EN ISO 11137-2:2007
Withdrawn
Withdrawn
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
Amended by
Published date
05-30-2007
Publisher
Withdrawn date
05-31-2010
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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 |
CEN/TC 204
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DIN EN ISO 11137-2:2007-09 | Equivalent |
| I.S. EN ISO 11137-2:2007 | Equivalent |
| BS EN ISO 11137-2:2007 | Equivalent |
| UNE-EN ISO 11137-2:2007 | Identical |
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