ISO 13485 compatibility with EN 14126

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes is a standard for a quality management system, while EN 14126:2003 Protective clothing against infective agents is a standard that is used to demonstrate the performance of protective garments against infective agents. Since protective garments against infection are a medical device, the manufacturer is supposed to have implemented a quality management system according to ISO 13485:2016. Therefore, the manufacturer of protective garments against infection must be in compliance with both standards.

Further articles can provide more information about ISO 13485:2016:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Clause-by-clause explanation of ISO 13485:2016 - https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485