Registration number (WIID)Project No.TitleStatus
5096EN 1658:1996Requirements for marking of in vitro diagnostic instrumentsAtcelts
5099EN 376:2002Information supplied by the manufacturer with in vitro diagnostic reagents for self-testingAtcelts
5100EN 591:2001Instructions for use for in vitro diagnostic instruments for professional useAtcelts
5095EN 592:1994In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for home useAtcelts
5113EN ISO 15195:2003Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)Atcelts
5105EN ISO 17511:2003In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)Atcelts
41043CEN/TS 16945:2016Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasmaAtcelts
27617EN ISO 18113-2:2009In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2009)Atcelts
27620EN ISO 18113-5:2009In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2009)Atcelts
65450CEN/TS 17390-1:2020Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 1: Isolated RNAAtcelts
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