SR EN IEC 60601-2-37:2024

Aparate electromedicale. Partea 2-37: Cerinţe particulare de securitate şi performanţe esenţiale pentru aparate medicale cu ultrasunete de monitorizare şi de diagnostic

IEC 60601-2-37:2024 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 document are not covered by specific requirements in this document except in 201.7.2.13. This document 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 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the pr

501,50 Lei

Status : In vigoare
Data aprobării : 31.12.2024
Număr de pagini : 127
ICS : 11.040.55 Echipament pentru diagnosticare,17.140.50 Electroacustica
Comitet tehnic : 22 - Echipamente electromedicale

Relaţii cu alte standarde: