ISO Documents | Standards

ISO 15189 Medical laboratories — Requirements for quality and competence

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ISO 15190E Medical laboratories — Requirements for Safety

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ISO 15193E 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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ISO 15194E 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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ISO 15195E Laboratory medicine — Requirements for reference measurement laboratories

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ISO 15197E In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

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ISO 15198E Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

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ISO 17511E 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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ISO 17593E 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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ISO 18113-1E In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements

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