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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)

Abstract

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.

Begin

2021-11-08

WI

00205372

Planned document number

FprEN ISO 23908

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

draft standard

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)
2024-09
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previous edition(s)

Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (ISO 23908:2011)
2013-02

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Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2404
Fax: +49 30 2601-42404

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