Norm

NEN-ISO 14117:2012 en

Actieve implanteerbare medische hulpmiddelen - Elektromagnetische compatibiliteit - EMC proefprotocollen voor implanteerbare hartpacemakers, implanteerbare cardioverter-defibrillatoren en cardiale synchroniserende apparaten

179,33

Over deze norm

Status Definitief
Aantal pagina's 97
Commissie Chirurgische implantaten
Gepubliceerd op 01-07-2012
Taal Engels
This International Standard specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization. It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges: 0 Hz ≤ f < 450 MHz; 450 MHz ≤ f ≤ 3 000 MHz This International Standard also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.

Details

ICS-code 11.040.40
33.100.01
Nederlandse titel Actieve implanteerbare medische hulpmiddelen - Elektromagnetische compatibiliteit - EMC proefprotocollen voor implanteerbare hartpacemakers, implanteerbare cardioverter-defibrillatoren en cardiale synchroniserende apparaten
Engelse titel Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

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