DIN EN ISO 11135:2020-04
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019

Standard No.

DIN EN ISO 11135:2020-04

Release Date

2020

Published By

German Institute for Standardization

Status

Be replaced 2023-05

Replace By

DIN EN ISO 11135:2023

Latest

DIN EN ISO 11135:2023-05

DIN EN ISO 11135:2020-04 history

• 2023 DIN EN ISO 11135:2023-05 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023 / Note: Date o...
• 2023 DIN EN ISO 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023
• 2020 DIN EN ISO 11135:2020-04 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018); German version EN ISO 11135:2014 + A1:2019
• 2020 DIN EN ISO 11135:2020 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014 + Amd.1:2018) (includes Amendment :2019)
• 1970 DIN EN ISO 11135 A1 E:2017-09
• 2014 DIN EN ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014); German version EN ISO 11135:2014
• 2012 DIN EN ISO 11135:2012 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2012); German version prEN ISO 11135:2012
• 1970 DIN EN ISO 11135 E:2011-09
• 2010 DIN ISO/TS 11135-2:2010 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008); German version CEN ISO/TS 11135-2:2008, Corrigendum to DIN ISO/TS 11135-2:2008-11; German version CEN ISO/TS 11135-2:2008/AC
• 2007 DIN EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007); English version of DIN EN ISO 11135-1:2007-08
• 2003 DIN 58948-6:2003 Sterilization - Low temperature sterilizers - Part 6: Operation of ethylene oxide sterilizers