TÜV Medical Health Services offer advice on the new sterilisation standards.
Henry Sibun provides a guide to validating sterilisation systems, following a revision of the relevant medical device sterilisation standards.
An article entitled ‘Setting new standards for medical devices’ and written by Henry Sibun, manager of TÜV Product Service’s Medical Health Services department, has been published in the ‘Cleanroom Technology’ magazine. The article covers the changes to medical device sterilisation standards over the past few years and also provides an overview of what a notified body auditor looks for in a company’s sterilisation validation procedures.
Information is also included on the changes to EN and ISO standards and on the specific revisions to the standards for ethylene oxide, moist heat and radiation sterilisation which have been re-issued recently.
To download the article please click here
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