[A test object for quality control of the instrument for doppler (duplex) ultrasonography, based on the Draft IEC 61685 Standard]. / Ein Testobjekt für die apparative Qualitätssicherung bei Ultraschall-Doppler(Duplex)-Geräten, ausgehend vom Normenentwurf IEC 61685.

ABSTRACT

PURPOSE: The authors, forming part of a multicenter project funded by the European Community, summarize the validation of a tissue-mimicking flow Doppler test object and of procedures for testing medical diagnostic Doppler equipment. The results of the project are expected to contribute to a future international IEC Standard concerning flow Doppler test objects (Draft IEC 61685 Standard) and for the European Medical Device Directive (MD 93/42/EEC). METHODS: Within this project a test protocol was developed that includes a set of different procedures, suitable for checking Spectral and Colour Doppler systems. The performance parameters for describing the image quality as well as the accuracy and the correct functioning of a system are in accordance with the definitions made in the Draft IEC 61685 Standard. RESULTS: A survey of the design and materials used for this Doppler test object will be presented with a special emphasis on the suitability of the procedures for routine measurement of performance parameters in hospitals. CONCLUSION: The test object satisfies the requirements of the Draft IEC 61685 Standard. The test procedures in combination with this test object can be used for checking different transducer models with nominal frequencies between 2.5-10.0 MHz.