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BSI - BS EN ISO 14708-6

Implants for surgery - Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

active, Most Current
Organization: BSI
Publication Date: 31 August 2022
Status: active
Page Count: 76
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS EN ISO 14708-6
August 31, 2022
Implants for surgery - Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
A description is not available for this item.

References

This document references:
ISO TR 14283 - Implants for surgery - Essential principles of safety and performance
Published by ISO on January 1, 2018
This document provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose. It is often the case that...
This document references:
8601-1 AMD 1 - Date and time — Representations for information interchange — Part 1: Basic rules AMENDMENT 1: Technical corrections
Published by ISO on October 1, 2022
A description is not available for this item.
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:
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 ISO on February 15, 2012
This International Standard specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. Table 1 gives a list of...
This document references:
ISO 14708-1 - 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 ISO on August 15, 2014
This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices. NOTE 1 For particular types of active implantable medical devices, these general...
This document is referenced by:
BS EN ISO 14708-2 - Implants for surgery - Active implantable medical devices Part 2: Cardiac pacemakers
Published by BSI on August 31, 2022
A description is not available for this item.
This document is referenced by:
BS ISO 14117 - TC - Tracked Changes (Redline) - Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
Published by BSI on February 24, 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.
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