Testing of medical devices & the latest developments in the ISO 10993 series – Part III: Have you kept up with what’s happened in the last three years

Do you follow the development of the ISO 10993 series of standards closely and are you always up to date? Do you check for changes and new developments daily, even before you have your first cup of coffee? If this doesn’t sound like you, may I offer you a taste of what’s been cooking in the last three years? Let’s start with two pieces of information which are “main courses” rather than “starters”.

ISO 10993-1:2018

The most important is most certainly the ISO 10993-1:2018 – to be precise, the part addressing evaluation and testing within a risk management process. In a nutshell, part 1 can be referred to as the mother of all other parts of the ISO 10993 series. A true provider, this part supplies the entire strategy in the form of a risk-based approach. Annex A of this standard offers a completely revised Table A.1, focusing closely on physical and/or chemical information and adding more biological endpoints to be considered. However, ISO 10993-1 is also generous enough to accept that some children need a different mother – like gas pathway devices, which need the ISO 18562-1 standard. We could spend more time on the ISO 10993-1:2018, but let’s continue with our next course.

ISO 10993-18:2020

Although spiced differently, the ISO 10993-18:2020’s ingredients for the chemical characterisation of MDs also make it a tasty dish. For details of chemical characterisation, check out my first article series published earlier. The most important changes in brief are the revised process flowchart, and the considerations of and focus on AET. Not sure what AET means? Don’t even bother trying to look it up in Wikipedia; you won’t find a single hit in this context, although some of the suggestions are quite funny – Allakaket Airport in Alaska, Academics Enterprise Trust, Assistant English Teacher…

AET

AET in the context of chemical characterisation stands for “analytical evaluation threshold”. When applied correctly, AET gives you an indication of how sensitive your method needs to be and the concentrations at which substances identified in analysis become irrelevant as no longer posing biological risks.

ISO 10993-7 AMD1:2019 & ISO 10993-15:2019

That second course was tasty, wasn’t it? Let’s finish our meal with dessert: ISO 10993-7 AMD1:2019 and ISO 10993-15:2019. The latter addresses the identification and quantification of degradation products from metals and alloys. The changes include a wider scope, considerations on nanomaterials and more information on technical details.

Committees on chemical topics seem to be harder-working than committees on other topics, as the last part of the series of standards that has been revised also addresses a chemical issue. The first amendment of the ISO 10993-7 informs about the allowable limits of ethylene oxide residues for neonates and infants.

Had enough for the last three years and for 2021? Don’t get up from the table too early – watch out for the last part of my article series. A nice cup of coffee to finish off the meal!