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

BS-EN-ISO-11135 - 2014/A1 EDITION - CURRENT
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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

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

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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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

Committee Number

CH/198