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DIN EN 14180:2025-08

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2025

Fecha edición: 2025-08-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: 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: <(Liste) for the performance and design of sterilizers intended to deliver an LTSF-process capable of sterilizing medical devices; > <(Liste) for the equipment and controls of these sterilizers 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.

Keywords: CE marking|Definitions|Design|Dimensions|Equipment safety|Formaldehyde|Gas sterilizers|Information|Instructions for use|Low temperatures|Marking|Materials|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Methods|Output determination|Performance requirements|Safety engineering|Safety of products|Safety requirements|Sound level|Sound power|Specification (approval)|Steam sterilizers|Sterilization (hygiene)|Sterilizers|Testing|Vapours
ICS: 11.080.10 - Material de esterilización
CTN:

Equivalencia Internacional

Idéntica EN 14180:2025

Reemplazo Normas

Reemplaza a DIN EN 14180:2014-09

Reemplaza a DIN EN 14180:2023-04

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