Biological evaluation of medical devices - Guidance on nanomaterials
Biological evaluation of medical devices - Guidance on nanomaterials
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1 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 document includes considerations on the:
— characterization of nanomaterials ;
— sample preparation for testing of nanomaterials ;
— release of nano-objects from medical devices;
— toxicokinetics of nano-objects ;
— biological evaluation of nanomaterials ;
— presentation of results;
— risk assessment of nanomaterials in the context of medical device evaluation;
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