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EN 62304:2006/AC:2008 Standard

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  Keywords:

#amendment #medical #device #software #software

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

Medical device software - Software life-cycle processesIEC 62304:2006

  Purpose

Amendment for EN 62304:2006

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN 62304:2006"

  Related Standards

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In vitro diagnostic medical devices Directive (98/79/EC)

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In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

EN ISO 14937:2009

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Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

EN 14254:2004

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In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

EN 14136:2004

In vitro diagnostic medical devices Directive (98/79/EC)

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN 13975:2003

In vitro diagnostic medical devices Directive (98/79/EC)

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

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