YY/T 0909-2013Low resistance syringe for single use (English PDF)
一次性使用低阻力注射器
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 0909-2013 is the English-translated version of 一次性使用低阻力注射器.
YY/T 0909-2013 is the Chinese pharmaceutical industry standard for the single-use low resistance syringe, the syringe whose plunger moves with a small force.
It specifies the terms and definitions, the requirements, the test methods, the packaging and the marking, covering the forces needed to start and to maintain the movement of the plunger, the graduation and its accuracy, the tightness of the barrel and of the connection, the dead space, the materials and their biological evaluation and sterility. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 0909-2013
National Standard of the People's Republic of China
- ICS
- 11.040.20
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
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
Indicated by the manufacturer of the syringe capacity.
NOTE: For example 5mL, 10mL, 20mL.
3.2 Scale capacity
When baseline axial movement of the piston or a few given the scale interval, the discharge from the syringe temperature of 20 °C ± 5 °C (Or in the tropics is 27 °C ± 5 °C) volume of water.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1962.1Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
- GB/T 1962.2Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB/T 14233.1Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB 15810Sterile syringes for single use
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB 18278 · GB 18280
Similar standards
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Related Standards
GB 15810-2019 — Sterile syringes for single use
GB 18278.1-2015 — Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 — Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
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