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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

EN 556-2:2015

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EN ISO 13485:2016/AC:2018

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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

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

EN 13612:2002/AC:2002

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Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN 13532:2002

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

General requirements for in vitro diagnostic medical devices for self-testing

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