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Which ISO standards are mandatory to purchase as an official version?

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Guest Created:   Nov 22, 2022 Last commented:   Nov 22, 2022

Which ISO standards are mandatory to purchase as an official version?

I would like to find out which ISO standards are mandatory to purchase when implementing ISO 13485. There are many different ones, and quite frankly, expensive. I understand that ISO 13485 or ISO 14971 /24971 must be purchased as an official version, but what about others?

Thanks.

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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.

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Kristina Zvonar Brkić Nov 22, 2022

Yes, you are right, ISO 13485 and ISO 14971 are mandatory. As for other standards, it depends on what your medical device is.

For all medical devices are also applicable following standards:

  • ISO 20417:2021 Information from the manufacturer
  • ISO 10993-1:2018 Biocompatibility
  • ISO 15223-1:2021 Labelling
  • IEC 62366-1:2015 Usability

There are also a lot of different technical standards. For example, if your medical device is sterile, then you need to have ISO standards relating to your type of sterilization. If your device requires electricity, then it has to be electromagnetic compatible.

List of all harmonized standards are published on several links as follows:

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Nov 22, 2022

Nov 22, 2022

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