Understanding and applying ISO 10993-12

ISO 10993 webinar series: Medical devices degradation profile (Part 4 of 7)



Approach for 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.

Not all medical devices require degradation profile evaluation. The degradation profile is evaluated in case there is the potential that degradation appears under conditions such as manufacturing process, sterilization, transportation, storage, clinical use.

In this webinar, we will discuss about the considerations, standards and reporting of degradation products for medical devices.

Date: 8 December 2021, Wednesday
Time: 9:00 AM CET/ 1:30 PM IST/ 3:00 AM EST (Session 1)
          2:00 PM CET/ 6:30 PM IST/ 8:00 AM EST (Session 2)
Duration: 1h (including 15 mins for Q&A)


  • Introduction to degradation

  • Impact of degradation in Biocompatibility of the devices

  • ISO Standard Briefing Degradation

  • Reporting of Degradation Products

  • Evaluation of Safety of Degradation Products

  • Q&A

About the speaker

Mr. Senthil Kumar AMr. Senthil Kumar A

Auditor and Biocompatibility Expert in Medical and Health Services, TÜV SÜD Products Services Division

Mr. Senthil Kumar A holds a Master of Philosophy in Biochemistry and is an experienced toxicologist. He is presently working as an Auditor and Biocompatibility Expert in Medical and Health Services, under TÜV SÜD Products Services Division based in India, where he is responsible for reviewing the biocompatibility assessment and toxicological risk assessments.

Mr. Senthil gained extensive knowledge in Pharmacology and Toxicology through his professional experience in various organizations as a Researcher and Study Director in a large number of in-vivo efficacy and toxicological studies. He has worked for different products research activities such as for herbal products/extracts, pharmaceuticals, bacteriophage derived products in various animal models based on different regulatory guidelines.

Other areas of expertise includes the research of non-clinical overview, toxicological profile, Common Technical Documentation (CTD), toxicological/safety assessment for cosmetics and Over-the-Counter (OTC) products.


Sign up for the rest of the ISO 10993 webinar series here.

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