ETSI EG 201 399 V2.2.1 (2010-08)
Electromagnetic compatibility and Radio spectrum Matters (ERM); A guide to the production of Harmonized Standards for application under the R&TTE Directive
Electromagnetic compatibility and Radio spectrum Matters (ERM); A guide to the production of Harmonized Standards for application under the R&TTE Directive
REG/ERM-RM-261
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
Standards Content (Sample)
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
2 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
Reference
REG/ERM-RM-261
Keywords
radio, regulation, terminal
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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
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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
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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";
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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.
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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.
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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".
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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"
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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 whether such test is a member of the essential radio test suite or of the other test suite.
interference: effect of unwanted energy due to one or a combination of emissions, radiation, or induction upon
reception in a radiocommunication system, manifested by any performance degradation, misinterpretation, or loss of
information which could be extracted in the absence of such unwanted energy
manufacturer: manufacturer or his authorized representative established in the Community (R&TTE Directive [i.1],
annex II), or the person responsible for placing the apparatus on the market (R&TTE Directive [i.1], article 6.3)
other test suite: test procedure(s) not referred to in annex III of the R&TTE Directive [i.1]
Radio Equipment (RE): radio equipment as defined in R&TTE Directive [i.1], article 2(c), subject to the general
exclusions within the R&TTE Directive [i.1] (see its Annex I)
skeleton document: pre-built deliverable, already laid out as required and containing essential titles and text blocks
TB: unless the context indicates otherwise this refers to the ETSI TB responsible for the development of the HS being
considered
Telecommunications Terminal Equipment (TTE): Telecommunications Terminal Equipment as defined in R&TTE
Directive [i.1], article 2(b) subject to general exclusions within the R&TTE Directive [i.1] (see its Annex I)
3.2 Abbreviations
For the purposes of the present document, the following abbreviations apply:
ATM Air Traffic Management
CCF Call Control reception Failure
CCR Control Channel correctly Received
CEN Comité Européen de Normalisation
CENELEC European Committee for Electrotechnical Standardization
CEPT Conference Européenne des Postes et Télécommunications
DOA Date Of Announcement
DOW Date Of Withdrawal
EC European Commission (often refered to as "Commission" in the present document)
ECC Electronic Communications Committee (a committee of CEPT)
ECI Equipment Class Identifier
NOTE: See R&TTE Directive [i.1], articles 4.1 and 11.1 and COMMISSION DECISION
2000/299/EC of 6 April 2000 [i.25].
EEA European Economic Area
EFTA European Free Trade Association
EIRP Equivalent Isotropic Radiated Power
EMC ElectroMagnetic Compatibility
NOTE: See "new" EMC Directive 2004/108/EC [i.4].
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11 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
EN European Norm
ER Essential Requirement
ERC European Radiocommunications Committee
NOTE: This committee of CEPT led later to ECC.
ERP Effective Radiated Power
ETSI TWP ETSI Technical Working Procedures
FAQ Frequently Asked Questions
HS Harmonized Standard
HS-RTT HS Requirements and conformance Test specifications Table
ISM Industrial Scientific Medical
LVD Low Voltage Directive
NOTE: See Directive 73/23/EEC [i.2], more recently replaced by 2006/95/EC [i.3].
MoU Memorandum of Understanding
Nb Number
OCG R&TTE ETSI's Operational Co-ordination Group sub-group on Radio Equipment & Telecommunications
Terminal Equipment
OJEU Official Journal of the European Union
PMR Private Mobile Radio
R&TTE Radio Equipment and Telecommunications Terminal Equipment
NOTE: See Directive 1999/5/EC [i.1].
RE Radio Equipment
RIS Radio Interface Specification
RSCom Radio Spectrum Committee
RSPG Radio Spectrum Policy Group
SMF System Monitoring Fail
SMP System Monitoring Pass
TB ETSI Technical Body
TCAM Telecommunication Conformity Assessment and Market surveillance committee
NOTE: See R&TTE Directive [i.1], articles 13, 14 and 15.
