YY/T 0909-2013 English PDFUS$509.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0909-2013: Low resistance syring for single use Status: Valid
Basic dataStandard ID: YY/T 0909-2013 (YY/T0909-2013)Description (Translated English): Low resistance syring for single use Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C31 Classification of International Standard: 11.040.20 Word Count Estimation: 22,259 Quoted Standard: GB/T 1962.1; GB/T 1962.2; GB/T 6682; GB/T 12809; GB/T 14233.1; GB/T 14233.2; GB 15810; GB/T 16886.1; GB 18278; GB 18279; GB 18280; YY/T 0114; YY/T 0242; YY/T 0243; YY/T 0466.1 Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the use of low resistance disposable syringe (hereinafter referred to as syringes) definitions, terminology, requirements, test methods, packaging, labeling. This standard applies to anesthesia puncture kits supporting the use of e 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 ForewordThis 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 syringe1 ScopeThis 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 referencesThe 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 requirements3 Terms and DefinitionsThe 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0909-2013_English be delivered?Answer: Upon your order, we will start to translate YY/T 0909-2013_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0909-2013_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0909-2013_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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