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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
Codes & Standards

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
Codes & Standards

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
Codes & Standards

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
Codes & Standards

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
Codes & Standards

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
Codes & Standards

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
Codes & Standards

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