Difference between ISO 13485 and EN 14683:2019

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:

• What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• Quality Management System: What is it? - https://advisera.com/9001academy/knowledgebase/quality-management-system-what-is-it/