Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine

[Kuldeep Singh]

Hi,

As we are manufacture of medical products Class IIB and manufacture dental X-Ray machine. I am new to this product and during testing i have a query for testing of IEC 60601-2-63. when i saw the predicate devices and i found IEC 60601-2-63 in their compliance table which Is Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment .

And i found there is no reference of this standard in EU list of harmonized standards. whereas in FDA certification it is mandatory. Please give your opinions for registration in Europe.

 

[Marcelo]

Standards are always voluntary in europe and most of the world.

 

[Kuldeep Singh]

but still there is question for testing of that particular standard i.e IEC 60601-2-63 ( Not harmonized standard as per EU Harmonized list updated on 17.11.17 on EU Website) .We have to testing with it also or EN 60601-2-54 & EN 60601-1-3 radiation related testing is sufficient.

 

[Marcelo]

For Europe, you can use any technical solution you want, any standard, anything, to comply with the essential requirements. The only drawback is that you do get presumption of conformity, if you do not use a harmonized standard.