I WHOULD LIKE TO KNOW ABOUT ETO VALIDATION PROTOCOL AS IN EN 550 STANDERDS
Dear Mr. Karthic
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.
Re: EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation
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
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