Source: https://www.scribd.com/document/377502833/Emc-Guide-2018-03-Final
Timestamp: 2018-11-18 03:48:20
Document Index: 261860503

Matched Legal Cases: ['art 6', 'ART 1', 'ART 2', 'ART 3', 'ART 4', 'ART 5', 'ART 6', 'art 1', 'art 2', 'art 2', 'art 3', 'art 3', 'art 4', 'art. 3', 'art 5', 'art 51', 'art 6']

Emc Guide 2018-03 Final | Electromagnetic Compatibility | European Union
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1 SCOPE ................................................................................................................... 8
1.1 General ........................................................................................................... 8
1.2 Geographic Application ............................................................................... 10
1.2.1 Application in non-EU States, countries & territories ......................... 10
1.2.2 Mutual Recognition Agreements (MRAs) ........................................... 10
1.2.3 Agreements on Conformity Assessment and Acceptance (ACAAs) ... 11
1.3 Placing on the market/putting into service................................................... 11
1.3.1 Placing on the market........................................................................... 11
1.3.2 Putting into service .............................................................................. 12
1.3.3 Special measures regarding equipment at trade fairs, etc .................... 12
1.4 Equipment and products .............................................................................. 12
1.4.1 Equipment without electrical and/or electronic parts .......................... 12
1.4.2 Explicit exclusions from the EMCD .................................................... 13
1.4.4 Inherently benign equipment ............................................................... 15
1.4.5 Custom built evaluation kits ................................................................ 17
1.4.6 Classification as apparatus or fixed installation................................... 18
1.5 Defining the scope of apparatus ................................................................... 19
1.5.1 Finished appliances .............................................................................. 21
1.5.2 Combination of finished products ........................................................ 21
1.5.3 Components/Sub-assemblies ............................................................... 22
1.5.4 Mobile installations.............................................................................. 23
1.6 Defining the scope for fixed installations .................................................... 23
1.6.1 Fixed installations ................................................................................ 23
1.6.2 Specific apparatus for fixed installations ............................................. 25
1.7 Specific Case: Jammers ............................................................................... 25
2 ESSENTIAL REQUIREMENTS ........................................................................ 25
3 OBLIGATIONS OF ECONOMIC OPERATORS .............................................. 26
4 CONFORMITY ASSESSMENT PROCEDURE FOR APPARATUS............... 26
4.1 Introduction .................................................................................................. 26
4.2 Risk analyses and risk assessment ............................................................... 29
4.3 EMC Assessment ......................................................................................... 29
4.3.1 General Concept ......................................................................................... 29
4.3.3 An EMC assessment where no harmonised standards have been applied .. 34
4.4 Documentation required by the EMCD ....................................................... 36
4.4.1 Technical documentation ..................................................................... 36
4.4.2 EU Declaration of Conformity............................................................. 38
4.5 CE Marking and information ....................................................................... 39
4.5.1 CE marking .......................................................................................... 39
4.5.2 Information on indentification ............................................................. 40
4.5.3 Information for traceability .................................................................. 40
4.5.4 Information concerning the use of apparatus ....................................... 40
4.5.5 Information when compliance is not ensured with essential
requirements in residential areas .......................................................................... 41
5 FIXED INSTALLATIONS ................................................................................. 42
5.1 Essential Requirements ................................................................................ 42
5.2 Documentation ............................................................................................. 44
5.3 Responsible person for fixed installations ................................................... 45
5.4 Requirements for specific apparatus for given fixed installations ............... 45
5.4.1. Obligations when the exemption clause is used for specific apparatus ..... 45
6 MARKET SURVEILLANCE OF THE EMCD .................................................. 46
7 NOTIFIED BODIES............................................................................................ 46
7.1 Introduction .................................................................................................. 46
7.2 Subcontracting ............................................................................................. 49
7.3 Information exchange .................................................................................. 49
7.4 Coordination between Notified Bodies ........................................................ 49
7.5 Complaints regarding the service provided by NB ...................................... 49
ANNEX 1 –.................................................................................................................. 51
Flowchart 6 - Overall flowchart ............................................................................... 51
ANNEX 2 - Guidance on using a harmonised standard .............................................. 52
ANNEX 3 - EMC assessment where harmonised standards do not exist or are not
fully (applied)............................................................................................................... 54
ANNEX 4 - Application of Directives 2014/53/EU, 2014/35/EU and 2014/30/EU ... 60
ANNEX 5 - Acronyms and abbreviations ................................................................... 63
ANNEX 6 - Organisations and Committees ................................................................ 66
FLOWCHART 1 – SCOPE ...................................................................................................................... 9
FLOWCHART 2 - CLASSIFICATION AS APPARATUS .................................................................. 19
FLOWCHART 3 - PROVISIONS APPLICABLE TO APPARATUS .................................................. 21
FLOWCHART 4 - INSTALLATIONS .................................................................................................. 25
FLOWCHART 5 - CONFORMITY ASSESSMENT PROCEDURE FOR APPARATUS ................... 28
FLOWCHART 6 - OVERALL FLOWCHART ..................................................................................... 51
complete. sometimes refers to external information over which the Commission has no control and for which the Commission assumes no responsibility. reached by consensus amongst Member States and other stakeholders. even if the word 'shall' is used in many parts of this Guide. is not necessarily comprehensive. accurate or up-to-date. they explain and clarify some of the most important aspects related to its application. the provisions of the EMCD prevail. Errors brought to the Commission’s attention. will be corrected. This Guide will be reviewed periodically to be kept up to date.Disclaimer These guidelines are intended to be a manual for all parties directly or indirectly affected by the “new” Electromagnetic Compatibility Directive 2014/30/EU (EMCD). The Guide is also intended to ensure the free movement of products in the EU Internal Market by agreement of these explanations and clarifications. Reference is therefore made. . does not constitute legal advice. is of a general nature only and is not intended to address the specific circumstances of any particular individual or entity. whenever necessary but not always. A product only benefits from the free circulation in the Union market if the product complies with the provisions of all the applicable Union legislation. the Commission accepts no responsibility or liability whatsoever with regard to the information in this Guide. . . This Guide is publicly available but is not binding in the sense of a legal act adopted by any of the EU institutions. The information: . They assist in the interpretation of the Directive but do not substitute for it. attention is drawn to the fact that all references to the CE marking and EU Declaration of Conformity relate to the EMCD only. Finally. In the event of any inconsistency between the provisions of the EMCD and this Guide. to other EU legal acts. 5 . However. The European Commission undertakes to maintain this Guide to ensure that the information is accurate and up to date.
2. Article 3(1)(1) 3 For the geographical application of the EMCD.to guarantee the free movement of equipment2 and to create an acceptable electromagnetic environment in the Union territory3. as compared to the old EMCD (Directive 2004/108/EC). Also in 2014. 1 The Blue Guide is the main reference document explaining how to implement the legislation based on the New Approach.europa. INTRODUCTION This Guide should always be read in conjunction with the 'Blue Guide' on the implementation of EU product rules1. In order to achieve this objective. subject to one year transitional period (ended on 12 June 2017). After 2010. It maintains the same objectives . The NLF is a flexible regulatory framework for the marketing of products. see section 1.eu/growth/single-market/goods/index_en. provisions have been put in place so that:  equipment shall comply with the requirements of the EMCD when it is made available on the market and/or put into service when properly installed. The EMCD is applicable as of 20 April 2016. The main objective of the EMCD is thus to regulate the electromagnetic compatibility of equipment. initiate an evaluation if non-compliances are established. The new EMCD (Directive 2014/30/EU) repeals and replaces the old EMCD (Directive 2004/108/EC). when appropriate. now covered by the New Legislative Framework. The purpose of this Guide is to give guidance on certain matters and procedures of the EMCD.htm 2 “equipment’ means any apparatus or fixed installation c.  the application of good engineering practice is required for fixed installations. relate with the alignment with the new legislative framework. with the possibility for the competent authorities of Member States to request evidence of compliance of the fixed installation. 6 . In 2014 a set of Directives (including the new EMCD and the new LVD) were aligned according to the NLF. Standardisation Regulation (EU) No 1025/2012 and Article 291 of the TFEU (Implementing Acts). maintained and used for its intended purpose. the Radio Equipment Directive (RED) entered into force and is applicable as of 13 June 2016. the Blue Guide was updated to the NLF. The latest version of the Blue Guide can be found via http://ec. The main changes in the new EMCD (Directive 2014/30/EU). and.
The essential requirements have not been modified and therefore the substance of the
harmonised standards for apparatus is not affected due to the new EMCD.
The scope remains mainly the same, compared to the old EMCD. The new EMCD
introduces only a new exception on Custom built evaluation kits (see section 1.4.5).
However, the scope of the EMCD has been indirectly affected and modified due to
the new RED, which has repealed and replaced the R&TTED 4 . The new RED,
compared to the R&TTED, has introduced some modifications (for more details, see
section 1.4.2.1 and Annex 4 of this Guide). As a result, equipment that was covered
by the R&TTED, but is not covered by the RED, is no longer excluded from the
EMCD and equipment which was not covered by the R&TTED, but it is covered by
the RED, is now excluded from the EMCD.
This Guide has been structured in a logical way suitable for users who need to ensure
that their equipment complies with the EMCD. It is divided into the following
1. Scope: allows economic operators to quickly decide whether their equipment
falls under the scope of the EMCD and if so, if it is apparatus or a fixed
4. Conformity assessment procedure for apparatus: gives information
including: the steps of an EMC assessment; information and documentation
requirements; EU Declaration of Conformity and CE marking. More detailed
guidance is provided for an EMC assessment where harmonised standards are
not used or do not cover all essential requirements.
5. Procedures for fixed installations: on the relevant requirements and
documentation needed for fixed installations, including the use of apparatus
specifically for incorporation into a particular fixed installation.
6. Market surveillance: relates to the duties of the national authorities ensuring
only compliant apparatus circulates in the Union.
7. Notified Bodies: their role, selection, coordination and the treatment of
Article 48 of the RED provides for a transitional period of one year.
The EMCD applies to a vast range of equipment encompassing electrical
The main objective of the EMCD is to guarantee the free movement of
equipment and to create an acceptable electromagnetic environment whilst
ensuring that equipment will function as intended in that environment. In
order to achieve it, a harmonised and acceptable level of protection is
required by the Directive, based on Article 114 of the TFEU, leading to
full harmonisation in the Union.
The level of protection required is further specified in the EMCD by
protection aims in the field of electromagnetic compatibility as defined in
Annex I of the EMCD.
Obviously, the goal of the essential requirements is not to guarantee
absolute protection of equipment (e.g. zero emission level or total
immunity). These requirements accommodate both physical facts and
practical reasons. To ensure that this process remains open to future
technical developments, the EMCD only describes the essential
requirements along general lines.
Essential requirements include both general requirements for equipment as
well as specific requirements for fixed installations.
When compliant with the provisions of the EMCD, equipment may be
made available on the market and/or put into service in the Union territory
and operated as designed and intended in the expected electromagnetic
The EMCD does not regulate the safety of equipment in respect of people,
domestic animals or property5. According to Article 1, the EMCD covers
exclusively the electromagnetic compatibility of equipment. However, it
should be noted that other directives may require higher requirements for
EMC phenomena in order to satisfy their specific safety provisions.
