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ISO 11137-2:2013

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO 11137-2:2013
Document Year: 2013
Pages: 68
Edition: 3
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products
  • ICS:
  • 11.080.01 Sterilization and disinfection in general

Life Cycle

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ISO 11137-2:2013
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