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ISO Documents | Standards

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Medical laboratories — Requirements for quality and competence
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Medical laboratories — Requirements for safety, 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 medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
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Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
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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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Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
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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 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 medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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