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

2021-12-13

WI

00205372

Planned document number

DIN EN ISO 23908

Project number

06302122

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 84/WG 8 - Sharps injury protection  

draft standard

Sharps injury protection - Requirements and test methods - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration (ISO/DIS 23908:2023); German and English version prEN ISO 23908:2023
2023-11
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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); German version EN ISO 23908:2013
2013-10

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