[The functionality and safety of medical electronic products--standardization in a troubled area of conflicting demands].
First, the paper deals with the fundamental importance of standardisation to manufacturers, users and experts; the special demands made by medical engineering on safety and function are outlined clearly and in detail. The application and significance of standards for the development, testing and approval of medical technical systems are illustrated by means of a unit for the extracorporeal disintegration of renal calculi (lithotripsy), and the principle, technology and use of such a unit are discussed. The paper concludes with the prospects for further development of medical engineering and possible consequences for standardisation work. At the same time, the increasing use of software is addressed in particular. Finally, the present work on standards and directives for Europe in 1992 is referred to once again. With reference to the forthcoming standardisation tasks, with hardly increasing resources, an appeal is made for their optimum use to achieve truly international standardisation.
Söder
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Siemens Aktiensgesellschaft, Bereich Medizinische Technik, Erlangen.
Pfeiler
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D004582:Electronics, Medical / Q000592:standards*; D005060:Europe; D006801:Humans; D013677:Medical Laboratory Science / Q000592:standards*; D012449:Safety
Funktionalität und Sicherheit von elektromedizinischen Produkten-Normung im Spannungsfeld gegensätzlicher Forderungen.