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 proceduresbecause 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).
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).
ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.
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