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Recognized Consensus Standards

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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 pilot)
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
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.3600 Pulse Generator, External Pacemaker, Dual Chamber Class 2 OVJ
§870.3600 Pulse-Generator, Pacemaker, External Class 3 DTE
§870.2900 Cable, Transducer And Electrode, Patient, (Including Connector) Class 2 DSA
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
FDA Technical Contact
 Ingmar Viohl
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  240-402-0233
  Ingmar.Viohl@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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