Electromagnetic compatibility and Radio spectrum Matters (ERM) - A guide to the production of Harmonized Standards for application under the R&TTE Directive

This revision of EG 201 399 is triggered in particular by a number of Action Points of the OCG R&TTE D : Actions 33/6 (editorial and substance), 36/3 (on alignment of text), 37/3 (more extensive usage of receiver parameters in harmonized standards) and 39/1(see document RTTED 39_05). Clarification of “E”, “O” and “X” is also sought. For further details see also document RTTED 39_09.Finally, the implications of the ERM_FLX report, TR 102 748, and the proposals made in TR 102 914 are also to be considered during this revision.

Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) - Navodilo za izdelavo harmoniziranih standardov v skladu z direktivo R&TTE

Ta dokument obravnava standarde HS, ki jih je organizacija ETSI oblikovala za uporabo v skladu z direktivo R&TTE [i.1] (člen 5) (samo te standarde, natančneje, ne obravnava vseh standardov ETSI).
Ta dokument se ne uporablja za dokumente, ki so jih oblikovali drugi organi za standarde (tj. CEN in CENELEC), čeprav se nekateri od teh standardov uporabljajo v skladu z direktivo R&TTE [i.1].

General Information

Status
Published
Publication Date
06-Feb-2012
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
07-Apr-2011
Due Date
12-Jun-2011
Completion Date
07-Feb-2012

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Final draft ETSI EG 201 399 V2.2.1 (2010-06)
ETSI Guide


Electromagnetic compatibility
and Radio spectrum Matters (ERM);
A guide to the production of Harmonized Standards
for application under the R&TTE Directive

---------------------- Page: 1 ----------------------
2 Final draft ETSI EG 201 399 V2.2.1 (2010-06)



Reference
REG/ERM-RM-261
Keywords
radio, regulation, terminal
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

Important notice
Individual copies of the present document can be downloaded from:
http://www.etsi.org
The present document may be made available in more than one electronic version or in print. In any case of existing or
perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF).
In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive
within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
http://portal.etsi.org/tb/status/status.asp
If you find errors in the present document, please send your comment to one of the following services:
http://portal.etsi.org/chaircor/ETSI_support.asp
Copyright Notification
No part may be reproduced except as authorized by written permission.
The copyright and the foregoing restriction extend to reproduction in all media.

© European Telecommunications Standards Institute 2010.
All rights reserved.

TM TM TM TM
DECT , PLUGTESTS , UMTS , TIPHON , the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered
for the benefit of its Members.
TM
3GPP is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners.
LTE™ is a Trade Mark of ETSI currently being registered
for the benefit of its Members and of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI

---------------------- Page: 2 ----------------------
3 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
Contents
Intellectual Property Rights . 5
Foreword . 5
Introduction . 6
1 Scope . 7
2 References . 7
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions and abbreviations . 9
3.1 Definitions . 9
3.2 Abbreviations . 10
4 Role and purpose of Harmonized Standards . 11
4.1 Background to the R&TTE Directive . 11
4.2 Role of Harmonized Standard in Presumption of Conformity . 12
5 Procedure for generation of Harmonized Standards . 12
5.1 Standardization mandate . 12
5.2 The drafting process . 13
5.3 Adoption of Harmonized Standards . 13
5.4 Submission to EC and Publication in the OJEU . 13
5.5 Revision of Harmonized Standards . 13
5.6 Withdrawal of Harmonized Standards . 13
6 Formulation of technical requirements . 14
6.1 Guiding principles . 14
6.1.1 General . 14
6.1.2 Level of technological independence . 14
6.1.3 Equipment attributes . 14
6.1.4 Evaluation of parameters . 15
6.2 Article 3.1(a): Safety and protection of health . 16
6.3 Article 3.1(b): EMC . 16
6.4 Article 3.2: "The effective use of the radio spectrum allocated to terrestrial/space radio communication
and orbital resources so as to avoid harmful interference" . 16
6.4.1 General . 16
6.4.2 Co-operation with ECC and EC (regulatory environment) / usage of spectrum . 17
6.4.3 Parameters forming the basis of regulation . 17
6.5 Article 3.3: Additional requirements . 18
7 Guidance for drafting Harmonized Standards . 18
7.1 General drafting considerations . 18
7.1.1 The HS skeleton . 18
7.1.2 Informative material in HSs . 18
7.1.3 Material to be avoided in HSs . 18
7.1.4 Difficulties with implementation of the present document . 19
7.2 Contents of the Harmonized Standard document . 19
7.2.1 The Title Page and "page 2" . 19
7.2.2 The Contents List . 19
7.2.3 The "Intellectual Property Rights" clause . 19
7.2.4 The "Foreword" clause . 20
7.2.5 The "Introduction" clause . 20
7.2.6 The "Scope" clause . 20
7.2.7 The " References" clause . 20
7.2.8 The "Definitions, Symbols and abbreviations" clause . 20
7.2.9 The "Technical requirements specifications" clause . 21
7.2.10 The "Testing for compliance with technical requirements" clause . 22
ETSI

