ISO Documents | Standards

Medical laboratories — Requirements for quality and competence
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Medical laboratories — Requirements for Safety
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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 — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials
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Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
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