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EVS-EN 60601-2-37:2008

Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

General information
Valid from 07.03.2008
Base Documents
IEC 60601-2-37:2007; EN 60601-2-37:2008
Directives or regulations
93/42/EEC Medical devices (MDD)
Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
Main
prEN IEC 60601-2-37:2023
02.09.2015
Amendment
02.11.2011
Amendment
07.03.2008
Main
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. 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 this standard.
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