ISO 10993 Webinar Series

Uncover strategic insights into the latest ISO 10993 framework

Uncover strategic insights into the latest ISO 10993 framework

TÜV SÜD is a globally known notified body in the medical device industry but how familiar are you with our testing services?

Join us in the TÜV SÜD ISO 10993 webinar series, hosted by our distinguished experts. This webinar series, now available on demand, aim to provide attendees with strategic insights into the latest ISO 10993 framework on evaluating the biocompatibility of medical devices to manage biological risk, while introducing our testing laboratory hubs in Europe, Asia and US in biological and chemical testing services.

Topics covered includes: 

  • Chemical characterisation 
  • Genotoxicity 
  • Carcinogenicity and reproductive toxicity
  • Medical devices degradation profile 
  • Toxicological risk assessment
  • Hemocompatibility testing
  • Biological Evaluation Plans (BEP) & common biocompatibility pitfalls

 Webinar Title

 Webinar Link

Part 1: Chemical Characterisation of Medical Devices

 

This webinar elaborates on the importance of chemical characterisation 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.

Elena Ciofi

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

Now available on-demand

Watch on-demand webinar

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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 will focus on assessment and evaluation of genotoxicity and will also discuss testing strategy as per the regulatory requirements.

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

 

 

Now available on-demand

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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 will 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

 

Now available on-demand

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Part 4: Medical Devices 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

Now available on-demand

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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 extractables/ leachables from Medical Devices.

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

Now available on-demand

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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

Now available on-demand

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Part 7: Importance of Biological Evaluation Plan & Common Biocompatibility Pitfalls

31 March, Thursday

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 – at least in theory – know what to do and what to avoid in order to get hassle-free through biocompatibility assessments.

Dr Shailendra Singh

 

Dr. Shailendra Singh

General Manager & Head of MHS-South Asia

 

 

 

Dr. Christoph D. Lindner
Team leader for Medical Device Testing of TÜV SÜD Product Service

Now available on-demand

Session 1

 

Session 2

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