CEN/TC 204/WG 9 - General requirements for sterilization
Preparation of standards providing general criteria by which sterilization processes (except the processes covered by EN 550, EN 552 and EN 554) can be validated and routinely monitored.
General requirements for sterilization
Preparation of standards providing general criteria by which sterilization processes (except the processes covered by EN 550, EN 552 and EN 554) can be validated and routinely monitored.
General Information
ISO 14937:2009 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.
It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and 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.
ISO 14937:2009 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.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 day
Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage
- Standard38 pagesEnglish languagesale 10% offe-Library read for1 day
ISO - Taking over of an ISO Technical Corrigendum
- Corrigendum4 pagesEnglish languagesale 10% offe-Library read for1 day