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This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled.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.
Status: PublishedPublication date: 2018-11
Edition: 2Number of pages: 10
Technical Committee: ISO/TC 84 Devices for administration of medicinal products and catheters
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