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BSI - BS PD ISO/TS 10974

Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

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Organization: BSI
Publication Date: 30 April 2018
Status: active
Page Count: 230
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

22/30429420 DC
May 27, 2022
Draft BS ISO 10974 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
A description is not available for this item.
BS PD ISO/TS 10974
April 30, 2018
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
A description is not available for this item.
BS PD ISO/TS 10974
September 30, 2012
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
A description is not available for this item.

References

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 references:
60601-2-33 INT 1 - MEDICAL ELECTRICAL EQUIPMENT – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Published by IEC on May 1, 2023
A description is not available for this item.
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 references:
ISO 27186 - Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
Published by ISO on November 1, 2020
This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document...
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 is referenced by:
AAMI TIR21900 - Guidance for uncertainty analysis regarding the application of ISO/TS 10974
Published by AAMI on January 1, 2018
This document provides guidance for some methods that could be used to evaluate the sources of uncertainty. It is important to note that there are many legitimate methods for analyzing the overall...
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