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prEN ISO 11138-6

Sterilization of health care products - Biological indicators - Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes (ISO/DIS 11138-6:2026) prEN ISO 11138-6

Publication date:   May 14, 2026

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40.60   Close of voting   Aug 3, 2026

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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This document specifies requirements for test organisms, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing vaporized hydrogen peroxide as the sterilizing agent.
NOTE 1 Requirements for validation and control of vaporized hydrogen peroxide sterilization processes are provided by ISO 22441 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for workplace safety.

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prEN ISO 11138-6
40.60 Close of voting
Aug 3, 2026




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