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

Oznaka:prEN ISO 11138-6

Odbor:HZN/TO 555

Ime odbora:Medicinski proizvodi

Nacrt objavljen za komentiranje:2026-06-10

Rok za komentiranje:2026-07-03

Broj komentara:0

Contact email:nacrti(at)hzn.hr

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Područje primjene nacrta:

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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