General information about your selection criteria
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
CEN Home 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
CEN Home 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)
CEN Home 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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