TDD Time Division Duplex
TDM Time Division Multiplex
TTCN Testing and Test Control Notation or (previously) Tree and Tabular Combined Notation
NOTE: Both are valid and have been used associated different version of TTCN.
TEDDI TErms and Definitions Database Interactive
TTE Telecommunications Terminal Equipment
TxD Transmission Disable command
TxE Transmission Enable command
4 Role and purpose of Harmonized Standards
4.1 Background to the R&TTE Directive
The R&TTE Directive [i.1] conforms to the EC Council Resolution of 7 May 1985 [i.7]. It introduced a market-led
approach into the Radio and Telecommunications Terminal Equipment sector, and removed the regime of type
approvals.
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12 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
The R&TTE Directive [i.1] covers apparatus within its scope that is either TTE (Telecommunications Terminal
Equipment) or RE (Radio Equipment), as defined in its articles 2(b) and 2(c), or that is both TTE and RE, but excludes
equipment listed in its annex I (radio amateur kits, certain marine equipment, cabling and wiring, receive-only
radio/TV, and at the time of the publication of the R&TTE Directive [i.1], certain civil aviation equipment and certain
air-traffic-management equipment), and equipment used exclusively for activities of the State (article 1.5). It applies
only to the communication aspects of certain medical devices (article 1.2) and vehicles (article 1.3). These limitations
on the scope of the Directive apply to all TTE or RE.
4.2 Role of Harmonized Standard in Presumption of Conformity
The Directive identifies essential requirements that are to be met. Conformity with the Essential Requirements in
article 3 of the R&TTE Directive [i.1] is declared by the manufacturer, and may be based on HSs (see R&TTE
Directive [i.1], article 5.1) or using other means.
In principle, HSs relate to equipment when installed, operated as intended, and not under fault conditions nor when
misused by the customer, deliberately or otherwise.
In certain circumstances, the Commission may also publish guidelines on the interpretation of HSs or the conditions
under which compliance with that standard raises a presumption of conformity.
5 Procedure for generation of Harmonized Standards
5.1 Standardization mandate
"Harmonised standards are European standards, which are adopted by European standards organisations, prepared in
accordance with the General Guidelines agreed between the Commission and the European standards organisations, and
follow a mandate issued by the Commission after consultation with the Member States" [i.37].
'Harmonised standard' means "a standard adopted by one of the European standardisation bodies listed in Annex I to
Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that
Directive" [i.38].
Reference [i.38] states, "Products which are in conformity with harmonised standards or parts thereof the references of
which have been published in the Official Journal of the European Union shall be presumed to be in conformity with
the requirements covered by those standards or parts thereof, set out in … [reference to the relevant part of the
legislation]."
As a result, Harmonized Standards are distinct from other ENs, in particular, in that:
• they are produced under a formally issued standardization mandate through the European Commission's
'98/34/EC procedure';
• when the standard has been adopted, a reference to it is placed in the Official Journal of the European Union
with an indication of the Directive for which the presumption of conformity should apply.
With the advent of the R&TTE Directive [i.1], the European Commission requested ETSI to propose a programme of
standardization work considered necessary under Directive. This programme of work provided the basis for a first
standardization mandate.
ENs cannot be quoted in the OJEU as HSs unless they have been developed under an EC standardization mandate.
Mandates under the R&TTE Directive [i.1] are proposed by the Commission, after consultation with TCAM, and
approved by the Committee established under the terms of Directive 98/34/EC [i.8] before being presented to ETSI.
Where a standardization mandate exists and has been accepted by ETSI, a situation may occur where ETSI technical
bodies consider that there is a need for a HS that is not covered by the mandate.
In such a situation, ETSI should adopt a work item under the ETSI TWP. The ETSI Secretariat will present the work
item to TCAM with a justification covering why the HS is required. If regarded as justified, the EC may decide to
modify the mandate or issue a new one. Such decisions require approval by the Committee established under the terms
of Directive 98/34/EC [i.8].
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13 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
5.2 The drafting process
Guidance of the drafting process is addressed separately in clause 7.
