Registration number (WIID)Project No.TitleStatus
83299-In vitro diagnostic examinations — Specifications for pre-examination processes for human specimens for the detection of infectious pathogens — Viruses, bacteria, fungi and parasitesIzstrādē
67446CEN/TS 17626:2021Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNAIzstrādē
5107EN 13641:2002Elimination or reduction of risk of infection related to in vitro diagnostic reagentsIzstrādē
83076prEN ISO 20776-1 revSusceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseasesIzstrādē
5116EN 12322:1999/A1:2001In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture mediaIzstrādē
74322CEN ISO/TS 5798:2022In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)Izstrādē
83075EN ISO 15195:2019/prA1Laboratory medicine — Requirements for the competence of calibration laboratories using reference measurement procedures — Amendment 1Izstrādē
29673prEN ISO 15190Medical laboratories - Requirements for safetyIzstrādē
5109EN 13532:2002General requirements for in vitro diagnostic medical devices for self-testingIzstrādē
5089-Methods for the determination of performance of culture mediaIzstrādē
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