EMC Regulatory Requirements: What you

need to know for the EU, EAEU & Australia

Dr Alex MartinC&R Webinar, 29 May 2018

Agenda

• What is EMC?

• Why has EMC legislation been introduced?

• The 2014 EU EMC Directive.

• The 2011 EAEU EMC Technical Regulation.

• The 2017 Australian Radiocommunications Labelling (EMC) Notice.

• Conclusion.

RINA Overview

• Originally established in 1861, RINA is an Italian-owned business active across

testing, inspection and certification as well as in engineering consultancy.

• In recent years it has grown through acquisitions, including Edif ERA (ERA

Technology Ltd) in 2016.

• As of 2018, RINA has a global network of 3,700 professionals across 65

countries.

• At Leatherhead in the UK, RINA’s Industry service includes consultancy on

technical and environmental regulation affecting electrical and electronic

equipment.

Product Regulatory Compliance

Support with product-related requirements, including:

Circular Economy

Global

Market Access

Chemicals

Responsible

Sourcing

What is EMC and why are

there laws related to it?

IEC Definition of EMC

“the ability of equipment or a system to function satisfactorily

in its electromagnetic environment without introducing

intolerable electromagnetic disturbance to anything in that

environment”

IEC Definition of the EME

“the totality of EM phenomena existing at a given location”

• Any electrical or electronic device creates an electromagnetic environment as

electrons are moved around to make the device work.

• Natural phenomena may also occur in the same location, e.g. lightning.

• In addition, electrostatic discharge can take place even when a device or

system is not in its normal functioning mode.

Additional Terms

• Emission: the generation and release into the environment of electromagnetic

energy by a specified source, whether deliberate or accidental.

• Susceptibility: the tendency of electrical equipment (“the victim”) to

malfunction or break down in the presence of unwanted emissions –

electromagnetic interference.

• Immunity: the opposite of susceptibility, meaning the ability of electrical

equipment to function correctly in the presence of electromagnetic interference

(it is “hardened” to it).

• Coupling: the means (pathways) by which emitted interference reaches the

victim.

Key Points

• EMC is the control of electromagnetic interference so that unwanted effects are

prevented.

• Different legislatures around the world have adopted EMC laws in light of

recognising the risks posed by electromagnetic interference; the intent of the

legislation is to reduce the risks such that they are tolerable (it is unlikely the

risks will ever be completely eliminated).

• The laws vary, but generally entail characterising the threat before specifying

requirements regarding emissions and susceptibility/immunity.

• For equipment manufacturers, regulatory compliance is likely to entail one or

more of: quietening noise; inhibiting coupling paths; and hardening potential

victims (e.g. via use of grounding/shielding).

The EU EMC Directive (2014/30/EU)

Scope and Definitions

• The Directive applies to “equipment” meaning “apparatus” and “fixed

installations”.

• The law applies when equipment is both placed on the market and put into

service.

• There are exclusions, including for radio equipment, aeronautical products,

“inherently benign” equipment, and custom built evaluation kits.

• As a law aligned with the New Legislative Framework, the Directive specifies

obligations for various “economic operators”:

• Manufacturers;

• Authorised Representatives;

• Importers;

• Distributers.

Essential Requirements

• There are general and specific essential requirements.

• The general requirements are that equipment is to be designed and

manufactured so that:

• The electromagnetic disturbance generated does not exceed the level

above which radio and telecommunications equipment or other

equipment cannot operate as intended; and

• It has a level of immunity to the electromagnetic disturbance to be

expected in its intended use which allows it to operate without

unacceptable degradation of its intended use.

• More specifically, fixed installations are to be “installed applying good

engineering practices and respecting the information on the intended use of its

components, with a view to meeting the [general] essential requirements”.

The Presumption of Conformity

• The Directive offers a presumption of conformity meaning that if in-scope

equipment adheres to relevant harmonised standards (EN standards) then the

equipment will be considered in compliance with essential requirements.

• There are a large number of harmonised standards, the listing of which is found

on the European Commission’s EMC webpages (DG GROW, Single Market).

• The listing pertains to product groups, e.g.

• EN 61326-1 Electrical equipment for measurement, control and

laboratory use – EMC requirements – Part 1: General requirements;

• EN 61326-2-1 Electrical equipment for measurement, control and

laboratory use – EMC requirements – Part 2-1: Particular requirements

– Test configurations, operational conditions and performance criteria for

sensitive test and measurement equipment for EMC unprotected

applications.

Manufacturer Obligations

• Carry out relevant conformity assessment procedure.

• Draw up technical documentation: (a) general description, (b) conceptual

design and manufacturing drawings, (c) relevant descriptions and explanations,

(d) list of harmonised standards applied, (e) results of design calculations, and

(f) test reports. Plus “an adequate analysis and assessment of the risk(s)”.

• Draw up a Declaration of Conformity.

• Affix the CE marking.

• Provide for traceability.

• Keep a register of non-conforming equipment and product recalls.

• Be prepared to take corrective actions.

European Commission Guide to the

EMC Directive

Section 2010 2018

Scope Guidance divided between three sub-

sections: general, defining the scope of

apparatus, and defining the scope of

fixed installations.

New guidance related to placing on the

market/putting into service, equipment and

products. Jammers case study is also new.

Essential

requirements

Presents an overview of mandatory

requirements.

Also presents an overview of mandatory

requirements.

Economic operator

obligations

Not present. Newly introduced in light of the Directive now

referring to such obligations.

Apparatus

conformity

assessment

procedure

Gives information including the usual

steps of an EMC assessment,

information and documentation

requirements.

Largely the same content, although new

guidance is introduced pertaining to risk

analyses and assessment. Similarly,

“information on identification” is new.

