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.