BS 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

Standard No.

BS EN ISO 11135:2014

Release Date

2014

Published By

British Standards Institution (BSI)

Status

Be replaced

Replace By

BS EN ISO 11135:2014+A1:2019

Latest

BS EN ISO 11135:2014+A1:2019(2020)

Replace

BS EN ISO 11135-1:2007 BS DD CEN ISO/TS 11135-2:2008

BS EN ISO 11135:2014 Referenced Document

• ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
• ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
• ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*， 2014-11-01 Update
• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
• ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
• ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
• ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process*， 2019-12-02 Update
• ISO 14001 Environmental management systems*， 2024-01-01 Update
• ISO 14040 Environmental management — Life cycle assessment — Principles and framework — Amendment 1*， 2023-12-21 Update
• ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
• ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
• ISO 15883 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment*， 2016-02-01 Update
• ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices*， 2017-09-30 Update
• ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
• ISO 9001 Quality management systems*， 2024-01-01 Update

BS EN ISO 11135:2014 history

• 0000 BS EN ISO 11135:2014+A1:2019(2020)
• 2020 BS EN ISO 11135:2014+A1:2019
• 2014 BS 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
• 2009 BS DD CEN ISO/TS 11135-2:2008 Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1
• 2007 BS EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
• 1994 BS EN 550:1994 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization

BS 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 has been changed from BS DD CEN ISO/TS 11135-2:2008 Sterilization of health care products. Ethylene oxide. Guidance on the application of ISO 11135-1.