Standard UNE-EN ISO 13485:2018 25.7.2018 preview

UNE-EN ISO 13485:2018

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

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STANDARD published on 25.7.2018


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141.40 USD

The information about the standard:

Designation standards: UNE-EN ISO 13485:2018
Publication date standards: 25.7.2018
SKU: NS-855341
The number of pages: 68
Approximate weight : 204 g (0.45 lbs)
Country: Spanish technical standard
Category: Technical standards UNE

The category - similar standards:

Medical equipment in generalManagement systems

These changes apply to this standard:

UNE-EN ISO 13485:2018/A11:2022 Change

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

Change published on 21.9.2022

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