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ISO 10993 Webinar Series

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 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

 Webinar Title

 Date

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

Watch on-demand webinar here

Now available on-demand

Part 2: Genotoxicity Assessment and Evaluation of Medical Devices

21 Oct 2021

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

Register now

 

Session 1:
10:00 AM CET/ 1:30 PM IST/ 4:00 AM EST 

Session 2:
3:00 PM CET/ 6:30 PM IST/ 9:00 AM EST 

Part 3: Carcinogenicity and Reproductive Toxicity

19 Nov 2021

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

 Register now

Session 1:
9:00 AM CET/ 1:30 PM IST/ 3:00 AM EST 

Session 2:
2:00 PM CET/ 6:30 PM IST/ 8:00 AM EST 

Part 4: Medical Devices Degradation Profile 

8 Dec 2021

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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Session 1:
9:00 AM CET/ 1:30 PM IST/ 3:00 AM EST 

Session 2:
2:00 PM CET/ 6:30 PM IST/ 8:00 AM EST 

Part 5: Toxicological Risk Assessment

6 Jan 2022

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  

Register now

Session 1:
9:00 AM CET/ 1:30 PM IST/ 3:00 AM EST 

Session 2:
2:00 PM CET/ 6:30 PM IST/ 8:00 AM EST 

Part 6: Hemocompatibility Testing of Medical Devices

27 Jan 2022

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

Register now

Session 1:
10:00 AM CET/ 2:30 PM IST/ 4:00 AM EST 

Session 2:
3:00 PM CET/ 7:30 PM IST/ 9:00 AM EST 

Part 7: Wrap up webinar

TBC

Dear customers, based on your requests during our ISO 10993 webinar series, we will come up with the topic for our last webinar in October. Wait and see!

TBC 

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