5.3 Adoption of Harmonized Standards
HSs are adopted according to specific procedures under the ETSI TWP.
Before a HS is submitted to the voting procedure, the standard should be finally examined to ascertain that the
conditions imposed by the R&TTE Directive [i.1], the conditions of the standardization mandate, and the conditions
stemming from the present document are met.
NOTE: ETSI may establish procedures to ensure that this is always the case.
5.4 Submission to EC and Publication in the OJEU
Once adopted by ETSI, HSs developed under a R&TTE Directive [i.1] mandate are presented to the Commission by the
ETSI Secretariat. It has been agreed between the Commission and ETSI that the presentation will be accompanied by
the translation of the title of the document into the official languages of the EU and EFTA.
The Commission will decide whether or not the HS is acceptable in whole or in part as suitable for establishing a
presumption of conformity against the relevant essential requirements. The EC may decide whether or not to cite the HS
or its revision (the whole or parts thereof) in the OJEU.
The ETSI Technical Working Procedures, clause 2.4 states, "ENs shall be transposed by the National Standards
Organizations (see Article 13.7 of the Rules of Procedure)." [i.39].
The ETSI Secretariat will set the Date Of Withdrawal (DOW) to eighteen months after Date Of Announcement (DOA)
unless the relevant ETSI TB advises otherwise.
ETSI TBs may add a note in the OJEU listing of HS (e.g. for explaining the transfer of one (set of) standard(s) to
another number). The note will appear across a whole row of the OJEU. The ETSI TB should provide this information
to the ETSI Secretariat if this possibility is chosen.
5.5 Revision of Harmonized Standards
Revisions of HSs developed under R&TTE Directive [i.1] mandate do not require a specific modification to the
standardization mandate. However, publication of the revised standard in the OJEU is necessary to amend the
requirements which give a presumption of conformity with the R&TTE Directive [i.1].
The TB should consider the cost and other implications on industry and other parties before proposing revisions to HSs.
If an ETSI TB considers that technical modifications to a HS are required, it should raise a work item according to the
ETSI TWP.
According to the MoU [i.19] between CEPT-ECC and ETSI, any modification of the HS which would require a
modification of ECC deliverables should lead to a coordination process between the two bodies. The same would apply
if ECC envisages a change in its regulation which would require a modification of HSs.
Adoption and submission of revisions of HSs are as explained in clauses 5.1 to 5.4.
5.6 Withdrawal of Harmonized Standards
After consultation of TCAM, the Commission may withdraw the OJEU reference to HSs by publication of a notice to
that effect in the OJEU. Presumption of conformity through that HS will then cease.
For the case where, following the Commission's action, the relevant ETSI TB considers that the HS should be
withdrawn, the ETSI TWP provide the procedures to be followed. The ETSI Secretariat will ensure that the standard is
archived so as to remain available if requested, including traceability that the standard had been published in the OJEU,
with the relevant dates of publication and withdrawal.
ETSI
14 Final draft ETSI EG 201 399 V2.2.1 (2010-06)
6 Formulation of technical requirements
6.1 Guiding principles
6.1.1 General
This methodology is based on the evaluation of applicable technical parameters for equipment corresponding to specific
attributes. The parameters and attributes are shown in annex A.
As a matter of principle, the decision of precisely how to demonstrate compliance with an essential requirement should
remain the duty of the applicable TB. However, it is important that a common set of principles be made available to
guide the TB when making decisions on content. Where a TB considers that deviation from the principles of annex A is
desirable, OCG R&TTE should be advised who may develop a formal justification for onward transmission to the EC
or other concerned parties.
6.1.2 Level of technological independence
ETSI technical bodies should take note, as a principal goal, that wherever possible, HSs which are technology
independent are preferred. The level of technological independence should remain the responsibility of the appropriate
TB. Means for judgement could be commonalities in equipment attributes and technical parameters as outlined below.
6.1.3 Equipment attributes
In producing HSs for application under the Directive, ETSI should ensure that the standards do not exceed the degree of
regulation envisaged by the Commission, and should apply discernment in order not to inhibit technological innovation
or the meeting of the needs of a free-market economy. To assist this objective, the present document defines groups of
products sharing similar fundamental attributes.
