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YY/T 0614-2017 English PDF (YY 0614-2007)

YY/T 0614-2017_English: PDF (YY/T0614-2017)
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YY/T 0614-2017English150 Add to Cart 0--9 seconds. Auto-delivery Single-use high-pressure angiographic syringes and accessories Valid YY/T 0614-2017
YY 0614-2007English479 Add to Cart 3 days [Need to translate] Single-use high-pressure angiographic syringes and accessories Obsolete YY 0614-2007


BASIC DATA
Standard ID YY/T 0614-2017 (YY/T0614-2017)
Description (Translated English) Single-use high-pressure angiographic syringes and accessories
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 11,183
Date of Issue 2017-02-28
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY 0614-2007
Drafting Organization Shandong Province, medical device product quality inspection center, Shenyang New Chi source medical supplies Co., Ltd., Wuxi City, Yushou Medical Devices Co., Ltd., Jiangsu Chen Ning Tai Medical Devices Co., Ltd.
Administrative Organization National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 25
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

BASIC DATA
Standard ID YY 0614-2007 (YY0614-2007)
Description (Translated English) Single-use high-pressure angiographic syringes and accessories
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 12,154
Date of Issue 2007-07-02
Date of Implementation 2008-08-01
Quoted Standard GB/T 1962.1; GB/T 1962.2; GB 8368; GB 15810; YY 0466
Drafting Organization Shenyang New Zhiyuan Medical Supplies Co., Ltd.
Administrative Organization National Technical Committee of Standardization for medical infusion
Regulation (derived from) Chinese industry standard filing Notice 2007 No. 9 (No. 93 overall)
Proposing organization National Standardization Technical Committee appliances Infusion
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the use of high contrast disposable syringe (hereinafter referred to angiography syringe) and accessories requirements. The primary angiographic syringe for medical departments in digital subtraction angiography (DSA), computer-controlled tomography (CT), magnetic resonance (MRI), ultrasound (US) other tests were various types of high-pressure injection equipment supporting the use. This standard does not include intravascular catheter guided puncture and related equipment requirements.


YY/T 0614-2017 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA 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 contents Foreword . 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 . 17  Foreword This 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. Single-use high-pressure angiographic syringes and accessories 1 Scope This 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 references The 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 valves YY 0804-2010 Transfer sets for pharmaceutical preparations - Requirements and test methods For angiographic syringes and accessories intended for use under non-clean conditions, the design shall be such that the contrast agent is always in isolation from the outside world during normal use. 6.1.4 6% Luer cone joint The conical joint for angiographic syringes and accessories shall meet the following requirements. - Cone fitting that complies with GB/T 1962.1 or GB/T 1962.2; - If the angiographic syringe uses an outer cone joint which complies with GB/T1962.1, it shall be equipped with a special locking device that can match with the internal cone joint that meets GB/T 1962.2. 6.1.5 Particle contamination Angiographic syringes and accessories shall be manufactured with minimal particulate contamination. The liquid access surface shall be smooth and clean. When the syringe is connected to the tubing and/or the inhaler (when the liquid is drawn into the angiographic syringe, the liquid passes through the inhaler, and when the liquid is expelled from the angiographic syringe, the liquid is passed through the connection tubing), and tested i accordance with YY/T 1556-2017, the particulate contamination index shall not exceed 90. 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. 6.2.3 Scale and mark If there are scales and marks on the angiographic syringe, the scale lines and marks shall be complete and clear. 6.2.4 Cone joint inner diameter The inner hole diameter of the Luer outer cone joint on the angiographic syringe shall not be less than 1.2 mm. 6.2.5 Adhesion Note 2. The symbol 2725 of ISO 7000 can be used to indicate the existence of a certain substance of interest, by replacing the “x” with the abbreviation of the substance. If no substance of interest is observed, the symbol “x” is drawn. f) Lot number or production date, beginning with “batch” or “LOT”, or using graphic symbols given in YY/T 0466.1-2009; g) Expiration date, with appropriate text, or use of graphic symbols given in YY/T 0466.1-2009; h) The name and address of the manufacturer and/or distributor; i) Recommended use environment (if necessary). 9.2 Shelf packaging or multiple-unit packaging The shelf packaging or multi-unit packaging (if used) shall have at least the following information. a) Text description of contents; b) Quantity; c) Use of graphic symbols given in YY/T 0466.1-2009 or equivalent text description to indicate asepsis; d) Lot number or production date, beginning with “batch” or “LOT”, or using graphic symbols given in YY/T 0466.1-2009; e) Expiration date, with appropriate text, or use of graphic symbols given in YY/T 0466.1-2009; f) The name and address of the manufacturer and/or distributor; g) Recommended storage conditions (if any); h) Models of suitable injection equipment; i) Recommended use environment (if necessary). Note. The symbol 2725 of ISO 7000 can be used to indicate the presence of a certain substance of interest, by replacing the “×××” with the abbreviation of the substance. If not containing the substance of interest, the symbol “x” is drawn on it. ......


