SS-EN-ISO-11137-2 › Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
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Included in this current edition are the following subparts:
2015 EDITION - July 8, 2015
FOR 2015 EDITION AMENDMENT 1 SEE - April 24, 2023
FOR 2015 EDITION AMENDMENT 1 SEE - April 24, 2023
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. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.
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Designation Name
SS-EN ISO 11137-2:2015
Revision Level
2015 EDITION
Status
Current
Publication Date
July 8, 2015
Language(s)
English
Page Count
88
International Equivalent
EN ISO 11137-2:2015(IDT); ISO 11137-2:2013(IDT)