Guest user Created: Jun 04, 2021 Last commented: Jun 05, 2021

List of ISO Standards for medical devices and IVD’s

Is there a list available with all the ISO Standards for medical devices and IVD’s?

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Kristina Zvonar Brkić Jun 05, 2021

According to the Medical device regulation MDR 20174/745, in Article 8 – Use of harmonized standards – is stated that medical device manufacturers must be in compliance with ISO standards published by the Official Journal of the European Union. Currently, valid lists of standards are:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.090.01.0001.01.ENG&toc=OJ:L:2020:090I:TOC />https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.129.01.0153.01.ENG
Please be aware that not all standards from that list are applicable for all medical devices.

For more information, see:

EU MDR Article 8 – Use of harmonised standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/

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Jun 04, 2021

Jun 05, 2021

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