M/575 AMD 2 - Medical Devices (MDR-IVDR)

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.

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.