CENELEC New Approach
CEN Home Work Item ID Standard Reference Directive(s) Technical Body Harmonisation Stage Ratified Current Status
8622 EN 45502-2-2:2008 90/385/EEC CEN/CLC/JWG AIMD 6060 2007-05-01 Published in OJEC
Title Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

CEN Home Work Item ID Standard Reference Directive(s) Technical Body Harmonisation Stage Ratified Current Status
7407 EN 45502-2-1:2003 90/385/EEC CEN/CLC/JWG AIMD 6060 2003-09-01 Published in OJEC
Title 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
12942 EN 45502-2-3:2010 90/385/EEC CEN/CLC/JWG AIMD 6060 2010-02-01 Published in OJEC
Title Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

CEN Home Work Item ID Standard Reference Directive(s) Technical Body Harmonisation Stage Ratified Current Status
12940 prEN 45502-2-X 90/385/EEC CEN/CLC/JWG AIMD 2098 - -
Title Active implantable medical devices -- Part 2-X: Neurostimulators

CEN Home Work Item ID Standard Reference Directive(s) Technical Body Harmonisation Stage Ratified Current Status
12941 prEN 45502-2-X 90/385/EEC CEN/CLC/JWG AIMD 2098 - -
Title Active implantable medical devices -- Part 2-X: Anti-tachy devices

CEN Home Work Item ID Standard Reference Directive(s) Technical Body Harmonisation Stage Ratified Current Status
4943 EN 45502-1:1997 90/385/EEC CEN/CLC/JWG AIMD 6060 1997-03-11 Published in OJEC
Title 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
12939 prEN 45502-2-X 90/385/EEC CEN/CLC/JWG AIMD 2098 - -
Title Active implantable medical devices -- Part 2-X: Infusion pumps

CEN Home Work Item ID Standard Reference Directive(s) Technical Body Harmonisation Stage Ratified Current Status
22891 prEN 45502-1:2013 90/385/EEC CEN/CLC/JWG AIMD 4020 - -
Title Active implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturer