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ISO/TC 212  - Clinical laboratory testing and in vitro diagnostic test systems

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Standards and projects under the direct responsibility of ISO/TC 212 Secretariat and its SCs

Standard and/or projectStageICSTC
ISO 15189:2012
Medical laboratories -- Requirements for quality and competence
60.60 11.100.01
03.120.10
ISO/TC 212
ISO 15190:2003
Medical laboratories -- Requirements for safety
90.93 11.100.01ISO/TC 212
ISO 15193:2009
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
90.60 11.100.10ISO/TC 212
ISO 15194:2009
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for certified reference materials and the content of supporting documentation
90.60 11.100.10ISO/TC 212
ISO 15195:2003
Laboratory medicine -- Requirements for reference measurement laboratories
90.60 11.100.99ISO/TC 212
ISO 15197:2013
In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
60.60 11.100.10ISO/TC 212
ISO 15198:2004
Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
90.60 11.100.10ISO/TC 212
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
60.60 11.100.10ISO/TC 212
ISO 17511:2003
In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials
90.60 11.100.10ISO/TC 212
ISO 17593:2007
Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
90.93 11.100.20ISO/TC 212
ISO 18113-1:2009
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements
90.20 11.100.10ISO/TC 212
ISO 18113-2:2009
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
90.20 11.100.10ISO/TC 212
ISO 18113-3:2009
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
90.20 11.100.10ISO/TC 212
ISO 18113-4:2009
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
90.20 11.100.10ISO/TC 212
ISO 18113-5:2009
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
90.20 11.100.10ISO/TC 212
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
90.60 11.100.10ISO/TC 212
ISO 19001:2013
In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
60.60 11.040.55
11.100.10
ISO/TC 212
ISO 20776-1:2006
Clinical laboratory testing and in vitro diagnostic test systems -- Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
90.60 11.100.20ISO/TC 212
ISO 20776-2:2007
Clinical laboratory testing and in vitro diagnostic test systems -- Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices -- Part 2: Evaluation of performance of antimicrobial susceptibility test devices
90.60 11.100.20ISO/TC 212
ISO/TS 22367:2008
Medical laboratories -- Reduction of error through risk management and continual improvement
90.20 11.100.01ISO/TC 212
ISO/TS 22367:2008/Cor 1:2009
60.60 11.100.01ISO/TC 212
ISO/TR 22869:2005
Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003
60.60 11.100.01ISO/TC 212
ISO 22870:2006
Point-of-care testing (POCT) -- Requirements for quality and competence
90.60 03.120.10
11.100.01
ISO/TC 212
ISO 23640:2011
In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents
60.60 11.100.10ISO/TC 212