ISO 7886-4:2018 PDF

Scope: This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber 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 This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto- disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled.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 document. NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

ISO 7886-4:2018 Referenced Document

ISO 3696 Water for analytical laboratory use; Specification and test methods
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
ISO 8537:2016 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

2018 ISO 7886-4:2018 Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature
2006 ISO 7886-4:2006 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature