BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
1.1 Inclusions
1.1.1 This European Standard specifies requirements for the development, validation and routine control of
a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides
guidance that may be applicable to other products and equipment.
1.1.2 This European Standard is intended to be applied by process developers, manufacturers of
sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with
responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1)
1.1.3 This European Standard covers sterilization processes which use a mixture of low temperature steam
and formaldehyde as sterilant, and which are working below ambient pressure only.
1.2 Exclusions
1.2.1 Sterilization processes validated and controlled in accordance with the requirements of this standard
should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies
such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific
recommendations have been produced in particular countries for the processing of materials potentially
contaminated with these agents.
1.2.2 This standard does not specify requirements for designating a medical device as “STERILE”. Such
requirements are given in EN 556-1.
1.2.3 This standard does not specify a quality management system for the control of all stages of
production of medical devices.
NOTE It is not a requirement of this standard to have a complete quality management system during manufacture or
reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in
the text. Attention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages of
production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.2 of
EN ISO 14937:2000.
1.2.4 This standard does not specify requirements for occupational safety associated with the design and
operation of LTSF sterilization facilities.
NOTE 1 Safety requirements for sterilizers are specified in EN 61010-2-040.
NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements.
1.2.5 This European Standard does not cover analytical methods for determining levels or residues of
formaldehyde and/or its reaction products.
NOTE 1 Attention is drawn to EN 14180.
NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulation specifying limits for the
level of formaldehyde residues on medical devices and products.
1.2.6 This European Standard does not cover preparatory measures that may be necessary before
sterilization such as cleaning, disinfection and packing.
NOTE For re-sterilizable medical devices, the manufacturer(s) of these devices should supply information on the
preparatory measures (see EN ISO 17664).
BS EN ISO 25424:2011 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 Sterilization of health care products - Biological indicators - Part 1: General requirements*， 2017-03-01 Update
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 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)*， 2022-11-30 Update
EN ISO 11737-1 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)*， 2021-05-31 Update
EN 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 (ISO 11737-2:2019)*， 2020-05-13 Update
EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)*， 2018-03-28 Update
BS EN ISO 25424:2011 history
2022BS EN ISO 25424:2019+A1:2022 Sterilization of health care products. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
1970BS EN ISO 25424:2019 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
2011BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
2007BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices has been changed from BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices.