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ISO Documents | Standards

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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 and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
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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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ISOTS 22583E Guidance for supervisors and operators of point-of-care testing (POCT) devices
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Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
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Medical laboratories — Application of risk management to medical laboratories
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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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