CEN/TC 140
| Project No. | EN 13532:2002 |
|---|---|
| Title | This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing. |
| Registration number (WIID) | 5109 |
| Scope | This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing. |
| Status | Izstrādē |
| ICS group | 11.100 |