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AAMI TIR33:2005 [ Withdrawn ]

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

Pages: 54
Publication date: 2006-10-25
Price: Contact

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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.
Document identifier
AAMI TIR33:2005 [ Withdrawn ]
Title
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
AAMI Category
General and Miscellaneous, Radiation
Publication date
2006-10-25
Status
Effective
International Relationship
Cross references
Latest version
AAMI TIR33:2005
History of version
AAMI TIR33:2005 * AAMI TIR 27 * AAMI/ISO TIR 13409 Amendment 1 * AAMI/ISO TIR 13409 + Amendment 1
Keywords
Classification
Pages
54
Price Contact

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