ISO 13485 Blog

Liza Horielikova

EU standards for protective equipment – available now for free

In light of the COVID-19 crisis, some of the European standards for certain medical devices and personal protective equipment can now be downloaded for free. This includes the 11 standards developed by the European Committee for Standardization (CEN) and 3 additional ones developed jointly with ISO.

EU standards for protective equipment

Providing free access to these standards during the Coronavirus outbreak enables companies that produce filtering masks, medical gloves, gowns, and other protective supplies to speed up the manufacturing process and enter the EU market quicker to help those in need.


Here is the list of CEN standards available for free download:

To learn which documents are needed to comply with EU MDR, download this free white paper: EU MDR Checklist of Mandatory Documents.

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