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

Standard No.

DIN EN ISO 11135:2014

Release Date

2014

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 11135 A1 E:2017-09

Latest

DIN EN ISO 11135:2023-05

Replace

DIN EN ISO 11135:2012 DIN EN ISO 11135-1:2007 DIN ISO/TS 11135-2:2010

DIN EN ISO 11135:2014 Referenced Document

• DIN 
• DIN EN 61010-1:2011 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements (IEC 61010-1:2010 + Cor. :2011); German version EN 61010-1:2010
• DIN EN ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003
• DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
• DIN EN ISO 10993-7:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); English version of DIN EN ISO 10993-7:2009-02
• DIN EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); English version of DIN EN ISO 11138-1:2006-09
• DIN EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006); English version of DIN EN ISO 11138-2:2009-09
• DIN EN ISO 11140-1:2012 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO/DIS 11140-1:2012); German version prEN ISO 11140-1:2012
• DIN EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version of DIN EN ISO 11607-1:2009-09

DIN EN ISO 11135:2014 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

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 has been changed from 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.