YY/T 0573.4-2020: Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention fracture

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Scope

This part of YY/T 0573 specifies the terms and definitions, naming and
classification, physical requirements, chemical requirements, biological
requirements, packaging, markings, etc. of sterile hypodermic syringes for
single use (hereinafter referred to as syringes) with re-use prevention features.
This part applies to sterile hypodermic syringes for single use, which are made
of plastic materials, with or without needles, used for aspirating liquids OR for
injection immediately after aspirating liquids, designed to prevent re-use. It is
suitable for the re-use prevention performance of syringe, which can prevent
accidental needle stick injury. This part does not involve the performance of
preventing accidental needle stick injury of this type of syringe.
This part does not apply to glass syringes, self-destructive fixed-dose vaccine
syringes, syringes with prefilled liquid medicine. This part does not involve the
compatibility of the syringe and the injection liquid.
This part does not specify the design requirements for self-destructive features.
Note: When the syringe is used beyond the intended use, which is specified in this part,
other standards apply.

Basic Data

Standard ID	YY/T 0573.4-2020 (YY/T0573.4-2020)
Description (Translated English)	Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention fracture
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.25
Word Count Estimation	23,287
Date of Issue	2020
Date of Implementation	2021-03-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the terms and definitions, nomenclature and classification, physical requirements, chemical requirements, biological requirements, packaging, marking, etc. This standard applies to single-use sterile syringes made of plastic materials, with or without needles, used for aspiration of medicinal liquids or for injection immediately after aspiration of liquids, and designed to prevent re-use. The performance of preventing repeated use of syringes applicable to accidental needle stick injury is not covered by this standard. This standard does not apply to glass syringes, self-destructing fixed-dose vaccine syringes and prefilled syringes. The compatibility of syringes and injection liquids is not covered in this standard. This standard does not specify design requirements for self-destruct features