IEC 60601-2-37 Ultrasonic Medical Diagnostic and Monitoring Equipment Testing
Medical electrical equipment – Part 2-37: the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-37 Scope:
IEC 60601 2 37 and EN 60601 2 37 testing applies to the basic safety and essential performance of ultrasonic diagnostic equipment as defined in 201.3.217, hereinafter referred to as ME equipment.
Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of this standard.
IEC 60601-3-2-37 testing 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.
Keystone Compliance assists manufacturers with IEC 60601-2-37 and EN 60601-2-37 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-37 test lab needs.