Is IEC 80601-2-60 necessary for Dental Laser?

A

Athir

#1
Hello,
I am developing a new dental laser. I am on the certification process with TUV rheinland. They told me that they think that IEC 80601-2-60 has to be applied (laser+ handpiece).
However for me I referred to IEC 60601-1.
Do you think that I need to buy IEC 80601-2-60 and try to follow it is instructions ? or IEC 60601-1 is enough and what can I tell them ?

Best Regards
 
Elsmar Forum Sponsor
#2
For the sake of people who may not be aware -

IEC 80601-2-60
Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES and DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT.
So it may be that there are specific dental performances / risks that are identified within the standard, although there is no explicit mention of lasers.

You might also consider 60601-2-22 which is for diagnostic and therapeutic lasers.

But also remember that the application of any standard is always voluntary. It is just that it is often the easiest way to show compliance with the (compulsory) Essential Requirements.

Edit:
Just noticed that 60601-2-22 is listed as a normative reference in 80601-2-60 suggesting that -2-60 does indeed cover dental lasers.
 
Last edited:

Peter Selvey

Staff member
Super Moderator
#3
I checked the IEC website which finally allows you to access a preview which not only includes the scope statement but also the definitions, which are necessary to understand the scope.

It looks as though if the treatment is dental via a hand piece, then it is applicable.

But, it is a relatively new standard. It has not yet been published as an EN standard. Typically standards are allowed at least 3 years before being used in any regulation, so the earliest should be Feb 2015. It should be optional at this stage, but it makes sense to apply so you are ready when the standard becomes part of the regulation.
 
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