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EVS-EN ISO 25424:2011

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)

General information

Withdrawn from 02.12.2019
Base Documents
ISO 25424:2009; EN ISO 25424:2011
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.12.2019
Main
03.08.2011
Main
Main
EVS-EN 15424:2007
1.1.1 This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. 1.1.2 This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1) 1.1.3 This European Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.

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