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EVS-EN IEC 60601-2-37:2024

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 16.12.2024
Base Documents
IEC 60601-2-37:2024; EN IEC 60601-2-37:2024
ICS Groups
11.040.55 Diagnostic equipment 17.140.50 Electroacoustics
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.12.2024
Main
EVS-EN IEC 60601-2-37:2024
02.09.2015
Amendment
EVS-EN 60601-2-37:2008/A1:2015
02.11.2011
Amendment
EVS-EN 60601-2-37:2008/A11:2011
07.03.2008
Main
EVS-EN 60601-2-37:2008

IEC 60601-2-37 applies to the basic safety and essential performance of ultrasonic diagnostic equipment, hereinafter referred to as ME equipment. If a clause or subclause is specifically intended to apply to ME equipment, or 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 IEC 60601-2-37 are not covered by specific requirements in this standard. IEC 60601-2-37 does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered.

IEC 60601-2-37:2024 text has been approved in Europe as EN IEC 60601-2-37:2024 without any changes.

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English