Changes to the Electromagnetic Compatibility (EMC) Directive€¦ · TÜV SÜD Product Service...

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Presentation by Pete Dorey

Changes to the

Electromagnetic

Compatibility (EMC)

Directive

Contents

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1 What is Electromagnetic Compatibility

(EMC)?

2 EMC Directive Overview

3 New EMC Directive 2014/30/EU

Problems at Home

Television Interference

Radio Interference

Telephone/Telecom

Interference

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Computer crashing

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Coupling Mechanisms

far-field radiated

near-field induced (capacitive or inductive)

conducted

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Contents

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1 Overview of Electromagnetic Compatibility

(EMC)?

2 EMC Directive Overview

3 New EMC Directive 2014/30/EU

EMC Directive 2004/108/EC

EQUIPMENT

APPARATUS FIXED INSTALLATIONS

Any finished appliance or

combination thereof

A particular combination of apparatus used

permanently at pre-defined locations

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The EMC Directive does NOT address safety.

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What is Apparatus?

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Includes ‘Mobile installations’

Mobile installations are defined as a combination of apparatus (and where applicable

other devices) intended to be moved and operated in a range of locations are deemed

to be apparatus. All provisions of the EMC Directive, as defined for

apparatus, apply to mobile installations.

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What is a Fixed Installation?

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EMC Directive Exclusions

• Equipment covered by Directive 1999/5/EC on Radio and telecommunications terminal equipment (R&TTE)

• Aeronautical products as referred to in Regulation (EC) No1592/2002

• Radio equipment used by Radio Amateurs

• Benign equipment (e.g. passive, cables, switches etc.)

• Excluded components (e.g. discrete components, assemblies not intended for the end user)

• Equipment where essential requirements are laid down in other Directives; e.g: Marine Equipment Directive (MED) 96/98/EC Automotive & other Vehicle Directives Medical Device Directives

• Note: Military/Defence/Security equipment is not excluded

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EMC Essential Requirements

• Essential Requirements include the ‘Protection Requirements’ such that Equipment shall be designed and manufactured to ensure that:

• the EM disturbance generated does not exceed the level

above which radio and telecommunications equipment or other equipment cannot operate as intended;

• it has a level of immunity to the EM disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use

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Enforcement

• In the UK the EMC Directive is enforced by OFCOM and Trading

Standards under the UK Regulations SI 2006 No 3418

• The maximum penalty for the supply of non-compliant equipment

is:

• Three months imprisonment and/or

• A £5000 fine

• More normally the manufacturer would be required to recall or

replace any non-compliant apparatus.

• The enforcing authorities have the power to suspend or prohibit

sale of apparatus for which they have reasonable evidence that it

does not comply.

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Contents

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1 Overview of Electromagnetic Compatibility

(EMC)?

2 EMC Directive Overview

3 New EMC Directive 2014/30/EU

New EMC Directive 2014/30/EU

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A new EMC Guide will also be prepared to

explain the details of the new EMC

Directive

Title: Directive 2014/30/EU of the European

Parliament and of the Council of 26 February 2014 on

the harmonisation of the laws of the member states

relating to electromagnetic compatibility

Reason for New EMC Directive

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• Alignment with the New Legislative Framework (NLF)

• EU Decision 768/2008/EC Common Framework for the

Marketing of Products

• EU Regulation EC 765/2008 - Regulation on Accreditation

and Market Surveillance (known as RAMS)

• NLF objectives:

