RO
SR EN ISO 14937:2010
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)
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.
Status :
Valid
Approval date : 3/31/2010
Publish date : 4/2/2010
Number of pages : 48
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Replaces SR EN ISO 14937:2003/AC:2004
- Replaces SR EN ISO 14937:2003/AC:2005
- Replaces SR EN ISO 14937:2003
- Normative reference SR EN ISO 13485:2004/AC:2010
- Normative reference SR EN ISO 10012:2004
- Normative reference SR EN ISO 10993-1:2010
- Normative reference SR EN 61010-2-040:2006
- Normative reference SR EN ISO 13485:2004
- Normative reference SR EN ISO 11737-1:2006/AC:2009
- Normative reference SR EN ISO 11737-2:2010
- Normative reference SR EN ISO 11737-1:2006