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Publication details

Publication CODE Title
IEC 62304:2006+AMD1:2015 CSV (2015-06) MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
 
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Description
IEC 62304:2006+A1:2015 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. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN version

EN/FR version

Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee TC 62/SC 62A
COMMON ASPECTS OF ELECTRICAL EQUIPMENT USED IN MEDICAL PRACTICE
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2015-06-26
ICS-Code (International Standards Classification) 11.040.01
NBN Status New
IEC publication date 2015-06-26
IEC stability date 2020-12-31
IEC file modification date 2015-06-25
IEC last modification date 2019-10-31