This standard specifies the technical requirements for single-use dispensing syringes (hereinafter referred to as dispensing syringes). This standard applies to dispensers for clinical extraction or preparation of pharmaceutical solutions.
YY/T 0821-2010 Referenced Document
GB 15810 Sterile syringes for single use*, 2019-10-14 Update
GB 15811 Sterile hypodermic needles for single use*, 2016-06-14 Update
GB 18278 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
GB 18279 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization*, 2023-09-08 Update
GB 18280 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
GB 18457 Stainless steel needle tubing for manufacture of medical devices
GB 8368 Infusion sets for single use—Gravity feed*, 2018-03-15 Update
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 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*, 2022-04-15 Update
GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.Part 1:General requirement*, 2015-12-10 Update
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
ISO 7864:1993 Sterile hypodermic needles for single use
ISO 8536-2 Infusion equipment for medical use — Part 2: Closures for infusion bottles*, 2023-01-31 Update
YY/T 0243 Plunger seal of syringes for single use*, 2016-03-23 Update
YY/T 0296 Disposable injection needle identification color code*, 2022-05-18 Update
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*, 2023-09-05 Update