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Elimination or reduction of risk of infection related to in vitro diagnostic reagents
90.93 Standard confirmed
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
90.93 Standard confirmed
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
90.93 Standard confirmed
In vitro diagnostic systems - Culture media for microbiology - Terms and definitions
90.20 Standard under periodical review
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
60.60 Standard published
Medical laboratories - Requirements for quality and competence
60.60 Standard published
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
90.92 Standard to be revised
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
90.93 Standard confirmed
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
60.60 Standard published
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
60.60 Standard published
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
10.99 New project approved
Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021)
60.60 Standard published
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
60.60 Standard published
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
60.60 Standard published