---------------------- Page: 3 ----------------------
4 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
7.2.11 The "Abstract Test Suite" clause . 22
7.2.12 The "HS Requirements and conformance Test specifications (HS-RTT) Table" annex . 23
7.2.13 "The EN title in the official languages" annex . 23
Annex A: Evaluation of technical parameters according to essential requirements applicable
to equipment attributes . 24
A.1 Equipment attributes. 24
A.2 Technical Phenomena. 26
A.3 Antennas, borderline of coverage of the Directive . 27
Annex B: Alternative formulations . 29
B.1 Alternative formulation of requirements under article 3.2 . 29
B.2 Second alternative formulation of requirements for Attribute "A" . 30
B.2.1 Control and monitoring functions of a Terminal . 30
Annex C: Background . 31
C.1 The "New approach" . 31
C.2 Scope of the Directive . 31
C.3 Implications for Telecommunications Terminal Equipment (TTE) . 31
C.4 Implications for Radio Equipment (RE) . 32
C.5 Equipment classes and equipment class identifiers . 32
C.6 Notified interfaces . 33
C.7 Specification of interfaces offered by public telecommunications operators . 33
Annex D: The modular nature of ETSI's R&TTE Harmonized Standards . 34
Annex E: Examples showing how to structure clauses addressing technical requirements . 36
E.1 Example of structure . 36
E.2 Example of structure for the description of a method of measurement . 36
Annex F: HS-RTT . 38
Annex G: "Frequently Asked Questions (FAQ)" relating to Harmonized Standards under
the R&TTE Directive and/or relating to the present document . 40
G.1 Introduction . 40
G.2 FAQs relating to the R&TTE Directive and the corresponding HSs . 40
History . 43

ETSI

---------------------- Page: 4 ----------------------
5 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
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://webapp.etsi.org/IPR/home.asp).
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), and is now submitted for the ETSI standards Membership Approval Procedure.
The present version of the document (i.e. version 2.2.1) is a development of the previous version, in particular it has
been brought up to date following recent events in TCAM, RSCom and in the OCG R&TTE Working Group of ETSI.
Some of the major developments appearing in version 2.2.1 with respect to version 2.1.1 are:
- the modification of the environmental profile to allow for the special case for the marine environment;
- the modification of the text of clause A.3 to correspond with the TCAM guidance and decision on antennas;
- the addition of guidance on the structure of clauses i.e. applicability, method of measurement, limit;
- enhanced guidance on definitions to be used in Harmonized Standards;
- replacement of a number of deliverables due to the production of EG 201 730 [i.13] to [i.16] and withdrawal
of TR 101 845 [i.34];
- precision of the text in clause C.7 on "interface specifications" in order to align it with clause 4.2 of the
R&TTE Directive [i.26].
During the revision, have also been:
- introduced changes consequential to the withdrawal of SR 001 470 [i.35] containing the pro-forma for the
production of Harmonized Standards and replacement by the Harmonized Standard skeleton document [i.22];
- introduced changes consequential to the withdrawal of SR 001 262 [i.36] and the inclusion of the ETSI
Drafting Rules in the ETSI Directives [i.6];
- avoided duplications of ETSI Drafting Rules text, by replacing text with a pointer to the ETSI Drafting Rules;
- deleted copyright release text;
- removed the occurrences of "candidate" in "candidate Harmonized Standard" since this terminology is no
longer used by ETSI;
- made modifications concerning the title translation text in order to correspond with the current practices;
- made the alignment of requirements on normative references in Harmonized Standards with the requirements
of the European Commission;
- clarified the wording in annexes A and F;
- made a split within the text of the "Scope", in order have both "Introduction" and "Scope";
ETSI

