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AAMI TIR33:2005 [ Withdrawn ]

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

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

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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.
 

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Published:
10/25/2006
Number of Pages:
54
Part of:
AAMI STBK10-3
 

Document History

  1. AAMI TIR33:2005

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

    • Most Recent

  2. AAMI TIR 27


    Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose - Method VD max

    • Historical Version

  3. AAMI/ISO TIR 13409 Amendment 1


    Sterilization of Health Care Products - Radiation Sterilization - Substantiation of 25 kGy as a Sterilization Dose for Small or Infrequent Production Batches - Amendment 1

    • Historical Version

  4. AAMI/ISO TIR 13409 + Amendment 1


    Sterilization of Health Care Products - Radiation Sterilization - Substantiation of 25 kGy as a Sterilization Dose for Small or Infrequent Production Batches

    • Historical Version