NA 176

DIN Standards Committee Health Technologies

Project

Sterilization of health care products - Chemical indicators - Part 4: Type 2 indicator systems as an alternative to the Bowie and Dick-type test for the detection of steam penetration (ISO/DIS 11140-4:2025); German and English version prEN ISO 11140-4:2025

Abstract

This document specifies the requirements for a Type 2 chemical indicator to be used in the steam penetration test for steam sterilizers for wrapped health care goods (instruments, etc., and porous materials). Chemical indicators conforming with this document are intended for use in combination with the standard test pack as described in EN 285. This document does not consider the performance of the standard test pack, but does specify the performance of the chemical indicator.

Begin

2022-08-18

WI

00102182

Planned document number

DIN EN ISO 11140-4

Project number

06302175

Responsible national committee

NA 176-03-08 AA - Indicators  

Responsible european committee

CEN/TC 102/WG 7 - Biological and chemical indicators  

Responsible international committee

ISO/TC 198/WG 6 - Chemical indicators  

draft standard

Sterilization of health care products - Chemical indicators - Part 4: Type 2 indicator systems as an alternative to the Bowie and Dick-type test for the detection of steam penetration (ISO/DIS 11140-4:2025); German and English version prEN ISO 11140-4:2025
2025-08
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previous edition(s)

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007); German version EN ISO 11140-4:2007
2007-07

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Contact

Dipl.-Phys.

Jenny Blum

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2034
Fax: +49 30 2601-42034

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