Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009, IDT)
This Malaysian Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.
This standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.
This standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.
This standard specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.
Published
• (none) / (none) / (none)
PDF
26/01/2021
49
NSC 18 - Medical Devices and Facilities for Healthcare
