Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $192.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

 

Document History

  1. ISO 11137-2:2013


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

    • Most Recent
  2. ISO 11137-2:2012


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

    • Historical Version
  3. ISO 11137-2/Cor1:2009


    Corrigendum

    • Historical Version
  4. ISO 11137-2:2006

    👀currently
    viewing


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

    • Historical Version
  5. ISO 11137:1995


    Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 11137-2/Cor1:2009

    Free
    Download


    Corrigendum