SS-EN-ISO-11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

SS-EN-ISO-11137-2 - 2015 EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of SIS standards.
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:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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.




Designation Name

SS-EN ISO 11137-2:2015

Revision Level




Publication Date

July 8, 2015



Page Count


International Equivalent

EN ISO 11137-2:2015(IDT); ISO 11137-2:2013(IDT)