Registration number (WIID)Project No.TitleStatus
5095EN 592:1994In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for home useAtcelts
5100EN 591:2001Instructions for use for in vitro diagnostic instruments for professional useAtcelts
29759EN ISO 23640:2011In vitro diagnostic medical devices - Stability testing of in vitro diagnostic reagents (ISO/DIS 23640:2009)Atcelts
5099EN 376:2002Information supplied by the manufacturer with in vitro diagnostic reagents for self-testingAtcelts
32667CEN ISO/TS 22367:2010Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009)Atcelts
65451CEN/TS 17390-3:2020Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC stainingAtcelts
37590LVS EN ISO 18113-2:2012In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)Atcelts
24452EN ISO 22870:2006Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006)Atcelts
5096EN 1658:1996Requirements for marking of in vitro diagnostic instrumentsAtcelts
23415EN ISO 20776-1:2006Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)Atcelts
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