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, IDT)
This Malaysian Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilisation process for medical devices.
This standard is intended to be applied by process developers, manufacturers of sterilisation equipment, manufacturers of medical devices to be sterilized and the organisations with responsibility for sterilising medical devices.
This standard covers sterilisation processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.
Published
• (none) / (none) / (none)
PDF
02/05/2019
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NSC 18 - Medical Devices and Facilities for Healthcare
