Biomedical subjects
Publications and source records attributed to H Wenner.
This article examines the requirements of EN 60601-1-4, which states that risk management is an integral part of the development of software for medical devices. Food and Drug Administration regulations are also compared to the requirements of the Medical Device Directive to provide guidance on developing software for the European and US markets.
Radioimmunologically estimated diurnal profiles of 17-hydroxyprogesterone (17-OHP) showed clearly increased values in 15 patients with adrenogenital syndrome aged 9-19 years who had been treated for at least 4 1/2 years with cortisol. Increases were pronounced in the morning: at 8 hours 58.6 nmol/l, at 12 hours 22.2 nmol/l, at 18 hours 23.7 nmol/l on average. By changing cortisol medication, in particular due to split doses, morning 17-OHP peak values could be lowered and the whole daily profile could be improved: at 8 hours 17.9 nmol/l, at 12 hours 9.3 nmol/l, at 18 hours 8.1 nmol/l on average. The total cortisol dosage had to be increased only marginally from an average of 26.7 to 30 mg/m2 body surface, however, the evening dosage was increased from 20% to 38% on average of the total dose. Measurement of serum 17-OHP diurnal profile is thus advantageous in treatment of adrenogenital syndrome with cortisol when compared to values obtained from 24-hour urine collections.