ISO 10993-18

So I guess there are a number of changes in medical device regulations.

From Pacific Biolabs: "The changes prescribe a toxicological risk assessment framework based on identification and quantitation of chemical entities present in a medical device. The revised guidance formalizes the use of the Analytical Evaluation Threshold. An AET is a level for a particular extractable or leachable above which the analytical lab should report the compound to facilitate assessment of the toxicological risk to patients."

Do we have the pertinent ISOs around? Has anyone dealt with testing like this before?


  • @Cassox I have all the docs for ISO 10993 Biological Evaluation of Medical Devices. I'll email you.
  • Thank you so much! Just saw them! You're fantastic.

  • @Satur9 Could you share publicly the documents ? Thank you

  • Nope, sorry. There are reasons I only shared them with Cassox. You might be able to find them online though. If you want screenshots of specific passages I can DM you.
  • Hmmm.. I know that if we searched the forums, people have attempted to make shared doc folder etc. for stuff we don't want to explicitly host. I feel like there's some resource that someone could point us to. If this doesn't exist, it needs to.

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