Biological evaluation of medical devices - Guidance on nanomaterials Ingestion-build-47553 statistical variation

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Biological evaluation of medical devices - Guidance on nanomaterials Ingestion-build-47553 statistical variation1 Scope This document describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano objects generated as products of degradation, wear, or from mechanical treatment processes (e. g. in situ grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials. This