The EMCD is therefore not a safety related Directive.
Functional safety aspects based on electromagnetic disturbances are
regulated for instance by the Machinery Directive 2006/42/EC, the Low
Voltage Directive 2014/35/EU and the General Product Safety Directive
2001/95/EC.
c. Article 2(4)
In order that the reader may easily decide whether an equipment falls
under the scope of the Directive, and the procedures that are to be applied,
a series or decision flow-charts have been incorporated into the Guide.
Flowchart 1 deals with the first step in this process.
Contains electrical/
Product families excluded
from EMCDexcluded
yes (*) (*)EMC Directive ceases
apply for requirements laid
no down more specifically by
other Direct ives
A To flow-chart 2
before deciding if it relates with the EMCD.2002. Annex 1. 7 is a comprehensive agreement.2 Geographic Application 1.MRA) of the Blue Guide and the relevant Commission’s website6. In cases where the manufacturer is not established within the territory of either the European Union or Switzerland. and Norway) and Turkey. which entered into force on 1 June 2002. Therefore. the relevant Swiss legislation is adapted to the EMCD. it shall be sufficient to indicate the name. 1. “Union”. it shall be sufficient to indicate the name. they apply to the EEA-EFTA States (Liechtenstein. 369. and Norway) and Turkey. when the terms “European Union”. 6 List of mutual recognition agreements 7 OJ L 114.2 Mutual Recognition Agreements (MRAs) MRAs are agreements established between the Union and the third countries for the purpose of mutual recognition of conformity assessment of regulated products.4. 1. 10 . Iceland. The most important adaptations which relate with the obligations of the economic operators are the following: (a) for the purpose of the obligations in Article 7(6) and 9(3) of the EMCD and the corresponding Swiss provisions. Iceland. countries & territories The geographical application is described in Chapter 2.2.2 (Mutual Recognition Agreements .8 "geographical application" of the Blue Guide. Specific information on MRAs may be found in Chapter 9. registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted. It is noted that it depends on the scope of each MRA. of the Agreement as amended by Decision No 1/2017 of the Committee established under the Agreement contains adaptations on the EMCD. The EMCD and this Guide shall be read in conjunction with the adaptations in the MRA. MRA with Switzerland The MRA concluded with Switzerland.2. 30. The EMCD also applies in the EEA-EFTA States (Liechtenstein. “territory” or 'Member States' are used in this Guide. In addition.1 Application in non-EU States. Chapter 9. p. registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted.
and whether it was manufactured as an individual unit or in series. 1. (b) for the purpose of the obligations in Article 7(3) and 9(7) of the EMCD and the corresponding Swiss provisions. it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keep the technical documentation and the EU declaration of conformity for 10 years after the equipment has been placed on the market in either the European Union or Switzerland.1 Placing on the market The EMCD applies to equipment placed on the market and then to any subsequent operation which constitutes making available until it reaches the end-user. (c) for the purpose of the obligation in Article 8(2) of the EMCD and the corresponding Swiss provisions. When equipment is constructed for own use or bought by a consumer in a third country while physically present in that country and brought by the 11 .3.3 Agreements on Conformity Assessment and Acceptance (ACAAs) Agreements on Conformity Assessment and acceptance of industrial products are intended to be established between the Union and the government of EU Neighbouring countries (for more details see Chapter 9.3 Placing on the market/putting into service 1. 1. Equipment shall comply with the legal requirements that were in place at the time of its placing on the market. In case the manufacturer is not established within the territory of either the European Union or Switzerland. A product is placed on the market when it is made available for the first time on the Union market. Placing on the market refers to each individual product.1 "Agreements on Conformity Assessment and Acceptance" of the Blue Guide).2. not to a type of product. it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request for 10 years after the equipment has been placed on the market in either the European Union or Switzerland. authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 8 (1) of the EMCD or the corresponding Swiss provisions.
1.and that equipment is not compliant with that other legislation.3 "Placing on the market" of the Blue Guide.3 of the Directive contains the following details on the conditions applicable at trade fairs. 2. to be put into service. exhibitions or demonstrations. On the other hand.1.6 of this Guide. For the special case concerning fixed installations. see Section 1. see Chapters 2. Article 5.2 and 2.4.regulating other aspects (other than EMC aspects) . equipment can be prohibited if it falls also within the scope of another legislation .3 Special measures regarding equipment at trade fairs. Therefore.3 of the Blue Guide. it is not considered to be placed on the market. consumer into the EU for the personal use of that person.3. if it is not compliant with the EMCD. placing on the market is considered not to take place where a product is displayed or operated under controlled conditions at trade fairs.1 Equipment without electrical and/or electronic parts Equipment which does not contain electrical and/or electronic parts will not generate electromagnetic disturbances and its normal operation is not 12 . However the provisions relating to the obligations of the economic operators (Chapter 2 of the EMCD) refer only to equipment placed on the market and made available on the market.3. exhibitions or demonstrations: a) a visible sign clearly indicates that such equipment may not be made available on the market and/or put into service until it has been brought into conformity with this Directive. 1. 1.2 Putting into service Articles 4 and 5 of the Directive refer also to putting into service. and b) demonstration may only take place provided that adequate measures have been taken to avoid electromagnetic disturbances. etc According to Chapter 2. Member States shall allow the putting into service and use of equipment if it complies with the EMCD and shall not allow equipment which was placed on the market.4 Equipment and products 1. For details on the placing on the market and making available on the market.
This means that the essential requirements in the EMCD are obligatory for that radio equipment.b. For further detailed explanation. applies to: . does not apply to pure wired telecom terminal equipment. Under Article 50 of the RED. and repealing Council Directive 91/670/EEC.2. Regulation (EC) No 1592/2002 and Directive 13 .pure radio sound and radio TV receive-only equipment. reference to the EMCD shall not be made in the EU Declaration of Conformity of a radio product under the R&TTED and now the RED. 1. Consequently. radio equipment falling under the scope of R&TTED and now the RED does not fall under the scope of the EMCD (Article 2. 1. references to the R&TTED shall be construed as references to the RED. the R&TTED has been replaced by the RED8. parts and appliances as referred to in Regulation (EC) No 216/20089 (as amended) are excluded from the EMCD. -equipment operating below 9 kHz. compared to the R&TTED. Radio-determination equipment is now clearly included within the scope of the RED.a).1 Radio equipment According to Article 2(2)(a) of the EMCD. However. The RED. affected by such disturbances.4.2. equipment without electrical and/or electronic parts is not in the scope of the EMCD. As of 13 June 2017.2 Aeronautical products According to Article 2.2. and include EMC essential requirements identical to those of the EMCD.4.2 Explicit exclusions from the EMCD The EMCD excludes the following types of equipment: 1. Hence. see Annex 4 and any guidance on RED published on the website of the European Commission. The RED covers most radio equipment. compared to the R&TTED. Aeronautical products. equipment within the scope of the R&TTED is excluded from the EMCD. The RED.4. 8 Article 48 of the RED provides for one year transitional period. Therefore the exclusion in Article 2(2)(a) of the EMCD shall be construed as any equipment falling within the scope of the RED. which intentionally emits and/or receives radio waves for the purpose of radio communication.2. 9 Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency.
The following list contains examples of equipment excluded for both emission and immunity purposes from the EMCD: . 11 Detailed information may be found in the RED Guide.2. Equipment brought to the market as spare parts which is obviously identified as a spare part by an identification number and is identical and from the same manufacturer as the corresponding original equipment manufacturer (OEM) part for an already type-approved vehicle (see Paragraph 3.10 is made available on the market (including cases where the intended use is for radio amateurs) then it is covered by the RED (see Annex I of the RED).8 of UNECE Regulation 10). 14 .4. as defined in the RED. Motor vehicles equipment: Regulation (EC) 661/2009. to that equipment in respect of such requirements from the date of implementation of that Union legislation.11 1. Equipment sold as aftermarket equipment.2015/0277 (COD).1 of UNECE Regulation 10) and if it is related to 2004/36/EC.c) radio equipment used by radio amateurs within the meaning of the Radio Regulations adopted in the framework of the Constitution of the International Telecommunication Union and the Convention of the International Telecommunication Union (unless if the equipment is made available on the market). 1.2. C. In any case if radio equipment. or shall cease to apply.3 Radio equipment intended for use by radio amateurs The EMCD excludes (Article 2. (UNECE Regulation 10). Hence the following are totally excluded from the scope of the EMCD: A. there is a proposal to replace this regulation: COM/2015/0613 final .2. 10 Radio equipment used by radio amateurs would normally satisfy the definition of 'Radio Equipment' in Article 2 of the RED. as amended. Vehicle and equipment subject to type approval under UNECE Regulation 10. B.4. the EMCD shall not apply. if within the scope of UNECE Regulation (see diagram in Paragraph 3. if the EMC requirements for equipment are wholly or partly laid down more specifically by other Union legislation.2.3 Equipment covered by other specific Union legislation According to Article 2(3) of the EMCD.
2. as amended.europa.2. 146.4. 1. Until 18 September 2016. 18.2014. 21.3. Covered by Directive 2014/32/EU16 – Non-automatic weighing instruments: Covered by Directive 2014/31/EU 17.9 of UNECE Regulation 10. – Two or three-wheel motor vehicles within scope of Regulation 168/201315.12 and 3.2. needs a DoC under the EMCD.2014 15 OJ No L 60. 14 OJ L 60.eu/growth/sectors/medical-devices/regulatory-framework_en 13 OJ L 257. OJ L 364.2014. – Agricultural and forestry tractors covered by Regulation (EU) No 167/201314. It is noted that equipment. 29.2014.2013. 29. p.8.1. OJ No L 53.4 Inherently benign equipment Equipment which is inherently benign in terms of electromagnetic compatibility is excluded from the scope of the EMCD18.3. amended by Commission Delegated Regulation (EU) No 134/2014. 7.2015 17 OJ L 96. intended for the installation in motor vehicles and is not related to immunity related functions (see paragraphs 2. The following are examples of equipment excluded for immunity purposes only from the EMCD: – Measuring instruments. -Medical devices (including Active implantable Medical Devices and In vitro Diagnostic Medical Devices) covered by the relevant applicable EU legislation on Medical Devices12. covered by Directive 2009/23/EC. this DoC shall refer to the EMCD as well as to the provisions stipulated in Paragraph 3.9 of UNECE Regulation 10). p.2.12. 107. 12 The regulatory framework on medical devices can be found at: https://ec. – Marine equipment: Covered by Directive 2014/90/EU13.3. 15 . as amended.2014 16 OJ No L 96.2013. amended by Commission Delegated Directive (EU) 2015/13. 2. 'immunity related functions' as defined in UNECE Regulation 10.3. Until 20 April 2016. OJ L 3. amended by Commission Delegated Regulation (EU) No 1322/2014. sold as aftermarket equipment. 28. covered by Directive 96/98/EC.
