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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 3-155
Standard
IEC 60601-2-47 Edition 2.0 2012-02
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
Scope/Abstract
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

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
§870.2300 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class 2 MWI
Regulation Number Device Name Device Class Product Code
§870.2800 Electrocardiograph, Ambulatory, With Analysis Algorithm Class 2 MLO
FDA Technical Contact
 Shawn Forrest
  FDA/OMPT/CDRH/ODE/DCD/CDDB/
  301-796-5554
  shawn.forrest@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Cardiovascular
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