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欧盟 EMC 指令 指引 Directive 2004_108_EC
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- 1/67 -–
Guide for the EMC Directive 2004/108/EC
(8th February 2010)
Ref. Ares(2015)1692637 - 21/04/2015

- 2/67 -–
Table of contents
INTRODUCTION.....................................................................................................5
1 SCOPE ..............................................................................................................8
1.1 General.......................................................................................................8
1.1.1 Equipment without electrical and/or electronic parts.........................10
1.1.2 Explicit exclusions from the EMC Directive.....................................11
1.1.3 Equipment covered by other specific Community Directives ............12
1.1.4 Inherently benign equipment.............................................................14
1.1.5 Classification as apparatus or fixed installation.................................15
1.2 Defining the scope of apparatus................................................................16
1.2.1 Finished appliances...........................................................................18
1.2.2 Combination of finished appliances (systems)...................................19
1.2.3 Components/Sub-assemblies.............................................................19
1.2.4 Mobile installations ..........................................................................20
1.2.5 Second-hand apparatus .....................................................................20
1.2.6 Products for own use ........................................................................21
1.3 Defining the scope for fixed installations..................................................21
1.3.1 Fixed installations.............................................................................21
1.3.2 Specific apparatus for fixed installations...........................................22
2 ESSENTIAL REQUIREMENTS.....................................................................23
3 CONFORMITY ASSESSMENT PROCEDURE FOR APPARATUS..............24
3.1 Introduction..............................................................................................24
3.2 EMC Assessment .....................................................................................25
3.2.1 General Concept......................................................................................25
3.2.2 Use of EMC European harmonised standards..........................................28
3.2.3 An EMC assessment where no harmonised standards have been applied .31
3.3 Documentation required by the EMC Directive........................................33
3.3.1 Technical documentation..................................................................33
3.3.2 EC Declaration of Conformity..........................................................34
3.3.3 The Concept of “holding at the disposal”..........................................36
3.4 CE Marking and information....................................................................37
3.4.1 CE marking ......................................................................................37
3.4.2 Other identifying marks ....................................................................39
3.4.3 Information for traceability...............................................................39
3.4.4 Information regarding installation, use and maintenance...................40

- 3/67 -–
3.4.5 Information when compliance is not ensured with the limits of the
protection requirements in residential areas......................................................41
4 FIXED INSTALLATIONS..............................................................................41
4.1 Essential Requirements ............................................................................41
4.2 Documentation.........................................................................................44
4.3 Responsible person for fixed installations.................................................44
4.4 Requirements for specific apparatus for given fixed installations..............44
4.4.1. Obligations when the exemption clause is used for specific apparatus.....45
5 ENFORCEMENT OF THE EMC DIRECTIVE...............................................46
5.1 Special measures regarding equipment at trade fairs, etc...........................46
6 NOTIFIED BODIES........................................................................................47
6.1 General concept........................................................................................47
6.2 Role of Notified Bodies............................................................................48
6.3 Selection of a Notified Body ....................................................................48
6.4 Coordination between Notified Bodies. ....................................................49
6.5 Complaints regarding the service of the NB..............................................49
ANNEX 1 - Overall Flowchart ................................................................................50
ANNEX 2 - Guidance on using a (harmonised) standard..........................................51
ANNEX 3 - EMC assessment where harmonised standards have not been applied in
whole or in part........................................................................................................53
ANNEX 4 – Transitional arrangements....................................................................59
ANNEX 5 Examples of EC Declarations of Conformity........................................61
ANNEX 6 Acronyms and abbreviations..................................................................66
Table of Flowcharts
FLOWCHART 1 – SCOPE..............................................................................................................10
FLOWCHART 2 – CLASSIFICATION AS APPARATUS..............................................................16
FLOWCHART 3 – PROVISIONS APPLICABLE TO APPARATUS ..............................................18
FLOWCHART 4 – INSTALLATIONS............................................................................................22
FLOWCHART 5 - CONFORMITY ASSESSMENT PROCEDURE FOR APPARATUS .................25

- 4/67 -–
Disclaimer
These guidelines are intended to be a manual for all parties directly or indirectly
affected by the “new” EMC (ElectroMagnetic Compatibility) Directive 2004/108/EC.
They assist in the interpretation of the Directive but do not substitute for it; they
explain and clarify some of the most important aspects related to its application. The
Guide is also intended to ensure the free movement of products in the EU Single
Market by agreement of these explanations and clarifications, reached by consensus
amongst Member States and other stakeholders
These Guidelines are publicly available, but they are not binding in the sense of legal
acts adopted by the Community. The legally binding provisions are those transposing
the EMC Directive at national level.
Finally, the reader’s attention is drawn to the fact that all references to the CE
marking and EC Declaration of Conformity relate only to the EMC Directive and that
the freedom to place an apparatus on the market in the EU Internal Market is only
guaranteed when applying all relevant legislation.

- 5/67 -–
INTRODUCTION
The purpose of this document is to give guidance on certain matters and procedures of
the Directive 2004/108/EC
1
on the approximation of the laws of the Member States
relating to electromagnetic compatibility
2
.
The Electromagnetic Compatibility (EMC) Directive 2004/108/EC repeals the
previous EMC Directive 89/336/EEC
3
(as amended by Directives 91/263/EEC
4
,
92/31/EEC
5
, 93/68/EEC
6
and 93/97/EEC
7
) and maintains the same objectives - to
guarantee the free movement of apparatus and to create an acceptable electromagnetic
environment in the Community territory
8
. The original protection requirements are
not changed in practice and apply to apparatus and to fixed installations.
The main objective of the EMC Directive is thus to regulate the compatibility of
equipment regarding EMC. In order to achieve this objective, provisions have been
put in place so that:
1
OJ No L390, 31.12.2004
2
The European Commission will undertake to maintain this guide. It is our goal to ensure that the information
provided is both timely and accurate. If errors are brought to our attention, we will try to correct them.
However, the Commission accepts no responsibility or liability whatsoever with regard to the information in
this guide.
This information is:
- of a general nature only and is not intended to address the specific circumstances of any particular individual
or entity;
- not necessarily comprehensive, complete, accurate or up to date;
- sometimes refers to external information over which the Commission services have no control and for which
the Commission assumes no responsibility;
- not professional or legal advice.
3
OJ No L 139, 23.5.1989
4
OJ No L 128, 23.5.1991
5
OJ No L126, 12.5.1992
6
OJ No L 220, 20.8.1993
7
OJ No L 290, 24.11.1993
8
According to the agreement related to the European Economic Area (EEA) (Council and Commission Decision
94/1/EC of 13 December 1993 (OJEC n° L 1 of 3 January 1994, p. 1) the territories of Liechtenstein, Iceland
and Norway have to be considered, for the implementation of Directive 94/9/EC, in the same right as of the
Community territory. When the term, “Community” territory, is used in this guide, the same applies to the
EEA territory. Directive 2004//108/EC is also applicable in other territories where a suitable international
agreement is in operation.
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