SS-EN-ISO-11137-2 › Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
Active implantable medical devices. Medical devices. In vitro diagnostic medical devices
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
SS-EN ISO 11137-2:2015
July 8, 2015
EN ISO 11137-2:2015(IDT); ISO 11137-2:2013(IDT)