Equipment attributes are defined in annex A.
A single equipment can have more than one attribute. The rules for specifying attributes are set out below, and are
designed such that, if required, new attributes may be added in the future for as yet unknown applications.
There is not necessarily any fixed relationship between these equipment attributes and the Equipment Classes [i.1]
assigned by the Commission.
The rules for establishing equipment attributes are:
1) Attributes should not exist to support a particular technology. They are technology independent.
2) Attributes should not by their nature provoke questions of intellectual property rights in any form.
3) Attributes are used to categorize fundamental technical differences.
4) Attributes may exist due to fundamental differences in the circumstances of the environment as related to the
essential requirements of the R&TTE Directive [i.1].
5) Attributes may exist for the purpose of differentiating operational properties.
6) Products having the same attribute should have similar technical requirements in respect of that attribute.
Subject to the above constraints, the objective is to establish a small number of attributes which collectively cover all
equipment falling under the R&TTE Directi
...
ETSI Guide
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
A guide to the production of Harmonized Standards
for application under the R&TTE Directive
2 ETSI EG 201 399 V2.2.1 (2010-08)
Reference
REG/ERM-RM-261
Keywords
radio, regulation, terminal
ETSI
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The copyright and the foregoing restriction extend to reproduction in all media.
© European Telecommunications Standards Institute 2010.
All rights reserved.
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ETSI
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
4 ETSI EG 201 399 V2.2.1 (2010-08)
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
ETSI
5 ETSI EG 201 399 V2.2.1 (2010-08)
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;
ETSI
6 ETSI EG 201 399 V2.2.1 (2010-08)
• 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
7 ETSI EG 201 399 V2.2.1 (2010-08)
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
8 ETSI EG 201 399 V2.2.1 (2010-08)
[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
9 ETSI EG 201 399 V2.2.1 (2010-08)
[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 accordance
with the applicable Community or national regulations"
ETSI
10 ETSI EG 201 399 V2.2.1 (2010-08)
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 whether such test is a member of the essential radio test suite or of the other test suite.
interference: effect of unwanted energy due to one or a combination of emissions, radiation, or induction upon
reception in a radiocommunication system, manifested by any performance degradation, misinterpretation, or loss of
information which could be extracted in the absence of such unwanted energy
manufacturer: manufacturer or his authorized representative established in the Community (R&TTE Directive [i.1],
annex II), or the person responsible for placing the apparatus on the market (R&TTE Directive [i.1], article 6.3)
other test suite: test procedure(s) not referred to in annex III of the R&TTE Directive [i.1]
Radio Equipment (RE): radio equipment as defined in R&TTE Directive [i.1], article 2(c), subject to the general
exclusions within the R&TTE Directive [i.1] (see its annex I)
skeleton document: pre-built deliverable, already laid out as required and containing essential titles and text blocks
TB: unless the context indicates otherwise this refers to the ETSI TB responsible for the development of the HS being
considered
Telecommunications Terminal Equipment (TTE): Telecommunications Terminal Equipment as defined in R&TTE
Directive [i.1], article 2(b) subject to general exclusions within the R&TTE Directive [i.1] (see its annex I)
3.2 Abbreviations
For the purposes of the present document, the following abbreviations apply:
ATM Air Traffic Management
CCF Call Control reception Failure
CCR Control Channel correctly Received
CEN Comité Européen de Normalisation
CENELEC European Committee for Electrotechnical Standardization
CEPT Conference Européenne des Postes et Télécommunications
DOA Date Of Announcement
DOW Date Of Withdrawal
EC European Commission (often refered to as "Commission" in the present document)
ECC Electronic Communications Committee (a committee of CEPT)
ECI Equipment Class Identifier
NOTE: See R&TTE Directive [i.1], articles 4.1 and 11.1 and COMMISSION DECISION
2000/299/EC of 6 April 2000 [i.25].
