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.
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.
Life cycle
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.PublishedIEC 62304:2006/Amd 1:2015
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00
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