Biocompatibility Testing and Evaluations for Medical Devices

Biocompatibility Conference 2015 Highlights

Understanding the latest status and updates to ISO 10993

Including:
o Revision of ISO 10993-1 and the risk management process
o Latest status of ISO 10993-4 blood compatibility revision and round robin
o Revision of ISO 10993-5 and round robin on cytotoxicity test methods

Notified Body perspective: Best strategies for successful biocompatibility submissions

• Understanding what needs to be included in a biocompatibility submission
• Reviewing examples of successful and unsuccessful biocompatibility submissions

Notified Bodies Panel Discussion: Overcoming common pitfalls with biocompatibility submissions to ensure regulatory approval

•What are the common pitfalls and how can these be overcome?
•What is expected to be included in biocompatibility submissions?

Understanding the current status of revision of ISO 10993-4 on blood compatibility and successful strategies for haemocompatibility testing and evaluations

• Clarifying the latest status of and modifications to ISO 10993-4, effects on blood, proposed revision
• Discussion of ISO/TC 194 WG 9 Haemolysis Round Robin evaluation

Practically applying ISO 10993-17 allowable limits for leachable substances

• Determining how ISO 10993-17 is practically applied during leachable evaluation
• Practical examples of leachable testing strategies for biocompatibility

Exploring the chemical characterisation risk assessment approach and complying with ISO 10993-18

• Reviewing how to successfully implement the chemical characterisation risk assessment approach
• Sharing experience with overcoming challenges or lack of clarity with ISO 10993-18

Clarifying when in vivo testing is necessary and choosing the right animal models

• Practically choosing the right animal model suitable for specific biocompatibility tests
• Outlining the pros and cons of different animal models for specific studies

Interactive Experience Exchange: Sharing experiences with justifications for biocompatibility test selections and exemptions

• Exploring the guidance available for justifying exemptions of biocompatibility testing
• Practical advice on reporting justifications for biocompatibility test exemptions

Ensuring device biocompatibility by proper cleaning and sterilisation processes

• Sharing best practice for validating cleaning and sterilisation process with respect to device biocompatibility
• Overcoming challenges associated with cleaning and sterilisation processes

Understanding what to do when you get biological effects testing failures and failure investigations

• What types of tests are more likely to exhibit failures and why?
• Why following proper procedures with regards to the biocompatibility assessment approach is so important
• What to do when you get a failure

Practical advice on working successfully with contract laboratories and service suppliers for biocompatibility testing

Hear from Coloplast A/S