Course objective and outcome
Evaluating the biocompatibility of medical devices throughout their entire lifecycle presents unique challenges, yet it is essential to understand how a device’s biocompatibility profile may evolve over time. The upcoming 2025 revision of ISO 10993-1 places even greater emphasis than the 2018 version on the need for lifecycle-wide assessments.
 
Despite this increased focus, both the 2018 and 2025 versions of the standard offer limited guidance on how to conduct end-of-life evaluations. Designing appropriate testing strategies—such as choosing between accelerated and real-time aging tests—can be particularly complex.
 
The course will begin with an overview of the key updates and concepts introduced in ISO 10993-1:2025, setting the stage for the main focus of the day: end-of-life biocompatibility evaluations. Participants will explore how to apply risk-based approaches to these evaluations, identify the types of additional data or testing that can help close risk gaps, and develop strategies to address device failures and changes over time.
 
Content
The course will address lifecycle evaluations for both single-use and reusable medical devices, with particular emphasis on single-use products. Cytotoxicity and chemical characterization will be discussed in the context of lifecycle assessments, highlighting when and how these tests can provide meaningful insights.
 
Lifecycle-related failures and supporting data will also be discussed. To conclude, the course will present a general framework for managing device changes, with a focus on how existing lifecycle data can be leveraged to support biocompatibility evaluations and reduce the need for redundant testing.
 
Course participants are invited to provide short case studies for discussion and will get feedback from Nelson Labs, please contact Medicoindustrien if interested.
 
Who should attend
Manufacturers who deal with biocompatibility questions related to life cycle evaluations or would like to increase their knowledge on how to deal with changes and failures.
 
Trainers
Elisabet Jamez, Biocompatibility Expert, Nelson Labs
Katleen Peymen, Healthcare Reprocessing Expert, Nelson Labs
 
Trainers will be onsite.