YY/T 0614-2017 PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY/T 0614-2017: Single-use high-pressure angiographic syringes and accessories 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 0614: Historical versions
YY/T 0614-2017: Single-use high-pressure angiographic syringes and accessories---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/YYT0614-2017YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.20 C 31 Replacing YY/T 0614-2007 Single-use high-pressure angiographic syringes and accessories Issued on. FEBRUARY 28, 2017 Implemented on. JANUARY 01, 2018 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 Introduction... 5 1 Scope... 6 2 Normative references... 6 3 Product type... 7 4 Product marking... 8 5 Materials... 9 6 Physical requirements... 9 7 Chemical requirements... 12 8 Biological requirements... 12 9 Markings... 12 10 Packaging... 14 Appendix A (Normative) Adhesion test... 15 Appendix B (Normative) Chemical performance test solution preparation method... 17ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0614-2007 “Single-use high-pressure angiographic syringes and accessories”. As compared with YY/T 0614-2007, in addition to editorial changes, the main technical changes of this standard are as follows. - ADD the 88 kPa negative pressure adhesion requirements of the angiographic syringe; - MODIFY the cork piercer requirements; - MODIFY the air intake device requirements; - ADD anti-reflux valve requirements and test methods; - REVISE the adhesion test method; - ADD a single package identifier; - ADD a shelf package or multi-unit packaging identifier; - DELETE the Appendix A Particle content determination method from the original standard, the particle content determination method makes reference to the test method as given in YY/T 1556-2017 Test methods for particle contamination of infusion, transfusion and injection equipment for medical use which is formulated at the period; - MODIFY the chemical test solution preparation method. Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard shall be under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC 106). Drafting organizations of this standard. Shandong Medical Device Product Quality Inspection Center, Shenyang Xinzhiyuan Medical Products Co., Ltd., Wuxi Yushou Medical Devices Co., Ltd., Jiangsu Guoyu Ningtai Medical Devices Co., Ltd. Main drafters of this standard. Yao Xiujun, Gao Na, Liu Han, Feng Zhong, Han Enxi, Xing Xijuan. The previous versions of YY/T 0614 are. - YY 0614-2007.1 ScopeThis standard specifies the requirements for the single-use high-pressure angiographic syringes and accessories (hereinafter referred to as angiographic syringes). The angiographic syringe is mainly used by the medical department to perform digital subtraction angiography (DSA), computer-controlled tomography (CT), magnetic resonance imaging (MRI), and ultrasound (US) examinations, together with various types of high-pressure injection device. This standard does not include requirements for endovascular catheters and related guidance puncture devices.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) are applicable to this standard. GB/T 1962.1 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment - Part 1.General requirement GB/T 1962.2 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment - Part 2.Lock fittings GB 15810 Sterile hypodermic syringes for single use YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1.General requirements YY 0585.4-2009 Fluid lines for use with pressure infusion equipment and accessories for single use - Part 4.Check valves3 Product typeFigure 1 ~ Figure 3 show the schematic diagrams of the structures of common angiographic syringes and accessories (inhalers, connecting lines, etc.).4 Product markingProducts marking is composed of product literal expression, this standard number, applicable angiographic imaging techniques code [such as computer- controlled X-ray tomography (CT), digital subtraction angiography (DSA), magnetic resonance imaging (MRI), ultrasound (US), etc.], injection equipment5 MaterialsThe materials used for the angiographic syringe and the parts given in clause 3 shall comply with the requirements of clause 6.6 Physical requirements6.1 General requirements 6.1.4 6% Luer cone joint The conical joint for angiographic syringes and accessories shall meet the following requirements. 6.1.5 Particle contamination Angiographic syringes and accessories shall be manufactured with minimal particulate contamination. 6.2 Angiographic syringe additional requirements 6.2.1 Lubricants The inner surface of the angiographic syringe jacket and the outer surface of the plunger shall have no lubricant accumulation. 6.2.2 Transparency The angiographic syringe jacket shall have sufficient transparency. 6.3 Additional requirements for inhaler 6.3.1 Puncture type inhaler 6.3.2 Tubular inhaler Tubular inhaler shall be compatible with angiographic syringes, the wall thickness shall not be less than 0.5 mm. 6.4 Additional requirements for connection pipelines 6.4.1 Size The internal diameter of the connection pipelines shall not be less than 1.0 mm, the length shall not be less than the nominal value. 6.4.4 Anti-backflow valve 6.4.4.1 Backflow pressure impedance At 23 °C ± 2 °C, the anti-backflow valve shall be able to withstand the nominal water pressure for 30 s along the backflow direction of the connection pipeline without leakage. 6.4.4.2 Blocking performance It shall meet the requirements of clause 6.7 of YY 0585.4-2009.7 Chemical requirementsThe provisions of GB 15810 apply to angiographic syringes and accessories, but the preparation method of test liquids is in accordance with Appendix B.8 Biological requirementsThe provisions of GB 15810 apply to angiographic syringes and accessories.9 Markings9.1 Single package The single package shall be marked with at least the following information. 9.2 Shelf packaging or multiple-unit packaging The shelf packaging or multi-unit packaging (if used) shall have at least the following information.10 Packaging10.1 Angiographic syringes and/or accessories shall be packaged in set or individually packaged, the packaging shall ensure that the contents remain sterile during the storage period. After opening the single package, there shall be open signs. ......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 0614-2017 be delivered?Answer: The full copy PDF of English version of YY/T 0614-2017 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 0614-2017_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0614-2017_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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