NEN-EN 13612
Performance evaluation of in vitro diagnostic medical devices
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 March 2003 |
| Status: | active |
| Page Count: | 17 |
| ICS Code (Laboratory medicine): | 11.100 |
scope:
Applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer.
Document History
NEN-EN 13612
March 1, 2003
Performance evaluation of in vitro diagnostic medical devices
Applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning,...
January 1, 2003
Performance evaluation of in vitro diagnostic medical devices
A description is not available for this item.
June 1, 1999
Performance evaluation of in vitro diagnostic medical devices
Applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning,...