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

SS-EN-ISO-11140-1 - 2014 EDITION - CURRENT


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This part of ISO 11140 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.NOTE 1 Biological test systems are regarded as those test systems which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138- series for biological indicators (BIs).The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.Relevant test equipment is described in ISO 18472.NOTE 2 Additional requirements for specific test indicators/indicator systems (Type 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.

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Active implantable medical devices. Medical devices. 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

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Designation Name

SS-EN ISO 11140-1:2014

Revision Level

2014 EDITION

Status

Current

Publication Date

Nov. 16, 2014

Language(s)

English

Page Count

48

International Equivalent

EN ISO 11140-1:2014(IDT); ISO 11140-1:2014(IDT)