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YY 1282-2016 English PDF (YY1282-2016)

YY 1282-2016 English PDF (YY1282-2016)

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YY 1282-2016: Intravenous catheter for single use

This standard specifies the requirements for the intravenous catheter for single use which inserts into the peripheral vascular venous of human body for infusion or transfusion, to ensure the compatibility with the corresponding infusion and blood transfusion devices.
YY 1282-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.20
C 31
Intravenous catheter for single use
ISSUED ON. MARCH 23, 2016
IMPLEMENTED ON. JANUARY 01, 2018
Issued by. China Food and Drug Administration of PRC
Table of contents
Foreword ... 4
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Structure ... 8
5 Physical requirements ... 9
5.1 Particulate contamination ... 9
5.2 Specifications ... 9
5.3 Catheter unit ... 9
5.4 Needle unit ... 12
5.5 Lubricants... 12
5.6 Flow rate ... 12
5.7 Venting ... 12
5.8 Flashback ... 12
5.9 Leakage free ... 13
5.10 Corrosion resistance ... 13
5.11 Ray detectability ... 13
5.12 Protective cover ... 13
5.13 Anti-acupuncture protection device ... 13
6 Chemical requirements ... 13
7 Biological requirements ... 14
7.1 Biocompatibility ... 14
7.2 Sterile ... 14
7.3 Bacterial endotoxin ... 14
8 Type inspection ... 14
9 Marking ... 14
9.1 Single package marking ... 14
9.2 Accompanying documents ... 15
9.3 Shelf package marking ... 16
10 Packaging ... 16
Appendix A (Normative) Microparticle contamination test method ... 17
Appendix B (Normative) Test method for bending resistance ... 18
Appendix C (Informative) Evaluation of catheter puncture performance ... 20 Appendix D (Normative) Flashback test method ... 23
Appendix E (Normative) Preparation of dissolved matter test solution ... 25 References ... 26
Foreword
Part of clause 5.2.1, part of clause 5.3.9, clause 5.11, part of clause 5.12, and part of clause 5.13 of this standard are recommended, AND the rest
is mandatory.
This standard was drafted in accordance with the rules given in GB/T
1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the
identification of these patents.
This standard shall be under the jurisdiction of the National Medical Infusion Apparatus Standardization Technical Committee (SAC/TC 106).
The main drafting organizations of this standard. Shandong Medical Devices Product Quality Inspection Center, Shanghai Medical Devices Testing Institute, Shandong Xinhua ANDE Health Care Co., Ltd., Weihai Jierui Medical Products Co., Ltd., Suzhou BD Medical Devices Co., Ltd.
The participating drafting organizations of this standard. Zhejiang KDL Medical Devices Co., Ltd., Jiangxi Hongda Medical Devices Group Co., Ltd., Suzhou Linhua Medical Devices Co., Ltd., Guangdong Baihe Medical Technology Co., Ltd.
The main drafters of this standard. Xu Hui, Lu Liyuan, Chen Jiansheng, Zhang Dehai, Miao Junsheng, Chen Yongquan, Pan Huaxian, Yao Xiujun, Wang Xin. Introduction
Compared with the traditional intravenous infusion needle, intravenous
catheter is simple in operation AND can protect the blood vessels, thus reducing the pain of patients from repeated vein puncture. It solves the poor clinic vascular conditions AND the intermittent intravenous infusion treatment problems within an expected period, AND improves the nurses working
efficiency and quality of care.
There are many types of intravenous catheter, AND with the development of the product, some types of intravenous catheter are to be abandoned. In order not to hinder the development of the product, this standard does neither specify the type of product NOR provide a typical intravenous catheter legend, which may bring some obstacles to the reader to understand this standard, AND it is recommended to read the chapter of terms and definitions.
When the intravenous catheter is indwelling blood vessels, the patient has the risk of loss of blood from the accidentally disconnected part; therefore, the lock connection method complying with GB/T 1962.2 shall be used between the
connection piece on the device AND the device; AND the connection between the intravenous catheter and its associated infusion set and blood transfusion device shall also adopt the lock connection method in accordance with GB/T 1962.2.
The patient's blood may carry a virus, so the intravenous catheter shall be designed to minimize the risk of blood flowing out of the system when used in the manner specified by the manufacturer.
For intravenous catheter with a lateral hole in the needle, it shall consider the risk of bending or breaking at the side hole during the puncture process. Intravenous catheter for single use
1 Scope
This standard specifies the requirements for the intravenous catheter for single use (hereinafter referred to as ?€?catheter?€?) which inserts into the peripheral vascular venous of human body for infusion or transfusion, to ensure the compatibility with the corresponding infusion and blood transfusion devices. This standard applies to catheters inserted into the human peripheral vascular venous system for infusion or blood transfusion.
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 document.
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment ?€? Part 2. Lock fittings
GB 8368 Infusion sets for single use, gravity feed
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection
equipment for medical use ?€? Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process
GB 18457 Stainless steel needle tubing for manufacture of medical devices GB 19633.1-2015 Packaging of final sterilized medical devices - Part 1. Materials, sterile barrier systems and packaging system requirements
YY 0285.1-2004 Sterile, single-use intravascular catheters ?€? Part 1. General requirements
YY 0285.5-2004 Sterile, single-use intravascular catheters ?€? Part 5.
Over-needle peripheral catheters
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 0581.1-2011 Infusion access adapters ?€? Part 1. Needle access adapters (Heparin plugs)
YY 0581.2-2011 Infusion access adapters ?€? Part 2. Needleless access
adapters
YY 0585.2-2005 Fluid lines for use with pressure infusion equipment and accessories for single use ?€? Part 2. Access...

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