Dear Collegues,

I would like to know, which are the autoclave components that, in case of replacements, involve the "performance requalification" in the autoclave itself. Besides, I wish to kwow if there are any detailed lines about this subject as the EN 554 is very vague on it. In particular is the vacuum pump a component that generates a "performance requalification"?

Thank you

Grazie per la collaborazione

Distinti saluti

Alberto Franceschini
Ufficio Marketing
Servizi Ospedalieri S.p.A.
Via G.Calvino, 33
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The control system defines the range of the performance values. The vacuum pump performance is defined too (the vacuum depth, waiting time (y/n), The max time to achieve the vacuum value etc.).
Changing exposure temperature or time, drying time (major parameters) require re-validation.
Change of piping diameter, change of steam inlet from proportional valve to a ball valve, improving or displacing insulation, putting an integrated steam Generator instead central steam supply, replacing a PT100 sensor to a thermocouple, modifying the Control unit (software), - are samples that may affect the sterilization efficiency.
A change or significant repair in the pressure vessel construction requires re-validation.
Look at ISO 13683 AND ISO 14937/E.9

MIKI