This technical 2-hour workshop will unpack the latest revision of ISO 10993-1, focusing on biocompatibility risk assessments for substance-based medical devices. Participants will learn how the updated standard embeds a dynamic, ISO 14971- aligned risk framework into biological evaluations.
The new document explicitly requires evaluation of reasonably foreseeable misuse scenarios (use beyond intended conditions) and extends the exposure assessment through the entire product life-cycle. These shifts challenge stakeholders to rethink biological effects.
New requirements mandate that evaluators explicitly identify and analyse reasonably foreseeable misuse events. Case studies will illustrate how to define misuse in context of substance-based devices (e.g. over-dosage or unintended exposure) and incorporate these scenarios into the biological evaluation plan.
Assessing safety throughout the device lifetime now includes factors like material aging, leachables over time, and end-of-life degradation.