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In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
90.60 Close of review
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
60.60 Standard published
General requirements for in vitro diagnostic medical devices for self-testing
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
60.60 Standard published
Performance evaluation of in vitro diagnostic medical devices
90.93 Standard confirmed
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
Medical laboratories - Requirements for quality and competence
60.60 Standard published
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
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
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 systems - Culture media for microbiology - Terms and definitions
90.60 Close of review
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
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA
60.60 Standard published
