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ILNAS-EN ISO 13485:2016/A11:2021 Edition 09/2021
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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  • 49.3 / copy
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Status

Standard - Active

Origin

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

Implementation

start of the vote on the project    31/10/2019   date of ratification (dor)    12/04/2021
end of the vote on the project    23/01/2020   date of anouncement (doa)    31/12/2021
start of the vote on the final project    14/01/2021   date of publication (dop)    31/03/2022
end of the vote on the final project    11/03/2021   date of withdrawal (dow)    31/03/2022


Publication Official Journal
of the Grand-Duchy of Luxembourg
18/03/2022
Reference Mémorial A N° 126

Relations

Relations to older standards
ILNAS-EN ISO 13485:2016

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