BS-EN-ISO-11135 › Historical Revision Information
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
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Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
Keywords
Verification;Medical instruments;Quality control;Microbiological analysis;Performance;Sterile equipment;Instructions for use;Sterilizers;Personnel;Sterilization (hygiene);Acceptance (approval);Hygiene;Medical equipment;Maintenance;Performance testing;Management;Ethylene oxide
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Document Number
BS EN ISO 11135:2014+A1:2019
Revision Level
2014/A1 EDITION
Status
Current
Publication Date
Jan. 15, 2020
Replaces
BS EN ISO 11135-1:2007;DD CEN ISO/TS 11135-2:2008
Page Count
102
ISBN
9780539127089
International Equivalent
EN ISO 11135:2014/A1:2019;ISO 11135:2014/Amd.1:2018;ISO 11135:2014/Amd 1:2018
Committee Number
CH/198