• Improved Market Surveillance – unsafe and non-

compliant products – obligations on Authorities,

Economic Operators

• Accreditation of Notified Bodies – to improve

quality of work

• Establish a common legal framework – align

conformity assessment procedures, definitions and

clarification of CE marking rules

• EMC is one of the Directives being aligned

New EMC Directive – Transitional Period

20 April 2014 20 April 2016

New DoCs for Apparatus

must be issued

Apparatus can still be

Placed on the market

Current EMC Directive

2004/108/EC

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Regulations published

Transposition to new EMC Directive

2014/30/EU

EMC Directive 2004/108/EC

Repealed

New EMC Directive

2014/30/EU

Scope Changes #1

• Second Hand equipment must

comply on first entry to the EU

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• Does not apply to custom built

evaluation kits for professionals

used solely at research &

development facilities

• Applies to distance selling – e.g. Internet

Scope Changes #2

• The new Radio Equipment Directive (RED) 2014/53/EU transposed 13 June 2016 has scope changes affecting EMC Directive: • Broadcast receivers (TV, Radio, Scanner)

move to RED from EMCD • Telecom terminal equipment moves to

EMCD from old R&TTE • Transmitters operating <9kHz move from

EMCD to RED (Tx not used in UK except amateur)

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Who is affected?

• Economic Operators • Manufacturers

• Authorised Representatives

• Importers

• Distributers

• Notified Bodies

• Enforcement Agencies

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Traceability

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• All Economic Operators must on request provide the Market

Surveillance Authorities with records;

• Identity of Economic Operators who have supplied the product

(e.g. manufacturer, importer)

• Identity of Economic Operators who have received the product

(e.g. importer, distributor)

• Records must be held for 10 years

• Does not apply to (non-CE marked) apparatus for Fixed

Installations

Product Labelling

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Manufacturer’s Trade Name/Mark:

Full Postal Address:

Web Address: (recommended but not mandatory)

Product Name/Type:

Batch/Serial Number:

Importer’s Label; Trade Name/Mark:

Full Postal Address:

Other Directives may require further data

Language

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Manufacturer’s Trade Name/Mark:

Full Postal Address:

Web Address: (recommended but not mandatory)

Product Name/Type: Batch/Serial Number:

Importer’s Label; Trade Name/Mark: Full Postal Address:

Other Directives may require further data

Manufacturers

• Product label manufacturer’s trade name/mark, postal

address on product (or if not possible, on packaging/

documentation)

• Provide instructions for use

• On demand provide Market Surveillance Authorities with

technical documentation, traceability of product and action on

non-conforming products

• Shall not place non-conforming products on market or

withdraw, recall if already on market – inform the Market

Surveillance Authorities if a risk with details of non-

compliance where ever the product is available

• Monitor changes to state of the art (i.e. harmonised

standards)

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Authorised Representatives

• Must hold a formal written mandate that authorises them to perform specific tasks

• Tasks cannot include responsibility for design, manufacturing or preparation of technical documentation

• Tasks can include affixing CE marking and drawing up and signing Declaration of Conformity

• As a minimum must hold a copy of the Declaration of Conformity and Technical Documentation for a specified period (10 years)

• On demand provide Market Surveillance Authorities with copies of technical documentation and action on non-conforming products

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Importers

• Product label Importer’s name/mark and postal address in addition to

Manufacturer’s on product (or if not possible, on packaging/documentation)

• Must verify that products are correctly marked and that instructions are in

in appropriate language and technical documentation is in place

• Must hold a copy of the Declaration of Conformity and retain for 10 years

after placing on the market

• On demand provide Market Surveillance Authorities with copies of

technical documentation, traceability of product and action on non-

conforming products

• Shall not place non-conforming products on market or withdraw, recall if

already on market – inform the manufacturer and Market Surveillance

Authorities if a risk

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Distributors

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• Must verify that products are correctly marked and that

instructions are in in appropriate language and Declaration of

Conformity and technical documentation are in place

• On demand provide Market Surveillance Authorities with copies

of technical documentation, traceability of product and action on

non-conforming products

• Shall not place non-conforming products on market or withdraw,

recall if already on market – inform the manufacturer and Market

Surveillance Authorities if a risk

Rebranding - Rebadging

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• Importers & Distributors can be considered manufacturers if

they place apparatus on the market under their own name or

trade mark, or modify apparatus already on the market

Declaration of Conformity

• A single Declaration of Conformity for all directives

– Recital(34) allows a dossier of individual DoCs

• Must follow prescribed model structure Annex IV

– Adds; identification may include a colour image,

– Name, number of Notified Body where used

• Translated into the language required by the Member State

where placed on the market

• The Declaration of Conformity to be “continuously updated” – not

defined but e.g.