– Induction motors without electronic circuits. provided that they include no active electronic part(s): – Cables and cabling19. – Batteries and accumulators (without active electronic circuits). Equipment is considered inherently benign in terms of electromagnetic compatibility if its inherent physical characteristics are such that: a) it is incapable of generating or contributing to electromagnetic emissions which exceed a level allowing radio and telecommunications equipment and other equipment to operate as intended. 18 C. Article 2(2d) 19 Manufacturers should be aware that the characteristics and installation of cables and cabling can have a significant impact upon the EMC performance of equipment 16 . – Pocket lamps (including those containing LEDs) without active electronic circuits. e.g. – Corded headphones.g. Both conditions need to be met in order to classify equipment as inherently benign. radio receivers). loudspeakers without amplification. and b) it will operate without unacceptable degradation in the presence of the electromagnetic disturbance normally present in its intended environment. The application of the above enables the exclusion of the following products (not exclusive) from the application of the EMCD. e. – Quartz watches (without additional functions. – Equipment containing only resistive loads without any automatic switching device. guitar inductive sensors without active electronic parts. – Electromagnetic relays without active electronic parts. cables accessories. or fan. – Home and building switches which do not contain any active electronic components. simple domestic heaters with no controls. – Passive antennas. thermostat. considered separately.
5 Custom built evaluation kits EMCD introduces an exemption for the custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes (Article 2.4. – Protection equipment which only produces transitory disturbances of short duration during the clearing of a short- circuit fault or an abnormal situation in a circuit and which do not include active electronic components. the EMCD shall not apply.e of the EMCD. A kit that has been built on the basis of a specific request from a specific customer or from a group of customers involved in a joint research and development project as for all or certain characteristics of the evaluation kit OR ii.d. Illustrative examples:  High voltage inductors. A kit that has been built for the specific requirements of a specific customer or a group of customers involved in a joint research and 17 . The exemption includes several elements and only if the products fulfil all the elements they can be exempted.2. – Electromagnetic locks without active electronic parts. and which do not include active electronic components. from the scope of the EMCD:  Custom-built i. on the basis of Article 2.2.  High voltage transformers. If the product under assessment is not included in the list of examples above and the EMC assessment establishes that the apparatus concerned is inherently benign in terms of electromagnetic compatibility (both for emission and immunity) according to Article 2. However. 1. such as fuses and circuit breakers without active electronic parts or active components. – Cathode ray tubes.e of the EMCD). it is recommended to document the results of the assessment and its conclusion.2. – High voltage types of equipment in which possible sources of disturbances are due only to localised insulation stresses which may be the result of the ageing process and are under the control of other technical measures included in non-EMC product standards.
18 . it is important that the correct category of equipment will be identified. Non-exhaustive list of examples of evaluation kits that do not benefit from this exemption (even if there is a possibility for the user to adapt it to his specific needs or to build it himself):  All devices/equipment used on a regular basis (such as laboratory equipment) to perform tests for the purposes of research and development or for other applications such as to demonstrate the conformity or quality of a product. The unique design and characteristics of the kit makes it solely suitable for that research and development project. to be used solely at research and development facilities Research and development facilities meaning public or private research and development bodies.  Evaluation kits A printed circuit board with an integrated circuit and support components to produce a working circuit for evaluation and development. it can no longer be considered a custom-built evaluation kit.  Destined for professionals (customers).  Evaluation equipment for users in general in R&D departments (in this case. 1.  For research and development purposes Evaluation kits to be used in testing for further development/ improvement of the function of the equipment under research and development.6 Classification as apparatus or fixed installation The EMCD defines equipment as any apparatus or fixed installation. As there are separate provisions for apparatus and fixed installations.4. If that evaluation kit is later on provided on a regular basis or once the kit is not used for that joint research and development project purpose. development project as for all or certain characteristics of the evaluation kit. the equipment is always the same and is not "custom built").
Classification as apparatus 1. One of the pre-conditions in order to be considered apparatus in the sense of the EMCD is that it is intended for the end-user.Flowchart 2 . making available) on the market as a single functional unit 21 . or both together.e. or the performance of which is liable to be affected by such a disturbance. According to Article 3(2) of the Directive "components” or “sub- assemblies” intended for incorporation into an apparatus by the end-user and "mobile installations" are also deemed to be apparatus. and liable to generate electromagnetic disturbance. or combination thereof made available (i.g. capable of accomplishing a specified purpose.2) 21 The International Electrotechnical Committee (IEC)’s Vocabulary – (IEV) 702-09-03 or 714-01-30 - defines "functional unit" as follows: "An entity of hardware or software. intended for the end-user. consumer) or legal entity 20 c. Article 3 (1.5 Defining the scope of apparatus The EMCD 20 defines "apparatus" as any finished appliance. In the context of this Guide end-user means any natural person (e. For EMC purposes this can only be hardware or combination of hardware & software 19 .
then the apparatus may be considered as inherently benign in terms of electromagnetic compatibility. or its normal operation may be affected by such disturbances. 20 . Another caveat is that the apparatus should be liable to cause electromagnetic disturbances.4.4). the EMCD does not apply (see section 1. Flowchart 3 summarises the provisions applicable to apparatus (see chapter 4 and section 5.4).g.(e. If both of these conditions are not fulfilled due to inherent characteristics of the apparatus. enterprise) using or intending to use the apparatus for its intended purpose. Generally an end-user is deemed to have no qualifications in the field of electromagnetic compatibility. and hence.
5. A finished appliance is considered as apparatus in the sense of the EMCD.2 Combination of finished products Under the EMCD. and 22 Article 3 (2) (2) of the EMCD.Flowchart 3 . 21 .  intended for the end-user to be operated together to perform a specific task.Provisions applicable to apparatus 1.5. if it is intended for the end-user and thus has to fulfil all the applicable provisions of the Directive. If the finished appliance is made available on the market the requirements of the EMCD has to be fulfilled.1 Finished appliances A finished appliance is any device or unit that delivers a function and has its own enclosure. a combination of several finished products is considered to be apparatus22 if:  is made available by an economic operator as a single functional unit. 1.
have a proper enclosure intended for their final use. is a single apparatus. if the following two criteria are satisfied: a) intended for incorporation into an apparatus by the end-user. the first criterion (paragraph a). is a single apparatus and all provisions of the EMCD apply to the combination as a whole (including the requirements on CE Marking.e. Based on the definitions of 'placing on the market' and 'making available on the market' (Article 3 of the EMCD).g.).5. The second criterion (paragraph b) is satisfied if the components/sub- assemblies are liable to generate electromagnetic disturbance or is liable to be affected by such disturbance. If any of these finished products are excluded from the EMCD and covered by another EU act (such as the RED). and b) liable to generate electromagnetic disturbance or the performance of which is liable to be affected by such disturbance. supplying a product is only considered as making available on the Union market.3 Components/Sub-assemblies In contrast to finished appliances. is satisfied once the components/sub-assemblies are considered as being 'placed on the market'.2. the obligation is on the manufacturer who makes available that product for the first time. when the product is intended for end use on the Union market. within the sense of the EMCD and as described above. At least any of the two situations need to 22 . which refers to the end user and hence to the end use. The interaction of the different radio/electrical/electronic products is taken into account in the risk assessment when a combination. Combining two or more CE marked finished appliances does not automatically produce a “compliant” system e.1 of the EMCD. as interpreted by the Blue Guide.: a combination of CE marked Programmable Logic Controllers and motor drives may fail to meet the essential requirements. components /sub-assemblies do not. in general. Thus. within the sense of the EMCD. components/sub-assemblies are covered by the EMCD. that specific finished product shall comply with that other EU act when it placed on the market i. Components/sub-assemblies are often intended to be fitted into or added to an apparatus in order to add an additional function. 1. contact details etc.  is liable to generate electromagnetic disturbance or the performance of which is liable to be affected by such disturbance Such a combination. Under Article 3.
g.4 of this Guide). other devices.4.1.6 Defining the scope for fixed installations 1. if placed on the EU market: a) Plug-in cards for computers.4).4 Mobile installations Mobile installations (e. 23 . f) Power supply units where they take the form of autonomous appliances or sold separately for installation by the end-user. e) USB memory sticks. "transistors". The instructions for use accompanying the component or sub-assembly should include all relevant information and should assume that adjustments or connections can be performed by an end-user not aware of the EMC implications.5. which are 23 For example electrical or electronic components forming part of electrical or electronic circuit". 1. c) Electric motors (except for induction motors without electronic circuits. see section 1. 1. where applicable. Illustrative examples of EMC components/ sub-assemblies covered by the EMCD. apply to mobile installations. thus not covered by the EMCD23 (see also section 1. as defined for apparatus. unless they fall within any of the exclusions of the EMCD.1 Fixed installations "Fixed installation".6. "thyristors" and "Integrated circuits resistors. be satisfied. Benign components/sub-assemblies are excluded. d) Computer disk drives. b) Programmable logic controllers. g) Electronic temperature controls. is defined as "a particular combination of several types of apparatus and. All provisions of the EMCD. SD cards. mobile LED videowalls) which 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.
airport luggage handling installations. water pumping stations. for example. to the smallest residential electrical installation through to national electrical or telephone networks. Examples of fixed installations: Industrial plants. wind turbine stations. However. computer networks. cable TV networks. Further guidance on fixed installations is provided in Chapters 2 and 5. telecommunication networks. airport runway lighting installations. power plants. including all commercial and industrial installations that have been constructed with the intention of being permanent The EMCD excludes “inherently benign” installations. storm surge barrier installations (with the control room etc. power supply networks. automatic warehouses. air conditioning installations. 24 .” “Fixed installation” is thus an all-encompassing term that applies. water treatment plants.assembled.). railway infrastructures. car assembly plants. skating hall ice rink machinery installations. “a- priori” application of this exclusion criterion to a predefined type of installation seems problematic and such an exclusion can only be made on a case–by-case basis. installed and intended to be used permanently at a predefined location.
Flowchart 4 .4. 1. Since jamming is inherent to their functional principle.g.Installations 1. Hence. 2 ESSENTIAL REQUIREMENTS The EMCD sets out mandatory “essential requirements” formulated in a general manner for all equipment (e. apparatus that will be incorporated into fixed installations need to comply with all of the provisions of the EMCD. unless if it falls within the scope of the RED. a jammer should be prohibited or restricted from being made available or withdrawn or recalled. apparatus and fixed installations) within its scope. These essential requirements define the results to be attained.6. The appropriate technical solutions to meet the 25 . However.2 Specific apparatus for fixed installations In general. It also allows adapting the equipment and product design as a result of technological progress.7 Specific Case: Jammers A jammer is covered by the EMCD. the EMCD provides an exception for apparatus intended for incorporation in a particular fixed installation and otherwise not made available on the market. normally it is not possible to construct jammers that fulfil the EMC essential requirements. but do not specify the detailed technical requirements. Additional information on the requirements for specific apparatus is given in section 5.
