YY/T 1797-2021 PDF EnglishUS$320.00 · In stock · Download in 9 seconds
YY/T 1797-2021: Endoscopic surgical instruments - Endoscopic cutter stapler and reload 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 1797-2021: Endoscopic surgical instruments - Endoscopic cutter stapler and reload---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/YYT1797-2021YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.30 C 36 Endoscopic surgical instruments - Endoscopic cutter stapler and reload Issued on. SEPTEMBER 06, 2021 Implemented on. SEPTEMBER 01, 2022 Issued by. National Medical Products Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative references... 4 3 Structure and materials... 5 4 Requirements... 9 5 Test methods... 13 6 Type inspection... 17 7 Label, instruction manual... 17 8 Packaging... 19 Appendix A (Informative) Test materials for anastomosis and cutting performance.. 20 Appendix B (Normative) Staple line suture strength test... 21 Appendix C (Normative) Test method for cutting edge sharpness... 23 Appendix D (Normative) Pressure performance test... 26ForewordThis Standard was drafted in accordance with the rules given in GB/T 1.1-2009. 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 Standard was proposed by the National Medical Products Administration. This Standard 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 Standard. Shanghai Medical Device Testing Institute, Victor Medical Instruments Co., Ltd., Shandong WeRay Surgical Medical Products Co., Ltd. and EziSurg Medical Co., Ltd. Chief drafting staffs of this Standard. Huang Shuze, Jiang Shihua, Yao Daqiang, Liu Qingfeng, Zou Fengping, Wang Wei, Zhang Qijin, Wang Lei, Yao Yao, Wang Hailong, Chen Zhaowei, Bao Minghui. Endoscopic surgical instruments - Endoscopic cutter stapler and reload1 ScopeThis Standard specifies the structure and materials, requirements, test methods, type inspection, labels, instruction manuals and packaging of endoscopic cutter stapler and reload (hereinafter referred to as stapler) used in endoscopic surgery. This Standard applies to disposable endoscopic cutter stapler and reload used in endoscopic surgery. Note. This stapler applies to anastomotic establishment and stump or incision closure in digestive tract reconstruction and organ resection.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies to this document. For undated references, the latest edition (including any amendment) applies to this document. GB/T 228.1, Metallic materials - Tensile testing - Part 1.Method of test at room temperature GB/T 1220, Stainless steel bars GB/T 3280, Cold rolled stainless steel plate, sheet and strip GB/T 4237, Hot rolled stainless steel plate, sheet and strip GB/T 4340.1, Metallic materials - Vickers hardness test. Part 1.Test method GB/T 6682-2008, Water for analytical laboratory use - Specification and test methods GB/T 10610, Geometrical product specifications (GPS) - Surface texture. Profile method - Rules and procedures for the assessment of surface texture GB/T 13810, Wrought titanium and titanium alloy for surgical implants GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for medical use - Part 1.Chemical analysis methods GB/T 16886, Biological evaluation of medical devices3 Structure and materials3.1 The stapler consists of a stapler body and some assemblies. According to the design of the cutter knife, the stapler can be divided into a type where the cutter knife is assembled to the assembly and a type where the cutter knife is assembled to the stapler body; according to the joint structure, it can be divided into the bending type and the non-bending type.4 Requirements4.1 Staple materials 4.2 Appearance 4.2.1 The stapler shall be smooth in appearance, clear in outline, free from defects such as burrs and scratches; the metal outer surface of the weld shall be free from defects such as cracks, welding slags, and weld tumors. Specifications of the staple line (nominal value) Staple original height (nominal value) 4.2.2 The shape and structure of the stapler head end shall be blunt, without sharp edges or corners. 4.2.3 The surface of the stapler (assemblies and stapler rod parts) shall be matt. 4.3 Corrosion resistance The corrosion resistance of the metal parts on the outer surface of the stapler head end shall not be lower than that specified in 5.4b) of YY/T 0149-2006. 4.4 Surface roughness The roughness Ra of the metal outer surface of the stapler assemblies and the stapler rod parts shall not be greater than 1.6 μm. 4.5 Dimensions The basic dimensions of the stapler shall meet the requirements of Table 1. 4.6 Hardness The hardness of the cutter knife shall not be less than 377HV0.2. 4.7 Assembly 4.8 Flexibility 4.8.1 The opening and closing of the stapler jaws shall be flexible, and there shall be no blocking phenomenon. 4.8.2 The joint structure and rotational structure of the stapler shall be flexible and free of obstacles. 4.9 Performance 4.9.1 The connection between the stapler body and the assemblies shall be firm and reliable. 