ISO 11137-2:2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Hardcopy , PDF
19-04-2006
09-04-2025
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.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
62
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| AS/NZS ISO 11137.2:2006 | Identical |
| UNE-EN ISO 11137-2:2006 | Identical |
| JIS T 0806-2:2010 | Identical |
| UNE-EN ISO 11137-2:2007 | Identical |
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