BS-EN-ISO-11135 › 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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Included in this current edition are the following subparts:
2014/A1 EDITION - Nov. 20, 2019
2014/A1 EDITION CORRIGENDUM 1 - Jan. 15, 2020
2014/A1 EDITION CORRIGENDUM 1 - Jan. 15, 2020
Keywords
Performance testing;Sterile equipment;Performance;Sterilizers;Instructions for use;Management;Microbiological analysis;Medical equipment;Ethylene oxide;Sterilization (hygiene);Acceptance (approval);Quality control;Personnel;Verification;Medical instruments;Maintenance;Hygiene
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Document Number
BS EN ISO 11135:2014+A1:2019
Revision Level
2014/A1 EDITION
Status
Current
Publication Date
Nov. 20, 2019
Replaces
BS EN ISO 11135-1:2007;DD CEN ISO/TS 11135-2:2008
Page Count
102
ISBN
9780580936173
International Equivalent
ISO 11135:2014/Amd.1:2018;EN ISO 11135:2014/A1:2019;ISO 11135:2014/Amd 1:2018
Committee Number
CH/198