A laminar flow test object based on the draft IEC 61685 standard for quality assurance of ultrasound Doppler equipment.

Purpose: The authors, forming part of a multicenter project funded by the E uropean Community, summarize the validation of a tissue-mimicking flow Dopp ler test object and of procedures for testing medical diagnostic Doppler eq uipment. 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 D oppler systems. The performance parameters for describing the image quality as well as the accuracy and the correct functioning of a system are in acc ordance with the definitions made in the Draft IEC 61685 Standard. Results: A survey of the design and materials used for this Doppler test object wil l 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 Standar d. 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.