YY/T 1282-2022_English: PDF (YY/T1282-2022)
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Intravenous catheter for single use
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YY/T 1282-2022
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| YY 1282-2016 | English | 145 |
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Intravenous catheter for single use
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| Standard ID | YY/T 1282-2022 (YY/T1282-2022) | | Description (Translated English) | Intravenous catheter 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Count Estimation | 23,227 | | Date of Issue | 2022-05-18 | | Date of Implementation | 2023-06-01 | | Older Standard (superseded by this standard) | YY 1282-2016 | | Drafting Organization | Shandong Medical Device Quality Inspection Center, Terumo Medical Products (Hangzhou) Co., Ltd., Bidi Medical Devices (Shanghai) Co., Ltd., Suzhou Linhua Medical Devices Co., Ltd., Zhejiang Kindly Medical Devices Co., Ltd., Weihai Jie Rui Medical Products Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd., Henan Tuoren Best Medical Equipment Co., Ltd., Jiangxi Sanxin Medical Technology Co., Ltd. | | Administrative Organization | National Technical Committee on Standardization of Medical Infusion Devices (SAC/TC 106) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements for disposable venous indwelling needles (hereinafter referred to as indwelling needles) for infusion or blood transfusion in the peripheral venous system inserted into the human body, so as to ensure compatibility with the corresponding infusion and blood transfusion apparatus. This standard applies to indwelling needles inserted into the peripheral venous system of the human body for infusion or blood transfusion. | | Standard ID | YY 1282-2016 (YY1282-2016) | | Description (Translated English) | Intravenous catheter for single use | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Word Count Estimation | 21,265 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2018-01-01 | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) |
YY/T 1282-2022
Intravenous catheter for single use
ICS 11.040.20
CCSC31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 1282-2016
Disposable intravenous indwelling needle
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Structure 2
5 Physical Requirements 2
5.1 Particulate contamination 2
5.2 Specification 2
5.3 Conduit assembly 3
5.3.1 External surface 3
5.3.2 Coordination 3
5.3.3 Bending resistance 4
5.3.4 Peak tension 4
5.3.5 Connection strength 4
5.3.6 Infusion port 4
5.3.7 Multiplexer 5
5.3.8 Extension tube 5
5.3.9 Blocking device 5
5.4 Needle Assembly 5
5.4.1 Needle tube 5
5.4.2 Needle tip 5
5.4.3 Connection strength 5
5.5 Lubricants 5
5.6 Flow 5
5.7 Exhaust 5
5.8 Healing 5
5.9 No leakage 5
5.10 Adhesion 6
5.11 Corrosion resistance 6
5.12 Radiation Detectability 6
5.13 Protection 6
5.14 Needle stick protection device 6
6 Chemical Requirements 6
7 Biological Requirements 6
7.1 Biocompatibility 6
7.2 Sterile 6
7.3 Bacterial endotoxins 6
8 Logo 7
8.1 Product marking 7
8.2 Single package mark7
8.3 Accompanying documents7
8.4 Shelf packaging signs 7
9 pack 8
Appendix A (normative) Particulate contamination test method 9
Appendix B (Informative) Evaluation of Indwelling Needle Puncture Performance 10
Appendix C (normative) Test method for bending resistance 12
Appendix D (normative) blood return test method 13
Appendix E (normative) Adhesion Test Method 14
Appendix F (normative) Preparation of extractable test solution 15
Reference 16
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document replaces YY 1282-2016 "Disposable Intravenous Indwelling Needle". Compared with YY 1282-2016, the main technical changes
as follows.
--- Added the term "high pressure contrast indwelling needle" (see 3.11);
--- Increased the requirements for tightness (see 5.10);
--- Deleted the type inspection (see Chapter 8 of the.2016 edition).
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Infusion Devices (SAC/TC106).
This document was drafted by. Shandong Medical Device Product Quality Inspection Center, Terumo Medical Products (Hangzhou) Co., Ltd., Bidi Medical
Equipment (Shanghai) Co., Ltd., Suzhou Linhua Medical Equipment Co., Ltd., Zhejiang Kindly Medical Equipment Co., Ltd., Weihai Jierui
Medical Products Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd., Henan Tuoren Best Medical Equipment Co., Ltd., Jiangxi Sanxin Medical
Therapeutic Technology Co., Ltd.
