ISO-11137-2 › Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Show Complete Document History
The following bibliographic material is provided to assist you with your purchasing decision:
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.
ISO 11137-2 is one of a 3-part series on the sterilization of health care products using radiation that replaced the original edition, ISO 11137:1995. The other two documents in the series are:
ISO 11137-1:2006, “Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices”
ISO 11137-3:2006, “Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects”
To find similar documents by classification:
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.
Customers who bought this document also bought:
June 1, 2013