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FprEN ISO 23908

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 (ISO/FDIS 23908:2024)

Publication date:   Oct 12, 2023

General information

50.60 Close of voting. Proof returned by secretariat   Nov 8, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

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Scope

This document provides clear methods for performance-testing for sharps-injury protection mechanisms, whether active or passive in design, for medical devices containing single-used ‘sharps’ for administration and/or extraction of body/blood fluids and/or medicinal substances. Testing will confirm usability and elimination of exposure to, and risk of accidental injury from, contaminated ‘sharps’ during the period of intended use, including the paths to final disposal.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Legislation 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 23908:2013

NOW

IN_DEVELOPMENT
FprEN ISO 23908
50.60 Close of voting. Proof returned by secretariat
Nov 8, 2024