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ISO 13485:2016 Edition 02/2016
Medical devices -- Quality management systems -- Requirements for regulatory purposes
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  • 152.7 / copy
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Status

Standard - Active

Origin

Technical Committee :
ISO/TC 210/WG 1 : Application of quality systems to medical devices

Implementation

start of the vote on the project    06/02/2015   date of ratification (dor)   
end of the vote on the project    07/05/2015   date of anouncement (doa)   
start of the vote on the final project    29/10/2015   date of publication (dop)    25/02/2016
end of the vote on the final project    31/12/2015   date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to older standards
ISO 13485:2003/Cor 1:2009
ISO 13485:2003

International Classification for Standards (ICS codes) :

03.120.10 : Quality management and quality assurance

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