Dear Sir/Madam,

We are a small hospital in Ankara/Turkiye and will likely to receive a new 1800liter EtO steriliser from a local manufacturer. Will you please tell me how will I made the commisioning as a part of EN550 validation. Yours,

Ali Tan Serbetci
Stemed

Dear,

EN 550: Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization says under 3. Definitions:
3.6 Commissioning: Obtaining and documenting evidence that equipment has been provided and installed in accordance with its specifications and that it functions within predertermined limits when operated in accordance with operational instructions.

And further under 5. Validation:
5.2 Commissioning shall demonstrate that the equipment specifications for the preconditioning (if used), sterilization and aeration equipment are met.
Commissioning shall commmence with the calibration of all instrumentation for controlling, indicating and recording the sterilization process.

Commissioning is normally carried out by the supplier of the sterilizer in situ. For the details of the commissioning I refer you to the EN 550.

Good luck,
Wim Renders

Dear,

Also in EN 1422: Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods you can find additive information.

Wim Renders

Dear Mr. Ali,

You must have already installed the sterlizer. The sterlizer apart from calibrating the instruments one is requred to undertake validation of the same to determine that the temperature disribution is correct. The validation agency is required to use atleast 6 temperature, 1pressure & 1humidity sensor while undertaking validation. The validation is required to be undertaken for 3 No load, 3partial load & 3Maximum loads.
Incase you need any furher information please feel free to ask as we are regularly undertaking validation of steam sterlisers.

Regards
Dileep