Biological evaluation of Medical Devices

Part 1 – Basics of biological evaluation of medical devices

The first part provides you with fundamental knowledge to understand how and when a biological evaluation, according to ISO 10993-1, should be performed. This first part outlines the structure of the biological evaluation and how to plan and conduct a biological evaluation within a risk management process. The course will also provide you with a working knowledge of the different biological tests available. We also share our experience related to selection of materials and experience from notified bodies.

– Get to understand the requirements and avoid the most common pitfalls!

Part 2 – Material characterization and testing

With the revisions of ISO 10993 part 1 and 18 in 2018 and 2020, respectively, and the ongoing revision of part 17, more emphasis is put on material characterization and a risk-based approach. In addition, MDR also sets higher demands on substances contained in and released from devices. This part of the course will provide you with a detailed understanding of the chemical chacterization process, and also important aspects to think of when it comes to ordering/performing tests for the biological evaluation.

After this course you will have increased knowledge and tools to perform biological evaluation and testing within a risk management process.

Course content

Day 1: Basics of biological evaluation where we, among other things, review the following topics:

• What is biocompatibility and why is a biological evaluation needed?
• The relation between ISO 10993 and the risk management standard ISO 14971
• Biological tests – overview of different parts of ISO 10993
• Structure of the biological evaluation
• What characterizes a “smart” choice of material?
• Can animal tests be avoided?

• What to think about during development and changes
• MDR, FDA and biocompatibility
• ”Common pitfalls” – avoid the typical mistakes
• Group discussions with practical examples for exercises

Day 2: Practical aspects of testing, Material characterization and toxicological evaluation, focus on ISO 10993-12, -17 and -18
Biological evaluation in more depth, including among others:

• Sample preparation (ISO 10993-12) and what you should consider in the communication with the test-house
• Chemical characterization in accordance with ISO 10993-18
• Overview and 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
• Toxicological assessments, part 17 – Basics on performance and important points to consider
• ISO 10993-17– upcoming changes; what we know today
• We will also briefly review the specific requirements for biological evaluation of breathing gas pathways (ISO 18562)
• Group discussions with practical examples for exercises

Who should attend

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

Previous knowledge level

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.

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