SS-EN ISO 11137-2:2015
Current
Current
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Published date
02-27-2019
Publisher
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This part of ISO 11137 specifies methods for 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.
| Committee |
TC 198
|
| DocumentType |
Standard
|
| PublisherName |
Standardiserings-Kommissionen I Sverige
|
| Status |
Current
|
| Standards | Relationship |
| ISO 11137-2:2013 | Identical |
| EN ISO 11137-2:2015 | Identical |
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