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EN ISO 11140-1:2009 Standard

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  Keywords:

#sterilization #variables #required #general #process

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

  Purpose

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 variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 11140-1:2005"

Anyway is still possible use the "EN ISO 11140-1:2005" until March 21st, 2010

  Related Standards

EN 60601-1-6:2010

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EN ISO 18778:2009

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EN 60601-1:2006/A1:2013

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Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN 60601-1:2006/AC:2010

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Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN 60601-1:2006

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN ISO 25539-2:2009/AC:2011

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

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