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Standards Development
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 implantassociated 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.
Antimicrobial orthopaedic and spinal implants differ in material, mechanism of action, release behaviour, anatomical location and intended use. A single antimicrobial assay therefore cannot provide a complete evaluation of benefit and risk. The proposed Technical Specification provides a common framework for linking intended patient benefit, added antimicrobial-related risks, preclinical evidence and clinical context. It integrates considerations relating to biological evaluation, toxicity, antimicrobial resistance, biofilm tolerance and antibiofilm efficacy, implant-specific in vitro testing, elution where applicable, in vivo evidence and clinical interpretation. Existing standards and methods address individual supporting domains, but the proposed document provides the overarching logic for selecting, justifying and integrating product-specific evidence. WG16 has developed a substantial draft, conducted expert consultation, consolidated comments and continued technical revision. Formal registration will allow the work to proceed under the ISO project framework and broaden P-member participation. (Please use this field or attach an annex)
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