BS EN ISO 11140-1:2014
Sterilization of health care products. Chemical indicators. General requirements
- Standard No.
- BS EN ISO 11140-1:2014
- Release Date
- 2014
- Published By
- British Standards Institution (BSI)
- Status
- Replace By
- BS EN ISO 11140-1:2014(2015)
- Latest
- BS EN ISO 11140-1:2014(2015)
- Replace
- BS EN ISO 11140-1:2009
BS EN ISO 11140-1:2014 Referenced Document
- EN 13060 Small steam sterilizers*， 2014-12-01 Update
- EN 14180 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
- EN 1422 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
- EN 285 Sterilization - Steam sterilizers - Large sterilizers*， 2018-09-01 Update
- EN 550 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
- EN 552 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999
- EN 556-1 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2023-12-23 Update
- 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 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
- ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
- ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
- ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
- ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
- ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
- ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
- ISO 11140-5:2007 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
- 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 13485 Medical devices - Quality management systems - Requirements for regulatory purposes*， 2016-03-01 Update
- ISO 14161 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
- ISO 15882 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
- ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment
- ISO 20857 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
- ISO 9001 Quality management systems*， 2024-01-01 Update
- ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories*， 2017-11-29 Update
- ISO/IEC 17050-1 Conformity assessment — Supplier's declaration of conformity — Part 1: General requirements
- ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
- ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
- ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
BS EN ISO 11140-1:2014 history
- 0000 BS EN ISO 11140-1:2014(2015)
- 2014 BS EN ISO 11140-1:2014 Sterilization of health care products. Chemical indicators. General requirements
- 2009 BS EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - General requirements
- 0000 BS EN ISO 11140-1:2005
- 1997 BS EN 867-2:1997 Non-biological systems for use in sterilizers - Process indicators (Class A)
