YY/T 1704.2-2020 PDF EnglishUS$110.00 · In stock · Download in 9 seconds
YY/T 1704.2-2020: Cervical dilator for single use - Part 2: Swollen dilator 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 1704.2-2020: Cervical dilator for single use - Part 2: Swollen dilator---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/YYT1704.2-2020YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 36 Cervical dilator for single use - Part 2: Swollen dilator ISSUED ON: FEBRUARY 21, 2020 IMPLEMENTED ON: JANUARY 01, 2021 Issued by: National Medical Products Administration Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Classification ... 4 4 Requirements ... 5 5 Test methods ... 7 6 Marks, packaging and instruction manual ... 8 7 Transport, storage ... 8 Cervical dilator for single use - Part 2: Swollen dilator1 ScopeThis Part of YY/T 1704 specifies the classification, requirements, test methods, marks, packaging and instruction manual, transport, storage and sterilization period for swollen cervical dilator for single use (hereinafter referred to as the dilator). This Part is applicable to the single-use swollen cervical dilator used for dilation of the uterus in the obstetrics and gynecology and family planning departments. This Part is not applicable to the cervical dilator made of metal.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 14233.1-2008, Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and testing YY/T 0171, Surgical instruments - Packaging, Marking and Instructions Pharmacopoeia of the People's Republic of China (2015 Edition) Part IV3 Classification3.1 Composition and structure 3.1.1 The dilator consists of a rod body and a placer (if any), as shown in Figure 1. 4.1.1 The rod of the dilator shall be smooth and uniform in color, and there shall be no defects such as cracks and burrs, and the head of the rod shall be smooth. 4.1.2 The dilator placer (if any) shall be smooth and free of sharp edges and burrs. 4.2 Dimensions The length and diameter of the dilator rod shall meet the requirements of Table 1. 4.3 Physical properties 4.3.1 The manufacturer shall specify the use time of the dilator and provide information on the diameter change with time after the rod has absorbed water (during use). 4.3.2 The dilator rod body shall have no cracks in the initial state and the state after water absorption (use time). 4.3.3 The dilator rod body and the placer (if any) shall be firmly connected in the initial state and the state after water absorption (use time). 4.3.4 There shall be no visible falling off after the dilator rod absorbs water. 4.4 Chemical properties 4.4.1 Heavy metals The total content of heavy metals in the dilator extract shall not exceed 1μg/mL. 4.4.2 PH Compare the dilator extract with the blank solution. The difference in pH shall not exceed 1.5. 4.5 Sterilization The dilator shall be sterilized by a confirmed sterilization process, and the sterilized dilator shall be sterile. 4.6 Residual ethylene oxide If the dilator is sterilized by ethylene oxide, the residual amount of ethylene oxide shall not exceed 10μg/g. 4.7 Biological evaluation The final product of the dilator shall be evaluated according to GB/T 16886.1. Take sample. Add water at a ratio: 0.1g of dilator (including placer, if any) to 5mL of water. Keep constant temperature at (37±1)°C for 1h. Separate the sample from water. Cool to room temperature as the extract. Take the same volume of water and place it in a glass container. Prepare blank control solution in the same way. 5.4.2 Heavy metals Test according to the method specified in 5.6.1 of GB/T 14233.1-2008, in accordance with the requirements of 4.4.1. 5.4.3 PH Test according to the method specified in 5.4.1 of GB/T 14233.1-2008, in accordance with the requirements of 4.4.2. 5.5 Sterilization It shall be carried out in accordance with the general principles "sterile test method" of part IV of the "Pharmacopoeia of the People's Republic of China" (Edition 2015), in accordance with the requirements of 4.5. NOTE: Each sterilization batch undergoes an effective monitoring process to make the product sterile. 5.6 Residual ethylene oxide Test according to the method specified in GB/T 14233.1-2008. Use gas chromatography in arbitration, in accordance with the requirements of 4.6. 5.7 Biological evaluation Evaluate according to the corresponding method of biological evaluation, in accordance with the requirements of 4.7.6 Marks, packaging and instruction manualThe marks, packaging and instruction manual of the dilator shall comply with the provisions of YY/T 0171.7 Transport, storage7.1 Transport Packaging and transportation requirements are in accordance with the ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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