4.9.5 The stapler shall be available for one-hand operability. 4.9.6 The stapler shall be provided with good stapling and cutting performance. When the assemblies are replaced, the cutting edge after each anastomosis shall be neat and free of burrs, and the distal-end length of the staple line shall be at least 1.5 times longer than the cutting line. The staples after each anastomosis shall be shaped like "B". 4.12 Protective device 4.12.1 The stapler shall have an empty staple cartridge protective device, so that it cannot be fired when the empty staple cartridge is installed by mistake. Note. Empty cartridge refers to fired assemblies. 4.13 Matching performance with trocar The stapler shall be smoothly inserted into the matched trocar specified in the manual, and pulled out smoothly. 4.14 Sterility The stapler shall be sterilized by a validated sterilization process and the product shall be sterile. 4.15 Bacterial endotoxin The bacterial endotoxin content of the stapler used for blood vessels shall be less than or equal to 20 EU/piece. 4.17.4 Reducing substances The difference of the consumption of potassium permanganate solution [c(1/5KMnO4) = 0.01 mol/L], compared with the same volume of blank control solution in the same batch, shall be less than or equal to 2.0 mL. 4.17.5 Evaporation residue The total dry residue of the dissolution solution shall be less than or equal to 2.0 mg. 4.18 Biological evaluation The stapler shall be biologically evaluated according to the provisions of the GB/T 16886 series standards, and there shall be no biocompatibility hazards. 4.19 Instruction manual5 Test methods5.1 Staple materials 5.2 Appearance Under the illumination of 300 lx ~ 750 lx, observe by normal or corrected visual acuity, and rub with hands, which shall meet the requirements of 4.2. 5.3 Corrosion resistance Carry out the test according to the boiling water test method in YY/T 0149-2006, which shall meet the requirements of 4.3. 5.4 Surface roughness The surface roughness shall be tested by the sample block comparison method or the profile method specified in GB/T 10610, which shall meet the requirements of 4.4. Use the profile method during arbitration. 5.7 Assembly 5.7.1 Imitate the use action to load and replace assemblies, which shall comply with the provisions of 4.7.1. 5.8 Flexibility After correctly loading the assemblies, imitate the use action to check the flexibility, which shall meet the provisions of 4.8. 5.9 Performance 5.9.3 Use the instrument to clamp the EVA low-foamed plate sample whose total thickness is 1/2 ~ 2/3 the original height of the staples; fix the stapler body on the fixture; apply a push-pull device to clamp the EVA low-foamed plate sample; then, measure the clamping force in axial direction, which shall comply with the provisions of 4.9.3. 5.9.6 Imitate the use action to match the EVA low-foamed plate sample whose total thickness is 1/2 ~ 2/3 the original height of the staples, where the cutter knife is assembled to the assembly, 5.9.7 Carry out the test according to the method specified in Appendix B, which shall meet the requirements of 4.9.7. 5.9.8 Imitate the use action to fire the stapler, which shall comply with the provisions of 4.9.8. 5.10 Cutter knife sharpness Carry out the test according to the method specified in Appendix C, which shall comply with the provisions of 4.10. 5.17 Chemical properties (polymer material of the part in contact with the patient) 5.17.1 Test liquid preparation Take the sample; put it in a glass container according to the ratio of 0.2 g of sample to 1 mL of test water (grade-2 water in accordance with GB/T 6682-2008); leach at the constant temperature of 37 ℃ ± 1 ℃ for 24 h; separate the sample from the liquid; cool to room temperature; use it as a test solution. Take the same volume of test water and place it in a glass container; prepare a blank control solution in the same way. 5.17.2 Appearance Take the test solution and observe the solution visually, which shall meet the requirements of 4.17.1. 5.17.3 pH value 5.18 Biological evaluation The stapler shall be biologically evaluated in accordance with the provisions of the GB/T 16886 series standards, which shall comply with the provisions of 4.18. 5.19 Instruction manual Observe visually, which shall meet the provisions of 4.19.6 Type inspectionType inspection items of the stapler are those specified in 4.1 ~ 4.17 and 4.19.7 Label, instruction manual7.1 Label The label of the stapler shall have at least the following contents or symbols. 7.2 Instruction manual The instruction manual for the stapler shall contain at least the following.8 Packaging8.1 The minimum sales package of the stapler shall be accompanied by an instruction manual, a quality certification mark or a product certification. 8.2 The product shall be packaged in a suitable way for sterilization. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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