Summary
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.
Notes
50.00 : Texte final reçu ou FDIS enregistré pour approbation formelle
Technical characteristics
| Publisher | International Organization for Standardization (ISO) |
| Publication Date | 12/03/2024 |
| Edition | 2 |
| Page Count | 14 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
Replaces
27/05/2011
Superseded
, Confirmed
Historical
Previous versions
27/05/2011
Superseded
, Confirmed
Historical