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This document provides a systems-based framework for planning and interpreting the preclinical and clinical evaluation of long-term implanted orthopaedic and spinal implants with antimicrobial properties. It addresses the intended antimicrobial benefit to patients; additional risks introduced by the antimicrobial component or property; development of a preclinical strategy using in vitro testing, in vivo testing, simulations and other relevant datasets; and clinical considerations relevant to implant-associated infection and clinical investigations. This document applies to surgically implanted orthopaedic and spinal implants manufactured from metals, ceramics, polymers or combinations of these materials and placed in direct contact with living tissue. It addresses implants whose primary mode of action is not antimicrobial activity. This document does not establish universal antimicrobial performance thresholds or prescribe a single detailed test method. Product-specific conditions, endpoints and acceptance criteria are to be justified for the intended use.
Reģistrācijas numurs (WIID)
95709
Darbības sfēra
This document provides a systems-based framework for planning and interpreting the preclinical and clinical evaluation of long-term implanted orthopaedic and spinal implants with antimicrobial properties. It addresses the intended antimicrobial benefit to patients; additional risks introduced by the antimicrobial component or property; development of a preclinical strategy using in vitro testing, in vivo testing, simulations and other relevant datasets; and clinical considerations relevant to implant-associated infection and clinical investigations. This document applies to surgically implanted orthopaedic and spinal implants manufactured from metals, ceramics, polymers or combinations of these materials and placed in direct contact with living tissue. It addresses implants whose primary mode of action is not antimicrobial activity. This document does not establish universal antimicrobial performance thresholds or prescribe a single detailed test method. Product-specific conditions, endpoints and acceptance criteria are to be justified for the intended use.
