This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
This part of ISO 7886 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this part of ISO 7886.
NOTE Syringes designed to reduce the risk of needlestick injuries can also comply with this part of ISO 7886 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties of syringes are not in themselves addressed in this part of ISO 7886.
BS EN ISO 7886-4:2009 Referenced Document
ASTM D5276-98 Standard Test Method for Drop Test of Loaded Containers by Free Fall
ASTM D999-01 Standard Test Methods for Vibration Testing of Shipping Containers*， 2024-04-19 Update
ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update
ISO 780 Packaging - Distribution packaging - Graphical symbols for handling and storage of packages*， 2015-12-01 Update
ISO 7864:1993 Sterile hypodermic needles for single use
ISO 7886-1:1993 Sterile hypodermic syringes for single use; part 1: syringes for manual use
ISO 8537:1991 Sterile single-use syringes, with or without needle, for insulin
ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods*， 2016-08-01 Update
BS EN ISO 7886-4:2009 history
2019BS EN ISO 7886-4:2019 Sterile hypodermic syringes for single use - Syringes with re-use prevention feature
2009BS EN ISO 7886-4:2009 Sterile hypodermic syringes for single use - Syringes with re-use prevention feature