DIN Standards Committee Heating and Ventilation Technology and their Safety
DIN EN 60601-2-37
; VDE 0750-2-37:2016-11
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
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung (IEC 60601-2-37:2007 + A1:2015); Deutsche Fassung EN 60601-2-37:2008 + A11:2011 + A1:2015
Overview
This product standard from the DIN EN 60601 (VDE 0750) series describes the safety requirements for ultrasonic equipment for medical diagnosis and monitoring. It is intended to increasingly improve indication of output values or corresponding indicators, as well as control at increasing energy levels of the diagnostically used fields. For all such diagnostic modalities it is the responsibility of the operator to understand the risk of the output values of the diagnostic ultrasonic equipment and to act accordingly in order to receive the required diagnostic information at minimum risk to the patient. For safety reasons Germany voted against the ratification of EN 60601-2-37. However, dominantly positive European voting result led to a ratification of the European Standard. The opposition was aimed in particular against the concept of the thermal and mechanical indices contained in the standard. Concerns regarding this concept are still present but have been put into perspective due to the latest research results as well as the risk management contained in the third edition of general safety standard IEC 60601-1. For this reason, the first German version of IEC 60601-2-37 is now available. The responsible committee is NA 080-00-16 GA Joint Working Committee NAR/DKE "Bildgebende Systeme" ("Imaging systems") at DIN Standards Committee Radiology in collaboration with Deutsche Röntgengesellschaft (German Radiological Society) and in cooperation with Joint Subcommittee GUK 821.3 "Medizinische Ultraschallgeräte" ("Ultrasonics") of the DKE (German Commission for Electrical, Electronic and Information Technologies) at DIN and VDE (www.dke.de).
Document: references other documents
Document: referenced in other documents
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
