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.
Status: Under developmentYou can help develop this draft international standard by contacting your national memberStage: DIS ballot initiated: 12 weeks [40.20]
Edition: 2Number of pages: 19
Technical Committee :ISO/TC 84ICS :11.040.25
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