EFHSS Questions and Answers - Question Q00713

Hi,

we are a manufacturer of sterile medical device and we have validated our steriliser with ref. to en 550. we need to revalidate the sterilization process this yr, can u highlight the min. requirements in revalidating the cycle. we use a "curve construction method" in the original validation, do I need to run the empty and humility(conditioning) cycle again in this validation.

In the original cycle we run at 0, 5, 10, 20 7 40 min for the microbial performance vali. can we jus run the 40min(kill time) for this revalidation.

appreciate yr comments. thanks

Jason

Jason.
It is difficult to answer you a "2005 answer" if your approach is based on a "1994 approach" (EN 550 issue date)
Are you aware that EN 1422, concerning ETO Sterilizers was published in 1997? EN 556-1 was issued in 2002, and ISO/EN 17665 (is intended to replace EN 550) reflect the appropriate approch. The last one is an excellent guidance.
miki