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EVS-EN 14180:2014

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

General information
Valid from 01.07.2014
Base Documents
EN 14180:2014
Directives or regulations
None

Standard history

Status
Date
Type
Name
Main
prEN 14180
01.07.2014
Main
08.10.2009
Main + amendment
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.
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