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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
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