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ILNAS-EN 62304:2006 Edition 07/2006
Medical device software - Software life-cycle processes
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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.

Status

Standard - Active

Origin

Technical Committee :
CLC/TC 62 : Electrical equipment in medical practice

Directives

90/385/EEC : Active implantable medical devices
93/42/EEC : Medical devices
98/79/EC : In vitro diagnostic medical devices

Implementation

start of the vote on the project    03/12/2004   date of ratification (dor)   
end of the vote on the project    03/02/2005   date of anouncement (doa)    01/09/2006
start of the vote on the final project    10/02/2006   date of publication (dop)    01/03/2007
end of the vote on the final project    10/04/2006   date of withdrawal (dow)    01/06/2009


Publication Official Journal
of the Grand-Duchy of Luxembourg
09/02/2007
Reference

Relations

Evolutions
prEN IEC 62304:2021
ILNAS-EN 62304:2006/A1:2015

Relations to international standards
IEC 62304:2006 (EQV) 

International Classification for Standards (ICS codes) :

11.040 : Medical equipment

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