Thoughts on amendments to ISO 10993-7 medical device ethylene oxide sterilization residuals

In January 2022, the United Kingdom adopted ISO 10993-7:2008 / Amd 1:2019 as BS EN ISO 10993-7:2008 / A1:2022 without modification. The amendments include new allowable limits for neonates and infants. In the article written by Frank Judge, our Consultant Chemist Chromatography, he reviews to amendments to the previous version which is applicable to medical devices but not fabrics, drapes, contact lenses or some other particular devices such as dialysis blood flow components.

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