[Functional properties of diagnostic ultrasound instruments. A concept of trial building blocks for implementing...

Today's medical diagnostic ultrasonic devices are complex technical systems and need adequate Quality Assurance (QA) with regard to ultrasonic safety and performance. As to ultrasonic safety the International Declaration Standard IEC 1157 issued in 1992 supports progress for design of future equipment. It will be increasing importance to connect and to balance out the requirements for acoustic safety and for the diagnostic potential of the equipment. In Germany the application of QA in ultrasonics has to consider limitations by structure. Against this background the author gives an overall view of QA for the performance of imaging and Doppler equipment. From recent technical and standardisation work expressing demands and solutions for QA derives a practical concept of a modular QA programme. As an example, the specific test steps and suitable instruments for the procedures are given for some QA programmes in B-mode and Doppler-mode (B, cwD, pwD). A proposal is made how to split up the QA programme into a level 1 left to the medical personnel and a level 2 put to practical use by technical services or equipment distributors.