Final Draft International Standard
ISO/FDIS 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
Reference number
ISO/FDIS 23908
Edition 2
Final Draft
International Standard
ISO/FDIS 23908
This draft is in the approval phase.
Will replace ISO 23908:2011


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.

General information

  •  : Under development
    : Final text received or FDIS registered for formal approval [50.00]
  •  : 2
  • ISO/TC 84
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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