---------------------- Page: 5 ----------------------
6 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
- added a new annex E; the previous annexes E and F became therefore F and G;
- added a reference to EC Decision 2000/299/EC [i.25];
- performed a number of editorial enhancements of text.
Introduction
The present document has 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.26]); furthermore, it establishes a methodology to allow those technical bodies to have a
consistent interpretation of the technical requirements needed to implement the essential requirements of the
R&TTE Directive [i.1].
Annex C to the present document gives some background to the R&TTE Directive [i.1]. Reference is made to the
framework of legal documents implementing the R&TTE Directive [i.1], but the present document should not be taken
as an interpretation, amplification, or restatement of any other documents. More generally, the present document
reminds the reader that there are a number of regulatory requirements that Members States and the various stakeholders
have to comply with. As clarified above, 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 the R&TTE Directive [i.1]
and/or the present document as well as their answers is provided in annex G.
ETSI

---------------------- Page: 6 ----------------------
7 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
1 Scope
The present document addresses those HSs produced for application under the R&TTE Directive [i.1] (article 5) by
ETSI (and only those; more specifically, it does not address all ETSI standards).
The present document is not applicable to documents produced by other standards bodies (i.e. CEN and CENELEC)
even if some of the standards they produce have application under the R&TTE Directive [i.1].
2 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
reference 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.
2.1 Normative references
The following referenced documents are necessary for the application of the present document.
Not applicable.
2.2 Informative references
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 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 (R&TTE Directive).
[i.2] Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member
States relating to electrical equipment designed for use within certain voltage limits
(LV Directive).
[i.3] 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.4] 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 (EMC Directive).
[i.5] Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to
telecommunications terminal equipment and satellite earth station equipment, including the mutual
recognition of their conformity.
[i.6] ETSI Directives: "ETSI drafting rules".
[i.7] Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards.
[i.8] Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical standards and regulations.
ETSI

---------------------- Page: 7 ----------------------
8 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
[i.9] ETSI TR 100 028 (V1.4.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
[i.10] CENELEC EN 60950 (all applicable parts): "Safety of information technology equipment".
[i.11] CENELEC TR 62102: "Electrical safety - Classification of interfaces for equipment to be
connected to information and communications technology networks".
[i.12] ETSI EG 201 838: "ElectroMagnetic Compatibility and Radio Spectrum Matters (ERM);
Publication of interface specifications under Directive 1999/5/EC; Guidelines for describing radio
access interfaces".
[i.13] ETSI EG 201 730-1: "Terminals' access to Public Telecommunications Networks; Application of
the Directive 1999/5/EC (R&TTE), article 4.2; Guidelines for the publication of interface
specifications; Part 1: General and common aspects".
[i.14] ETSI EG 201 730-2: "Terminals' access to Public Telecommunications Networks; Application of
the Directive 1999/5/EC (R&TTE), article 4.2; Guidelines for the publication of interface
specifications; Part 2: Analogue narrow-band wireline interfaces".
[i.15] ETSI EG 201 730-3: "Terminals' access to Public Telecommunications Networks; Application of
the Directive 1999/5/EC (R&TTE), article 4.2;Guidelines for the publication of interface
specifications; Part 3: Digital wireline interfaces".
[i.16] ETSI EG 201 730-4: "Terminals' access to Public Telecommunications Networks;Application of
the Directive 1999/5/EC (R&TTE), article 4.2;Guidelines for the publication of interface
specifications; Part 4: Broadband multimedia cable network interfaces".
[i.17] ETSI EN 300 718-3: "Electromagnetic compatibility and Radio spectrum matters (ERM);
Avalanche Beacons; Transmitter-receiver systems; Part 3: Harmonized EN covering essential
requirements of article 3.3e of the R&TTE Directive".
[i.18] ETSI EN 301 025-3: "Electromagnetic compatibility and Radio spectrum Matters (ERM); VHF
radiotelephone equipment for general communications and associated equipment for Class "D"
Digital Selective Calling (DSC); Part 3: Harmonized EN under article 3.3 (e) of the R&TTE
Directive".
[i.19] ETSI CEPT MoU.
NOTE: See http://webapp.etsi.org/agreementview.
[i.20] ERC/ECC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.21] ETSI EN 301 489 (all parts): " Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services".
[i.22] Harmonized Standard skeleton document.
NOTE: See http://portal.etsi.org/edithelp/Files/zip/ETSI_HS_EN_skeleton.zip.
[i.23] Radio Spectrum Policy Group Opinion on Streamlining the regulatory environment for the use of
spectrum (RSPG08-246).
[i.24] ETSI TR 102 914: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Aspects
and implications of the inclusion of receiver parameters within ETSI standards".
[i.25] COMMISSION DECISION 2000/299/EC of 6 April 2000 "establishing the initial classification of
radio equipment and telecommunications terminal equipment and associated identifiers ".
[i.26] Guide to the R&TTE Directive 1999/5/EC Version of 20 April 2009.
[i.27] ETSI EN 300 296-1: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Land
Mobile Service; Radio equipment using integral antennas intended primarily for analogue speech;
Part 1: Technical characteristics and methods of measurement".
ETSI

