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BSI - BS 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)

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Organization: BSI
Publication Date: 31 October 2008
Status: active
Page Count: 108
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS EN 45502-2-2
October 31, 2008
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
A description is not available for this item.
BS EN 45502-2-2
October 31, 2008
Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
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...

References

This document references:
IEC 60068-2-64 - Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance
Published by IEC on October 1, 2019
This part of IEC 60068 demonstrates the adequacy of specimens to resist dynamic loads without unacceptable degradation of its functional and/or structural integrity when subjected to the specified...
This document references:
EN 60068-2-27 - Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
Published by CENELEC on May 1, 2009
This part of IEC 60068 provides a standard procedure for determining the ability of a specimen to withstand specified severities of non-repetitive or repetitive shocks. The purpose of this test is to...
This document references:
EN 60068-2-47 - Environmental testing Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests
Published by CENELEC on June 1, 2005
A description is not available for this item.
This document references:
EN 60068-2-64 - Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
Published by CENELEC on September 1, 2008
This part of IEC 60068 demonstrates the adequacy of specimens to resist dynamic loads without unacceptable degradation of its functional and/or structural integrity when subjected to the specified...
This document references:
EN 28601 - Data Elements and Interchange Formats - Information Interchange - Representation of Dates and Times
Published by CEN on January 1, 1992
A description is not available for this item.
This document is referenced by:
BS ISO 27185 - Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements
Published by BSI on March 31, 2012
A description is not available for this item.
This document is referenced by:
BS 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 BSI on January 20, 2004
A description is not available for this item.
This document is referenced by:
BS ISO 27186 - Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
Published by BSI on December 31, 2020
A description is not available for this item.
This document is referenced by:
BS ISO 14117 - Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Published by BSI on September 30, 2019
A description is not available for this item.
This document is referenced by:
BS 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 BSI on January 20, 2004
A description is not available for this item.
This document is referenced by:
BS 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 BSI on January 31, 2017
A description is not available for this item.
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