ETSI EG 201 399 V3.1.1 (2015-03)

ETSI EG 201 399 V3.1.1 (2015-03)






ETSI GUIDE
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
A guide to the production of Harmonized Standards for
application under the Radio & Telecommunication Terminal
Equipment Directive 1999/5/EC (R&TTE) and a first guide on
the impact of the Radio Equipment Directive 2014/53/EU (RED)
on Harmonized Standards

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2 ETSI EG 201 399 V3.1.1 (2015-03)



Reference
REG/ERM-RM-271
Keywords
radio, regulation
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3 ETSI EG 201 399 V3.1.1 (2015-03)
Contents
Intellectual Property Rights . 6
Foreword . 6
Modal verbs terminology . 6
Introduction . 6
1 Scope . 7
2 References . 7
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions, symbols and abbreviations . 11
3.1 Definitions . 11
3.2 Symbols . 12
3.3 Abbreviations . 12
4 Role and purpose of Harmonized Standards . 14
4.1 Background to the Radio Directives . 14
4.1.1 Background to the R&TTE Directive . 14
4.1.2 Background to the RED . 14
4.1.3 Major changes from the R&TTE Directive to the RED . 14
4.1.4 Comparison of the Scopes of the R&TTE Directive and of the RED . 15
4.1.5 Examples of changes in the terminology used in the RED . 18
4.1.6 Further information on the timeline . 18
4.1.7 Multi-module equipment . 18
4.1.8 European Standardization systems : different approached for the development of standards . 18
4.2 Role of Harmonized Standard in Presumption of Conformity . 19
5 Procedure for generation of Harmonized Standards . 19
5.0 Introduction . 19
5.1 Standardization Requests . 19
5.2 The drafting process . 20
5.3 Adoption of Harmonized Standards . 20
5.4 Submission to EC and Publication in the OJEU . 20
5.5 Revision of Harmonized Standards . 21
5.6 Withdrawal of Harmonized Standards . 21
6 Formulation of technical requirements in Harmonized Standards . 21
6.0 Introduction . 21
6.1 Guiding principles . 21
6.1.0 Introduction. 21
6.1.1 General . 21
6.1.2 Innovation . 21
6.1.3 Choice of parameters . 22
6.1.3.0 General . 22
6.1.3.1 Transmitter parameters . 22
6.1.3.2 Receiver parameters . 22
6.2 Article 3.1(a): Protection of health and safety (and protection of property) . 23
6.3 Article 3.1(b): EMC . 23
6.4 Article 3.2 of the R&TTE Directive and of the RED . 23
6.4.0 Introduction. 23
6.4.1 General . 23
6.4.2 Co-operation with ECC and EC (regulatory environment) / usage of spectrum . 24
6.4.3 Parameters forming the basis of regulation . 24
6.4.4 Particular cases . 24
6.4.4.1 Installation of radio equipment . 24
6.4.4.2 Antennas . 24
6.4.4.3 Antenna mast amplifiers . 25
6.4.4.4 Software Defined Radios (SDRs) . 25
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4 ETSI EG 201 399 V3.1.1 (2015-03)
6.4.4.5 Radiodetermination equipment . 25
6.4.4.6 Chargers . 25
6.4.4.7 Other particular devices . 25
6.5 Article 3.3: Additional requirements . 25
7 Guidance for drafting Harmonized Standards . 26
7.1 General drafting considerations . 26
7.1.1 The HS skeleton . 26
7.1.2 Informative material in HSs . 26
7.1.3 Material to be avoided in HSs . 27
7.1.4 Difficulties with implementation of the present document . 27
7.2 Contents of the Harmonized Standard document . 27
7.2.0 Introduction. 27
7.2.1 The Title Page and "page 2" . 27
7.2.2 The Contents List . 27
7.2.3 The "Intellectual Property Rights" clause . 27
7.2.4 The "Foreword" clause . 28
7.2.5 The "Introduction" clause . 28
7.2.6 The "Scope" clause . 28
7.2.7 The "References" clause . 28
7.2.8 The "Definitions, Symbols and abbreviations" clause . 28
7.2.9 The "Technical requirements specifications" clause . 29
7.2.10 The method of measurements and "Testing for compliance with technical requirements" clause . 30
7.2.11 The "Abstract Test Suite" clause . 31
7.2.12 The " HS Requirements Table (HS-RT) Table" annex . 31
7.2.13 Translation of the titles into the official languages . 31
7.3 Effects on the Harmonized Standards of the transition from the R&TTE to the RED . 32
7.3.0 Introduction. 32
7.3.1 Naming/numbering of Harmonized Standards. 32
7.3.2 Effect of the change from the R&TTE to the RED . 32
7.3.2.1 Choice of the parameters . 32
7.3.2.2 Value of the parameters . 32
7.3.3 Transposition dates, Transition periods and effect on new (versions of) Harmonized Standards . 33
7.3.4 Particular case of HSs being drafted at the time of publication of the RED . 33
7.3.5 Particular case of HSs being revised at the time of publication of the RED . 34
Annex A: "Correlation table" . 35
Annex B: Technical parameters and essential requirements . 36
B.1 Typical technical requirements . 36
B.2 Antenna requirements and assessment . 37
B.2.1 Background . 37
B.2.2 Guidelines. 38
Annex C: Background . 39
C.1 The legislative background . 39
C.1.1 The "New approach" . 39
C.1.2 The "NLF" Decision . 39
C.1.3 The "Framework Directive" . 39
C.2 Scope of the Radio Directives . 39
C.2.1 R&TTE Directive . 39
C.2.2 RED . 40
C.3 Implications for Telecommunications Terminal Equipment (TTE) . 40
C.3.1 R&TTED . 40
C.3.2 RED . 40
C.4 Implications for Radio Equipment (RE) . 40
C.4.1 R&TTE Directive . 40
C.4.2 RED . 41
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5 ETSI EG 201 399 V3.1.1 (2015-03)
C.5 Equipment classes and equipment class identifiers . 41
C.6 Notified interfaces . 42
C.6.1 R&TTED . 42
C.6.2 RED . 42
C.7 Specification of interfaces offered by public telecommunications operators . 42
C.7.1 R&TTED . 42
C.7.2 RED . 42
C.8 Other relevant Directives for radio equipment . 42
Annex D: The modular nature of ETSI's R&TTE and RED Harmonized Standards . 45
D.0 General . 45
D.1 Under the R&TTE . 45
D.2 Under the RED . 48
Annex E: Examples showing how to structure clauses addressing technical requirements . 50
E.1 Example of structure . 50
E.2 Example of structure for the description of a method of measurement . 50
Annex F: HS-RT . 52
Annex G: "Frequently Asked Questions (FAQ)" relating to Harmonized Standards under
the R&TTE Directive, the RED and/or relating to the present document . 53
G.1 Introduction . 53
G.2 FAQs relating to the R&TTE Directive, the RED and the corresponding HSs . 53
Annex H: Bibliography . 56
History . 57

