scope:

This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms of devices including a single use sharp, for administration and/or extraction of body/blood fluids and/or medicinal substances.

The sharps injury protection mechanisms it covers can be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection.

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.

It does not give requirements for the storage and handling of the device, sharps, or sharps protection before the sharp is used to penetrate the tissue.

The following devices are excluded from the scope because their SIPM 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:

- devices for medication loading and transfer, utilizing a blunt tip design;

- invasive products whose intended use is to access small spaces, particularly ear, nose and throat and ophthalmic procedures.