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ISO 11135:2014/Amd 1:2018 Edition 10/2018
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release
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Status

Standard - Active

Origin

Technical Committee :
ISO/TC 198/WG 1 : Industrial ethylene oxide sterilization

Implementation

start of the vote on the project    08/08/2017   date of ratification (dor)   
end of the vote on the project    01/11/2017   date of anouncement (doa)   
start of the vote on the final project    22/06/2018   date of publication (dop)    15/10/2018
end of the vote on the final project    19/08/2018   date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Evolutions
ISO/DIS 11135.2

International Classification for Standards (ICS codes) :

11.080.01 : Sterilization and disinfection in general

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