YY/T 0806-2010 PDF EnglishUS$190.00 · In stock · Download in 9 seconds
YY/T 0806-2010: Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other medical devices 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 0806-2010: Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other medical devices---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/YYT0806-2010 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.20 C 31 Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other medical devices ISSUED ON: DECEMBER 27, 2010 IMPLEMENTED ON: JUNE 01, 2012 Issued by: China Food and Drug Administration Table of ContentsForeword ... 3 Introduction ... 4 1 Scope ... 5 2 Normative references ... 5 3 Requirements ... 6 4 Test method ... 7 5 Marking ... 9 6 Packaging and storage ... 9 References ... 10 Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other medical devices1 ScopeThis Standard specifies the requirements for polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other medical devices This Standard does not apply to polycarbonate copolymers.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 1033.1-2008, Plastics - Methods for determining the density of non- cellular plastics - Part 1: Immersion method liquid pyknometer method and titration method (ISO 1183-1:2004, IDT) GB/T 1843-2008, Plastics - Determination of izod impact strength GB/T 2547-2008, Plastic resins - Sampling GB/T 3682, Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics GB/T 9352-2008, Plastic - Compression moulding of test specimens of thermoplastic materials GB/T 14233.1-2008, Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process GB/T 2918-1998, Plastics - Standard atmospheres for conditioning and testing Visual inspection. 4.4 Physical properties 4.4.1 Melt volume-flow rate Take particle samples according to GB/T 3682. 4.4.2 Density Take particle samples according to method B in GB/T 1033.1-2008. 4.4.3 Izod notched impact strength Take samples prepared in 5.1 and carry out according to method A in GB/T 1843-2008. 4.4.4 Radiation-resistant materials For radiation-resistant sterilization polycarbonate materials for medical use, take a 3 mm-thick test piece; after 30 kGy radiation, place it under natural light conditions for 15 days; test the yellow index before and after radiation according to HG/T 3862. 4.5 Chemical properties of dissolved substances 4.5.1 Preparation of test solution Weigh particle samples and use the class-2 test water as specified in GB/T 6682-2008 to rinse them; add water in a ratio of 1:5 of mass (g) to water (mL); seal with a lid; place them in a pressure steam sterilizer, at 121 °C ± 1 °C of saturated steam, for 30 min; separate the sample from the solution; cool to room temperature. Take the same batch of water to prepare blank control solution by the same method. 4.5.2 Reducing substance Take the test solution and control solution, which are prepared according to 4.5.1, and carry out according to 5.2.2 of GB/T 14233.1-2008. 4.5.3 pH value Take the test solution and control solution, which are prepared according to 4.5.1, and carry out according to 5.4.1 of GB/T 14233.1-2008. 4.5.4 Evaporation residue Take the test solution and control solution, which are prepared according to 4.5.1, and carry out according to 5.5 of GB/T 14233.1-2008. 4.5.5 Metal ion Take the test solution that is prepared according to 4.5.1, and carry out according to 5.6.1 of GB/T 14233.1-2008 and/or the atomic absorption spectrophotometry (AAS) or equivalent method. 4.5.6 UV absorbance Take the test solution that is prepared according to 4.5.1, and carry out in the wavelength range of 250 nm ~ 320 nm according to the provisions of 5.7 of GB/T 14233.1-2008.5 MarkingThe marking on the outer packaging bag of the medical polycarbonate material product shall include the following contents: a) Product name; b) Manufacturer's name or trademark; c) Model; d) Batch number; e) Net weight.6 Packaging and storage6.1 Packaging Polycarbonate materials for medical use shall be at least double-packed, and the packaging shall ensure that the product will not be contaminated during transportation and storage. 6.2 Storage Polycarbonate materials for medical use shall be stored in a ventilated, dry and clean warehouse with well-maintained firefighting facilities. Store away from heat sources and avoid direct sunlight. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 0806-2010 be delivered?Answer: The full copy PDF of English version of YY/T 0806-2010 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 0806-2010_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0806-2010_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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