IEC 60601-2-47 Edition 2.0 2012-02 Medical Standard

Medical Electrical Equipment - Part 2-47: Particular Requirements For The Basic Safety And Essential Performanceof Ambulatory Electrocardiographic Systems

60601-2-47 Edition 2.0 2012-02

Standard Organization: IEC

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

Recognition Number

Cardiovascular

Recognition Date

2018-09-17

Recognition List

050

Recognition Number

3-155

Extent

Complete standard

Standards Orgs

IEC International Electrotechnical Commission http://www.iec.ch/

STG

Cardiovascular

FDA Tech

Shawn Forrest FDA/OMPT/CDRH/ODE/DCD/CDDB/ 301-796-5554 shawn.forrest@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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