International Standard
IEC 62304:2006
Medical device software — Software life cycle processes
Reference number
IEC 62304:2006
Edition 1
2006-05
© ISO 2024
International Standard
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Published (Edition 1, 2006)
This standard was last reviewed and confirmed in 2021. Therefore this version remains current.
This standard has 1 amendment.

IEC 62304:2006

Format
Language
CHF 345
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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.

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

Format
Language
CHF 270
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Life cycle

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