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
