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Sterilisation Q&A

  •   How long do we have to comply with the new ISO 10993-7:2008 standard?

    Answered August 5th, 2009 by Expert: Peter Strain

    ISO 10993-7 was published in October 2008 and has a three-year transition period, so the 1995 version will be withdrawn officially in 2011. However, any revalidation projects or assessment of ethylene oxide levels for new or existing products should be performed in accordance with the 2008 version of the standard.

    In my opinion, it is important to begin assessments to ISO 10993-7:2008 as soon as possible because it may be necessary to redesign or optimise the sterilisation cycle to meet the more stringent requirements contained in the latest version of the standard.

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