Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 62B/557/CDV:2005)
Abstract
The approach and the philosophy used in drafting this particular standard for safety of ULTRASONIC DIAGNOSTIC EQUIPMENT are consistent with those in current standards in the IEC 60601-2 series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems: In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls with increasing energy levels in the interrogating field of diagnosis. Thus, for all such diagnostic modalities, it is the responsibility of the OPERATOR to understand the risk of the output of the equipment, and to act appropriately in order to obtain the needed diagnostic information with the minimum risk to the PATIENT.
Begin
2004-03-12
Planned document number
IEC 62B/557/CDV
Responsible national committee
DKE/GK 813 - Elektrische und mechanische Sicherheit in der radiologischen Technik
