ÖNORM EN ISO 11137-2:2023 10 01
Current
Current
The latest, up-to-date edition.
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Amended by
Available format(s)
Hardcopy
Language(s)
German - English
Published date
01-10-2023
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).
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