Biological evaluation of medical devices, Part 2

Part 2 – How to perform a biological evaluation, focus on ISO 10993-1, -17 and -18

Course description:

Part 2 offers knowledge about how to plan and conduct a biological evaluation within a risk management process. Focus is on the main part of the standard, ISO 10993-1, but also on part 17 and 18. With the revision of part 1, even more emphasis will be on chemical characterization and towards a risk based approach. The up-coming changes also increase the demand on knowledge. After this course you will have basic knowledge and tools to perform biological evaluation and testing within a risk management process.

Course outline

Second part of the course with focus on the biological evaluation process, including among others:

• The Biological Evaluation Plan and its parts – a structured way to connect ISO 10993 with risk management and identify appropriate testing strategies
• The Biological Evaluation Report – key elements to be covered (and what the reviewer wants to see)
• ISO 10993-1, -17 and -18 – Upcoming changes; what we know today
• Selection of chemical testing methods for material characterization and the use of results
• Points to consider when using chemical characterization to reduce the number of animal tests
• Extractables and Leachables, part 18 – Basic on performance and important points to consider
• Toxicological assessments, part 17 – Basic on performance and important points to consider
• Group discussions with practical examples for exercises

Who should attend

People working with design and development, project management, regulatory affairs or quality.
The course is also suitable for suppliers of materials and components, to facilitate understanding of their customer needs and requirements.

Prerequisites

To be able to grasp and make use of the course content you should have basic knowledge of the medical device regulation with respect to design control.