EEA European Economic Area
EFTA European Free Trade Association
EIRP Equivalent Isotropic Radiated Power
EMC ElectroMagnetic Compatibility
NOTE: See "new" EMC Directive 2004/108/EC [i.4].
EN European Norm
ER Essential Requirement
ETSI
11 ETSI EG 201 399 V2.2.1 (2010-08)
ERC European Radiocommunications Committee
NOTE: This committee of CEPT led later to ECC.
ERP Effective Radiated Power
ETSI TWP ETSI Technical Working Procedures
FAQ Frequently Asked Questions
HS Harmonized Standard
HS-RTT HS Requirements and conformance Test specifications Table
ISM Industrial Scientific Medical
LVD Low Voltage Directive
NOTE: See Directive 73/23/EEC [i.2], more recently replaced by 2006/95/EC [i.3].
MoU Memorandum of Understanding
Nb Number
OCG R&TTE ETSI's Operational Co-ordination Group sub-group on Radio Equipment & Telecommunications
Terminal Equipment
OJEU Official Journal of the European Union
PMR Private Mobile Radio
R&TTE Radio Equipment and Telecommunications Terminal Equipment
NOTE: See Directive 1999/5/EC [i.1].
RE Radio Equipment
RIS Radio Interface Specification
RSCom Radio Spectrum Committee
RSPG Radio Spectrum Policy Group
SMF System Monitoring Fail
SMP System Monitoring Pass
TB ETSI Technical Body
TCAM Telecommunication Conformity Assessment and Market surveillance committee
NOTE: See R&TTE Directive [i.1], articles 13, 14 and 15.
TDD Time Division Duplex
TDM Time Division Multiplex
TTCN Testing and Test Control Notation or (previously) Tree and Tabular Combined Notation
NOTE: Both are valid and have been used associated different version of TTCN.
TEDDI TErms and Definitions Database Interactive
TTE Telecommunications Terminal Equipment
TxD Transmission Disable command
TxE Transmission Enable command
4 Role and purpose of Harmonized Standards
4.1 Background to the R&TTE Directive
The R&TTE Directive [i.1] conforms to the EC Council Resolution of 7 May 1985 [i.7]. It introduced a market-led
approach into the Radio and Telecommunications Terminal Equipment sector, and removed the regime of type
approvals.
ETSI
12 ETSI EG 201 399 V2.2.1 (2010-08)
The R&TTE Directive [i.1] covers apparatus within its scope that is either TTE (Telecommunications Terminal
Equipment) or RE (Radio Equipment), as defined in its articles 2(b) and 2(c), or that is both TTE and RE, but excludes
equipment listed in its annex I (radio amateur kits, certain marine equipment, cabling and wiring, receive-only
radio/TV, and at the time of the publication of the R&TTE Directive [i.1], certain civil aviation equipment and certain
air-traffic-management equipment), and equipment used exclusively for activities of the State (article 1.5). It applies
only to the communication aspects of certain medical devices (article 1.2) and vehicles (article 1.3). These limitations
on the scope of the Directive apply to all TTE or RE.
4.2 Role of Harmonized Standard in Presumption of Conformity
The Directive identifies essential requirements that are to be met. Conformity with the Essential Requirements in
article 3 of the R&TTE Directive [i.1] is declared by the manufacturer, and may be based on HSs (see R&TTE
Directive [i.1], article 5.1) or using other means.
In principle, HSs relate to equipment when installed, operated as intended, and not under fault conditions nor when
misused by the customer, deliberately or otherwise.
In certain circumstances, the Commission may also publish guidelines on the interpretation of HSs or the conditions
under which compliance with that standard raises a presumption of conformity.
5 Procedure for generation of Harmonized Standards
5.1 Standardization mandate
"Harmonized standards are European standards, which are adopted by European standards organisations, prepared in
accordance with the General Guidelines agreed between the Commission and the European standards organisations, and
follow a mandate issued by the Commission after consultation with the Member States" [i.37].
"Harmonized standard" means "a standard adopted by one of the European standardisation bodies listed in Annex I to
Directive 98/34/EC on the basis of a request made by the Commission in accordance with article 6 of that
Directive" [i.38].
