Name:
DANSK DS/EN 13612/AC PDF
Published Date:
03/24/2003
Status:
[ Active ]
Publisher:
Dansk Standard
This standard 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. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.
| Edition : | 02 |
| File Size : | 1 file , 50 KB |
| Number of Pages : | 6 |
| Product Code(s) : | DS-005, DS-005 |
| Published : | 03/24/2003 |
