ISO-11138-4 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes

ISO-11138-4 - 2ND EDITION - CURRENT
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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.

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Document Number

ISO 11138-4:2017

Revision Level

2ND EDITION

Status

Current

Publication Date

March 1, 2017

Committee Number

ISO/TC 198