Manufacturers contact F2 Labs from around the world for assistance with EU regulations. While F2 Labs primarily focuses on electro-mechanical devices, including medical devices, we have also assisted many people with an understanding of what is legally required.
An example of this could be a manufacturer of an aircraft sub-assembly that has an installed laser as a part of the sub-assembly. The device itself is used in a military / security application and is powered from the aircraft battery. The question to F2 Labs in this case is usually, “what is applicable?” Since in our experience the end-user in the EU oftentimes is not able to provide this information to the manufacturer, we try to help.
In this case the device is DC powered and is below the voltage levels of the LVD 2014/35/EU scope. The LVD is applicable as per Article 1, paragraph 2:
Next, we look at Annex II and see this:
Specialized electrical equipment for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate.
Note that although the equipment is not scope of the LVD per Annex II, it must be in the scope of some other safety requirement in order to really be “out of scope”… if you had to rely on Annex II for exclusion. And this equipment happens to be excluded even before we get to Annex II… because it operates from an input voltage lower than the scope of the LVD (per Article 1, paragraph 2) – DC products with a voltage lower than 50 DC are not in scope.
In other words: if it is in the scope of the LVD and is also aeronautical equipment it can only be excluded from the LVD if it falls under the aeronautical regulation. You cannot exclude your equipment from the LVD because it’s aeronautical and then also exclude it from the aeronautical regulation.
Now we look at the EMC Directive 2014/30/EU. See Article 2, Scope 1:
Next, see Article 2, (2.), (b):
OK, here is a wrinkle. The EMCD 2014/30/EU is not applicable to aeronautical products if they are in the scope of Regulation (EC) No. 216/2008. Immediately we see Article 2 (2.) in Regulation No. (EC) 216/2008:
So, it is excluded from this regulation because it has a military / security application. This means therefore it is not excluded from the EMCD 2014/30/EU (because only aeronautical equipment in the scope of Regulation No (EC) 216/2008 is excluded from the EMCD 2014/30/EU).
We advise compliance with the EMC Directive 2014/30/EU using whatever applicable harmonized EMC testing standards are relevant.
Interesting to note that the Low Voltage Directive 2014/35/EU is nuanced because although the subject equipment could not escape the Low Voltage Directive 2014/35/EU due to being in the scope of Regulation No (EC) 216/2008, it is still out of scope due to being below the minimum voltage limit.
And there is a laser. Overall assemblies are in the scope of the harmonized Low Voltage Directive standard for laser safety, EN 60825-1:
But this is not in the scope of the Low Voltage Directive, so now what?
Our advice is this:
- Comply with the EMC Directive 2014/30/EU
- Have it tested to an appropriate safety testing standard, probably EN 62368-1, and receive a compliant report.
- Have the apparatus tested to IEC/EN 60825-1 and receive a compliant report.
- Indicate that the equipment is compliant to the EMC Directive 2014/30/EU on the EU declaration of conformity and also show that it has been tested to the appropriate EN safety standards, including laser testing, by listing those standards and report numbers on the document, but do not claim compliance to the Low Voltage Directive 2014/30/EU.
We can be contacted at this link. We can be reached by phone at 877-405-1580 and are here to help you.
F2 Labs is here to help.
