This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
EN 14180:2014 Referenced Document
EN 10027-2:1992 Designation systems for steels - Part 2: Steel numbers
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EN 13445-5:2009 Unfired pressure vessels - Part 5: Inspection and testing
EN 13445-6:2009 Unfired pressure vessels - Part 6: Requirements for the design and fabrication of pressure vessels and pressure parts constructed from spheroidal graphite cast iron
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EN 14180:2014 history
2014EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
2003EN 14180:2003 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing Incorporates Amendment A2: 2009