ISO 11137-2:2012
Withdrawn
View Superseded by
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Hardcopy , PDF
English, French
03-15-2012
04-09-2025
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.
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| BS EN ISO 11137-2:2012 | Equivalent |
| I.S. EN ISO 11137-2:2012 | Equivalent |
| DIN EN ISO 11137-2:2012-07 | Equivalent |
| BS EN ISO 11137-2:2012 | Identical |
| UNE-EN ISO 11137-2:2012 | Identical |
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