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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)

Draft Public enquiry
Comment end date 2026-07-21
Export comments Read draft and comment

Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas
2. Projektas
3. Viešoji apklausa
From 2026-05-22 till 2026-07-21
4. Closure of enquiry
5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

ICS

11.080.01 - Sterilization and disinfection in general

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 102

Number of comments

0

Comment start date

2026-05-22

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.