ISO-11137-2 Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose

ISO-11137-2 - 3RD EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of ISO standards.
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.

ORDER

Price:

$243.00       

Notes

Claudia's Notes:
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:

11.080.01 (Sterilization and disinfection in general)

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.

Document Number

ISO 11137-2:2013

Revision Level

3RD EDITION

Status

Current

Publication Date

June 1, 2013

Committee Number

ISO/TC 198