Fixed installations Guidance spans relevant requirements

and documentation. Comment also

made on the use of apparatus in fixed

installations.

No change from 2010.

Market

surveillance

Gives information on the duties of

authorities; specific comment regarding

the use of apparatus at trade fairs.

Very similar to 2010, although the use of

apparatus at trade fairs comment is removed.

The EAEU EMC Technical

Regulation (TR CU 020/2011)

Scope and Definitions

• The Regulation applies to “technical means that can cause electromagnetic

interference, and/or quality of operation which depends on the influence of

external electromagnetic interference”. The application pertains to making

technical means “available for circulation”.

• “Technical means” is “any electrical, electronic and radio-electronic product, as

well as any products containing electrical and/or electronic components, which

can be categorized as a component unit and installation”.

• Like the EU EMC Directive, there are exclusions, e.g. for technical means

“passive with respect to electromagnetic compatibility”. Annex 1 gives a list.

• Obligations fall upon manufacturers, authorised representatives and importers.

No obligations fall upon distributors, however.

EMC Requirements

• The law requires that technical means should be designed and manufactured in

such a way that:

• Any electromagnetic interference generated does not affect

communications and other equipment;

• Equipment has a level of immunity to electromagnetic interference

(noise) such that it can operate in the electromagnetic environment as

intended.

• Annex 2 of the Regulation lists types of electromagnetic interference spanning

the likes of low-frequency conductive electromagnetic interference (e.g. power

supply voltage fluctuation) through to electrostatic discharges.

• The EMC requirements are to be met either “directly” or through use of

standards, which is voluntary. Relevant standards are listed in the Regulation;

they are mainly GOST R versions of CISPR/IEC standards.

Manufacturer Obligations - 1

• Carry out relevant conformity assessment procedure. This is not a matter of

self-certification but entails working with an EAEU accredited test house and

obtaining either an EAC Declaration or Certificate of Conformity.

• Obtaining a Certificate is mandatory in the case of household appliances,

personal computers and peripherals, electric tools and electronic musical

instruments. The process is likely to entail submission of internal audit reports

and test reports while copies of the required “operational documents” will be

expected. Third party factory audit and sample testing of equipment may be

expected too.

• Applicants for either an EAC Declaration or Certificate of Conformity must be a

legal entity registered in an EAEU Member State (RU, AM, BY, KZ, KGZ).

Manufacturer Obligations - 2

• Affix the EAC marking to the equipment, maybe also on packaging and in

instructions.

• Label the equipment with a name and/or designation (e.g. type, brand, model);

its main features and characteristics; the name of the manufacturer; and the

name of the country of manufacture. This information is also to go in

accompanying “operational documents”.

• Label the equipment packaging with the manufacturer’s name and/or trademark

as well as the equipment name and/or designation (type, brand, model, etc.).

• Provide accompanying operational documents that, in addition to equipment

designation/manufacturer information, give information on: installation; safe use

and any usage restrictions; relevant storage, delivery, marketing and disposal

requirements; location, month and year of manufacture; how to determine the

year of manufacture.

• Operational documents must be hard (paper) copies and in Russian and other,

relevant EAEU Member State languages.

The Australian Radiocommunications

Labelling (EMC) Notice 2017

Scope and Definitions

• The Notice applies to “devices” [undefined] that pose a risk of causing an

interference impact on other devices that use the radiofrequency spectrum.

Devices are of high, medium or low risk.

• High-risk refers to Group 2 ISM equipment that entails the intentional

use of electromagnetic radiation for the treatment of material, e.g. a

microwave oven.

• Medium-risk may have an interference impact “if operated in

contravention of an applicable standard”, e.g. DECT device.

• Low-risk, as medium-risk but the interference impact is “low”, e.g. a

garage door control.

• Requirements apply when devices are “supplied”. Supply is broadly defined and

can include the lending of a device to another person.

• Obligations fall upon suppliers, meaning Australian based device importers

and/or manufacturers (or their authorised representatives, “agents”).

Supplier Requirements (medium- to

high-risk devices)

• Register with the regulatory authority, ACMA.

• Prepare compliance records. These span the following:

• A method of uniquely identifying the device (brochure, manual, etc.);

• A signed Australian Supplier’s Declaration of Conformity;

• A complete copy of an EMC test report to the relevant standard, in

English;

• A technical construction file [defined in the Notice].

• Affix the Regulatory Compliance Mark (RCM) to the device.

• Significantly, EMC standards are mandatory although ACMA does not specify

which of these standards must be used for any given device – it is up to the

supplier to choose, likely in tandem with a test house (the supplier should be

able to justify their choice).

In Conclusion

Same Risk, Different Regulatory

Requirements

• Countries may work together on international standards regarding EMC, but

regional/national regulatory regimes can and do differ:

• Standards are normally voluntary but can be mandatory while some

may additionally confer a presumption of conformity when used;

• Conformity assessment may be via self-certification or necessitate using

a suitably accredited certification body (test house);

• Business registration may be a necessity;

• Different compliance markings arise, etc. etc.

• It is important to research and understand the EMC (plus product safety and

environmental) legislation that applies in all the countries that you distribute and

sell in. If not technically, then administratively requirements differ. Do not

assume that, for example, an EU Declaration of Conformity and supporting

technical documentation will be accepted elsewhere in the world.

Sources & Further Information

• RINA Product Regulatory Compliance Team.

• Compliance & Risks – C2P.

• European Commission (DG GROW).

• Eurasian Economic Commission (Technical Regulation & Accreditation

Department).

• Australian Communications and Media Authority.

Electrical & Electronic Equipment

and the Environment

• ---

14-15 November 2018, Heathrow

Dr Alex Martin

Product Regulatory Compliance

+44 (0)1372 367032

alex.martin@rina.org

- Meeting the technical and regulatory

compliance challenges