Items to be displayed:
| Standard and/or project | Stage | ICS | TC |
|---|---|---|---|
| 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 | 11.100.01 | ISO/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 | 60.60 | 11.100.10 | ISO/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 | 60.60 | 11.100.10 | ISO/TC 212 |
| ISO 15195:2003 Laboratory medicine -- Requirements for reference measurement laboratories | 90.60 | 11.100.99 | ISO/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 | 11.100.10 | ISO/TC 212 |
| ISO 15198:2004 Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer | 90.20 | 11.100.10 | ISO/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 | 11.100.10 | ISO/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 | 11.100.10 | ISO/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 | 11.100.20 | ISO/TC 212 |
| ISO/TR 18112:2006 Clinical laboratory testing and in vitro diagnostic test systems -- In vitro diagnostic medical devices for professional use -- Summary of regulatory requirements for information supplied by the manufacturer | 60.60 | 11.100.10 | ISO/TC 212 |
| ISO 18113-1:2009 In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements | 60.60 | 11.100.10 | ISO/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 | 60.60 | 11.100.10 | ISO/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 | 60.60 | 11.100.10 | ISO/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 | 60.60 | 11.100.10 | ISO/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 | 60.60 | 11.100.10 | ISO/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 | 11.100.10 | ISO/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 | 11.100.20 | ISO/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 | 11.100.20 | ISO/TC 212 |
| ISO/TS 22367:2008 Medical laboratories -- Reduction of error through risk management and continual improvement | 90.60 | 11.100.01 | ISO/TC 212 |
| ISO/TS 22367:2008/Cor 1:2009 | 60.60 | 11.100.01 | ISO/TC 212 |
| ISO/TR 22869:2005 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003 | 60.60 | 11.100.01 | ISO/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 | 11.100.10 | ISO/TC 212 |
