AAMI TIR33:2005

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax

Association for the Advancement of Medical Instrumentation , 10/25/2006

Publisher: AAMI

File Format: PDF

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Description

Standard By:Association for the Advancement of Medical Instrumentation , 10/25/2006

Published:10/25/2006

Pages:54

AAMI TIR33:2005 PDF

This technical report describes a method of substantiation of 25 kGy as the sterilization dose for radiation sterilization of health care products with an average bioburden for the entire product unit (SIP=1) < 1000 colony-forming units (cfu). Application of the method of substantiation of 25 kGy described in this technical report may be used to meet the requirements specified under subclause 6.2.2 relating to product qualification in ISO 11137.