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.


General information 

  • Status
     : Under development
  • Edition
     : 2
    Number of pages
     : 19
  • Technical Committee
     : ISO/TC 84 Devices for administration of medicinal products and catheters
  • ICS
     :
    11.040.25 Syringes, needles and catheters

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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