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Labeling of medical device accessories

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Guest user Created:   Sep 01, 2022 Last commented:   Sep 01, 2022

Labeling of medical device accessories

I am looking for information on labeling of medical device accessories. Specifically, we have a handpiece to improve delivery of laser energy from the fiber to the patient tissue. The notified body (under MDD) advised us to put the same laser safety labels on the handpiece (laser class, etc) as we already have on the laser itself. I cannot find any advise like this in the standards (IEC60601-1, IEC60601-2-22, IEC60825-1)

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Sep 01, 2022

The standard that talks about symbols for medical products is ISO 15223-1:2021. There is no laser symbol specifically in it, but it says that the manufacturer is responsible for conducting a risk analysis based on which he will assess what information he must provide to the user. In your risk analysis, the danger of laser beams must be covered, so it is logical that such a symbol exists on the product.

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Sep 01, 2022

Sep 01, 2022

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