Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards— 50 стр.
$iI$in $iv$ii$it$ir$io diagnostic test systems. Qualitative nucleic acid-based $ii$in $iv$ii$it$ir$io examination procedures for detection and identification of microbial pathogens. General requirements, terms and definitions— 32 стр.