Biological-Evaluation Planning for Photopolymer Devices: Material State, Contact Category, Endpoints and Evidence Integration

Biological evaluation of a photopolymer device is not a material label or a fixed panel of tests. It is a risk-management process applied to the final, clinically relevant device state. For vat-photopolymerised devices, resin identity alone is insufficient because printing, washing, drying, post-curing, support removal, finishing, cleaning, sterilisation, ageing and packaging can alter conversion, accessible surface, residues, extractables and degradation behaviour. Contact type, duration, frequency and exposed population then determine which biological hazards and endpoints require evidence. This review defines an evidence architecture that begins with intended use and a frozen material- process-device configuration. It links body-contact categorisation, chemical and physical characterisation, prior knowledge, toxicological assessment and targeted biological testing through explicit gap analysis. Evidence is weighted by relevance to the final device, methodological adequacy and uncertainty; a favourable result cannot compensate for an unrepresented material state or contact scenario. The output is a traceable biological-evaluation plan with decision rules, change triggers and residual-risk statements. The framework does not prescribe a universal test matrix or claim that one resin, process or endpoint establishes device safety.

ER-251 · Version 0.4.