Efficacy of the biocide incorporated in a treated article against target organisms in the intended use must be demonstrated as one component of an application dossier. This guidance document covers efficacy testing of articles treated with antimicrobials in the manufacturing process with the intention of the achieving an external effect and of articles which have been in some way modified during service so as to exert an antimicrobial effect.
Guidance Document on the Evaluation of the Efficacy of Antimicrobial Treated Articles With Claims for External Effects
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