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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 029 Date of Entry 08/20/2012 
FR Recognition Number 3-102
Standard(Included in ASCA)
IEC  60601-2-31 Edition 2.1 2011-09
Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred
to as ME EQUIPMENT.
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
§870.2900 Cable, Transducer And Electrode, Patient, (Including Connector) Class 2 DSA
§870.3600 Pulse-Generator, Pacemaker, External Class 2 DTE
§870.3600 Pulse Generator, External Pacemaker, Dual Chamber Class 2 OVJ
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

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
 Luke Ralston
  FDA/CDRH/OPEQ/OHTII/
  301-796-6362
  Luke.Ralston@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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