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
Order from DIN Media
