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

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

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

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

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 :)

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

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?

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 :)