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ISO 11138-5:2017

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ISO 11138-5:2017

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

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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.

Author ISO/TC 198 Sterilization of health care products
Editor ISO
Document type Standard
Format Paper
Edition 2
ICS 11.080.01 : Sterilization and disinfection in general
Number of pages 7
Replace ISO 11138-5:2006
Modified by ISO 11138-5:2017/NP Amd 1
Weight(kg.) 0.1119
Year 2017
Country Switzerland