This standard specifies the terms and definitions, classification and marking, requirements, type inspection, packaging, marking, transportation and storage of plungers for disposable syringes (hereinafter referred to as plungers). This standard applies to the pistons used in single-use syringes. The piston can be applied to single-use sterile syringes and single-use sterile insulin syringes, etc., but is not suitable for syringes prefilled with medical solution and syringes matching the medical solution.
YY/T 0243-2016 Referenced Document
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments 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 within a risk management process*， 2022-04-15 Update
GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
GB/T 3512 Rubber, vulcanized or thermoplastic.Accelerated ageing and heat resistance tests.Air-oven method
GB/T 531.1 Rubber,vulcanized or thermoplastic.Determination of indentation hardness.Part 1:Duromerer method( Shore hardness)
GB/T 6682 Water for analytical laboratory use.Specification and test methods
GB/T 7759.1 Rubber, vulcanized or thermoplastic.Determination of compression set.Part 1:At ambient or elevated temperatures
GB/T 7766-2008 Rubber products.Test methods for chemical analysis
YY/T 0681.1 Sterile Medical Device Packaging Test Methods Part 1: Guidelines for Accelerated Aging Tests*， 2018-12-20 Update
YY/T 0243-2016 history
2016YY/T 0243-2016 Plunger seal of syringes for single use
2003YY/T 0243-2003 Plunger of sterile syringes for single use