ISO 10993 Webinar Series

 Webinar Title

Part 1: Chemical Characterization of Medical Devices

This webinar elaborates on the importance of chemical characterization of medical devices within the biological evaluation and the connected risk management process. The underlying standards such as the ISO 10993-1, ISO 10993-17 and especially ISO 10993-18 are explained.

Ms. Elena Ciofi
Head of Healthcare, Food Contact and Food laboratories,
TÜV Italia SRL

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Part 2: Genotoxicity Assessment and Evaluation of Medical Devices

Genotoxicity is an essential endpoint to be evaluated to ensure safety of medical devices. ISO 10993-3 describes methods of detection of genotoxicity, carcinogenicity and reproductive toxicity hazard. This webinar focuses on assessment and evaluation of genotoxicity and covers testing strategy as per the regulatory requirements.

Dr. Shailendra Singh
General Manager & Head of MHS-South Asia

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Part 3: Carcinogenicity and Reproductive Toxicity

Carcinogenicity and reproductive toxicity testing of medical devices is quite rare because the requirement is limited to applications of new materials used in implanted devices and those with a permanent contact. Before advancing to clinical trials, materials that are found to be genotoxic in mammalian cells must be evaluated for carcinogenicity in animals. In this webinar, we go through the standard and regulatory requirements for medical devices, as well as considerations for carcinogenicity and reproductive toxicity.

 Dr. J.S.I. Rajkumar
 Biocompatibility Expert and Auditor,
 TÜV SÜD South Asia, Medical and Health Services

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Part 4: Medical Device Degradation Profile 

Degradation products shall be taken into account for their relevance to the overall biological evaluation of the medical device. Materials used for medical devices construction can lead to degradation products when exposed to biological environment or external mechanical wear. These degradation products can be either reactive or stable. In this webinar, we will discuss about the considerations, standards and reporting of degradation products for medical devices.

Mr. Senthil Kumar A
Auditor and Biocompatibility Expert in Medical and Health Services,
TÜV SÜD Products Services Division

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Part 5: Toxicological Risk Assessment

The potential of a chemical substance leached from the medical device or material to cause adverse biological reaction is considered as toxicological hazard. The probability of quantified degree of adverse reaction in response to specific exposure level of the hazard. In this webinar, we will discuss about the toxicological risk assessment of extractable/leachables from Medical Devices.

Mr. Senthil Kumar A
Auditor and Biocompatibility Expert in Medical and Health Services,
TÜV SÜD Products Services Division  

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Part 6: Hemocompatibility Testing of Medical Devices

This webinar elaborates on the importance of hemocompatibility testing of medical devices with regards to data interpretation, choice of blood species, anticoagulation as well as direct & indirect testing. The underlying standards such as the ISO 10993-1 and ISO 10993-4 are explained.

Mr. Jan Herzer
Product Specialist, TÜV SÜD Group

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Part 7: Biological Evaluation Plan and Common Biocompatibility Pitfalls

This webinar will show you the concept and strategies for biological evaluation plans (BEP) as well as common pitfalls during the assessment of the biocompatibility. After this webinar, you will know what to do and what to avoid in order to get hassle-free biocompatibility assessments.

Dr. Shailendra Singh

General Manager & Head of TÜV SÜD MHS-South Asia

Dr. Christoph D. Lindner

Team leader for Medical Device Testing of TÜV SÜD Product Service

Watch On-Demand Webinar Here