Source: http://codeofchina.com/standard/YYT0908-2013.html
Timestamp: 2020-04-10 05:46:11
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YY/T 0908-2013 English Version, YY/T 0908-2013 Single-use filter for syringe (English Version) - Code of China
Position: Chinese Standard in English/YY/T 0908-2013
YY/T 0908-2013 Single-use filter for syringe (English Version)
Standard No.: YY/T 0908-2013 Status: valid remind me the status change
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Standard No.: YY/T 0908-2013
English Name: Single-use filter for syringe
Chinese Name: 一次性使用注射用过滤器
Issued by: SDA
Issued on: 2013-10-21
1 Scope This standard specifies classification and marking, materials, physical, chemical and biological requirements, marking and packaging of single-use filter for syringe. This standard is applicable to single-use filter for syringe (hereinafter referred to as filter); the filter, used together with syringe, is applied to muscle injection and intravenous injection of medicine in clinical treatment, addition of medicine to liquid bottle, and filtration of insoluble particles in chemical liquid. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the normative document (including any amendments) applies. GB/T 1962.1 The Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirement GB/T 1962.2 The Conical Fittings with a 6% (Luer) Taper For Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods GB 8368 Infusion Sets for Single Use - Gravity Feed GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods GB/T 14233.2 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods GB 15810 Sterile Hypodermic Syringes for Single Use GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process YY 0321.3 Single-use Filter for Anesthesia YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels Labelling and Information to be Supplied - Part 1: General Requirements YY 0770.1 Filter Material for Medical Infusion Equipment - Part 1: Fluid Filter Material 3 Classification and Marking
Foreword	I 1 Scope 2 Normative References 3 Classification and Marking 4 Materials 5 Physical Requirements 6 Chemical Requirements 7 Biological Requirements 8 Marking 9 Package Appendix A (Normative Appendix) Physical Test Appendix B (Normative Appendix) Rules for Inspection Test
* GB/T 1962.1-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement
* GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
* GB 8368-2005 Infusion sets for single use, gravity feed
* GB/T 14233.1-2008 Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods
* GB 15810-2001 Sterile hypodermic syringes for single use
* GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
* YY/T 0466.1-2009 devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
* YY 0770.1-2009 Filter material for medical infusion equipments.Part 1:Fluid filter material
Referred in YY/T 0908-2013:
Standard No. YY/T 0908-2013
Single-use filter for syringe
一次性使用注射用过滤器
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