2. Getting involved
3. Standards Committees
4. DKE

DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Overview

These particular requirements set out special requirements for 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. Hazards inherent in the intended physiological function of medical equipment or medical systems within the scope of this document are not covered by specific requirements in this document except as provided in 7.2.13 and 8.4.1 of the General specifications. These particular requirements do 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. The standard differs from DIN EN 60601-2-37 (VDE 0750-2-37):2016-11 as follows: a) technical and editorial changes resulting from the amended general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and its collateral standards IEC 60601-1-xx; b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

Document: references other documents

Document: referenced in other documents

Responsible national committee

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