Name:
DANSK DS/EN ISO 11137-2 PDF
Published Date:
04/27/2012
Status:
[ Revised ]
Publisher:
Dansk Standard
ISO 11137-2:2011 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. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
| Edition : | 12 |
| File Size : | 1 file , 670 KB |
| Number of Pages : | 90 |
| Product Code(s) : | DS-081, DS-081 |
| Published : | 04/27/2012 |