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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
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
60.60 Standard published
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
60.60 Standard published
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
60.60 Standard published
Single-use containers for human venous blood specimen collection (ISO 6710:2017)
60.60 Standard published
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
60.60 Standard published
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
60.60 Standard published
Medical device software - Software life-cycle processes
60.60 Standard published
Medical device software - Software life-cycle processes
60.60 Standard published
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Medical devices - Part 1: Application of usability engineering to medical devices
60.60 Standard published
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
60.60 Standard published