Правовая библиотека и анализ дел · Австрия · Бельгия · Европейский союз
LAWxPERT Вход Бесплатная учётная запись

S.L. 585.1 · sl/585.1 (S.L. 585.1)

S.L. 585.1 ст. 77Acceptable levels.

PART VI

ДействуетОфициальный текст

(1) If tests show that the equipment has or is producing doses other than the acceptable levels, or a malfunction has occurred that could affect patient dose, it shall be removed from clinical use and shall be reported to the Secretariat.

(2) Acceptable levels are deemed the tolerances specified in the manufacturer’s specifications or the current European Union Criteria which ever is the most stringent.