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  • BSI
    23/30458211 DC BS EN 14180. Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers.Requirements and testing
    Edition: 2023
    $76.00
    / user per year

Description of 23/30458211 DC 2023

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 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.

Standard Number23/30458211 DC
TitleBS EN 14180. Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers.Requirements and testing
StatusDefinitive
Publication Date2023-04-11
DescriptorsMedical equipment, Formaldehyde, Testing, Steam, Steam sterilizers, Sterilizers, Sterilization (hygiene), Low temperatures
ICS11.080.10 Sterilizing equipment
CommitteeCH/198
PublisherBSI
Pages121

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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