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ISO Documents | Standards

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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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In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice

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Medical laboratories — Application of risk management to medical laboratories
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Point-of-care testing (POC) — Requirements for quality and competence
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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
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Basic semen examination — Specification and test methods

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In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
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Biorisk Management for Laboratories and Other Related Organizations

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA

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