26 . These general requirements cover all relevant EMC phenomena for both emission and immunity. if harmonised standards are not used or only used in part. 3 OBLIGATIONS OF ECONOMIC OPERATORS Guidance on the basic obligations of economic operators can be found in the Blue Guide chapter 3 “the actors in the product supply chain and their obligations”. This includes evidence that the apparatus complies with the relevant harmonised standards or.g. requirements are not imposed as long as the equipment complies with the essential requirements. Technical documentation shall be prepared by the manufacturer to demonstrate evidence of compliance with the essential requirements. EMC specific obligations are to be found in chapter 4 of this EMC Guide. “Specific requirements for fixed installations”. 4 CONFORMITY ASSESSMENT PROCEDURE FOR APPARATUS 4.1 Introduction Apparatus shall comply with the essential requirements referenced in Article 6 and detailed in Annex I of the EMCD. The essential requirements are split into two parts: “General requirements” for all equipment (e. The essential requirements lay down the necessary elements for protecting public and general interest. Compliance with the essential requirements is mandatory. These are legally-binding for all equipment in the scope of the EMCD. Compliance with these essential requirements shall be demonstrated by applying one of the conformity assessment procedures referenced in Article 14 and detailed in Annex II and Annex III of the EMCD. a detailed technical justification including a list of other relevant technical specifications applied. Only compliant equipment may be placed on the market and/ or put in service in the Union. apparatus and fixed installations).
24 C.2 27 .4 and Annex III part B. The manufacturer shall take all measures necessary to ensure that the apparatus are manufactured in accordance with the technical documentation 24 The manufacturer may involve a Notified Body during the conformity assessment procedure which is set out in Annex III (when module B + C. on the packaging and accompanying documentation. i. Annex II.e. Annex III. if not possible due to the nature or the size of the product. is chosen the manufacturer shall ensure that the apparatus is manufactured in conformity with the type described in the EU-type examination certificate). The manufacturer shall also draw up an EU Declaration of Conformity and affix the CE marking on the product or.
Flowchart 5 .Conformity assessment procedure for apparatus EMC assessment of apparatus Harmonised standards applied ? yes partly no Check compliance Check compliance with Harmonised with HS where Standards(HS) applicable Detailed assessment Detailed assessment of EMC aspects not of all EMC aspects of covered by HS the apparatus Test Reports Description of the solutions adopted to meet the essential requirements Technical Documentation EU-type examination by a yes Notified Body ? no Annex III followed Annex II followed EU-type examination certificate Declaration of Conformity CE marking 28 .
the electromagnetic compatibility assessment must confirm that the apparatus meets the essential requirements. The EMC assessment needs to take into account all normal intended operating conditions of the apparatus. 4.1 General Concept The manufacturer shall perform an EMC assessment of the apparatus 25 based on the relevant phenomena in order to ensure that he meets the essential requirements.1.3. On basis of the knowledge of the relevant EMC phenomena for the apparatus and its intended operating environments the EMC assessment according to chapter 4. As noted above the EMCD does not require the mandatory intervention from a third party (e. This documentation shall make it possible to assess the conformity of the apparatus to the relevant requirements. notified body or laboratory) when carrying out the assessment.4. it is recommended to document the results of the assessment and its conclusion. This EMC assessment is considered to be an adequate analysis and assessment of the risk(s). and shall include an adequate analysis and assessment of the risk(s). In cases where the apparatus can take different configurations.2 29 .3 EMC Assessment 4. The manufacturer is fully responsible for applying the appropriate method of assessment.3 can be performed. the apparatus is excluded from the scope of EMCD and no further actions are necessary. 26 25 Recital 30 and Article 14 26 Annex II. Recommendations are given in this Guide to help in this process.2 Risk analyses and risk assessment The conformity assessment procedures for apparatus require the manufacturer to establish technical documentation. See also Blue Guide section 4. Where the EMC assessment establishes that the apparatus concerned is inherently benign in terms of electromagnetic compatibility (both for emission and immunity) according to Article 2(2d). “in all possible configurations identified by the manufacturer as representative of its intended use”. In EMCD the concept of risk refers to risks in relation to the electromagnetic compatibility protection aims specified in Annex I “Essential Requirements” and not to safety.g.1 "Definition of essential requirements". However.
Where a manufacturer assembles a final apparatus using components from other manufacturers. this EMC assessment has to be performed following a defined methodology. For example. one could use the harmonised standards to cover emission phenomena and a detailed technical EMC assessment for immunity aspects. After having identified the risks of the apparatus. Once these risks are identified and the manufacturer has determined the measures to address those risks in order to comply with the essential requirements he can choose to apply the harmonised standards applicable to his product or he can choose other technical specifications. three methods are possible for the EMC assessment: a) Application of EMC harmonised standards having checked whether the chosen harmonised standard(s) covers all the phenomena relevant to the product. but the manufacturer is and remains fully responsible for the compliance of his apparatus with the provisions of the Directive. Any conformity assessment procedure requires the manufacturer to start with an analysis of the specific risks of the product to address them in order to comply with the essential requirements because not all products present the same risks. b) An EMC assessment where no harmonised standards have been applied and the manufacturer applies his own methodology (other technical specifications). The manufacturer may ask a third party to perform the EMC assessment for him or help him with part of it. the manufacturer of the final apparatus must retain 27 The specific services and operation of Notified Bodies are described in chapter 7 30 . In practice. Harmonised standards (see the definition in the relevant chapter of the Blue Guide) provide a recognised methodology to demonstrate compliance with the essential requirements and are usually the preferred way to demonstrate compliance. it is never the responsibility of a third party such as a Notified Body or an EMC test laboratory27.the EMC assessment is the sole responsibility of the manufacturer. combining the two previous methods. To re-iterate . c) Mixed assessment.
2 Use of EMC harmonised standards Harmonised standards are European standards that have been adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation (for example the EMC Directive).3.2 of the Blue Guide “Making available on the market” 31 .3. In this case the provisions explained at 4.3. The use of the worst case approach needs to be documented in the technical documentation29. the EMC assessment shall confirm that the apparatus meets the essential requirements in all of the configurations foreseeable by the manufacturer as representative of normal use in intended applications. overall control and is responsible for the compliance of the final apparatus28.1. at the choice of the manufacturer. This means that for apparatus which is continuously produced over a long period. 28 It is therefore recommended that any manufacturer of apparatus incorporating components and sub- assemblies from other sources should request information on their EMC characteristics and method of incorporation as part of the commercial process. The date of cessation of the superseded standard provides a transition period (usually between 18 and 36 months) during which either the old or the new harmonised standards may be used. 29 Within the immunity and emission phenomena to be covered. The manufacturer is responsible for identifying the possible configurations and the choice of the worst case(s). different worst case selections may occur (because of non-related phenomena).1 The “Worst Case” approach Where apparatus can take different configurations. the applicable standards may change in the course of time. Each harmonised standard contains information (including a table at Annex ZZ) on how to achieve the presumption of conformity with the corresponding essential requirements of the EMC Directive. Compliance with the applicable harmonised standards whose reference is listed in the OJEU under the EMC Directive gives presumption of conformity with the corresponding essential requirements of the EMCD. The EMCD refers to the moment of placing on the market for each individual apparatus 30 . 4.2 concerning the reference of the superseded standards and the date of cessation of Presumption of Conformity should be taken into account. This may increase the number of cases to be investigated 30 See section 2. to benefit from Presumption of Conformity. 4.
4. the change may only relate to a small range in scope. the manufacturer has the obligation to demonstrate that his products are in conformity with essential requirements with the means he has chosen.12 ff) 32 . As harmonised standards are voluntary this is of course an acceptable solution. However. The European Commission publish a link to the relevant edition of the OJEU on their web page relevant to the EMC Directive. or one particular clause or phenomenon. it may be that the manufacturer wishes to continue to meet the essential requirements by continuing to use of the “old” edition (that has ceased to be harmonised) plus other technical solutions if necessary.2. Information on standards is also available on the CENELEC.11. ETSI and CEN web-sites: 31 REGULATION (EU) No 1025/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 (OJEU L316 14. After this time if the manufacturer wishes to continue to benefit from the Presumption of Conformity and the apparatus is not yet placed on the EU market.2012 p.1 List of harmonised standards The list of harmonised standards published in the OJEU is regularly updated. For example.3. but this would not give the presumption of conformity that application of the later edition would confer. In this case. the apparatus needs to conform to the later harmonised standard and a new EU Declaration of Conformity is required to include the reference to it (which is often a later edition/version with the same reference number). Harmonised standards under the EMCD are drawn up and adopted by the three European Standardisation Organisations (ESO) recognised in the Standardisation Regulation31: – European Committee for Standardization (CEN) – European Committee for Electro technical Standardization (CENELEC) – European Telecommunications Standards Institute (ETSI) Detailed information on the general EU policy regarding harmonised standards is available at the web-site of the European Commission. Where new editions become available and are to be applied it does not necessarily mean that a complete EMC re-assessment of an existing product is necessary. The evaluation may be restricted to those modifications directly affecting the apparatus concerned. This will require the manufacturer to make an EMC evaluation to the later harmonised standard and he may consider it necessary to carry out some re-testing.
A list of members of CENELEC is available at: http://www. The main aspects that are generally required to be covered are: . When the manufacturer chooses to apply harmonised standards he shall select them in the following precedence order: . They are divided into generic environments but do not contain specific guidance of how to operate and load equipment during the testing phase of an EMC assessment.eu www.eu/ ETSI standards can be downloaded from the ETSI web-site without cost and are sometimes distributed by National standards bodies or third parties.eu In order to obtain the text of CEN or CENELEC standards. Each harmonised standard identifies the essential requirements which it covers in an annex.cenelec.Product family standards (if available) .org www.3.2 Relevant harmonised standards The selection of the relevant harmonised standards is the responsibility of the manufacturer.cenelec.Generic standards Product-specific (family) standards are those written by ESO’s taking into account the environment. Further guidance for the application of harmonised standards is given in Annex 2.2. It may be necessary to apply several harmonised standards to cover all essential requirements of the Directive. www.Product-specific standards (if available) .Radiated disturbances .Conducted disturbances at mains and telecommunication ports 33 . 4.cen. Generic standards could be used in the absence of either product-specific or product-family standards.etsi. operating and loading conditions of the equipment and are considered the best to demonstrate to compliance to the Directive. you should contact the national members of CEN or CENELEC or the standardisation body of your country if you are located outside the territory of CEN/CENELEC members.
1.Immunity to transient phenomena Applying several standards may be necessary to address all relevant phenomena in all relevant frequency ranges. want to assess their apparatus according to the essential requirements. generic and product (family) standards. explains the general structure of the EMC standardisation and the respective roles of EMC standards. If the manufacturer chooses not to follow the harmonised standards. 4. – The manufacturer may want to apply any other standards or specifications not harmonised in the context of the EMCD.3.3 An EMC assessment where no harmonised standards have been applied A manufacturer may wish to declare the conformity of his apparatus directly to the essential requirements. by addressing the EMC risks with other means. The manufacturer will need to provide clear evidence of compliance. 34 .Immunity to continuous radiated and conducted disturbances .g. For multi-function apparatus. crucial when manufacturers of new or innovative apparatus for which standards do not exist. Useful practical information on the selection of the appropriate CENELEC standards may be found in the CENELEC Guide 25 ”Use of EMC standards for the application of the EMCD” which is available on the CENELEC website. also available on the same website. – The manufacturer uses test methods not covered by the harmonised standards. The CENELEC Guide 24. – The apparatus uses technologies. or cannot be used. incompatible with or not yet taken into account by harmonised standards. and generic standards are not applicable. without reference to harmonised standards.3 Conformity with the essential requirements: Other possibilities). This is usually the case where: – There are no harmonised standards or where they do not cover all the essential requirements applicable to the apparatus. he has the obligation to demonstrate that his products are in conformity with the essential requirements by the use of other means of his own choice (Blue Guide. This option allows flexibility for technical development. This assessment needs to follow a technical methodology to ensure that the requirements of the EMC Directive are met. . e. basic standards. it may also be necessary to select standards relevant to all primary functions. paragraph 4.
