CENELEC
International Standards and Conformity Assessment
for all electrical, electronic and related technologies
CEN/CLC/JWG AIMD |
CEN/CENELEC Joint Working Group Active Implantable Medical Devices |
CEN/CLC/JWG AIMD Working Documents
The Working documents of the technical bodies (with the exception of the voting results) are available on the Collaboration Tool.
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Reference,Title
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Downloads
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Circulation date
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Closing date
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Voting / Comments
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IEC parallel vote
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prEN 45502-1:2010 (pr=22891) Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
 EN |
Procedure Result | No | ||
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prEN 45502-2-2:2006 (pr=8622) Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) |
EN |
2006-11-14 | Procedure Result | No | |
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prEN 45502-2-3:2006 (pr=12942) Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
EN |
2006-11-08 | Procedure Result | No | |
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FprEN 45502-2-3:2008 (pr=12942) Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
EN |
2008-09-09 | Procedure Result | No | |
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FprEN 45502-2-3:2009 (pr=12942) Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
EN |
2010-01-12 | Procedure Result | No |
CEN/CLC/JWG AIMD Documents open for vote
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Reference,Title
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Downloads
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Circulation date
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Closing date
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Type
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IEC parallel vote
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|---|---|---|---|---|---|
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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 |
 EN FR DE |
2013-04-26 | 2013-07-26 | Draft for 2 nd ENQ | No |
Other Documents accessible to CEN/CLC/JWG AIMD
Reference,Title | Downloads |
|---|---|
Definitive Text - EN 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer | |
Definitive Text - EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | |
Definitive Text - EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | |
Definitive Text - EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | |
Definitive Text - EN 45502-2-2:2008/corrigendum Apr. 2009 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | |
Definitive Text - EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems | |
Definitive Text - EN 45502-2-2:2008/corrigendum Apr. 2009 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | |
Definitive Text - EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) | |
Definitive Text - EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems | |
Definitive Text - EN 45502-2-3:2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems | |
Definitive Text - EN 45502-2-2:2008/corrigendum Apr. 2009 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) | |
