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Homepage>UNE standards>UNE EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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in stockReleased: 2022-09-21
UNE EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

UNE EN ISO 13485:2018/A11:2022

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Productos sanitarios. Sistemas de gestión de la calidad. Requisitos para fines reglamentarios. (ISO 13485:2016).

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Standard number:UNE EN ISO 13485:2018/A11:2022
Pages:30
Released:2022-09-21
Status:Amendment
DESCRIPTION

This standard UNE EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) is classified in these ICS categories:

  • 11.040.01
  • 03.100.70
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ISO 9000 : 2015, ISO 9001 : 2015, ISO 14001 : 2015
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