24347

AAMI/ISO TIR 13409 + Amendment 1 [ Withdrawn ]

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 05/09/1996

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Full Description

Describes method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1,000 colony forming units(cfu) that are manufactured in small quantities.

Includes amendment (TIR13409/A1).
 

Product Details

Published:
05/09/1996
Number of Pages:
13
File Size:
2 files , 300 KB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI TIR33:2005


    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

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

    • Historical Version