SRPS EN ISO 11137-2:2011

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

Scope

ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.