Status
Forslag
Kommentarfrist:
Kommentarfrist:
Type
Standard
Varenummer
M380557
Komite
CEN/TC 205
ISO/TC 84
International arbejdsgruppe WG
CEN/TC 205
ISO/TC 84
Internationale relationer
ISO/FDIS 23908 IDT, FprEN ISO 23908 IDT
Dansk udvalg
ICS grupper
Antal sider
26
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.