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DANSK DS/EN ISO 11137-2 [ Active ]

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

standard by Dansk Standard , 07/06/2015

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Full Description

SAME AS ISO 11137-2

This part of ISO 11137 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.

 

Product Details

Edition:
15#
Published:
07/06/2015
Number of Pages:
86
File Size:
1 file , 1.8 MB
Product Code(s):
DS-081, DS-081
 

Document History

  1. DANSK DSF/EN ISO 11137-2/PRA1


    Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)

    • Historical Version

  2. DANSK DS/EN ISO 11137-2

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    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

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  3. DANSK DS/EN ISO 11137-2


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

    • Historical Version

  4. DANSK DS/EN ISO 11137-2


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

    • Historical Version

  5. DANSK DS/EN ISO 11137-2


    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. DANSK DS/EN ISO 11137-2/A1


    Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1 (ISO 11137-2:2013/Amd 1:2022)