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Sterilisation Validation of Re-Usable Hospital Instruments

J

Jimmy2

#1
Hi,
I wander if anyone can offer any advice.

I want to perform sterilisation validation as per annex d of ISO 17665 - half cycle validation for the USA market but also for the Europian market. In the UK typical hospital cycles can be only 3 minutes at 134 degrees. This varies acroos europe up to 20 minutes.
Is it a Europian requirment to do the half cycle approach? Is it OK to do the actual cycle for Europe (i.e. 3 minutes for a 3 minute cycle) rather than the half cycle approach?
I am thinking the thing to do would be to validate the 3 minute cycle which would also cover the other longer cycles but feel that 1.5 minutes may not kill all biological indicators.

Also is it worth getting ISO 17665 pt 2 for more details (I only have pt 1).
 
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