Testing of medical devices & the latest developments in the ISO 10993 series – Part IV: Nothing to expect for the rest of 2021 except Christmas?
I don’t drink coffee, but I do like taking a coffee break with a glass of water or juice in my hand. And I especially like coffee breaks where people chat and swap ideas about the topics, they are most interested in. For me this would definitely be the biocompatibility of medical devices (MD). The Limulus Bio Connect Coffee Break, organised by Limulus Bio, offers the opportunity for exactly this type of break. Full disclosure for transparency and compliance reasons: I neither have a collaboration with Limulus nor get any kind of sponsorship.
Advancements in 2021
At one of those coffee breaks, participants discussed upcoming advancements in 2021. Apparently, the new ISO 10993-10 governing sensitisation is going to be published in early autumn this year. Remember what sensitisation is all about? Sensitisation denotes the reaction of the adaptive immune system to a sensitising substance. It leads to a delayed immune response, triggering an allergy which persists for a long time or even for life. So, this is definitely one to avoid.
ISO 10993-10:2021 (not published yet)
Exciting, isn’t it? Just a few more weeks and months to go until the update of ISO 10993-10 is published. What will be new? Well, the entire part on irritation will be removed from the standard as it now forms the ISO 10993-23:2021 standard already published. Furthermore, it seems that a stepwise approach will be recommended for sensitisation, too. Fine, but what about in-vitro alternatives for sensitisation? As far as I know, in-vitro alternatives will be discussed in an Annex, including recommendations on how to obtain regulatory acceptance. At present, acceptance of in-vitro sensitisation by any major authority is not expected within the next years. What is your opinion on this issue? Any insights, any guesses about when this will be? Let me know!
Final conclusion
To sum up this series of articles, I’ll give you a quick outline of my own thoughts. Irritation testing of medical devices in accordance with ISO 10993-23:2021 has made the leap to an in-vitro alternative, which is applicable for many but not all MDs. ISO 10993-12:2021 does not deliver any big surprises on the extraction of MDs; in fact, part 1 from 2018 and part 18 from 2020 included way more advancements, driving forward the general assessment of biocompatibility. So, what will bring your MD forward? Your expertise, that is for sure. I hope that I have been able to contribute to your expertise with the information in this series. Should you need more information or require services in the fields of testing (in-vivo, in-vitro and chemical tests) or toxicological risk assessments, contact us at:
https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-testing (in English) OR
We will be happy to hear from you, whichever channel you use!
Board Certified Toxicologist | Drug Discovery & Preclinical Development | Biocompatibility | Medical Device Testing |
3yInformative Christoph. Looking forward updated and latest version ISO 10993-10. Perhaps, updated standard will give new insights in selection of in-Vivo and in-vitro skin sensitisation test models and also clear information on non-animal model selection based on device types. However, it is clear that more research and validations should happened on application of non-animal models for medical devices.