– Reference to available documents such as any harmonised standards. This selection is the responsibility of the manufacturer based on knowledge of the electromagnetic environment and awareness of the statistical aspects involved. EMC environment – Types of disturbances created by or affecting the apparatus. tests methods. These deviations may concern the phenomena considered. – Limits adopted for emission. etc. These should be set taking into account of the reasonable expectations of the user. – Specification of the performance criteria of the apparatus. This may cover also aspects relevant for apparatus that may be moved and must have emission and immunity characteristics appropriate for several environments. This should also cover the power supply voltage and frequency aspects relevant to the apparatus. such as: – Nature of the apparatus (apparatus characteristics). 35 . recommendations. descriptions and classification of the environments in which the apparatus will be used.. test facilities or test levels. – Clear specification of relevant sources and effects of the electromagnetic phenomena covered and compatibility levels applied. The assessment required for a particular apparatus will depend on several factors. etc.. – Performance criteria for immunity. It may encompass (but is not limited to) the following: – Description and definition of the apparatus operating conditions and its intended purpose. – Intended use. – Environmental conditions. – Test levels with regard to the immunity of the apparatus. – Specification. The EMCD requires the manufacturer to document all steps taken and decisions made to check the conformity of the apparatus for those aspects for which the manufacturer has chosen this method of assessment. – Location of use.– The apparatus is physically too large to be tested in the facility described in the harmonised standard or where “in-situ” testing is foreseen and not adequately covered by a harmonised standard. – Indication of any deviations made to available reference documents.
– Any specification of general or specific requirements taken to limit emission of disturbances. This may include information on the levels of occurrence and statistical distribution of the disturbances. basic EMC standards. regardless if the Annex II “internal production control” or Annex III “EU-type examination that is followed by Conformity to type based on internal production control” was chosen. – Description on how components are selected. in order to ensure that. To-reiterate. – Any description of the solutions adopted in order to comply with the essential requirements. maintained or used.4. their drafts as well as standards related to EMC but not harmonised under the Directive e. – EMC design considerations and/or calculation results.1 Technical documentation The manufacturer draws up the technical documentation providing evidence of the conformity of the apparatus with the essential requirements of this Directive. presenting background theory. Reference sources of information for the manufacturers undertaking this method of assessment may continue to include harmonised standards. results and conclusion. Detailed guidance on the selection of electromagnetic phenomena to be assessed in the EMC assessment is given in Annex 3 to this Guide. when put into service. 36 .g. – Assessment of whether compliance with the essential requirements is ensured in residential areas or not. ferrites etc. 4. the apparatus is in conformity with the essential requirements. If this is not the case the restriction of use shall be clearly established. – Information on shielding. filters. arguments. where this route is chosen the apparatus does not benefit from a presumption of conformity. including the list of the relevant technical specifications applied. – Assessment of whether any specific precautions have to be taken when the apparatus is assembled. installed.4 Documentation required by the EMCD The documentation required by the EMCD comprises of the technical documentation and the EU Declaration of Conformity 4. theoretical studies or other examinations carried out. – Statistical evaluations. – Worst case selection criteria for series of apparatus with similarities. cable screening and routing.
the EU Declaration of Conformity and the product. At a minimum this will be a dated list of the European harmonised standards applied and the results obtained on their application. – if harmonised standards have not been applied or have been applied only in part then a description of the steps taken to meet the essential requirements – an EMC Assessment described in Annex II of the Directive . examinations carried out etc. including the following: – an identification of the product covered by the technical documentation. This identification should allow unambiguously linking between the technical documentation. The amount of information required will depend on the complexity of the apparatus. A list of other technical specifications used shall be included in case where harmonised standards are not used. and shall include an adequate analysis and assessment of the risk(s). sub-assemblies. – if harmonised standards have been applied then evidence of compliance is required.must be included. – if a manufacturer is using the procedure of Annex III of the EMCD.3 "Technical documentation" Blue Guide 4th paragraph. The documentation includes test reports. simple apparatus may be fully defined in one line whereas more complex apparatus may need a complete description (a picture may be included). further to a reasoned request from a competent national authority. It must contain all necessary practical (technical) details. provide all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the apparatus with this Directive. – a general description of the apparatus. then the EU-type examination certificate issued by a Notified Body shall be included.The purpose of the technical documentation is to make possible to assess the conformity of the apparatus to the relevant requirements. In that event the technical documentation shall specify which parts of the harmonised standard have been applied. in a language which can be easily understood by that authority. design calculations made. – descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus. Section 4. etc. – conceptual design and manufacturing drawings and schemes of components. Referring to Article 7 (9) of the EMC Directive as well as chapter 3 "The actors in the product supply chain and their obligations" of the Blue Guide the manufacturer shall. circuits.. 37 .
in relation to which conformity is declared. Object of the declaration (identification of apparatus allowing traceability.. See also section 4. (name. Name and address of the manufacturer or his authorised representative . . or references to the other technical specifications. the manufacturer shall assume responsibility for the compliance of the apparatus with the requirements laid down in this Directive.4 "EU Declaration of Conformity" of the Blue Guide In most cases. it must be signed by the manufacturer or his authorised representative.4. including the date of the standard. . function and the signature. it may include a colour image of sufficient clarity where necessary for the identification of the apparatus). Apparatus model/Product (product. type. Where applicable. batch or serial number). will be those of the harmonised standards cited in OJEU that are applicable to the apparatus. including the date of the specification. If harmonised standards have 38 . . As the DoC is an "official" declaration of compliance with the legislation. That the EU Declaration of conformity is issued under the sole responsibility of the manufacturer. That the object of the declaration described above is in conformity with the relevant Union harmonisation legislation. . Place and date of issue. . the dated references to the specifications under which conformity is declared. . . Signed for and on behalf of. Additional information. Name. . the notified body . The Directive specifies in Annex IV the model structure of the DoC as follows. . number) performed … (description of intervention) and issued the certificate … (EU-type examination certificate number). . References to the relevant harmonised standards used.4. By drawing up the EU Declaration of Conformity.2 EU Declaration of Conformity The compliance of apparatus with all relevant essential requirements is declared by an EU Declaration of Conformity (DoC) issued by the manufacturer based inside or outside the EU or his authorised representative in the EU..
the manufacturer must provide DoC. CE marking may be required to show conformity with other Directives that require CE marking.5. Where apparatus is subject to more than one Union act requiring an EU DoC. it shall be affixed to the packaging and to the accompanying documentation. If any national competent authority request an EU DoC. Article 19(1) sets out the exemptions of affixing CE marking (as well as other applicable requirements) on apparatus which is intended for incorporation into a particular fixed installation and is otherwise not made available on the market. If it is not possible or not warranted on account of the nature of the apparatus. The DoC can take any form as long as the information prescribed in the model structure in Annex IV of the EMCD is included as a minimum. whether the single DoC or the full set/bundle of DoC depending on the request. 4.1 CE marking The EMCD requires that the apparatus bears the CE marking as an attestation of compliance with the EMCD. The single EU Declaration of Conformity can be made up of a dossier containing all relevant individual EU Declarations of Conformity. 39 . the DoC is considered incomplete and therefore not valid and may lead to an appropriate action from the competent authorities of a Member State.1 "CE marking ".5 CE Marking and information 4. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008 and shall have the following format: The CE marking shall be affixed visibly. legibly and indelibly to the apparatus or to its data plate. a single EU DoC shall be drawn up in respect of all such Union acts. Further details on CE marking and potential exemptions from the marking requirements on the product like “not possible or not warranted on account of the nature of the product” are given in the Blue Guide. That declaration shall contain the identification of the Union acts concerned including their publication references. a reference to any identifiable non- harmonised standards or specifications that have been applied shall be included. section 4.5. However. If any of the minimum required content is missing. not been used or only partially used.
5. The traceability requirements shall be affixed on the apparatus itself. in order to ensure that.2 Information on indentification The EMCD requires that apparatus be identified by “type. However. Specific apparatus intended to be incorporated into a given fixed installation (using the provisions of Article 19(1)) and otherwise not made available may have this identification information in the accompanying documentation and not on the apparatus. installed. batch or serial number or other element allowing their identification of the apparatus”. The Blue Guide gives more information as to which circumstances exemptions to these marking requirements can be applied. manufacturers shall indicate their name. allowing for the manufacturer to choose his own method for identification of an apparatus for regulatory purposes. where appropriate also on the packaging. .2. The address shall indicate a single point at which the manufacturer can be contacted. it may be included on its packaging or in a document accompanying the apparatus. when put into service. In cases where that is not possible. 4.5. All contact details shall be in a language easily understood by end-users and market surveillance authorities. the identification of the apparatus must unambiguously correlate with the DoC and the technical documentation. registered trade name or registered trade mark and the postal address at which they can be contacted. A comprehensive explanation and details about the traceability requirements can be found in the Blue Guide section 4.5 of this guidelines ). Importers (when the apparatus is imported) shall also indicate their name. the apparatus is in conformity with the essential requirements of the EMCD.5.2 "Traceability provisions".4 Information concerning the use of apparatus Apparatus shall be accompanied by the following: . A clear indication on restriction of use in residential areas.4. 40 .3 Information for traceability In order to facilitate traceability. registered trade name or registered trade mark and the postal address at which they can be contacted. There is flexibility in this requirement. 4.5. maintained or used. Information on any specific precautions that must be taken when the apparatus is assembled. if the compliance with the essential requirements of the EMCD is not ensured in residential areas (further details in chapter 4.
this must be specified to allow for proper installation and use. see also Blue Guide section 3. The EMCD requires that apparatus for which compliance with the essential requirements in residential areas is not ensured by the manufacturer (for example if there are limits for the residential environment in standards which are exceeded) shall be accompanied by a clear indication of this restriction of use. If so.1 under point 4 (Manufacturer). Apparatus may need assembling or special consideration in respect of its installation for it to comply during use with the essential requirements of the Directive. shall be clear. as determined by the Member State concerned. . Examples of cases where it is relevant to provide more detailed information: . If there are any particular earthing aspects related to the apparatus for EMC purposes. Where the apparatus is connected to other apparatus there may be a need to have specific types of cables and connectors (e. and the apparatus will still comply with the essential requirements of the EMCD. 4. 18 point 2 41 .5 Information when compliance is not ensured with essential requirements in residential areas32 The EMCD recognises that the electromagnetic environment of residential areas needs particular attention. double screened. for example. where appropriate also on the packaging. . as well as any labelling. Therefore all information necessary for correct assembly. understandable and intelligible. take one of the following forms (decided by the manufacturer on his 32 EMCD Art. screened. Such instructions and information. In such areas. in a language which can be easily understood by consumers and other end-users. Information required to enable apparatus to be used in accordance with the intended purpose of the apparatus shall be included in the instructions accompanying the apparatus. A clear indication may.g. recognising of course that earthing for safety purposes cannot be compromised. broadcast receivers may be expected to be used in close proximity to other apparatus. Information on any precaution that needs to be observed for the apparatus to maintain its compliance with the essential requirements regarding use and maintenance needs to be included. etc). installation and use has to be provided. If no information is given with the apparatus it is presumed that users can install and use the apparatus without any special considerations regarding the EMC aspects.5.
