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Is ISO 13485 for medical devices only?

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Guest user Created:   Aug 10, 2020 Last commented:   Aug 19, 2020

Is ISO 13485 for medical devices only?

ISO 13485 is for medical devices only or for products as well like hand sanitizers and chemicals used on masks?

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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 Aug 19, 2020

As is stated in the section 1 Scope of the ISO 13485:2016, this standard is applicable for medical devices or related services. In section 3 Terms and definitions, in 3.11 is stated what is considered as medical device. According to that, hand sanitisers and chemicals used on masks are not medical devices. 

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Aug 10, 2020

Aug 19, 2020