YY 0614-2007 Single-use high-pressure angiographic syringes and accessories ICS 11.040.20 C31 People's Republic of China pharmaceutical industry standards Disposable syringes and accessories high pressure contrast Posted 2007-07-02 2008-08-01 implementation State Food and Drug Administration issued Foreword The Standard Appendix A, Appendix B and Appendix C is a normative appendix. This standard by the National Standardization Technical Committee Infusion equipment for medical and centralized. Drafting of this standard. Shenyang new Zhiyuan Medical Supplies Limited. Participated in the drafting of this standard. Shenzhen Andrew Hi-Tech Industrial Co., Ltd. Wuxi-life medical equipment Limited. The main drafters of this standard. Liu Han, Qiaowen E, Zhangwen Guo, Feng Zhong, Liu Jian. introduction Disposable syringe and high pressure contrast accessory (such as connecting pipe, inhalation pipe) is high-pressure injection equipment described in this standard Supplies, transport equipment as a contrast agent, in a short time will focus on the contrast agent injected into the patient's blood vessels or organs. With digital subtraction angiography (DSA), the control computer tomography (CT), magnetic resonance (MRI), ultrasound (US) and other diagnostic The development of technology for imaging, scanning, imaging accuracy and success rate is rising requirements. Each device on the syringe contrast appearance The structure, dimensions, bearing capacity have more stringent requirements. Taking into account the diversity and complexity of current and future high-pressure injection equipment, this standard Registration does not require suitability (such as interface size, the sliding performance) angiographic syringe injection devices with special requirements. Disposable syringes and accessories high pressure contrast 1 Scope This standard specifies the use of disposable syringes contrast high pressure (hereinafter referred to as a contrast injector) and the requirements of Annex. The main angiographic injector To provide the health sector during the digital subtraction angiography (DSA), the control computer tomography (CT), magnetic resonance (MRI), ultrasound (US) and other tests, and are various types of high-pressure injection equipments. This standard does not include a guide catheter and related equipment requirements puncture a blood vessel. 2 Normative references The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 1962.1 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 1. General requirements (GB/T 1962.1-2001, idt ISO 594-1. 1986) GB/T 1962.2 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings (GB/T 1962.2-2001, idt ISO 594-2.1998) GB 8368 disposable infusion gravity infusion of formula (GB 8368-2005, ISO 8536-4.2004, MOD) GB 15810 single-use sterile syringes (GB 15810-2001, eqv ISO 7886-1.1993) YY 0466 medical devices for medical equipment marking, labeling, and information provided by the symbol (YY 0466-2003, ISO 15223. 2000, IDT) 3 Product Type Figures 1 to 3 shows the common angiographic syringes and accessories (inhalation, connecting piping, etc.) schematic structure type. Note. Figures 1 to 3 for the type just for illustrative, is not the only type of product. 1 --- syringe piston; 2 --- with a ring of the piston; 3 --- syringe jacket; 4 --- with locking means 6% luer outer cone. Schematic diagram 1 syringe ......

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