The descriptions used in harmonised standards (for example “this is a class A product”) are not suitable without further explanation. other devices. 33 Article 19 (2) 42 . .1 (see 2nd paragraph) and other devices outside the scope of the EMCD.4. installed and intended to be used permanently at a predefined location Owing to their characteristics. they are not subject to the requirements for CE marking. Measures are prescribed in the EMCD to enable the competent authorities to handle complaints concerning disturbance generated by fixed installations33.1 Essential Requirements "Fixed installation" means a particular combination of several types of apparatus and. This product must not be used in residential areas. As indicated in Section 4. which are assembled.2 and 5. fixed installations have to comply with the essential requirements and other specific requirements (Annex I of the Directive) which are applicable to them. 5 FIXED INSTALLATIONS 5. However. This information shall be in a language which can be easily understood by consumers and other end users. Such use must be avoided unless the user takes special measures to reduce electromagnetic emissions to prevent interference to the reception of radio and television broadcasts. there is a possibility of some exemption for apparatus under certain conditions as detailed in Article 19(1) of the EMCD (See also sections 1. However. the information should be included on the packaging (if present) and also in the accompanying documentation for example instructions for use. This product may cause interference if used in residential areas. assessment of the severity of a potential problem if the apparatus is used in such locations): . Apparatus incorporated in a fixed installation is subject to all provisions applicable to apparatus under the EMCD. fixed installations are not subject to certain rules of free movement within the Union. A fixed installation may be assembled by the incorporation of several apparatus including specific apparatus as described in Article 19. as they are not understood by the general public. Therefore.5. where applicable.6.4 of this Guide). DoC or for formal EMC assessment before putting into service. as determined by the Member State concerned.
43 . 2 mean practices which are good for EMC purposes at the specific site in question. filters etc). General information on good engineering practice within the context of installations is available in several EMC handbooks. For example some technical reports published by standardisation bodies deal with installation and mitigation guidelines for EMC. these instructions may concern: – the specified environment (especially the EMC environment). The two basic requirements relating to the use of components and to good engineering practice can be summarised as follows: Intended use of components This means that all the EMC instructions given by the manufacturer for all the component sub-parts used in the fixed installation have to be taken into account. Since a fixed installation is installed in a pre-defined location the instructions for use should ensure that the components are installed in this specific location. etc. – the specifications and length of the cables required for external connections. components not subject to the EMCD.1. This applies to any sub- part. For example. specific apparatus for the fixed installation. – the required use of additional auxiliary devices (protection devices. apparatus. The “good engineering practices” referred to in Annex I.2 of the Directive require that fixed installations shall be installed taking account good engineering practices and the information provided by the respective manufacturers regarding the intended use of the components that make up the fixed installation. courses and technical reports.). – Any special precautions for EMC (equipotential earthing etc. whether those parts are large machines.The specific essential requirements in Annex II. Good engineering practice Good engineering practice comprises of suitable technical behaviour taking account recognised standards and codes of practice applicable to the particular fixed installation. – the conditions for use. in order to comply with the essential requirements set out in Annex II.
). Good engineering practice.Immunity: take appropriate actions to ensure that sensitive equipment is protected against the various types of disturbances that might be expected.Emissions: take appropriate actions to mitigate the source of disturbances by EMC design. screening etc. Standards for installations cannot cover all specific local conditions: therefore it is necessary to be aware of some guiding principles when aiming to demonstrate installation according to good engineering practices: .2 Documentation The level of detail of the documentation may vary from very simple information to much more detailed documentation for complex installations involving important potential EMC aspects. When applying the essential requirements to a defined fixed installation. . Whilst there is a need to have regard for the ‘state of the art’ practices it does not necessarily follow that they are relevant for all installations. control and telecommunication ports etc. Examples of types of installations to which these documentation requirements might apply are Solar/PV Installations and domestic heating and cooling systems. It should be noted that it is not the purpose of the EMCD to ensure electromagnetic compatibility between specific equipment inside the borders of the defined fixed installation. use and maintenance provided by the supplier of each apparatus. by the addition of filters or of absorption devices etc. equipotential earthing. – The coupling mechanism with the external environment. the instructions for installation.Coupling and radiation: take appropriate actions in respect of distances. . Where installations are comprised solely of apparatus placed on the market in conformity with the EMCD and carrying the CE marking. particularly in the field of EMC. selection of cables. on request. In an analogy with apparatus. 44 .g. it is fundamental to identify: – The ports/interfaces where conducted (high or low frequency) disturbances may cross the borderline from or towards the fixed installation (power supply port. it is essential to define the borderlines/geographical limits of this fixed installation in order to distinguish it clearly from the external environment. e. – The radiation towards or from the external environment. are in constant evolution. the responsible person satisfies the documentation requirements placed on him by being able to provide. 5.
A link provider- customer is required. the reader’s attention is brought to the final sentence of recital (32) which states: “Should apparatus be incorporated into more than one identical fixed installation. the following information are required in the accompanying documentation: the type. However. if he is not established within the Union. installers. the batch.3 Responsible person for fixed installations Member States are responsible for establishing provisions to identify such persons who are responsible for a fixed installation34. the conformity assessment procedure for apparatus. together with their specific locations need to be identified alongside each unit of specific apparatus intended for incorporation. 5. designers. 34 Art. operators or responsible persons of the fixed installation for which that specific apparatus is intended. 19(3) of the EMCD 45 .5.4. This exemption is extra-ordinary and that it is only provided on a case-by- case basis. For the apparatus to which this exemption may apply. the subsequent EU Declaration of Conformity and the specific marks and information for apparatus and affixing CE marking are not compulsory. An apparatus can only benefit from this exemption if there is a direct link between the manufacturer of that specific apparatus and the owners. the name and address of the importer.1.4 Requirements for specific apparatus for given fixed installations The general principle is that all apparatus are subject to all the relevant provisions of the EMCD. Obligations when the exemption clause is used for specific apparatus In the case of such specific apparatus.” The characteristics of the identical installations. The storage of “specific apparatus” units intended for more than one fixed (identical) installation is therefore permitted so long as these conditions are fulfilled 5. However. the EMCD provides at Article 19(1) the possibility of exception for apparatus intended for incorporation in a given fixed installation and which are otherwise not commercially available. the essential requirements for those apparatus considered in isolation from fixed installation. the serial number or any other identifying information of the apparatus as well as the name and address of the manufacturer and. identifying the electromagnetic compatibility characteristics of these installations should be sufficient to ensure exemption from the conformity assessment procedure.
market surveillance is important for interests of economic operators.under the scope of the Directive. in order to comply with the requirements of Article 6 of the Directive.eu/DocsRoom/documents/23041 46 . followed by Module C). because it helps to eliminate unfair competition. The conformity assessment procedure is described in Annex III of the Directive (Module B. he or his authorized representative may request a Notified Body to involve in the conformity assessment procedure of the apparatus. Procedures and details on European harmonised market surveillance can be found in the Blue Guide chapter 7 on Market Surveillance and in the “Horizontal good practices on market surveillance”35. The accompanying documentation has to identify the fixed installation for which the specific apparatus is intended and the electromagnetic compatibility characteristics of the fixed installation.europa. Member States are required to take all appropriate measures to ensure that equipment is placed on the market and/or put into service only if it complies with the requirements of the EMCD.due to their nature . This obligation is complementary to that requiring Member States to allow free movement of equipment that is in compliance with the EMCD. Furthermore. in order not to compromise the conformity of the given fixed installation 6 MARKET SURVEILLANCE OF THE EMCD The purpose of market surveillance is to ensure that the provisions of the EMCD are complied with across the Union. workers and other users are entitled to an equivalent level of EMC protection throughout the single market.1 Introduction Notified Bodies can carry out tasks as a Notified Body under the EMCD only for apparatus under the scope of the Directive but not for fixed installations . Consumers. 35 “Horizontal good practices on market surveillance” on http://ec. when properly installed. maintained and used for its intended purpose. Regardless of whether the manufacturer has applied harmonised standards or not. Further. 7 NOTIFIED BODIES 7. the accompanying documentation shall provide information on the precautions to be taken for the incorporation of the specific apparatus. regardless of the origin of the product.
2 Conformity Assessment procedure of Annex III of the Directive The Directive requires compliance of apparatus when it is “properly installed and maintained and used for its intended purpose”. This could be.e. other technical references and professional decision available at that time. only the radiated emission requirements). 47 .7.g. In the case of the Notified Body report not coming to a positive conclusion that the apparatus concerned is satisfying the requirements of the Directive. The records should identify any documents referenced in the assessment and the particular parameters applied to determine compliance with the essential requirements. The Notified Body shall inform the applicant accordingly giving detailed reasons for its refusal in the report. The Notified Body must base its EU Type Examination Certificate on the requirements of the Directive and the Notified Bodies professional assessment of the technical documentation taking due account of relevant standardisation. emission and/or immunity or just a part of one of the essential requirements. the Notified Body can then issue an EU-Type Examination Certificate to the applicant indicating the aspects of the essential requirements that have been assessed. a validity period of the Certificate. If the review concludes that the documentation demonstrates compliance with the requirements of the Directive. A Notified Body shall follow the process in Article 32 (3) of the Directive when it refuses to issue the EU Type Examination certificate and the process in Article 32 (4) and (5) when it suspends or withdraws the certificate. An aspect relevant to the intended purpose could be the number of units of apparatus likely to be put into service and their overall potential for harmful effects to networks or the radio spectrum or to other apparatus. for example. The Notified Body must prepare an evaluation report that records the technical documentation that was reviewed and the Notified Body decision(s) with regards to the technical design being adequate (or not) to meet the relevant essential requirements. In all cases. The Notified Body should therefore note any inconsistencies between the stated intended purpose and obvious uses of the apparatus so that its EU-Type Examination may be suitably qualified and is not open to misinterpretation. e. The application from the manufacturer or his authorised representative for a EU-type examination should specify which aspects of the essential requirements are requested to be assessed by the Notified Body (i. The Notified Body should maintain records documenting the rationale used to arrive at a particular decision. the EU Type Examination Certificate of the Notified Body can state conditions (if any) for its validity. When compliance of the apparatus is confirmed by the Notified Body report. the Notified Body shall assess the compliance for the aspects as requested by the applicant. the Notified Body shall refuse to issue an EU Type Examination certificate.
