As announced by our French CEN representative, Dominique Weill, former president of STERIGENE at the last A3P conference in Biarritz, the results of the second public inquiry were fully reviewed between February 10th & 13th 2015 at a WG3 meeting in Berlin.
EN285 Version 2015: major changes
The positions are now clear-cut and we are of course available to anyone motivated by anticipation prior to the official release scheduled for November 2015.
Major changes to the EN285 were ratified among the 298 points, some useful, others subtle and even some futile. The debate is closed and unless it is invalidated in its procedure by the European Commission it is highly likely that the standard will be adopted and approved. To give you a preview we lift the veil:
- The independence of measuring chains for control and for recording on autoclaves is confirmed;
- The French proposal for the verification of both chains was selected: an error detection system will verify and report any discrepancy between measurement chains ;
- To avoid confusion, unfortunately the notion of “monitoring” disappears: either we control (regulation and supervision), or we record;
- The logic of a minimum of 3 tests for steam qualification will now be integrated;
- Acceptance of IAPWS pressure / temperature correlation tables as a reference;
- Henceforth the need to verify the Ƭ90 for all temperature sensors in accordance with a proposed procedure;
- Prohibition of the use of the term “concentration” for NCG (non-condensable gas) replaced with “volume of gas for 100 cm3 of condensate”;
- Disappearance of the title 0.9 Now in accordance with good engineering practice, the requirement on the title of saturated steam, quantified before entering the steriliser (never on the output) must be greater or equal to 0.95 and this is a requirement, not an recommendation.