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ISO Documents | Standards

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In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples, 2nd Edition
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In vitro diagnostic systems — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
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In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide

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In vitro diagnostic test systems — Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens
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In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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ISO 18113-5E In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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ISO 18153E In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of assigned values for catalytic concentration of enzymes assigned to calibrators and control materials
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ISO 19001E In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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ISO 20166-3E Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA
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ISO 20184-2E Molecular In Vitro Diagnostic Examinations - Specifications For Pre-Examination Processes For Frozen Tissue - Part 2: Isolated Proteins
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