---------------------- Page: 8 ----------------------
9 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
[i.28] Commission Decision 2004/71/EC of 4 September 2003 on essential requirements relating to
marine radio communication equipment which is intended to be used on non-SOLAS vessels and
to participate in the Global Maritime Distress and Safety System (GMDSS).
[i.29] ETSI TErms and Definitions Database Interactive (TEDDI).
NOTE: See http://webapp.etsi.org/Teddi/.
[i.30] ITU Radio Regulations.
[i.31] DECISION No 676/2002/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of
7 March 2002 on a regulatory framework for radio spectrum policy in the European Community
(Radio Spectrum Decision).
[i.32] ETSI TR 102 579: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Report
providing guidance for the production of Community Specifications for application under the
Single European Sky Interoperability Regulation EC 552/2004".
[i.33] Interoperability Regulation EC 552/2004: "Regulation on the interoperability of the European Air
Traffic Management network".
[i.34] ETSI TR 101 845: "Fixed Radio Systems; Technical Information on RF Interfaces applied by
Fixed Service Systems including Fixed Wireless Access (FWA) in the light of the R&TTE
Directive (Article 4.2)".
[i.35] ETSI SR 001 470: "Guidance to the production of candidate Harmonized Standards for application
under the R&TTE Directive (1999/5/EC); Pro-forma candidate Harmonized Standard".
[i.36] ETSI SR 001 262: "ETSI drafting rules".
[i.37] Guide to the implementation of directives based on the New Approach and the Global Approach,
European Commission, 2000.
[i.38] 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, and repealing Council Decision 93/465/EEC.
[i.39] ETSI Directives: "ETSI Technical Working Procedures", 28 Jan. 2010.
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in R&TTE Directive [i.1] and the following
apply:
equipment class: has the same meaning as equipment class in the R&TTE Directive [i.1], article 2f: "a class identifying
particular types of apparatus which under this Directive are considered similar and those interfaces for which the
apparatus is designed"
NOTE: Apparatus may belong to more than one equipment class.
See also COMMISSION DECISION 2000/299/EC of 6 April 2000 [i.25].
essential radio test suite: one or more test procedure(s), referred to in annex III of the R&TTE Directive [i.1]
essential requirement: has the same meaning as essential requirement in the R&TTE Directive [i.1]
harmful interference: has the same meaning as harmful interference as in the R&TTE Directive [i.1],
article 2i: "interference which endangers the functioning of a radionavigation service or of other safety services or
which otherwise seriously degrades, obstructs or repeatedly interrupts a radiocommunications service operating in
accordance with the applicable Community or national regulations"
ETSI

---------------------- Page: 9 ----------------------
10 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
Harmonized Standard: has the same meaning as harmonized standard in the R&TTE Directive [i.1], article 2h: "a
technical specification adopted by a recognized standards body under a mandate from the Commission in conformity
with the procedures laid down in Directive 98/34/EC [i.8] for the purposes of establishing a European requirement,
compliance with which is not compulsory"
NOTE: Unless the context indicates otherwise, this is restricted to those Harmonized Standards within the scope
of the present document.
HS Requirements and conformance Test specifications Table (HS-RTT): table annexed to a Harmonized Standard
concisely setting out explicit references to the specification of each technical requirement and, where appropriate, the
corresponding test procedure which may be executed to demonstrate that a particular equipment conforms with that
requirement
NOTE: It also indicates w
...

