ISO 25424:2009
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
- Standard No.
- ISO 25424:2009
- Release Date
- 2009
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 25424:2018
- Latest
- ISO 25424:2018/Amd 1:2022
ISO 25424:2009 Referenced Document
- EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Incorporates Amendment A2: 2009
- EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
- EN ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
- EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements
- EN ISO 11140-3:2009 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 11140-3:2007, including Cor 1:2007)
- EN ISO 11140-4:2007 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dicktype test for detection of steam penetration
- EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
- EN ISO 11737-2:2000 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process ISO 11737-2: 1998
- EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Incorporating corrigendum June 2007 [Superseded: CEN EN 46003, CEN EN ISO 13488]
ISO 25424:2009 history
- 2022 ISO 25424:2018/Amd 1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment
- 2018 ISO 25424:2018 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
- 2009 ISO 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
