We have a problem with our small sterilizer Quality Certification… In order to pass our Quality Acreditation in Spain, acording to EN 13060. We purchased it years ago, and neither Manufacturer nor local provider didn’t send OQ and PQ at that time. Manufacturer doesn’t keep that document’s because they are about a model of 2009. Our problem is that our sterilizer was classified class S when manufactured, (without prevacuum instead), and now it seems to be changed to class N, unable to process wrapped material. We made chemical and biological test with positive feedback, but we are not sure if it’s enough to demostrate afectiveness, because current EN 13060 doesn’s accept wrapped material in class N, and we can’t get any manufacturer test about operation and performance in these conditions.
Thanks a lot for your help,