Language: English
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 24-48 hours
    • $258.00
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $326.00
    • Add to Cart

We Recommend

 

About This Item

 

Full Description

Abstract

ISO 11137-2:2013 specifies methods for 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. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
 

Document History

  1. ISO 11137-2:2013

    👀currently
    viewing


    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


    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