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SRPS EN ISO 11140-1:2015

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

Jun 22, 2015

General information

60.60     Jun 22, 2015

ISS

Z076

European Norm

11.080.01  

English  

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Scope

ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

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.

93/42/EEC

Medical devices

Directive 93/42/EEC
90/385/EEC

Active implantable medical devices

Directive 90/385/EEC
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 11140-1:2011

NOW

PUBLISHED
SRPS EN ISO 11140-1:2015
60.60 Standard published
Jun 22, 2015

Related project

Adopted from EN ISO 11140-1:2014

Adopted from ISO 11140-1:2014 IDENTICAL