EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation

[karthic]

I would like to know about ETO Validation Protocol as in EN 550 Standard

[bio_subbu]

In Reply to Parent Post by karthic

I WHOULD LIKE TO KNOW ABOUT ETO VALIDATION PROTOCOL AS IN EN 550 STANDERDS

Dear Mr. Karthic

FYI

EN 550 is replaced by ISO 11135-1:2007 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) and Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1 (TIR11135-2:2008) please use revised one.

Regards
S. Subramaniam

[harry]

Welcome to the Cove,

Scroll down to the 'Similar Discussion Threads' box below for a few threads on the same subject.

[Ajit Basrur]

In Reply to Parent Post by karthic

I would like to know about ETO Validation Protocol as in EN 550 Standard

Welcome Karthic.

I have changed your text from all capital letters to a regular sentence and also corrected typo errors.

My friend moderator have posted your question in the appropriate forum

[MIREGMGR]

In Reply to Parent Post by karthic

I would like to know about ETO Validation Protocol as in EN 550 Standard

We're not so good at telling people the entire extent of what a regulatory/quality professional should know and do to meet appropriate compliance requirements for topics as big as "EtO validation".

We can answer specific questions, though. Do you have such a question?

[Ajit Basrur]

MIREGMGR is absolutely right

Karthic, if you are working with some employer, you would already have this, isnt it ? In that document, if you are looking for soemthing very specific or are unsure of anyhting, pl come back without any hesitations