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BSI BS EN 14180:2025

Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
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BSI BS EN 14180:2025

Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing

PUBLISH DATE 2025
PAGES 132
BSI BS EN 14180:2025

1.1 This document 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.

1.2 This document specifies minimum requirements:

  • for the performance and design of sterilizers intended to deliver an LTSF process capable of sterilizing medical devices;
  • for the equipment and controls of these sterilizers which are needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.

1.3 This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.

1.4 This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

SDO BSI: British Standards Institution
Document Number EN 14180
Publication Date May 20, 2025
Language en - English
Page Count 132
Revision Level
Supercedes
Committee CH/198
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