SLOVENSKI STANDARD
SIST-V ETSI/EG 201 399 V2.2.1:2012
01-marec-2012
Elektromagnetna združljivost in zadeve v zvezi z radijskim spektrom (ERM) -
Navodilo za izdelavo harmoniziranih standardov v skladu z direktivo R&TTE
Electromagnetic compatibility and Radio spectrum Matters (ERM) - A guide to the
production of Harmonized Standards for application under the R&TTE Directive
Ta slovenski standard je istoveten z: EG 201 399 Version 2.2.1
ICS:
33.060.01 Radijske komunikacije na Radiocommunications in
splošno general
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
SIST-V ETSI/EG 201 399 V2.2.1:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-V ETSI/EG 201 399 V2.2.1:2012

---------------------- Page: 2 ----------------------

SIST-V ETSI/EG 201 399 V2.2.1:2012

ETSI EG 201 399 V2.2.1 (2010-08)
ETSI Guide


Electromagnetic compatibility
and Radio spectrum Matters (ERM);
A guide to the production of Harmonized Standards
for application under the R&TTE Directive

---------------------- Page: 3 ----------------------

SIST-V ETSI/EG 201 399 V2.2.1:2012
 2 ETSI EG 201 399 V2.2.1 (2010-08)



Reference
REG/ERM-RM-261
Keywords
radio, regulation, terminal
ETSI
650 Route des Lucioles
F-06921 Sophia Antipolis Cedex - FRANCE

Tel.: +33 4 92 94 42 00  Fax: +33 4 93 65 47 16

Siret N° 348 623 562 00017 - NAF 742 C
Association à but non lucratif enregistrée à la
Sous-Préfecture de Grasse (06) N° 7803/88

Important notice
Individual copies of the present document can be downloaded from:
http://www.etsi.org
The present document may be made available in more than one electronic version or in print. In any case of existing or
perceived difference in contents between such versions, the reference version is the Portable Document Format (PDF).
In case of dispute, the reference shall be the printing on ETSI printers of the PDF version kept on a specific network drive
within ETSI Secretariat.
Users of the present document should be aware that the document may be subject to revision or change of status.
Information on the current status of this and other ETSI documents is available at
http://portal.etsi.org/tb/status/status.asp
If you find errors in the present document, please send your comment to one of the following services:
http://portal.etsi.org/chaircor/ETSI_support.asp
Copyright Notification
No part may be reproduced except as authorized by written permission.
The copyright and the foregoing restriction extend to reproduction in all media.

© European Telecommunications Standards Institute 2010.
All rights reserved.

TM TM TM TM
DECT , PLUGTESTS , UMTS , TIPHON , the TIPHON logo and the ETSI logo are Trade Marks of ETSI registered
for the benefit of its Members.
TM
3GPP is a Trade Mark of ETSI registered for the benefit of its Members and of the 3GPP Organizational Partners.
LTE™ is a Trade Mark of ETSI currently being registered
for the benefit of its Members and of the 3GPP Organizational Partners.
GSM® and the GSM logo are Trade Marks registered and owned by the GSM Association.
ETSI

