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YY/T 0909-2013: Low resistance syring for single use
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 0909-2013	English	509	Add to Cart	4 days [Need to translate]	Low resistance syring for single use

YY/T 0909-2013: Low resistance syring for single use

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Low resistance syring for single use ICS 11.040.20 C31 People's Republic of China pharmaceutical industry standards Low resistance disposable syringe Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this standard may involve patents. The standard release Institutions do not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national medical syringe (needle) Standardization Technical Committee (SAC/TC95) centralized. This standard was drafted. Yang Ling, Zhejiang Medical Devices Co., Ltd., Shanghai Medical Device detection. The main drafters of this standard. Hu Junfei, Luojian Bing, Wang Minjun, Xiadan Ping, Wei Yaozhen land from the original. Low resistance disposable syringe

1 Scope

This standard specifies the use of disposable syringes low resistance (hereinafter referred to as injector) definitions, terminology, requirements, test methods, packaging, Identity. This standard applies to anesthesia puncture kits instruments supporting the use of high viscosity or manual syringe injection of drugs.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including with amendments) apply to this document. GB/T 1962.1 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 1. General requirements GB/T 1962.2 syringes, needles and other medical equipment - 6% (Luer) taper fittings - Part 2. Lock fittings Laboratory use specifications and test methods GB/T 6682 Analysis Design and construction principles GB/T 12809 gauge of laboratory glassware GB/T 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14233.2 Infusion, transfusion, injection equipment - Part 1. Biological Test Method GB 15810 single-use sterile syringes GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test GB 18278 Sterilization of health care products industry validation and routine control of moist heat sterilization GB 18279 ethylene oxide sterilization of medical devices - Validation and routine control GB 18280 Sterilization of health care products Requirements for validation and routine control of radiation sterilization YY/T 0114 Infusion, transfusion, syringes polyethylene Compound YY/T 0242 medical infusion, transfusion, injection equipment with Polypropylene YY/T 0243 disposable sterile syringe plunger Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Nominal capacity nominalcapacity Indicated by the manufacturer of the syringe capacity. NOTE. For example 5mL, 10mL, 20mL. 3.2 Scale capacity graduatedcapacity When baseline axial movement of the piston or a few given the scale interval, the discharge from the syringe temperature of 20 ℃ ± 5 ℃ (Or in the tropics is 27 ℃ ± 5 ℃) volume of water. ...