IEC 61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION
Designation
61391-1 Edition 1.1 2017-07 CONSOLIDATED VERSION
Organization
IEC
Recognition number
12-312
Recognition date
2018-06-07
Scope
This International Standard describes methods of calibrating the spatial measurement facilities and point-spread function of ultrasonic imaging equipment in the ultrasonic frequency range 0,5 MHz to 15 MHz. This standard is relevant for ultrasonic scanners based on the pulse-echo principle of the types listed below: - mechanical sector scanners; - electronic phased-array sector scanners; - electronic linear-array scanners; - electronic curved-array sector scanners; - water-bath scanners based on any of the above four scanning mechanisms; - 3D-volume reconstruction systems
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.