BS ISO 14117:2019 - Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

BS ISO 14117:2019

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

Status : Current   Published : September 2019

Format
PDF

Format
HARDCOPY



This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems.

NOTE

This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.

It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:

  • 0Ã? HzÃ? â?¤Ã?  Ã??Ã? <Ã? 385Ã? MHz;

  • 385Ã? MHzÃ? â?¤Ã?  Ã??Ã? â?¤Ã? 3Ã? 000Ã? MHz

This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.




Standard NumberBS ISO 14117:2019
TitleActive implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
StatusCurrent
Publication Date04 September 2019
Normative References(Required to achieve compliance to this standard)ISO 14708-1:2014, BS EN ISO 14708-2:2019, ISO 14708-6:2019, ISO 14708-2:2019, BS EN ISO 14708-6:2019
Informative References(Provided for Information)EN 301489-35, EN 50527-1, ISO/IEC Guide 51, IEEE C95.1:2005, EN 45502-2-2, EN 50527-2-1, ERC Recommendation 70-03, IEEE Std 802.15.6-2012, DIN VDE 0848-3-1, EN 301489-1, ANSI/AAMI PC69:2000, EN 301489-27, IEEE C95.6:2003, EN 50061, EN 45502-2-1, ANSI/AAMI PC69:2007, ANSI C63.5-1988, prEN 50527-2-2, EN 301489-29, EN 301489-31, ISO 11318:2002, ISO 5841-3:2013, ISO 27186:2010
ReplacesBS ISO 14117:2012
International RelationshipsISO 14117:2019
Draft Superseded By18/30362932 DC
DescriptorsSafety measures, Signal generators, Electrical medical equipment, Heart, Prosthetic devices, Electrical impedance, Implants (surgical), Pulse circuits, Cardiology, Type testing, Defibrillators, Medical equipment, Pulse generators
ICS11.040.40
33.100.01
Title in FrenchDispositifs médicaux implantables actifs. Compatibilité électromagnétique. Protocoles d'essai EMC pour pacemakers cardiaques implantables, défibrillateurs implantables et dispositifs de resynchronisation cardiaque
CommitteeCH/150/2
ISBN978 0 580 99091 5
PublisherBSI
FormatA4
DeliveryYes
Pages146
File Size10.07 MB
Price£328.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Worldwide Standards
We can source any standard from anywhere in the world