| Directive Area: | Active implantable medical devices
90/385/EEC
|
| CEN Technical Body: | CEN/CENELEC Joint Working Group on Active Implantable Medical Devices (CEN/CLC/JWG AIMD) |
| List of 3 mandated standardization projects found for your selection criteria |
|
Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| MD000001 | EN 45502-1:1997 | 90/385/EEC | CEN/CLC/JWG AIMD | 3/11/1997 | Ratified | ||
| Title of standard | Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer | ||||||
|
Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| MD000002 | EN 45502-2-1:2004 | 90/385/EEC | CEN/CLC/JWG AIMD | 9/1/2003 | Ratified | ||
| Title of standard | Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | ||||||
|
Work Item ID |
Standard Reference |
Directive(s) |
Technical Body |
Harmonisation Stage |
Ratified |
Current status |
|---|---|---|---|---|---|---|---|
| MD000005 | EN 45502-2-3:2010 | 90/385/EEC | CEN/CLC/JWG AIMD | 2/1/2010 | Ratified | ||
| Title of standard | Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems | ||||||
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