1 Scope
This Standard specifies classification and nomenclature, requirements, test methods, inspection rules, packing and labeling of sterile hypodermic syringes (hereinafter referred to as "syringes") for single use.
This Standard is applicable to the manual syringes intended for the aspiration of fluids or for the injection of fluids immediately after filling.
This Standard is not applicable to syringes for use with insulin, single-use syringes made of glass, syringes with needles permanently attached, syringes for use with powerdriven syringe pumps, syringes pre-filled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below.
GB/T 1962.1-2001 Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain other Medical Equipment — Part 1: General Requirements (idt ISO 594-1:1986)
GB/T 1962.2-2001 Conical Fittings with a 6 % (Luer) Taper for Syringes, Needles and Certain other Medical Equipment — Part 2: Lock Fittings (idt ISO 594-2:1998)
GB 2828-1987 Sampling Procedures and Tables for Lot-by-lot Inspection by Attributes (Apply to Inspection of Successive Lots or Batches)
GB 2829-1987 Sampling Procedures and Tables for Periodic Inspection by Attributes (Apply to Inspection of Process Stability)
GB 6682-1992 Water for Analytical Laboratory Use — Specification and Test Methods
GB/T 14233.1-1998 Test Methods for Infusion Transfusion Injection Equipments for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-1993 Test Methods for Infusion Transfusion Injection Equipments for Medical Use — Part 2: Biological Test Methods
GB/T 16886.1-2001 Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing (idt ISO 10993-1:1997)
YY 0243-1996 Rubber Plunger of Sterile Syringes for Single Use
YY/T 0313-1998 Package, Label, Transport and Storage for Medical Polymer Products
