Upload
leduong
View
218
Download
3
Embed Size (px)
Citation preview
TÜV SÜD Product Service Slide 1
Presentation by Pete Dorey
Changes to the
Electromagnetic
Compatibility (EMC)
Directive
Contents
TÜV SÜD Product Service Slide 2
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
3
Computer crashing
TÜV SÜD Product Service Slide 3
Coupling Mechanisms
far-field radiated
near-field induced (capacitive or inductive)
conducted
TÜV SÜD Product Service Slide 4
Contents
TÜV SÜD Product Service Slide 5
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
6
The EMC Directive does NOT address safety.
TÜV SÜD Product Service Slide 6
What is Apparatus?
7 TÜV SÜD Product Service Slide 7
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.
8 TÜV SÜD Product Service Slide 8
What is a Fixed Installation?
9 TÜV SÜD Product Service Slide 9
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
TÜV SÜD Product Service Slide 10
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
11 TÜV SÜD Product Service Slide 11
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.
12 TÜV SÜD Product Service Slide 12
Contents
TÜV SÜD Product Service Slide 13
1 Overview of Electromagnetic Compatibility
(EMC)?
2 EMC Directive Overview
3 New EMC Directive 2014/30/EU
New EMC Directive 2014/30/EU
14
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
15
• 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
16
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
17
• 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)
18
Who is affected?
• Economic Operators • Manufacturers
• Authorised Representatives
• Importers
• Distributers
• Notified Bodies
• Enforcement Agencies
19
Traceability
TÜV SÜD Product Service Slide 20
• 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
TÜV SÜD Product Service Slide 21
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
TÜV SÜD Product Service Slide 22
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)
23
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
24
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
25
Distributors
26
• 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
TÜV SÜD Product Service Slide 27
• 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
28
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
TÜV SÜD Product Service Slide 29
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
TÜV SÜD Product Service Slide 30
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
31
Module B/C EU-Type Examination
TÜV SÜD Product Service Slide 32
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
TÜV SÜD Product Service Slide 33
(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
TÜV SÜD Product Service Slide 34
• 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
35 TÜV SÜD Product Service Slide 35
• 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
36 TÜV SÜD Product Service Slide 36
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
37 TÜV SÜD Product Service Slide 37
Pete Dorey
Tel: 01489 558211
Email: [email protected]
www.tuv-sud.co.uk
Questions?
38 TÜV SÜD Product Service Slide 38