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Clinical investigation of medical devices for human subjects - Clinical investigation plans Ingestion-build-63114 Methods are validated in terms

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Methods are validated in terms of the probability of detection (POD) and of the precision of the POD

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General conditions for the tests Classification

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Clinical investigation of medical devices for human subjects - Clinical investigation plans Ingestion-build-63114 Methods are validated in termsClinical investigation of medical devices for human subjects Part 2: Clinical investigation plans BS EN ISO 14155 2 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimizing the scientific validity and reproducibility of the results of a clinical

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