ISO-11138-5 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

ISO-11138-5 - 2ND EDITION - CURRENT
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ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.

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

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11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO 11138-5:2017

Revision Level

2ND EDITION

Status

Current

Publication Date

March 1, 2017

Committee Number

ISO/TC 198