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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 3-161
Standard
ISO  14117 Second edition 2019-09
Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
N/A Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
N/A Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
N/A Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
Relevant FDA Guidance and/or Supportive Publications*
Information To Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Device; Guidance for Industry and Food and Drug Administration Staff, Issued on July 11, 2016.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Seth Seidman
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2477
  seth.seidman@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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