Biological Evaluation of Medical Devices:Application of ANSI/AAMI/ISO 10993 Parts 1 and 17
This webinar addresses two parts of the international standard ANSI/AAMI/ISO 10993 and its application for manufacturers, researchers, laboratories, and regulators involved in development, testing, or approval of medical devices. Dr. Molly Ghosh of the U.S. Food and Drug Administration (FDA), and Dr. Jon Cammack of The Science Cooperative, LLC, provide expertise on biological evaluation of devices and will offer a forum where you can ask questions and get answers.
Dr. Ghosh provides an overview of the non-clinical safety assessment of medical devices, including the testing strategy, sample preparation, and test methods recommended in the ANSI/AAMI/ISO 10993-1:2009 standard. Dr. Cammack provides an overview of ANSI/AAMI/ISO 10993-17:2002(R) 2008, including a practical example of how to apply the standard and the emerging concept of the Threshold of Toxicological Concern (TTC) in medical devices. Dr. Ghosh and Dr. Cammack are active leaders in developing and revising ANSI/AAMI/ISO 10993 standards, and give their perspective as standards authors and experts, as well as standards users, in their presentations.
Don’t miss this opportunity to hear directly from FDA and industry on biocompatibility!
| WHO SHOULD PURCHASE |
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| This webinar is designed for engineers, scientists, quality assurance professionals, regulatory affairs professionals, laboratory managers, regulators, and any other individuals involved in development, testing, or approval of medical devices. | |
| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
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PROGRAM-AT-A-GLANCE
- Overview of the non-clinical safety assessment of medical devices
- Testing strategy
- Sample preparation
- Test methods
- Overview of ANSI/AAMI/ISO 10993 Part 17
- Calculating allowable limits for leachables from medical devices
- Practical example of how to apply the standard
- The emerging concept of the TTC
SPEAKERS
- Chandramallika (Molly) Ghosh, PhD, DABT, Senior Staff Fellow, Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices, Office of Device Evaluation, CDRH, FDA
- Jon N. Cammack, PhD, DABT, President & CEO, The Science Cooperative, LLC
WEBINAR CD
Includes pdf of handout materials and webinar recording on CD. Please note that the CD will be available three weeks after the program.
- $295 for webinar registrants
- $395 for non-registrants
- domestic and international shipping rates apply
WAYS TO PURCHASE
- Online - Buy online.
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781.
- Mail - Select and download the order form and mail with payment to:
AAMI Webinar CD
10993, Parts 1 and 17
PO Box 0211
Annapolis Junction, MD 20701-0211