RO
SR EN ISO 11137-2:2007
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2006 defines product families for dose establishment and dose auditing.
Status :
Withdrawn
Approval date : 9/28/2007
Publish date : 9/30/2007
Withdrawal date : 8/31/2012
Number of pages : 66
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Replaces SR EN 552:2001/A2:2003
- Replaces SR EN 552:2001/A1:2003
- Replaces SR EN 552:2001
- Normative reference SR EN ISO 11737-1:2006
- Normative reference SR EN ISO 11737-2:2002
- Normative reference SR EN ISO 13485:2004
- Normative reference SR EN ISO 11137-1:2006
- Replaced by SR EN ISO 11137-2:2012
- Amended by SR EN ISO 11137-2:2007/AC:2009