Free Live Webinar ISO 10993-12:2021: Going into details of sample preparation
About the webinar
Appropriate testing of medical device should go into details to ensure that no medical device constituents or materials used at any manufacturing step can compromise the biocompatibility of the final product.
The preparation process of test samples for medical device materials and subcomponents, choosing suitable extraction vehicles and conditions as well as appropriate reference materials are described in ISO 10993-12.
An important update to the standard was published in January 2021 and it contains changes regarding:
- Adjusting definitions to match with recently updated ISO 10993-18
- Revision of 10.3.1 extraction condition table and Annex D regarding exhaustive extraction
- Scope modification to include extractions only for biological evaluation tests
The key changes to ISO 10993-12:2021 and its consequences for the manufacturing and testing procedures are discussed in our new live webinar ‘ISO 10993-12:2021: Going into details of sample preparation’.
Join our webinar on 10.05.2021 to get the answers to the following questions:
- What are the main changes manufacturers need to consider in ISO 10993-12:2021?
- What are the current requirements for test samples?
- What aspects do you have to keep in mind while performing extraction procedures?
Who should attend: Managers, directors, engineers, and scientists responsible for research and development, product development, quality assurance, and regulatory compliance.
About the speaker:
Dr. Kathrin Schalk, Group Leader & Study Director Chemical Characterization, Eurofins BioPharma Product Testing Munich
Judith Leschhorn, Head of Medical Device Sales, Eurofins BioPharma Product Testing Munich
“ISO 10993-12:2021: Going into details of sample preparation”
The webinar is presented in ENGLISH.
