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
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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.Product Information
Published:
10/25/2006
Pages:
54
AAMI TIR33:2005
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