Posts

Choosing EMC/Radio Standards for CE/UKCA – Generic vs Specific

A short post prompted by a (summarised) request from a customer:

 

We’d like to test to the following standards for our CE/UKCA marking

– EN 61326-1 (Class B emissions, Industrial immunity)
– EN 61000-6-2 (Industrial Level Immunity)
– EN 61000-6-3 (Class B Emissions)

 

This customer is very compliance conscious, as their products end up in all kinds of harsh and hazardous environments where they are protecting the health and safety (and lives in many cases) of their customers.

As such, it is understandable that they want to “throw the kitchen sink” at the EMC performance. Selecting Class B emissions and industrial immunity is a great way of demonstrating the robustness of your product in a wide range of electromagnetic environments.

So, why not quote all of the standards on the Declaration of Conformity (DoC)?

 

Guidance is Available

Thankfully the European Commission has published guidance on selecting Harmonised EMC and Radio standards for assessing the product to.

In each of these standards, a primacy or order of application, is given to the Harmonised Standards.

 

Guide for the EMCD (Directive 2014/30/EU)

4.3.2.2 Relevant harmonised standards

The selection of the relevant harmonised standards is the responsibility of the manufacturer.
When the manufacturer chooses to apply harmonised standards he shall select them in the following precedence order:

– Product-specific standards (if available)
– Product family standards (if available)
– Generic standards

Product-specific (family) standards are those written by ESO’s taking into account the environment, operating and loading conditions of the equipment and are considered the best to demonstrate to compliance to the Directive.

 

An example of a product specific standard would be EN 61326-2-6Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2012)”

These product specific standards often refer back to the root family standard, EN 61326-1 in this case.

Only if the manufacturer’s equipment does not fall into a product standard should the generic standards be applied.

 

Guide to the Radio Equipment Directive 2014/53/EU

5.2 Generic harmonised standards vs product specific harmonised standard

A manufacturer which has the intention to apply a harmonised standard for the conformity assessment of its products, has to apply in priority the product specific harmonised standard and only if this one is not available, the generic one, in order to benefit of presumption of conformity with the essential requirements of the RED.

 

Applying Multiple Standards

There are cases where applying several different Harmonised Standards could be the correct thing to do.

For example, if the equipment is a piece of measurement equipment that incorporates a lot of IT functionality (networking, data storage, PC control) then the manufacturer could decide to assess against EN 61326-1 for laboratory equipment and against EN 55032 for IT equipment. Both standards would appear in the test report and on the DoC.

 

Presumption of Conformity

Remember that using Harmonised Standards (or Designated Standards for UKCA) gives you a “Presumption of Conformity” without further requirement to demonstrate compliance with the relevant directives/laws.

As this interesting piece on kan.de notes:

 

“Ultimately, the presumption of conformity is no more than a reversal of the burden of proof. This means that a product complying with the relevant [harmonised] standards may be challenged, for example by the market surveillance authority, only if actual evidence can be produced that the manufacturer has violated the requirements of the directives.”

 

Annex ZZ of a Harmonised Standard is your friend when it comes to understanding this link between the standards and the directives.

 

When the DoC Doesn’t Quite Cover It

This example of EN 61326-1 illustrates one of the problems of applying a Harmonised Standard that has multiple levels within it.

In this case, the EMC performance of equipment complying with EN 61326-1 could fall into one of six distinct categories.

Emissions

  • Class A (industrial)
  • Class B (domestic)

Immunity

  • Controlled (shielded and filtered environment)
  • Basic (domestic/commercial)
  • Industrial (heavy machinery)

On the face of it, a product tested to Class A / Controlled (poor EMC performance) can’t be distinguished from one that has passsed Class B/Industrial limits (excellent EMC performance).

What to do?

The way I suggest overcoming this and informing the end user a little more clearly about the performance of the product is to explicitly state in the DoC what levels the product was assessed against during any testing.