---------------------- Page: 4 ----------------------

SIST-V ETSI/EG 201 399 V2.2.1:2012
 3 ETSI EG 201 399 V2.2.1 (2010-08)
Contents
Intellectual Property Rights . 5
Foreword . 5
Introduction . 6
1 Scope . 7
2 References . 7
2.1 Normative references . 7
2.2 Informative references . 7
3 Definitions and abbreviations . 9
3.1 Definitions . 9
3.2 Abbreviations . 10
4 Role and purpose of Harmonized Standards . 11
4.1 Background to the R&TTE Directive . 11
4.2 Role of Harmonized Standard in Presumption of Conformity . 12
5 Procedure for generation of Harmonized Standards . 12
5.1 Standardization mandate . 12
5.2 The drafting process . 13
5.3 Adoption of Harmonized Standards . 13
5.4 Submission to EC and Publication in the OJEU . 13
5.5 Revision of Harmonized Standards . 13
5.6 Withdrawal of Harmonized Standards . 13
6 Formulation of technical requirements . 14
6.1 Guiding principles . 14
6.1.1 General . 14
6.1.2 Level of technological independence . 14
6.1.3 Equipment attributes . 14
6.1.4 Evaluation of parameters . 15
6.2 Article 3.1(a): Safety and protection of health . 16
6.3 Article 3.1(b): EMC . 16
6.4 Article 3.2: "The effective use of the radio spectrum allocated to terrestrial/space radio communication
and orbital resources so as to avoid harmful interference" . 16
6.4.1 General . 16
6.4.2 Co-operation with ECC and EC (regulatory environment) / usage of spectrum . 17
6.4.3 Parameters forming the basis of regulation . 17
6.5 Article 3.3: Additional requirements . 18
7 Guidance for drafting Harmonized Standards . 18
7.1 General drafting considerations . 18
7.1.1 The HS skeleton . 18
7.1.2 Informative material in HSs . 18
7.1.3 Material to be avoided in HSs . 19
7.1.4 Difficulties with implementation of the present document . 19
7.2 Contents of the Harmonized Standard document . 19
7.2.1 The Title Page and "page 2" . 19
7.2.2 The Contents List . 19
7.2.3 The "Intellectual Property Rights" clause . 20
7.2.4 The "Foreword" clause . 20
7.2.5 The "Introduction" clause . 20
7.2.6 The "Scope" clause . 20
7.2.7 The " References" clause . 20
7.2.8 The "Definitions, Symbols and abbreviations" clause . 20
7.2.9 The "Technical requirements specifications" clause . 21
7.2.10 The "Testing for compliance with technical requirements" clause . 22
ETSI

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SIST-V ETSI/EG 201 399 V2.2.1:2012
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7.2.11 The "Abstract Test Suite" clause . 23
7.2.12 The "HS Requirements and conformance Test specifications (HS-RTT) Table" annex . 23
7.2.13 "The EN title in the official languages" annex . 24
Annex A: Evaluation of technical parameters according to essential requirements applicable
to equipment attributes . 25
A.1 Equipment attributes. 25
A.2 Technical Phenomena. 27
A.3 Antennas, borderline of coverage of the Directive . 28
Annex B: Alternative formulations . 30
B.1 Alternative formulation of requirements under article 3.2 . 30
B.2 Second alternative formulation of requirements for Attribute "A" . 31
B.2.1 Control and monitoring functions of a Terminal . 31
Annex C: Background . 32
C.1 The "New approach" . 32
C.2 Scope of the Directive . 32
C.3 Implications for Telecommunications Terminal Equipment (TTE) . 32
C.4 Implications for Radio Equipment (RE) . 33
C.5 Equipment classes and equipment class identifiers . 33
C.6 Notified interfaces . 34
C.7 Specification of interfaces offered by public telecommunications operators . 34
Annex D: The modular nature of ETSI's R&TTE Harmonized Standards . 35
Annex E: Examples showing how to structure clauses addressing technical requirements . 37
E.1 Example of structure . 37
E.2 Example of structure for the description of a method of measurement . 37
Annex F: HS-RTT . 39
Annex G: "Frequently Asked Questions (FAQ)" relating to Harmonized Standards under
the R&TTE Directive and/or relating to the present document . 41
G.1 Introduction . 41
G.2 FAQs relating to the R&TTE Directive and the corresponding HSs . 41
History . 44

