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  • BSI
    BS EN ISO 23908:2025 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
    Edition: 2025
    $468.02
    / user per year

Description of BS EN ISO 23908:2025 2025

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).

Standard NumberBS EN ISO 23908:2025
TitleSharps 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
StatusDefinitive
Publication Date2025-11-06
ReplacesBS EN ISO 23908:2013
Identical National Standard OfEN ISO 23908, ISO 23908
DescriptorsSafety devices, Medical equipment, Syringes, Instructions for use, Performance testing, Blood transfusion equipment, Parenteral infusion equipment, Injection instruments, Safety measures, Marking, Performance, Catheters
ICS11.040.99 Other medical equipment, 11.040.25 Syringes, needles and catheters
CommitteeCH/84
ISBN978 0 539 24731 2
PublisherBSI
Pages30



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About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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