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6 ETSI EG 201 399 V3.1.1 (2015-03)
Intellectual Property Rights
IPRs essential or potentially essential to the present document may have been declared to ETSI. The information
pertaining to these essential IPRs, if any, is publicly available for ETSI members and non-members, and can be found
in ETSI SR 000 314: "Intellectual Property Rights (IPRs); Essential, or potentially Essential, IPRs notified to ETSI in
respect of ETSI standards", which is available from the ETSI Secretariat. Latest updates are available on the ETSI Web
server (http://ipr.etsi.org).
Pursuant to the ETSI IPR Policy, no investigation, including IPR searches, has been carried out by ETSI. No guarantee
can be given as to the existence of other IPRs not referenced in ETSI SR 000 314 (or the updates on the ETSI Web
server) which are, or may be, or may become, essential to the present document.
Foreword
This ETSI Guide (EG) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio
spectrum Matters (ERM).
The drafting of the present document has been triggered by the publication of the Radio Equipment Directive (RED) i.e.
Directive 2014/53/EU [i.1].
In the present document the major differences between the R&TTE Directive [i.2] and the RED [i.1] and their impact in
the drafting of Harmonized Standards have been highlighted. This approach has been followed as ETSI is working, at
the moment when the present version of the Guide is being written, on a work programme whereby the Harmonized
Standards supporting the R&TTE Directive [i.2] will be converted to support the RED [i.1]. It is therfore necessary to
have the elements identifying what should be changed when converting the Harmonized Standards.
Modal verbs terminology
In the present document "shall", "shall not", "should", "should not", "may", "need not", "will", "will not", "can" and
"cannot" are to be interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of
provisions).
"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.
Introduction
Earlier versions of the present document had been prepared to assist ETSI Technical Bodies in the preparation of
Harmonized Standards for application under the Radio Equipment and Telecommunications Terminal Equipment
Directive (R&TTE Directive [i.2]) only. In addition, the present document addresses the first guidance on the impact on
the drafting of Harmonized Standards for application under the Radio Equipment Directive (RED) [i.1]; furthermore, it
supports a consistent interpretation of the technical (and possibly non-technical) requirements needed to implement the
essential requirements of these Directives.
ETSI has published more than two hundred Harmonized Standards in relation to the R&TTE Directive. Therefore, the
present document includes detailed comparisons of the two Radio Directives [i.2] and [i.1] (in particular in clause 4).
Aspects relating to the transition between the R&TTE Directive [i.2] to the RED [i.1] are covered in clause 7.3 of the
present document.
Annex C to the present document gives some background to the R&TTE Directive [i.2] and to the RED [i.1]. Reference
is made to the framework of legal documents implementing these Directives, but the present document should not be
taken as an interpretation, amplification, or restatement of any other documents. A number of requirements originate
from the legal framework in place and not from the present document.
A short list of Frequently Asked Questions (FAQs) relating to Harmonized Standards under these Radio Directives [i.2]
and [i.1], and/or the present document as well as their answers is provided in annex G.
NOTE: At the time of drafting the present document, TCAM had not yet had the opportunity of offering
clarifications on the RED. A TCAM guide on the RED is planned to be prepared.
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7 ETSI EG 201 399 V3.1.1 (2015-03)
1 Scope
The present document gives guidance to ETSI Technical Bodies and Rapporteurs on the production of Harmonized
Standards (HSs) produced by ETSI for application:
• under the R&TTE Directive [i.2] (article 5); and
• a first guide under the RED [i.1] (articles 16 and 17).
NOTE: In the present document, where "the Radio Directives" is written, this means the R&TTE Directive [i.2]
and/or to the RED [i.1], as appropriate.
2 References
2.1 Normative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
Referenced documents which are not found to be publicly available in the expected location might be found at
http://docbox.etsi.org/Reference.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are necessary for the application of the present document.
Not applicable.
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
NOTE: While any hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee
their long term validity.
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] 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.
NOTE: The "RED".
[i.2] Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio
equipment and telecommunications terminal equipment and the mutual recognition of their
conformity.
NOTE: The "R&TTE Directive".
[i.3] 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 (recast).
NOTE: The "Directive LVD" of 2014.
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8 ETSI EG 201 399 V3.1.1 (2015-03)
[i.4] Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member
States relating to Electrical Equipment designed for use within certain voltage limits.
NOTE: The "LV Directive".
[i.5] 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 certain voltage limits.
[i.6] 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 r
...