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Oximeter and Heart Rate Measurement

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Guest user Created:   Oct 26, 2020 Last commented:   Oct 27, 2020

Oximeter and Heart Rate Measurement

What accuracy (in terms of %age) is required for device to get ISO certified? or what is the acceptable error range for readings?

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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.

Expert
Kristina Zvonar Brkić Oct 27, 2020

Medical devices can not be ISO certified. Medical devices are certified according to product standard Medical device directive (MDD) or Medical device regulation (MDR). 

Nor in the ISO 13485:2016 standard nor in the MDD or MDR, there is no direct value for the accuracy. This data is usually in the technical standards. If you can tell me more about your medical device, what it is, I can guide to tehcnicals tnadrds that is applicable for it. 

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Oct 26, 2020

Oct 27, 2020