Standard No.:	YY 1282-2016
English Name:	Intravenous catheter for single use
Chinese Name:	一次性使用静脉留置针
Chinese Classification:	C31    General and microsurgical devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.20 11.040.20    Transfusion, infusion and injection equipment 11.040.20
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2016-03-23
Implemented on:	2018-1-1
Status:	superseded
Superseded by:	YY/T 1282-2022 Intravenous catheter for single use
Superseded on:	2023-6-1
Target Language:	English
File Format:	PDF
Word Count:	10000 words
Translation Price(USD):	140.0
Delivery:	via email in 1 business day

1 Scope This standard specifies the requirements of single-use intravenous catheter (hereinafter referred to as "intravenous catheter") for transfusion by inserting into peripheral venous system of human body so as to ensure it is suitable for corresponding transfusion apparatus. This standard is applicable to intravenous catheter used for transfusion by inserting into peripheral venous system of human body. 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 referenced document (including any amendments) applies. 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 the Manufacture of Medical Devices GB 19633.1-2015 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems 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 Devices - Symbols to Be Used with Medical Device Labels, Labeling 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 Adapter - Part 2: Needleless Access Adapters YY 0585.2-2005 Fluid Lines for Use with Pressure Infusion Equipment and Accessories for Single Use - Part 2: Accessories YY/T 0586 Medical Polymer Products - Test Methods of Radiopacity

Foreword i Introduction ii 1 Scope 2 Normative References 3 Terms and Definitions 4 Structure 5 Physical Requirements 5.1 Particle Pollution 5.2 Specification 5.3 Catheter Unit 5.4 Needle Unit 5.5 Lubricant 5.6 Flow Speed 5.7 Venting 5.8 Flashback 5.9 No Leakage 5.10 Corrosion Resistance 5.11 Radio-detectability 5.12 Protective Sleeve 5.13 Puncture Resistant Protection Device 6 Chemical Requirements 7 Biological Requirements 7.1 Biocompatibility 7.2 Sterility 7.3 Bacteria Endotoxin 8 Type Inspection 9 Marks 9.1 Marks for Unit Package 9.2 Attached Documents 9.3 Packaging Marks for the Storage Racks 10 Packaging Annex A (Normative) Test Method for Particle Pollution Annex B (Normative) Test Method for Bending resistance Annex C (Informative) Puncture Performance Evaluation for the Intravenous Catheter Annex D (Normative) Flashback Test Method Annex E (Normative) Preparation of Inspection Solution for the Dissolved Matter Bibliography