logo. The manufacturer shall inform the Notified Body that holds the technical documentation relating to the EU-Type examination certificate of all modifications to the approved type that may affect the conformity of the apparatus with the essential requirements of this Directive or the conditions for validity of that certificate. then the apparatus becomes a new product entering the market. o Technical documentation identification o Unique identification of the documentation etc. including brand/trade name. address etc.  Notified Body number. o Description of apparatus. Annex III. If for the new product the manufacturer wishes to apply Module B/C again 48 . However.  Scope of examination whether the certificate is covering emission and/or immunity. A revision number and/or copy number shall be included if applicable. of the party requiring the EU Type Examination Certificate.Annex III of the Directive provides for the Notified Body to give an evaluation report and an EU Type Examination Certificate based on the technical documentation reviewed.  Date of issue of the Certificate and its Validity  Applicant details: Name.the text stating that the apparatus is compliant.  Clear identification of the apparatus. address etc. a Notified Body is free to choose its own format and may include additional information such as the reference standards. hardware and software (where it affects the Directive conformity) revision.6 sets out information to be included as a minimum in the EU Type Examination Certificate. intended purpose and other remarks/observations. The following are the suggestion of contents to be included in a EU type examination certificate by a Notified Body Title “(Directive 2014/30/EU -Notified Body) EU-Type Examination certificate” or similar text and avoiding the use of words such as “opinion” and “declaration”. Insert on the Certificate:  Notified Body Name.  Authorised signatory (signature block including printed name of the signatory). identification details of the apparatus etc.  EU Type Examination Certificate number . If the product has been subject to substantial changes that may have a significant impact on its compliance with the EMCD (EMC Characteristics of the apparatus. o Reference of any build status/design documentation taken into account.this shall be the unique number of EU Type Examination Certificate. model/type designation. taken into consideration irrespective of the actual physical format of the documentation  Conclusions of the examination  Certification text . Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.). The original EU Type Examination Certificate is then not valid anymore.. The goal is to give the minimum information from the following list such that a third party would be able to uniquely identify the item in question.
The EUANB liaises with relevant organisations such as CENELEC.2. Notified Bodies should check with the Notified Body Coordination Group – EUANB .e. 7.4 Coordination between Notified Bodies Recognizing that it is necessary for the conformity assessment routes to be applied consistently by all parties in order to achieve an open and competitive market throughout Europe. Notified Body decisions are always solely issued in the name and under the responsibility of the Notified Body (see section 5. or check if there are other procedures available elsewhere.and involve a Notified Body then he is free to choose any Notified Body for this assessment.EUANB has been set up. ETSI and EMC ADCO. Notified bodies shall inform the notifying authority accordingly. 7. Where a manufacturer is dissatisfied with the service provided. EMCWP) and facilitates the convergence of conformity assessment practices in the regulatory sphere. The notified body remains fully responsible for the tasks performed by the subcontractor or the subsidiary.5 Complaints regarding the service provided by NB Notified Bodies are required to have a policy and procedure for the resolution of complaints received from clients or other parties. etc. the European Association of EMC Notified Bodies . 7. called Technical Guidance Notes — TGNs — which have been drawn up to assist Notified Bodies in their task. Furthermore EUANB provides Reference Documents solely for its members containing information to support the work of the Notified Bodies.5 of the Blue Guide "Subcontracting by notified bodies"). 49 . provided that the subcontractor or subsidiary also meets the requirements set out in Article 24 of the EMCD. and agreement of the client must be obtained for activities to be performed by the subcontractor or subsidiary.3 Information exchange Article 34 and Annex III (paragraph 8) of the Directive contain requirements for Notified Bodies to provide specific information to certain organisations such as other Notified Bodies. He is not obliged to choose the original Notified Body. notifying authorities. Subcontracting does not therefore entail the delegation of powers or responsibilities. The EUANB issues information sheets. he should file a complaint with the Notified Body in question.2 Subcontracting The Notified Body can subcontract limited specific conformity assessment tasks or have recourse to a subsidiary. A complaint can also be filed by the manufacturer with the national notification authority. (See Annex 6 of this Guide) The EUANB contributes to the effective implementation of relevant legislation in cooperation with the Working Party set up under the Directive (i. 7.whether any mechanism has made available to allow notification of specific information as required under the above mentioned Article.
Where non-compliant apparatus has been subject to the conformity assessment procedure involving the service provided by a Notified Body. the authority supervising the Notified Body will need to take appropriate action and inform the Commission and the other Member States accordingly. 50 .
Overall flowchart 51 .ANNEX 1 – Flowchart 6 .
relevant for its equipment. the manufacturer is required to address the residual risks not covered by the harmonised standards to ensure that all the phenomena are considered. These explanations should demonstrate on how essential requirements are met. from the way described above. In such cases.2 of this document) and if the applied harmonised standard does not cover all the phenomena expected from the equipment. The only secure way for the manufacturer is thus to apply. the standards referred to. They have to evaluate this risk when they declare conformity to a harmonised standard by allowing themselves such deviations. etc. As most EMC standards include a series of tests with associated measurement methods to perform the EMC assessment.) this standard describes or refers to. this implies that all relevant tests with regard to test and measurement methods as indicated should be done exactly as required by the standard Notes on some practices There are circumstances where the manufacturer deviates. The harmonised standard may contain additional requirements that are not relevant to the presumption of conformity against the EMCD however.Guidance on using a harmonised standard Referencing a harmonised standard in a DoC means that the manufacturer takes responsibility of the conformity of their equipment with all the relevant provisions listed in the annex of that standard and that this can be demonstrated by applying the methods (tests. comparison with similar apparatus) with sufficient certitude that the requirements of the standard will be met. explanations have to be added to the technical documentation. 52 . while making the EMC assessment. The requirements and limits of the harmonised standard are expected to be met when the equipment is tested to the specification in the standard. The technical documentation should give detailed information on such deviations. The deviations described hereafter imply a risk for the manufacturer.g. under their full responsibility. the harmonised standard is required to contain an annex which provides information on correlation of its technical requirements with the essential requirements of the Directive. design precautions. Based on the risk analysis (see clause 4. measurement methods.ANNEX 2 . a) Manufacturers may decide in some cases not to perform some tests if they can satisfy themselves by other means (e. They may also decide under their sole responsibility not to perform some tests if the inherent physical characteristics of the apparatus are such that negligible disturbances will occur in a given frequency band. without any deviation. if the tests were executed.
53 . More information may be found in EN 55016-2 (CISPR 16-2) on this particular subject. This possibility is depending on its availability in the applied Harmonised Standard.b) A pre-scan measurement is made to quickly obtain information on the unknown emission spectrum of the apparatus in order to decide whether a full complete measurement is considered necessary.
One should be aware that the problem of electromagnetic compatibility may become worse with the trend towards smaller devices operating at higher frequencies. taking into account the common use of radiocommunication products) in combination with the phenomena to be assessed.g. On the other hand it is not feasible to aim for 100 % performance in all situations. In the field of electromagnetic immunity the sources that may create immunity problems are also constantly changing. applying new RF technologies that may require a different protection against disturbances. For emissions there may be special cases. The selection of phenomena to be assessed depends on the environment where the apparatus is being used. Higher speed switching logic increases emissions 54 . for immunity.ANNEX 3 . Although the EMCD does not specify a frequency range. There exists a finite probability that the apparatus in practice will experience disturbance levels the severity of which is above those specified as characteristic of the apparatus. where additional mitigation measures may have to be employed for individual apparatus to reduce the electromagnetic emission further below any specified levels. For some apparatus.e. temporary degradation in performance may be acceptable for certain apparatus. The technology of electromagnetic compatibility has developed over a long period of time and is a fairly complex subject. This does not mean there is a need to apply a full assessment within this range as certain phenomena are limited in frequency range (e. An identical situation may occur for low frequency phenomena. it is general practice to take account of the range of frequency encompassed in the EMC assessment from 0 Hz to 400 GHz. electromagnetic phenomena are inherently limited in frequency range by the principle of construction or the physical nature of the apparatus.EMC assessment where harmonised standards do not exist or are not fully (applied) The EMCD requires the identification of the relevant disturbances and EMC phenomena for the apparatus and the environments where it operates in order to determine the relevant assessment to be performed.g. The use of the radio spectrum is subject to constant changes. for conducted high frequency emission: the frequency range to take into account is usually 9 kHz to 30 MHz). i. for instance when highly susceptible apparatus is being used in proximity. This issue may be taken into account during the assessment. The frequency range to be applied in the assessment depends on the nature of the apparatus and its intended use. However it is important to make sure that the relevant frequency range has been covered (e.
voltage fluctuations) for all apparatus intended to be connected directly to low- voltage public distribution systems. (c) Immunity aspects. (b) High frequency emission aspects. It may also be necessary in some cases to consider a phenomenon that is not listed in the list of examples. EMC covers conducted and radiated phenomena over the whole frequency range from 0 Hz to 400 GHz and may relate to many different phenomena such as given in the following non-exhaustive list of examples. b) signals superimposed on power lines. with circuits packaged more closely together. apparatus sensitive to precise zero crossing in time on the AC (Alternating Current) mains voltage or to specific harmonic components. unless it can be justified that a phenomenon is not relevant for the apparatus to be assessed. c) voltage fluctuations on the mains supply In general. most apparatus are normally not disturbed by voltage fluctuations. nature and interaction of interference sources that are active within the apparatus. decreases immunity. Generally the three main aspects to be covered are: (a) Low-frequency emission on the mains supply (harmonics. Furthermore the mechanisms for radiation from apparatus are complex due to the different number. this phenomenon may be 55 . However. List of examples of electromagnetic phenomena Conducted low frequency phenomena Emission Immunity Harmonics and voltage fluctuations likely a) harmonics. therefore. interharmonics on the to be produced on the mains supply by mains supply apparatus intended to be directly connected to the low-voltage public This phenomenon may be relevant to power distribution system. May be relevant for apparatus operating at low level of sensitivity such as residual current operated protection devices. while low operating voltages and currents. For the detailed technical EMC assessment the phenomena in the list need to be considered. voltage fluctuations have an amplitude not exceeding 10 %.
e) voltage unbalance. d) voltage dips and interruptions on the mains supply To be considered generally for all types of apparatus. relevant for apparatus intended to be installed at locations where the mains have larger fluctuations. g) induced low frequency voltages For sensitive low level measuring instruments. In general only relevant for apparatus which are susceptible to magnetic fields (for example Hall effect devices. Only applicable in special cases for three phase apparatus f) power frequency variations of the mains supply This may apply to apparatus intended to be installed at locations where the power frequency has large variations (for example apparatus connected to an emergency power supply). h) DC (Direct Current) component in AC networks. CRT 56 . If the principle of the apparatus requires or involves a particular sensitivity to such phenomena. this should be indicated in the user documentation. 2) transient. For special cases as residual current circuit breakers Radiated low-frequency field phenomena Emission Immunity Generally not relevant a) magnetic fields 1) continuous.