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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://webapp.etsi.org/IPR/home.asp).
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 present version of the document (i.e. version 2.2.1) is a development of the previous version, in particular it has
been brought up to date following recent events in TCAM, RSCom and in the OCG R&TTE Working Group of ETSI.
Some of the major developments appearing in version 2.2.1 with respect to version 2.1.1 are:
• the modification of the environmental profile to allow for the special case for the marine environment;
• the modification of the text of clause A.3 to correspond with the TCAM guidance and decision on antennas;
• the addition of guidance on the structure of clauses i.e. applicability, method of measurement, limit;
• enhanced guidance on definitions to be used in Harmonized Standards;
• replacement of a number of deliverables due to the production of EG 201 730 [i.13] to [i.16] and withdrawal
of TR 101 845 [i.34];
• precision of the text in clause C.7 on "interface specifications" in order to align it with clause 4.2 of the
R&TTE Directive [i.26].
During the revision, have also been:
• introduced changes consequential to the withdrawal of SR 001 470 [i.35] containing the pro-forma for the
production of Harmonized Standards and replacement by the Harmonized Standard skeleton document [i.22];
• introduced changes consequential to the withdrawal of SR 001 262 [i.36] and the inclusion of the ETSI
Drafting Rules in the ETSI Directives [i.6];
• avoided duplications of ETSI Drafting Rules text, by replacing text with a pointer to the ETSI Drafting Rules;
• deleted copyright release text;
• removed the occurrences of "candidate" in "candidate Harmonized Standard" since this terminology is no
longer used by ETSI;
• made modifications concerning the title translation text in order to correspond with the current practices;
• made the alignment of requirements on normative references in Harmonized Standards with the requirements
of the European Commission;
• clarified the wording in annexes A and F;
• made a split within the text of the "Scope", in order have both "Introduction" and "Scope";
• added a new annex E; the previous annexes E and F became therefore F and G;
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• added a reference to EC Decision 2000/299/EC [i.25];
• performed a number of editorial enhancements of text.
Introduction
The present document has 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.26]); furthermore, it establishes a methodology to allow those technical bodies to have a
consistent interpretation of the technical requirements needed to implement the essential requirements of the
R&TTE Directive [i.1].
Annex C to the present document gives some background to the R&TTE Directive [i.1]. Reference is made to the
framework of legal documents implementing the R&TTE Directive [i.1], but the present document should not be taken
as an interpretation, amplification, or restatement of any other documents. More generally, the present document
reminds the reader that there are a number of regulatory requirements that Members States and the various stakeholders
have to comply with. As clarified above, 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 the R&TTE Directive [i.1]
and/or the present document as well as their answers is provided in annex G.
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1 Scope
The present document addresses those HSs produced for application under the R&TTE Directive [i.1] (article 5) by
ETSI (and only those; more specifically, it does not address all ETSI standards).
The present document is not applicable to documents produced by other standards bodies (i.e. CEN and CENELEC)
even if some of the standards they produce have application under the R&TTE Directive [i.1].
2 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
reference 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.
2.1 Normative references
The following referenced documents are necessary for the application of the present document.
Not applicable.
2.2 Informative references
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 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 (R&TTE Directive).
[i.2] Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member
States relating to electrical equipment designed for use within certain voltage limits
(LV Directive).
[i.3] 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.4] 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 (EMC Directive).
[i.5] Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to
telecommunications terminal equipment and satellite earth station equipment, including the mutual
recognition of their conformity.
[i.6] ETSI Directives: "ETSI drafting rules".
[i.7] Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards.
[i.8] Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a
procedure for the provision of information in the field of technical standards and regulations.
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[i.9] ETSI TR 100 028 (V1.4.1): "Electromagnetic compatibility and Radio spectrum Matters (ERM);
Uncertainties in the measurement of mobile radio equipment characteristics".
[i.10] CENELEC EN 60950 (all applicable parts): "Safety of information technology equipment".
[i.11] CENELEC TR 62102: "Electrical safety - Classification of interfaces for equipment to be
connected to information and communications technology networks".
[i.12] ETSI EG 201 838: "ElectroMagnetic Compatibility and Radio Spectrum Matters (ERM);
Publication of interface specifications under Directive 1999/5/EC; Guidelines for describing radio
