For material used in the part of contacting with patients, it shall conduct biological safety evaluation according to principles and requirements in GB/T , so as to prove that it has good biocompatibility. Biological evaluation shall consider the results of biological test. The selection of test items are conducted according to the guideline of GB/T Relevant parts of GB/T are preferred for all the tests. For material that has previously been proved as applicable, if it can prove that the following manufacturing process is insufficient to produce any biological safety hazards, then it may be exempted from repeated biological test. Note 1: When device s material in design has demonstrable history of using in specific application OR any obtainable material s and/or device s information from other aspects, it shall be regarded that the material has been proved as applicable. Note 2: If metal material uses medical metal material that is suitable in application scope of national or industrial standard, it may be exempted from repeated biological test Polymeric material s dissolving precipitates in the part of contacting with patients Surface / appearance: colorless and transparent, no foreign matter inspected by visual inspection ph: ph difference is less than Heavy metal: leachables are less than 5.0 µg/ml Potassium permanganate reducing substances: consumption difference with standard test solution is less than 2.0 ml Evaporation residue: less than 2.0 mg. 4.2 Appearance Except for special purpose, there shall not have any possible safety-harm on the outer surface There is no floss, loosing, other obvious abnormalities or damage for wire Page 6 of 12

7 5.3.4 Use a universal measuring tool to measure, according to requirements in Performance tests Tensile strength test Apply the nominal tension, provided by the manufacturer, to the whole stone retrieval forceps. No damage or fracture on each part of stone retrieval forceps Coil the insertion portion into a circle or arc of which the radius is 10 cm; push the handle; the stone retrieval forceps shall be open and close smoothly Coil the insertion portion into a circle or arc of which the radius is 10 cm; open the stone retrieval forceps; turn the handle; the stone retrieval forceps shall rotate smoothly. 5.5 Tolerance tests High temperature and high pressure resistance test After 20 tests of high temperature and high pressure resistance, it shall still comply with requirements in 4.2 and Corrosion resistance test Conduct boiling water test in YY/T for the portion that uses stainless steel, according to requirements in For other materials, it shall conduct once according to the sterilization method, as designated in the instructions for use by the manufacturer. There shall have no corrosion Repeated operation resistance For operation of actual-practice simulation, it shall comply with requirements in Sterility requirement test Conduct in the method specified in GB/T , according to requirements in Conduct in gas chromatography specified in GB/T , according to requirements in Luer fitting test Conduct according to relevant tests in GB/T , GB/T , and requirements in Page 11 of 12