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BSI - 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)

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Organization: BSI
Publication Date: 20 January 2004
Status: active
Page Count: 98
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS EN 45502-2-1
January 20, 2004
Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
A description is not available for this item.

References

This document references:
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)
Published by BSI on October 31, 2008
A description is not available for this item.
This document references:
IEC 60068-2-47 - Environmental testing – Part 2-47: Tests – Mounting of specimens for vibration, impact and similar dynamic tests
Published by IEC on April 1, 2005
This part of IEC 60068 provides methods for mounting products, whether packaged or unpackaged, as well as mounting requirements for equipment and other articles, for the series of dynamic tests in...
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:
IEC 60068-2-27 - Environmental testing – Part 2-27: Tests – Test Ea and guidance: Shock
Published by IEC on February 1, 2008
Object To provide a standard procedure for determining the ability of a specimen to withstand specified severities of shock.
This document references:
ISO 5841-3 - Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for implantable pacemakers
Published by ISO on April 15, 2013
This part of ISO 5841 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements...
This document references:
BS EN 45502-1 - Implants for surgery — Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Published by BSI on June 30, 2015
A description is not available for this item.
This document references:
BS EN 45502-1 - Implants for surgery — Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Published by BSI on June 30, 2015
A description is not available for this item.
This document references:
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)
Published by BSI on October 31, 2008
A description is not available for this item.
This document is referenced by:
BS 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 BSI on January 31, 2017
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.
This document is referenced by:
BS EN 45502-2-3 - Active implantable medical devices Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
Published by BSI on March 31, 2010
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.
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