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
