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International ISO standards

Publication date

March 2017

Number of pages

8 p.

Reference

ISO 11138-3:2017

ICS Codes

11.080.01 Sterilization and disinfection in general

Print number

1

Sumary

Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes

ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.

NOTE 2 National or regional regulations can provide requirements for work place safety.

Replaced standards (1)

ISO 11138-3:2006

July 2006

International standard Cancelled

Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes

ISO 11138-3:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. Moist heat as the sterilizing agent is defined in ISO 11138-3:2006 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

Standard replaced by (1)

ISO 11138-3:2006

July 2006

International standard Cancelled

Sterilization of health care products - Biological indicators - Part 3 : biological indicators for moist heat sterilization processes

ISO 11138-3:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. Moist heat as the sterilizing agent is defined in ISO 11138-3:2006 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

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