A marriage of ISO 10993 and ISO 14971
Biocompatibility Evaluation with a Risk Management model for efficient testing programs
Date and Time
This webinar will be delivered twice. You may choose to join at the date and time that suits you best, or you may join both sessions!
- Tuesday 7 October 2014, 1pm-2pm Pacific Daylight Time (US), and again on
- Thursday 9 October 2014, 11am-12pm Central European Time
When registering, please ensure to select “Show in my Time Zone” for your correct local date and time.
ISO 10993-1:2009 sets out a risk based approach which emphasises that biological evaluations should be based upon the current scientific knowledge of the materials used supplemented by testing where there is insufficient information to assure safety. In other words testing (especially on animals) is the last step, not the first. This can cut months from development programs and regulatory approvals and save substantial costs.
This risk management approach to biological evaluation is set out in ISO TR 15499 Guidance on the conduct of biological evaluation within a risk management process. ISO TR 15499 shows how to meet both ISO 10993 and ISO 14971 requirements in a biological evaluation.
This webinar will provide an overview of:
- ISO 10993 part 1 evaluation requirements and the ISO TR 15499 Risk management model
- Additional requirements of US FDA, including the G95-1 Blue Book Memo and the 2013 Draft Biocompatibility guidance.
- Materials characterization
- Reducing regulatory and testing risk through careful materials selection
- Consideration of processing aids and additives such as colorants
- Special cases e.g. mucosal contact testing, specific tissue exposures
- Uses of approaches such as thresholds of toxicological concern to determine safety of low level unknown contaminants.
|Dr Arthur Brandwood
CEO, Brandwood Biomedical
Dr Arthur Brandwood has more than 20 years’ experience in biomaterials evaluation, with particular emphasis on implantable and patient-contacting materials. He has been an accredited expert since 1992 to ISO with direct involvement in preparation of ISO 10993 standards. Dr Brandwood chaired the working group which prepared the ISO TR 15499: 2012 Guidance on the conduct of biological evaluation within a risk management process.
Dr Brandwood is the past President of the Australian Society for Biomaterials, and former Director of the Biomaterials laboratories of Australia’s regulatory authority, the Therapeutic Goods Administration (TGA), where he also held the position of Director of Medical Devices Registrations. He has held academic positions in London and Sydney and is currently Visiting Professor in Biomedical Engineering at the University of Sydney.
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