The common mode voltage (or current) is measured primarily for signal and control lines.: or control) in close proximity to mains. except the simplest ones. which do not contain any source likely to generate high frequency disturbances. b) electric fields. and special apparatus to be installed in high magnetic field environments). 57 . symmetrical mode) – unsymmetrical mode (combines both modes by using specific artificial test networks) NOTE the unsymmetrical mode voltage is primarily measured at the mains network. Relevant only for special applications in measurements Conducted high-frequency phenomena Emission Immunity Generally relevant for most electronic a) induced voltages or currents and for many electrical apparatus. this characteristic should be indicated in the user documentation. fast transient aspects should voltage or as a current. If apparatus is intended for use in a low magnetic field environment. either as a In general. – common mode (also called The surge aspects should be assessed for asymmetrical mode) apparatus which are connected to networks leaving the building or mains in – differential mode (also called general. a) induced voltages or currents b) unidirectional transients . Exceptions may occur for apparatus 1) continuous waves. There are two methods of assessing conducted disturbances. 2) modulated waves. i. Induced high frequency voltages or currents are generally relevant for 3) discontinuous waves electronic apparatus. c) oscillatory transients. 2) modulated waves. 1) continuous waves. Both methods can be assessed for apparatus which are be used to assess the three types of connected to mains or have cables (signal conducted disturbances.e.
b) electric fields. Exceptions may occur for apparatus In general. b) broadband continuous disturbance. apparatus. Generally relevant for most electronic and for many electrical apparatus. Exclusions may include non- electronic apparatus. the radiated immunity to which do not contain any source likely to electromagnetic fields is relevant to all generate high frequency disturbances. Generally magnetic fields are considered up to 30MHz and electromagnetic fields above 30MHz up to 6000MHz. 3) transients. 2) modulated waves. c) electromagnetic fields c) electromagnetic fields 1) continuous waves. This test is mainly applicable to apparatus to be installed in electrical plants (for example telecontrol centres in close proximity to switchgear). 3) transients. 2) modulated waves.Account should be taken of the following types of disturbance: a) narrowband continuous disturbance. Pulse magnetic fields. b) electric fields. Electrostatic discharge phenomena (ESD) Immunity 58 . and c) broadband discontinuous disturbance Radiated high-frequency field phenomena Emission Immunity a) magnetic fields. a) magnetic fields. 1) continuous waves.
Exclusions may include apparatus limited for use in high humidity environments or in ESD-controlled environmental conditions and non-electronic apparatus. 59 .In general. Direct and indirect discharges should be taken into account. electrostatic discharge aspects are applicable to all apparatus to be used in an environment where electrostatic discharges may occur.
which has been excluded from the R&TTE Directive. the making available on the market or putting into service of radio equipment covered by this Directive which is in conformity with the relevant Union harmonisation legislation applicable before 13 June 2016 and which was placed on the market before 13 June 2017. for the aspects covered by this Directive. RED (Directive 2014/53/EU). With regard to Directive 1999/5/EC (the R&TTE Directive). now falls within the scope of the Directive. Member States shall transpose the RED into national legislation by 12th June 2016 and apply it from 13th June 2016. (3) radio-determination equipment is now clearly included within the scope of the Directive.e. the references of the harmonised standards for the R&TTE Directive. 60 . The RED contains the following transitional period (Article 48): Member States shall not impede. The RED replaced Directive 1999/5/EC – the ‘R&TTE Directive’ - from 13 June 2016. this equipment will in future be covered by the LVD/EMC Directive (5) custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes is explicitly excluded from the RED. the RED has introduced the following changes: (1) sound and TV receive-only equipment. which has been excluded from the R&TTE Directive. It is noted that. the intention is to keep valid. Scope of RED The new Radio Equipment Directive (RED) already entered into force (on 11/06/2014). since the R&TTED can be applicable during the transitional period.ANNEX 4 .Application of Directives 2014/53/EU. during the above transitional period. (4) telecom terminal equipment now falls outside the scope of the Directive. as well as the notified bodies notified under the R&TTED. now falls within the scope of the Directive. 2014/35/EU and 2014/30/EU INTRODUCTION The purpose of this annex is to provide guidance on the date of applicability for the new Directives of the electrical sector i. (2) equipment operating below 9 kHz. new LVD (Directive 2014/35/EU) and new EMCD (Directive 2014/30/EU).
Animal fences (1kHz –9kHz). OVERVIEW ON THE APPLICABILITY OF LEGISLATION 1.e. 2) The new LVD/EMCD no longer apply to products covered by the RED. The new LVD replaced Directive 2006/95/EC and the new EMCD replaced Directive 2004/108/EC as of 20/4/2016. LAN internet access gateways. GENERAL COMMENT The RED can apply to products placed on the market on or after 13 June 2016 (not before). Telephone exchanges. Pay telephones.Scope of NEW LVD/EMCD The new LVD and the new EMCD entered into force on 18/04/2014 and apply as of 20/04/2016. Railway applications (500Hz –2kHz). Metal detectors (3kHz –20kHz). telephone answering machines. switches home networking adapters. Examples are: Standalone broadcast receivers (not under the control of a network) that receive radio waves (i. Electronic article surveillance –EAS (10Hz –1kHz). routers. The new LVD and EMCD did not modify the scope of the repealed Directives. PRODUCTS WITHIN OLD LVD/EMCD AND CONTINUE TO BE WITHIN NEW LVD/EMCD (EVEN AFTER APPLICABILITY OF RED) 61 . Stud finder (<9kHz). While the revision of LVD/EMCD has not changed their scope. the changes to the scope of the current R&TTE Directive have direct consequences for the scope of the two Directives: 1) The new LVD/EMCD applies to products that were covered by the R&TTE Directive but not covered now by the RED (telecommunication terminal equipment). Robotic lawnmowers (1kHz –9kHz). This is about all wireline telecommunication products as far as they have no radio function encompassed. Fax machines. Examples of those products are telephones. The new LVD/EMCD can apply to products placed on the market on or after 20 April 2016 (not before). subject to the following new exception that has been explicitly inserted: 'custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes'. Consequently broadcast receivers that do not intentionally receive and/or transmit radio waves stay under the scope of the EMC-D and do not move under the scope of the RED. Broadcast receivers that include DVB-T modules and/or are Wi-Fi enabled).
PRODUCTS WITHIN R&TTED AND THEN OUTSIDE RED-FOR EXAMPLE TERMINAL EQUIPMENT -Products placed on market before 13 June 2016: R&TTED -Products placed on market after 12 June 2016: RED is not applicable. if applicable to the product in question 62 .-Products placed on market before 20 April 2016: old LVD/EMCD -Products placed on market on or after 20 April 2016: new LVD/EMCD 2. PRODUCTS WITHIN OLD/NEW LVD/EMCD BUT THEN FALL WITHIN RED (AFTER APPLICABILITY OF RED)-FOR EXAMPLE TELEVISION AND SOUND BROADCASTING RECEIVERS -Products placed on market before 20 April 2016: old LVD/EMCD -Products placed on market between 20 April 2016 and 12 June 2016 : new LVD/EMCD -Products placed on market between 13 June 2016 and 12 June 2017: RED or new LVD/EMCD -Products placed on market after 12 June 2017: RED 4. PRODUCTS WITHIN R&TTED AND REMAIN WITHIN THE SCOPE OF RED -Products placed on market before 13 June 2016: R&TTED -Products placed on market between 13 June 2016 and 12 June 2017: R&TTED or RED -Products placed on market after 12 June 2017: RED 3. new LVD/EMCD.
29.3. 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 (OJ L 96.europa.htm CEN European Committee for Standardisation CENELEC European Committee for Electrotechnical Standardization CISPR International Special Committee on Radio interference (Comité International Spécial des Perturbations Radioélectriques) DoC EU Declaration of Conformity EEA European Economic Area EMC Electromagnetic Compatibility EMC ADCO EMC Administrative Co-operation Working Group of market surveillance authorities EMCD or new EMCD.eu/growth/single-market/goods/index_en.ANNEX 5 . 79) ESD Electrostatic discharge ESO European Standardisation Organisation European Telecommunications Standards Institute ETSI EU European Union EUANB EU Association of Notified Bodies IEC International Electrotechnical Commission IEV International Electrotechnical Vocabulary ISO International Organization for Standardization ITU International Telecommunication Union 63 . p.Acronyms and abbreviations Blue Guide The 'Blue Guide' on the implementation of EU product rules 2016: http://ec.2014.
p.2008). -Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products. -Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218. 31.8. and repealing Council Decision 93/465/EEC (OJ L 218.8. 13. OJEU Official Journal of the European Union Old EMCD Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (OJ L 390.2004. 13. MRA Mutual Recognition Agreement NB Notified Body NLF New Legislative Framework which includes: -Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218.8. 24) Old LVD Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to Electrical Equipment designed for use within 64 .2008).12.LED Light emitting diode LVD or new LVD Directive 2014/35/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 the making available on the market of electrical equipment designed for use within certain voltage limits. 13.2008).
certain voltage limits (OJ L 374.2014. RF Radio frequency TGN Technical Guidance Note TR Technical Report 65 . 10)– RED Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153. p 62). 22.4.5. 7. p. 27/12/2006) R&TTE Directive or Directive 1999/5/EC of the European Parliament and R&TTED of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (OJ L 91.1999.
the Technical Secretary of the EUANB should be contacted. such as the USA. ETSI. to discuss matters relating to EMCD. as well as in the Countries that have a Mutual Recognition Agreement with the EU covering EMC. EMC ADCO (EMC Administrative Co-operation Working Group of market surveillance authorities) The aim of EMC ADCO is to: − exchange information on national market surveillance activities.ANNEX 6 . To acquire membership. CENELEC. The Technical Secretary of the EUANB is appointed by the European Commission whilst the Chairman is elected by the members. − promote effective market surveillance and enforcement of the EMC Directive. 66 . Australia and Switzerland. All meetings are open to members only with other invited relevant organisations such as representatives of the EU Commission. etc. − stimulate the exchange of information and co-operation between members on operational issues. where all working documents are stored for access by the members only. Membership of EUANB is open to Notified Bodies listed in NANDO that are notified under the EMCD and this guarantees access to relevant material to Notified Bodies to support their work. operated by the EU Commission. − encourage the harmonisation of market surveillance practices to ensure equitable treatment of economic operators in Europe. Furthermore the Association has a specific protected area on the CIRCABC website. − reduce the overlapping of national surveillance operations. It publishes Technical Guidance Notes and Reference Documents that are available to all Notified Bodies that have access to the CIRCABC section for Notified Bodies.Organisations and Committees EUANB (European Union Association of EMC Notified Bodies) EUANB provides a forum for co-ordination and co-operation for Notified Bodies concerned with the assessment of compliance of apparatus under the Directive with regulations and technical standards in the European Economic Area. EUANB operates a mail server where members can raise questions and provide answers and comments as the experts within the Association. EMC ADCO. These discussions provide material to be stored on the protected database for future reference by the members. Canada. The Association meets twice a year in a location within the EEA. New Zealand.
− organise regular joint cross-border EMC market surveillance campaigns to check the compliance level at European level in specific sectors and to raise economic operator and consumer’s awareness of the need for conformity with the requirements of the EMC Directive. − promote the application of the ‘risk analysis’ approach to maximize mutual effectiveness and make the best use of resources.− provide support and guidance for members on practical problems. Canada and other interested countries and encourage the collaboration in the field of market surveillance in a globalised market. 67 . − promote the exchange of information on the regulations in the field of EMC with other economies as US.
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