ISO/TC 212
| Registration number (WIID) | Project No. | Title | Status |
|---|---|---|---|
| 31718 | ISO 18153:2003 | In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials | Atcelts |
| 42641 | ISO 15189:2007 | Medical laboratories — Particular requirements for quality and competence | Atcelts |
| 56115 | ISO 15189:2012 | Medical laboratories — Requirements for quality and competence | Atcelts |
| 40984 | ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements | Atcelts |
| 81712 | ISO/TS 5798:2022 | In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods | Atcelts |
| 35173 | ISO 22870:2006 | Point-of-care testing (POCT) — Requirements for quality and competence | Atcelts |
| 38590 | ISO/TR 18112:2006 | Clinical laboratory testing and in vitro diagnostic test systems — In vitro diagnostic medical devices for professional use — Summary of regulatory requirements for information supplied by the manufacturer | Atcelts |
| 69984 | ISO 17511:2020 | In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples | Atcelts |
| 56027 | ISO 16256:2012 | Clinical laboratory testing and in vitro diagnostic test systems — Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases | Atcelts |
| 69985 | ISO 21151:2020 | In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples | Atcelts |
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