1 Scope
This standard specifies the requirements for intravenous needles (with a nominal outside diameter of 0.36 mm to 1.2 mm for the needle tubing) for single use (hereafter referred to as " transfusion needles"), so as to ensure that they are compatible with corresponding gravity feed infusion sets, infusion sets used for pressure infusion devices or blood transfusion apparatuses.
This standard provides guidelines for the performance and quality specifications of materials used for transfusion needles.
Quality specifications for transfusion needles supplied in conjunction with infusion sets and blood transfusion apparatuses are given in Chapter 3 and Chapter 8 (8.1 and 8.3) of this standard.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 1962.1 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirement (GB/T 1962.1-2001, idt ISO 594-1:1986)
GB/T 1962.2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings (GB/T 1962.2-2001, idt ISO 594-2:1998)
GB/T 6682 Water for Analytical Laboratory Use - Specification and Test Methods (GB/T 6682-2008, ISO 3696:1987, MOD)
GB 8368-2005 Infusion Sets for Single Use, Gravity Feed (ISO 8536-4:2004, MOD)
GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods
GB/T 14233.2 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 (GB/T 16886.1-2001, idt ISO 10993-1:1997)
GB 18457 Stainless Steel Needle Tubing for the Manufacture of Medical Devices (GB 18457-2001, eqv ISO 9626:1991)
YY 0286.4-2006 Special Infusion Sets - Part 4: Single-use Infusion Equipment for Use with Pressure Infusion Apparatus (ISO 8536-8:2004, IDT)
YY/T 0296 Hypodermic Needles for Single Use - Color Coding for Identification (YY/T 0296-1997, ISO 6009:1992, IDT)
3 Structural Type and Naming
Structural type, name of each part and length (L) of needle tubing of typical transfusion needles are shown in Figure1:
Foreword i
Introduction iii
1 Scope
2 Normative References
3 Structural Type and Naming
4 Marking Example
5 Materials
6 Physical Requirements
7 Chemical Requirements
8 Biological Requirements
9 Marking
10 Package
Annex A (Normative) Physical Test Method
Annex B (Normative) Chemical Analysis Method for Dissolved Matter
Annex C (Informative) Type Inspection
Annex D (Informative) Relevant Information for Further Evaluating the Quality of Needle Tubing and Needle Point of Transfusion Needle
Bibliography
