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BSI - BS ISO 14117

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

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Organization: BSI
Publication Date: 30 September 2019
Status: active
Page Count: 146
ICS Code (Electromagnetic compatibility in general): 33.100.01
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS ISO 14117
September 30, 2019
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
A description is not available for this item.
BS ISO 14117
March 31, 2013
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
A description is not available for this item.

References

This document references:
EN 45502-2-1 - Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Published by CENELEC on December 1, 2003
This Part 2-1 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias. The tests that are specified in EN 45502 are type tests, and...
This document references:
EN 45502-2-2 - Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
Published by CENELEC on March 1, 2008
This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat...
This document references:
EN 50061 - Safety of Implantable Cardiac Pacemakers
Published by CENELEC on May 1, 1988
A description is not available for this item.
This document references:
EN 50527-1 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
Published by CENELEC on December 1, 2016
This European Standard provides a procedure to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a...
This document references:
EN 50527-2-1 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-1: Specific assessment for workers with cardiac pacemakers
Published by CENELEC on December 1, 2016
This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted pacemakers. It offers different approaches for doing the...
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