prEN ISO 23908
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)

Standard No.

prEN ISO 23908

Published By

European Committee for Standardization (CEN)

Replace

EN ISO 23908:2013

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.

prEN ISO 23908 history

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

Standard and Specification