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CSA ISO 15197:15 (R2020)
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (Adopted ISO 15197:2013, second edition, 2013-05-15)
- English, French
- Published in 2015
- Reaffirmed in 2020
- Published by CSA Group
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CSA ISO 20166-1:22
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA (Adopted ISO 20166-1:2018, first edition, 2018-12)
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
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CSA ISO 20166-2:22
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins (Adopted ISO 20166-2:2018, first edition, 2018-12)
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
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CSA ISO 20166-3:22
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA (Adopted ISO 20166-3:2018, first edition, 2018-12)
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
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CSA ISO 20166-4:22
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques (Adopted ISO 20166-4:2021, first edition, 2021-07)
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
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CSA ISO 20186-1:22
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA (Adopted ISO 20186-1:2019, first edition, 2019-02)
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
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CSA ISO 20186-2:22
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA (Adopted ISO 20186-2:2019, first edition, 2019-02)
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
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CSA ISO 20186-3:22
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma (Adopted ISO 20186-3:2019, first edition, 2019-09)
- English, French
- Published in 2022
- Published by CSA Group
- Subscription Available
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ISO 13079:2011
Laboratory glass and plastics ware -- Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
- English, French
- Published in 2011
- Published by ISO
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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
- English, French
- Published in 2009
- Published by ISO
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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
- English, French
- Published in 2009
- Published by ISO
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ISO 15197:2013
In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- English, French
- Published in 2013
- Published by ISO
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ISO 15198:2004
Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
- English
- Published in 2004
- Published by ISO
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ISO 16256:2021
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
- English, French
- Published in 2021
- Published by ISO
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ISO 17511:2020
In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
- English, French
- Published in 2020
- Published by ISO
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ISO 18113-1:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
- English, French
- Published in 2022
- Published by ISO
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ISO 18113-2:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
- English, French
- Published in 2022
- Published by ISO
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ISO 18113-3:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
- English, French
- Published in 2022
- Published by ISO
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ISO 18113-4:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
- English, French
- Published in 2022
- Published by ISO
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ISO 18113-5:2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
- English, French
- Published in 2022
- Published by ISO
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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
- English
- Published in 2003
- Published by ISO
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ISO 19001:2013
In vitro diagnostic medical devices -- Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- English, French
- Published in 2013
- Published by ISO
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ISO 20166-1:2018
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 1: Isolated RNA
- English, French
- Published in 2018
- Published by ISO
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ISO 20166-2:2018
Molecular in vitro diagnostic examinations -- Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 2: Isolated proteins
- English, French
- Published in 2018
- Published by ISO
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ISO 20166-3:2018
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue -- Part 3: Isolated DNA
- English, French
- Published in 2018
- Published by ISO
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ISO 20166-4:2021
Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques
- English, French
- Published in 2021
- Published by ISO
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ISO 20184-1:2018
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissue -- Part 1: Isolated RNA
- English, French
- Published in 2018
- Published by ISO
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ISO 20184-2:2018
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for frozen tissue -- Part 2: Isolated proteins
- English, French
- Published in 2018
- Published by ISO
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ISO 20184-3:2021
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
- English, French
- Published in 2021
- Published by ISO
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ISO 20186-1:2019
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 1: Isolated cellular RNA
- English, French
- Published in 2019
- Published by ISO
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ISO 20186-2:2019
Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood -- Part 2: Isolated genomic DNA
- English, French
- Published in 2019
- Published by ISO
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ISO 20916:2019
In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice
- English, French
- Published in 2019
- Published by ISO
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ISO 21151:2020
In vitro diagnostic medical devices — Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
- English, French
- Published in 2020
- Published by ISO
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ISO 21474-1:2020
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
- English
- Published in 2020
- Published by ISO
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ISO 21474-2:2022
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
- English, French
- Published in 2022
- Published by ISO
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ISO 23118:2021
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
- English, French
- Published in 2021
- Published by ISO
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ISO 23640:2011
In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents
- English, French
- Published in 2011
- Published by ISO
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ISO 29701:2010
Nanotechnologies -- Endotoxin test on nanomaterial samples for in vitro systems -- Limulus amebocyte lysate (LAL) test
- English, French
- Published in 2010
- Published by ISO
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ISO 4307:2021
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
- English, French
- Published in 2021
- Published by ISO
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ISO 6717:2021
In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
- English, French
- Published in 2021
- Published by ISO