IEC 62304:2006 

Medical device software - Software life cycle processes

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IEC 62304:2006+AMD1:2015 CSV

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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. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

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Relevant for

cyber security

smart city


Additional information

Publication typeInternational Standard
Publication date2006-05-09
Edition1.0
Available language(s)English, English/French, French, Spanish
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
Stability date  2018
Pages155
File size2331 KB

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