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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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
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
Aug 19, 2020