Sampling methods for acceptance testing of medical products for in vitro diagnostics. Statistical aspects
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Application of external quality assessment schemes in assessing the quality of diagnostic methods in vitro
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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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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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In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
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Splints for the upper and lower extremities. Technical requirements and test methods
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In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media
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General requirements for in vitro diagnostic medical devices for self-testing
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Performance evaluation of in vitro diagnostic medical devices
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Stability testing of in vitro diagnostic reagents
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Elimination or reduction of risk of infection related to in vitro diagnostic reagents
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In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans
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