The main drafters of this document. Li Yuanyu, Wu Liqun, Xu Yuanmei, Wang Guohui, Zhang Qian, Qi Xiaoqing, Zhang Dehai, Chen Jiansheng, Zhang Jing, Liu Xiaohong,
Shi Kai.
The previous versions of this document and its superseded documents are as follows.
---First released in.2016 as YY 1282-2016;
---This is the first revision.
introduction
Compared with the traditional intravenous infusion needle, the venous indwelling needle has the advantages of simple operation, can protect the blood vessels, and relieve the pain of repeated puncturing of the vein.
It solves the clinical problems of poor vascular conditions and intermittent intravenous infusion therapy expected for a period of time, and improves the work efficiency of nurses.
quality of care.
There are many types of intravenous indwelling needles. With the development of products, some types of indwelling needles have been eliminated. In order not to hinder the development of the product
This document does not specify the types of products, nor does it give typical illustrations of intravenous indwelling needles, which may have certain implications for readers’ understanding of the standard.
barriers, it is recommended to read the Terminology and Definitions chapter.
During the indwelling of the venous indwelling needle in the blood vessel, the patient is at risk of losing blood from the accidental disconnection of the connecting piece.
The connector and the device should be connected by a locking connection in accordance with GB/T 1962.2; the venous indwelling needle and the infusion set used with it
The connection with the blood transfusion set also needs to be connected by means of locking connection in accordance with GB/T 1962.2.
The patient's blood may carry the virus, therefore, the IV catheter should be designed so that the blood flow when used as specified by the manufacturer
The risk to outside the system is minimal.
For venous indwelling needles with side holes, the risk of bending or breaking at the side holes during puncture needs to be considered.
Among the rapidly developing imaging diagnostic techniques, computed tomography (CT) and magnetic resonance imaging (MRI) techniques are used in clinical
It has been more and more widely used; for early and small lesions, CT and MRI scans are often due to low resolution and low lesion display.
However, by injecting contrast agent, the imaging effect can be significantly enhanced after the contrast agent enters the lesion tissue.
It is easy to observe the size, boundary, location, etc. of the lesion, so contrast-enhanced CT scan and enhanced MRI scan are used in the diagnosis of tumors and other diseases.
has been widely used.
Disposable intravenous indwelling needle
1 Scope
This document specifies single-use venous indwelling needles (hereinafter referred to as "indwelling catheters") for infusion or blood transfusion into the peripheral venous system of the human body.
Needle") to ensure compatibility with the corresponding infusion and blood transfusion equipment.
This document applies to indwelling needles inserted into the peripheral venous system of the human body for fluid or blood transfusion.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 1962.2 Syringes, needles and other medical devices - 6% (Luer) conical connectors - Part 2.Locking connectors
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
GB 8368 Disposable infusion set gravity infusion type
GB/T 14233.2-2005 Test methods for medical infusion, blood transfusion and injection equipment - Part 2.Biological test methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process
GB/T 18457 Manufacturing of stainless steel needle tubes for medical devices
GB/T 19633.1 Packaging for terminally sterilized medical devices - Part 1.Requirements for materials, sterile barrier systems and packaging systems
YY 0285.1-2017 Intravascular catheters for single-use sterile catheters Part 1.General requirements
YY 0285.5-2018 Intravascular catheters - One-time use sterile catheters - Part 5.Peripheral catheters with trocars
YY 0581.1-2011 Infusion connectors - Part 1.Puncture connectors (heparin caps)
YY 0581.2-2011 Infusion connectors - Part 2.Needleless connectors
YY 0585.2-2019 Disposable liquid circuits and accessories for pressure infusion equipment - Part 2.Accessories
YY/T 0615.1 Requirements for labelling "sterile" medical devices Part 1.Requirements for terminally sterilized medical devices
ISO 23908 Sharps Injury Protection Requirements and Test Methods for Disposable Hypodermic Needles, Catheter Guide Devices, and Blood Sampling
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
terminal end
The catheter is inserted as far as possible into the end of the patient's vein.
3.2
The maximum outer diameter of the catheter.
......
YY 1282-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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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