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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 60627:2001/AC:2002

Medical devices Directive (93/42/EEC)

Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter gridsIEC 60627:2001

EN ISO 11737-1:2006

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Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

EN ISO 10993-7:2008

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-7:2008/AC:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-9:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

EN ISO 10993-13:2010

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medic...

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