NBN EN ISO 11137-2:2015
Active , Modified Standard
Most Recent

NBN EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Base standard
Most recent standard

Summary

ISO 11137-2:2013 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. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

Technical characteristics

Publisher Bureau de Normalisation Belge (NBN)
Publication Date 07/24/2015
Cancellation Date 12/31/2015
Page Count 87
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