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ILNAS-EN ISO 13485:2003/AC:2009 Edition 08/2009
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
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Status

Standard - Superseded

Origin

Technical Committee :
CEN/CLC/TC 3 : Quality management and corresponding general aspects for medical devices

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      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)   
start of the vote on the final project      date of publication (dop)   
end of the vote on the final project      date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Evolutions
ILNAS-EN ISO 13485:2012

Relations to older standards
ILNAS-EN ISO 13485:2003/AC:2007
ILNAS-EN ISO 13485:2003

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

International Classification for Standards (ICS codes) :

03.120.10 : Quality management and quality assurance
11.040.01 : Medical equipment in general

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