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RS ISO 23908: 2024
Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods

Abstract

This document provides requirements and test methods to evaluate the performance and usability of sharps
injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or
extraction of blood or body fluids and/or medicinal substances.
The sharps injury protection mechanisms covered by this document can be provided integral to the device
or for assembly with the device prior to use.
The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated
sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal
requirement or the manufacturers’ decision.
This document does not cover
— devices for medication loading and transfer, utilizing a blunt tip design, or
— invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to
perform ophthalmic procedures
because their SIPMs have been found to adversely affect the usability and can increase the risk for patients
versus the benefit of the intended use of the device.
This document does not cover solid-core needles used for surgery (e.g. suture needles).

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 23908: 2024	ADOPTED ISO STANDARDS	Health care technology	23	Second Edition Jul 2026	Available