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General requirements for in vitro diagnostic medical devices for self-testing
90.93 Standard confirmed
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
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
60.60 Standard published
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
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 - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
90.93 Standard confirmed
Susceptibility 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 diseases (ISO 20776-1:2019, including Corrected version 2019-12)
60.60 Standard published
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
60.60 Standard published
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024)
40.60 Close of voting
Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
40.60 Close of voting