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ISO 11138-4:2017

Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes

Standard Details

ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.

NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.

NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

General Information

Status : Published
Standard Type: Main
Document No: ISO 11138-4:2017
Document Year: 2017
Pages: 8
Edition: 2
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products
  • ICS:
  • 11.080.01 Sterilization and disinfection in general

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ISO 11138-4:2017
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