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naSRPS EN ISO 11140-3:2024

Sterilization of health care products - Chemical indicators - Part 3: Type 2 indicators for use in the Bowie and Dick-type steam penetration test (ISO/DIS 11140-3:2025)

General information

40.20     Jul 31, 2025

40.60    Sep 30, 2025

ISS

Z076

European Norm

11.080.20  

English  

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Scope

ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN ISO 11140-3:2011

NOW

PROJECT
naSRPS EN ISO 11140-3:2024
40.20 DIS ballot initiated: 12 weeks
Jul 31, 2025

Related project

Adopted from prEN ISO 11140-3 IDENTICAL

Adopted from ISO/DIS 11140-3 IDENTICAL

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