| Directive Area: | Active implantable medical devices
90/385/EEC
|
| CEN Technical Body: | Clinical investigation of medical devices (CEN/TC 258) |
| List of 2 mandated standardization projects found for your selection criteria |
|
Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00258006 | EN ISO 14155-1:2009 | 90/385/EEC | CEN/TC 258 | 6/27/2009 | Ratified | ||
| Title of standard | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) | ||||||
|
|
Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| 00258007 | EN ISO 14155-2:2009 | 90/385/EEC | CEN/TC 258 | 6/27/2009 | Ratified | ||
| Title of standard | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) | ||||||
Data loaded from the CEN Management Centre database on 9/2/2010 6:12:59 AM