Iso 11135:1994 - Validation and Control of Ethylene Oxide Sterilization

[Karichan]

Hi,

What is the standard of ISO 11135? Can anybody kindly help me to answer my students.

Regards
Kari

[Bill Ryan]

Welcome Kari!

I'm not familiar with the standard but as I searched the net, it appears to be a standard for controlling a sterilization process for medical devices.

Maybe someone else can be more specific.

Bill

[Aaron Lupo]

That would be correct Bill. ISO 11135:1994 is titled Medical Devices - Validation and routine control of ethylene oxide sterilization the corresponding EN standard is EN 550.

11135 establishes the requirements and guidance for validation and routine control of ETO sterilization for medical devices.

[Cathy]

I am familiar with BS EN 550. It is basically identical to ISO11135. I have and introduction for BS EN 550 to attach.....but.......

I have tried to post an attachment but I can't get it to attach???
Cathy

[Cathy]

I finally got the attachment to attach(??) !!

[Karichan]

Thanks Cathy, your attached file is helpful.