– Due to changes in the product design

– Due to changes in the harmonised standards (state of the art)

– Due to change of manufacturer’s details

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Top Tip: If product likely to be in continuous production beyond April

2016, to avoid reissuing DoC list both current and new EMC Directives

Conformity Assessment Procedures

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Annex II – Module A Internal Production Control

– No significant change compared to 2004/108/EC Directive

– Self declaration by the manufacturer

Annex III Part A Module B EU-type examination (by Notified

Body)

Annex III Part B Module C Conformity to type based on

internal production control

Module A Internal Production Control

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Declaration of Conformity

CE Marking

Article 14 Conformity assessment

procedures for apparatus

Annex II Module A

Internal Production Control

EMC assessment &

technical documentation

Manufacturing process & monitoring

Module B - Notified Body

• Notified Body is a conformity assessment body (CAB) and UK

BIS policy requires an accreditation certificate issued by national

accreditation body (UKAS)

• Manufacturer selects a single Notified Body (within EU, or EFTA

(Norway) or MRA (Australia, USA, Switzerland, New Zealand) –

listed in NANDO database

• No Notified Body number required for CE marking as no

involvement in production control, but name & number required

on Declaration of Conformity

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Module B/C EU-Type Examination

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Article 14 Conformity assessment procedures for apparatus

Annex III Module B

EU-type examination

(Notified Body)

Manufacturer’s application

(technical documentation)

Notified Body evaluates

technical design /

technical documentation,

evaluation report & EU-type

examination certificate

Annex III Module C

Internal Production Control

(Manufacturer)

Manufacturing process

& monitoring

Declaration of Conformity

CE Marking

EU-type examination certificate

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(Notified Body & Number)

Manufacturer’s name & address

Identification of approved type

Conclusions of the examination

Essential requirements covered by the

examination (emission and/or immunity)

Conditions for validity

Annexes if required

Notified Body Ongoing Duties

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• Notified Body monitors conformity; – Changes to state of the art (i.e. harmonised standards)

– Manufacturer informs Notified Body of product modifications

– Notified Body asks manufacturer for corrective actions if product becomes non-

conforming, otherwise suspend or withdraw certificate

• Notified Body informs Notifying Authority of; – Certificates issued or withdrawn

– On request - Refusal, restriction, suspension or withdrawal of certificates

– Change to their notified scope or status

– Subcontracting

– Requests for information by Market Surveillance Authorities

• Notified Body informs other Notified Bodies for the

same product of; • Refusal, restriction, suspension or withdrawal of a certificate

and on request, positive assessments and additions

• What is Electromagnetic Compatibility (EMC)?

• EMC Directive Overview

• New EMC Directive 2014/30/EU

Summary

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• Notified Body Assessment

• Technical Documentation Compilation

• Technical Documentation Review

• Guidance in conducting an EMC Assessment

• Guidance in applying good EMC engineering

practices in Fixed Installations

• Technical training, briefings and support for

suppliers of rail infrastructure

• United Kingdom Accreditation Service (UKAS)

accredited test laboratory for testing both at

permanent premises and in-situ

• Radio Frequency (RF) and Low Frequency (LF) electromagnetic

field surveys

• Power Quality measurements

TÜV SÜD EMC Services

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Training Courses

• EMC Design - 3 days

• EMC Compliance of Military & Avionics Equipment - 1 day

• RF & Microwave Radiation Safety Course - 2 days

Keep up-to-date

http://www.tuv-sud.co.uk/uk-en/activity/training

http://www.tuv-sud.co.uk/uk-en/activity/webinars

Additional Training Courses and Webinars

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Pete Dorey

Tel: 01489 558211

Email: peter.dorey@tuv-sud.co.uk

www.tuv-sud.co.uk

Questions?

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