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ISO/DIS 11138-6

Sterilization of health care products — Biological indicators — Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes

General information

40.20     May 11, 2026

ISO

ISO/TC 198

International Standard

11.080.01  

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Scope

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.

Life cycle

NOW

PROJECT
ISO/DIS 11138-6
40.20 DIS ballot initiated: 12 weeks
May 11, 2026

National adoptions

naSRPS EN ISO 11138-6:2024  
ISS

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

40.20   DIS ballot initiated: 12 weeks

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