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Difference between ISO 13485 and EN 14683:2019

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Guest user Created:   Jan 05, 2021 Last commented:   Jan 07, 2021

Difference between ISO 13485 and EN 14683:2019

What is the difference between ISO 13485 and EN 14683:2019?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jan 07, 2021

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes - is a standard that is applicable for all manufacturers of medical devices, it is considering the quality management system of the manufacturing the medical device.

EN 14683:2019 Medical face masks. Requirements and test methods – is a standard that covers requirements under which medical masks must be produced and which tests must be performed to prove that medical masks are in compliance with this standard.

So, those two standards complement each other, which means that medical masks must be designed and made according to the EN 14683:2019, but the manufacturer must have implemented a quality management system in accordance with ISO 13485:2016.

For more information about ISO 13485:2016 please see the following articles:

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Jan 05, 2021

Jan 07, 2021