GB 15810-2019 (English Version) PDF

Scope: This standard specifies the nomenclature physical requirements, chemical requirements, biological requirements, and BRREICES for single-use sterile syringes (hereinafter referred to as "syringes"). This standard applies to manual syringes for aspiration of liquids or injections immediately after aspiration of liquids. This standard does not apply to insulin syringes, glass syringes, syringes with permanent needles, syringes with power-driven syringe pumps, self-contained fixed-dose vaccine syringes, prevention of re-use of syringes, syringes prefilled with liquid medicine by the manufacturer, and syringes with medicines. Liquid matching syringes, etc.

GB 15810-2019 Referenced Document

GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use—Part 1: Chemical analysis methods*， 2022-10-14 Update
GB/T 14233.2 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
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 1962.2 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
GB/T 6682 Water for analytical laboratory use.Specification and test methods
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update

2019 GB 15810-2019 Sterile syringes for single use
2001 GB 15810-2001 Sterile hypodermic syringes for single use--Part 1: Syringes for manual use
0000 GB 15810-1995