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Project

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 62B/1318/CDV:2023); German and English version prEN IEC 60601-2-37:2023

Abstract

This document applies to the basic safety and essential performance of Ultrasonic diagnostic equipment as defined in 201.3.217. Knowledge of the reasons for these requirements will not only facilitate the proper application of this particular standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of new developments in technology. The safety standard is intended to increase sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis and enable the operator to understand the risk of the output of the ultrasonic medical diagnostic and monitoring equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the patient. The approach and philosophy used in this particular standard are consistent with those in standards of the IEC 60601-2-x series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems.

Begin

2022-09-06

Planned document number

DIN EN IEC 60601-2-37

Project number

02231201

Responsible national committee

DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik  

draft standard

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 62B/1318/CDV:2023); German and English version prEN IEC 60601-2-37:2023
2023-12
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previous edition(s)

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007 + A1:2015); German version EN 60601-2-37:2008 + A11:2011 + A1:2015
2016-11

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