CENELEC - Standards Development - List of Technical Bodies - CEN/CLC/JWG AIMD

CEN/CLC/JWG AIMD

CEN/CENELEC Joint Working Group Active Implantable Medical Devices

 
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CEN/CLC/JWG AIMD Work programme

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Fcst. voting date
prEN 45502-1:2013 (pr=22891)
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
4060 2010-03-222013-07-292013-08-192012-04-30

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CEN/CLC/JWG AIMD Publications

Reference, Title
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EN 45502-1:1997 (pr=4943)
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
1997-08-27 export to doc file  EN
EN 45502-2-1:2003 (pr=7407)
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
2003-12-22 export to doc file  EN
EN 45502-2-2:2008 (pr=8622)
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
2008-03-31 export to doc file  EN  FR  DE
EN 45502-2-3:2010 (pr=12942)
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
2010-02-19 export to doc file  EN  FR  DE

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CEN/CLC/JWG AIMD Maintenance cycle

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EN 45502-1:1997 (pr=4943)
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
1997-08-272010-05-012013-05-01CEN/CLC/JWG AIMDprEN 45502-1:2013
EN 45502-2-1:2003 (pr=7407)
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
2003-12-222008-12-222011-12-22CEN/CLC/JWG AIMD 
EN 45502-2-2:2008 (pr=8622)
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
2008-03-312013-03-312016-03-31CEN/CLC/JWG AIMD 
EN 45502-2-3:2010 (pr=12942)
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
2010-02-192015-02-192018-02-19CEN/CLC/JWG AIMD 

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TC 3 Project files


CEN/CLC/JWG AIMD TC/SC in figures

Current Stage
Year
Year -1
Year -2
Year -3
Year -4
Year >5
Enquiry stage010000
Published000013

CEN/CLC/JWG AIMD Figures overall

Total publications
32
Published in last 3 years
7
Total work in progress
15
Total proposals
0
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CEN/CLC/JWG AIMD Environment

Reference
Clause
Categories - Aspects
Product Life Cycle
Information
Confirmed

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CEN/CLC/JWG AIMD EU Directive(s)

Reference
Stage code
Directive
OJ Status
OJ Reference
Mandate
EN 45502-1:1997 (pr=4943)
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
6060 90/385/EEC
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
PUB C 22/01 M/432
prEN 45502-1:2013 (pr=22891)
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
4060 90/385/EEC
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
NEW M/432
EN 45502-2-1:2003 (pr=7407)
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
6060 90/385/EEC
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
PUB C 22/01 M/432
EN 45502-2-2:2008 (pr=8622)
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
6060 90/385/EEC
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
PUB C 22/01 M/432
EN 45502-2-3:2010 (pr=12942)
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
6060 90/385/EEC
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
PUB C 22/01 M/432