Handling IEC1157: Complicated output measurements - A challenge
article
The parameters listed in IEC1157 standard 'Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment' are mainly based on the safety aspects of medical ultrasound in diagnostic examinations. The standard can be used in the process of satisfying the European medical device directive 93/42/EEC (CE-mark). In Germany, satisfying IEC1157 is already required by other regulations. As the complexity of diagnostic equipment increases, the acoustic output parameters to be specified become complicated to measure. This paper deals with some of the complications, based on the experience of our group. The group provides professional acoustic output measurements (IEC/FDA standards).
Topics
TNO Identifier
233338
ISSN
0041624X
Source
Ultrasonics, 34(2-5), pp. 139-145.
Pages
139-145
Files
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