access interfaces".
[i.13] ETSI EG 201 730-1: "Terminals' access to Public Telecommunications Networks; Application of
the Directive 1999/5/EC (R&TTE), article 4.2; Guidelines for the publication of interface
specifications; Part 1: General and common aspects".
[i.14] ETSI EG 201 730-2: "Terminals' access to Public Telecommunications Networks; Application of
the Directive 1999/5/EC (R&TTE), article 4.2; Guidelines for the publication of interface
specifications; Part 2: Analogue narrow-band wireline interfaces".
[i.15] ETSI EG 201 730-3: "Terminals' access to Public Telecommunications Networks; Application of
the Directive 1999/5/EC (R&TTE), article 4.2;Guidelines for the publication of interface
specifications; Part 3: Digital wireline interfaces".
[i.16] ETSI EG 201 730-4: "Terminals' access to Public Telecommunications Networks;Application of
the Directive 1999/5/EC (R&TTE), article 4.2;Guidelines for the publication of interface
specifications; Part 4: Broadband multimedia cable network interfaces".
[i.17] ETSI EN 300 718-3: "Electromagnetic compatibility and Radio spectrum matters (ERM);
Avalanche Beacons; Transmitter-receiver systems; Part 3: Harmonized EN covering essential
requirements of article 3.3e of the R&TTE Directive".
[i.18] ETSI EN 301 025-3: "Electromagnetic compatibility and Radio spectrum Matters (ERM); VHF
radiotelephone equipment for general communications and associated equipment for Class "D"
Digital Selective Calling (DSC); Part 3: Harmonized EN under article 3.3 (e) of the R&TTE
Directive".
[i.19] ETSI CEPT MoU.
NOTE: See http://webapp.etsi.org/agreementview.
[i.20] ERC/ECC Recommendation 70-03: "Relating to the use of Short Range Devices (SRD)".
[i.21] ETSI EN 301 489 (all parts): " Electromagnetic compatibility and Radio spectrum Matters (ERM);
ElectroMagnetic Compatibility (EMC) standard for radio equipment and services".
[i.22] Harmonized Standard skeleton document.
NOTE: See http://portal.etsi.org/edithelp/Files/zip/ETSI_HS_EN_skeleton.zip.
[i.23] Radio Spectrum Policy Group Opinion on Streamlining the regulatory environment for the use of
spectrum (RSPG08-246).
[i.24] ETSI TR 102 914: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Aspects
and implications of the inclusion of receiver parameters within ETSI standards".
[i.25] Commission Decision 2000/299/EC of 6 April 2000 "establishing the initial classification of radio
equipment and telecommunications terminal equipment and associated identifiers ".
[i.26] Guide to the R&TTE Directive 1999/5/EC Version of 20 April 2009.
[i.27] ETSI EN 300 296-1: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Land
Mobile Service; Radio equipment using integral antennas intended primarily for analogue speech;
Part 1: Technical characteristics and methods of measurement".
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[i.28] Commission Decision 2004/71/EC of 4 September 2003 on essential requirements relating to
marine radio communication equipment which is intended to be used on non-SOLAS vessels and
to participate in the Global Maritime Distress and Safety System (GMDSS).
[i.29] ETSI TErms and Definitions Database Interactive (TEDDI).
NOTE: See http://webapp.etsi.org/Teddi/.
[i.30] ITU Radio Regulations.
[i.31] Decision No 676/2002/EC of the European Parliament and of the Coucil of 7 March 2002 on a
regulatory framework for radio spectrum policy in the European Community (Radio Spectrum
Decision).
[i.32] ETSI TR 102 579: "Electromagnetic compatibility and Radio spectrum Matters (ERM); Report
providing guidance for the production of Community Specifications for application under the
Single European Sky Interoperability Regulation EC 552/2004".
[i.33] Interoperability Regulation EC 552/2004: "Regulation on the interoperability of the European Air
Traffic Management network".
[i.34] ETSI TR 101 845: "Fixed Radio Systems; Technical Information on RF Interfaces applied by
Fixed Service Systems including Fixed Wireless Access (FWA) in the light of the R&TTE
Directive (Article 4.2)".
[i.35] ETSI SR 001 470: "Guidance to the production of candidate Harmonized Standards for application
under the R&TTE Directive (1999/5/EC); Pro-forma candidate Harmonized Standard".
[i.36] ETSI SR 001 262: "ETSI drafting rules".
[i.37] Guide to the implementation of directives based on the New Approach and the Global Approach,
European Commission, 2000.
[i.38] 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, and repealing Council Decision 93/465/EEC.
[i.39] ETSI Directives: "ETSI Technical Working Procedures", 28 Jan. 2010.
3 Definitions and abbreviations
3.1 Definitions
For the purposes of the present document, the terms and definitions given in R&TTE Directive [i.1] and the following
apply:
equipment class: has the same meaning as equipment class in the R&TTE Directive [i.1], article 2f: "a class identifying
particular types of apparatus which under this Directive are considered similar and those interfaces for which the
apparatus is designed"
NOTE: Apparatus may belong to more than one equipment class.
See also Commission Decision 2000/299/EC of 6 April 2000 [i.25].
essential radio test suite: one or more test procedure(s), referred to in annex III of the R&TTE Directive [i.1]
essential requirement: has the same meaning as essential requirement in the R&TTE Directive [i.1]
harmful interference: has the same meaning as harmful interference as in the R&TTE Directive [i.1], article 2i:
"interference which endangers the functioning of a radionavigation service or of other safety services or which
otherwise seriously degrades, obstructs or repeatedly interrupts a radiocommunications service operating in acco
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