Norm

ISO 14117:2019 en

Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

166,18 201,08 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 134
Commissie Chirurgische implantaten
Gepubliceerd op 01-09-2019
Taal Engels
ISO 14117 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 in conjunction with transvenous lead systems. 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 ≤ ƒ < 385 MHz; - 385 MHz ≤ ƒ ≤ 3 000 MHz This document 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
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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