Example:

 

This equipment was assessed against the following Harmonised Standards:

– EN 61326-1:2013Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements” (Class B emissions, Industrial Immunity)

 

I hope you enjoyed this short dive into standards land. It’s a nice place to visit but you wouldn’t want to live there!

Speak soon,

James

 

ukca mark

Brexit & UKCA Mark Updates

Because of the United Kingdom leaving the EU, the CE Mark will no longer be recognised as demonstrating conformity with UK legislation.

Instead the CE Mark will be replaced by the UKCA mark (UK Conformity Assessed) which will be required to sell your products in the UK. This mark can coexist with the CE mark on the same label.

The transition period starts this coming January 2021 and UKCA marks become mandatory for the UK on 1 Jan 2022.

Whilst it sounds like a year in enough time to get everything in order think back to university and how much time you had to finish your dissertation – am I right? Start sooner rather than later, especially if you have multiple products.

unit 3 compliance ce mark to ukca mark transition

This applies to goods sold (“placed on the market” to use the correct term) in England, Scotland and Wales. Northern Ireland will still require CE marking due to the Irish border.

 

How can we help?

  • Preparation of UK Declaration of Conformity
  • Updating your Technical Documentation to meet the new requirements
  • EMC or safety testing to meet the technical standards required

 

Action Stations for UKCA

You will need to create a new “UK Declaration of Conformity” similar to the EU Declaration of Conformity (which you will still need for CE marking). Contact me if you need a template. If you’ve been a customer and we’ve performed CE marking testing for you then we’ll be sending out UK DoC templates for your products before the end of this year.

The EU Technical Documentation that I’m sure you keep up to date for all your products will need an additional section with references to the UK Statutory Instruments (equivalent to the Directives) and Designated Standards. Let me know if you need some help with this.

Add the UKCA mark to your product label. You can find image files on the gov.uk website. It must be at least 5mm high.

It can be applied as a temporary label until 1 January 2023 after which it must be “permanently attached” in the same fashion as you currently apply the CE mark.

The product, or documentation where this is not possible, must have the manufacturer’s name and UK address shown. If the manufacturer is outside the UK, this must be the importer’s address.

 

UK Manufacturers Selling to EU

You are now a “3rd country” and will need an EU Sales Office (assuming you don’t already have one) whose address and contact details will need to go on the EU Declaration of Conformity. Various companies offer an “EU Authorised Representative Service” which can be found with a little searching.

If you use a UK based Notified Body, they will probably have already been in touch to discuss what is happening with your compliance certification. If not, get in touch with them sharpish and ask about your compliance status.

 

Key Dates

1st January 2021

UKCA becomes valid and can be placed on electrical / electronic products to demonstrate conformity with UK legislation.

CE mark enters transition period but is still valid for 12 months.

This transition period applies if you currently self declare CE compliance using an EU Declaration of Conformity (the vast majority of products do this).

 

1st January 2022

CE mark ceases to be valid in the UK.

UKCA mark becomes mandatory.

 

Legal Eagles

The EU directives relating to CE marking are already UK law. SI 2019 No. 696 will modify the below SIs (and more) to add UKCA marking and change the terminology. All compliance documentation must refer to these Statutory Instruments instead of the EU Directives.

Notified Bodies become Approved Bodies.

Harmonised Standards become Designated Standards and use the BS prefix (e.g. BS EN, BS ETSI EN). No list of Designated Standards is available yet, this is likely going to be published around 1 Jan 2021 where the list gets transposed from existing standards.

Edit: List of Designated Standards is now available on the gov.uk website

Most standards change at a slow pace so we’ll have to wait and see how quickly changes to the IEC, CENELEC and ETSI standards filter through to the UK standards list. Certainly no massive changes in technical requirements will happen overnight.

 

References

Guidance: Placing manufactured goods on the market in Great Britain from 1 January 2021 (Gov.uk)

Guidance: Guidance Using the UKCA mark from 1 January 2021 (Gov.uk)

UKCA information from the clever chaps over at Conformance.co.uk