Reference number
IEC 62304:2006
© ISO 2025
International Standard
IEC 62304:2006
Medical device software — Software life cycle processes
Edition 1
2006-05
Read sample
Published (Edition 1, 2006)
This publication was last reviewed and confirmed in 2021. Therefore this version remains current.
This standard has 1 amendment.

IEC 62304:2006

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Abstract

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.

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Medical devices - the basics

This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.

  • ISO 13485:2016
  • ISO 13485:2016 A practical guide
  • ISO 14971:2019
  • ISO/TR 24971:2020
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General information

  • Status
     : Published
    Publication date
     : 2006-05
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 1
    Number of pages
     : 151
  • Technical Committee :
    ISO/TC 210
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 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2015

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Format
CHF 280
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Life cycle

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