EN ISO 11137-2:2012
Withdrawn
Withdrawn
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
Published date
03-15-2012
Publisher
Withdrawn date
09-30-2012
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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
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| 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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