Reference [i.38] states, "Products which are in conformity with harmonized standards or parts thereof the references of
which have been published in the Official Journal of the European Union shall be presumed to be in conformity with
the requirements covered by those standards or parts thereof, set out in … [reference to the relevant part of the
legislation]."
As a result, Harmonized Standards are distinct from other ENs, in particular, in that:
• they are produced under a formally issued standardization mandate through the European Commission's
'98/34/EC procedure';
• when the standard has been adopted, a reference to it is placed in the Official Journal of the European Union
with an indication of the Directive for which the presumption of conformity should apply.
With the advent of the R&TTE Directive [i.1], the European Commission requested ETSI to propose a programme of
standardization work considered necessary under Directive. This programme of work provided the basis for a first
standardization mandate.
ENs cannot be quoted in the OJEU as HSs unless they have been developed under an EC standardization mandate.
Mandates under the R&TTE Directive [i.1] are proposed by the Commission, after consultation with TCAM, and
approved by the Committee established under the terms of Directive 98/34/EC [i.8] before being presented to ETSI.
Where a standardization mandate exists and has been accepted by ETSI, a situation may occur where ETSI technical
bodies consider that there is a need for a HS that is not covered by the mandate.
In such a situation, ETSI should adopt a work item under the ETSI TWP. The ETSI Secretariat will present the work
item to TCAM with a justification covering why the HS is required. If regarded as justified, the EC may decide to
modify the mandate or issue a new one. Such decisions require approval by the Committee established under the terms
of Directive 98/34/EC [i.8].
ETSI
13 ETSI EG 201 399 V2.2.1 (2010-08)
5.2 The drafting process
Guidance of the drafting process is addressed separately in clause 7.
5.3 Adoption of Harmonized Standards
HSs are adopted according to specific procedures under the ETSI TWP.
Before a HS is submitted to the voting procedure, the standard should be finally examined to ascertain that the
conditions imposed by the R&TTE Directive [i.1], the conditions of the standardization mandate, and the conditions
stemming from the present document are met.
NOTE: ETSI may establish procedures to ensure that this is always the case.
5.4 Submission to EC and Publication in the OJEU
Once adopted by ETSI, HSs developed under a R&TTE Directive [i.1] mandate are presented to the Commission by the
ETSI Secretariat. It has been agreed between the Commission and ETSI that the presentation will be accompanied by
the translation of the title of the document into the official languages of the EU and EFTA.
The Commission will decide whether or not the HS is acceptable in whole or in part as suitable for establishing a
presumption of conformity against the relevant essential requirements. The EC may decide whether or not to cite the HS
or its revision (the whole or parts thereof) in the OJEU.
The ETSI Technical Working Procedures, clause 2.4 states, "ENs shall be transposed by the National Standards
Organizations (see article 13.7 of the Rules of Procedure)." [i.39].
The ETSI Secretariat will set the Date Of Withdrawal (DOW) to eighteen months after Date Of Announcement (DOA)
unless the relevant ETSI TB advises otherwise.
ETSI TBs may add a note in the OJEU listing of HS (e.g. for explaining the transfer of one (set of) standard(s) to
another number). The note will appear across a whole row of the OJEU. The ETSI TB should provide this information
to the ETSI Secretariat if this possibility is chosen.
5.5 Revision of Harmonized Standards
Revisions of HSs developed under R&TTE Directive [i.1] mandate do not require a specific modification to the
standardization mandate. However, publication of the revised standard in the OJEU is necessary to amend the
requirements which give a presumption of conformity with the R&TTE Directive [i.1].
The TB should consider the cost and other implications on industry and other parties before proposing revisions to HSs.
If an ETSI TB considers that technical modifications to a HS are required, it should raise a work item according to the
ETSI TWP.
According to the MoU [i.19] between CEPT-ECC and ETSI, any modification of the HS which would require a
modification of ECC deliverables should lead to a coordination process between the two bodies. The same would apply
if ECC envisages a change in its regulation which would require a modification of HSs.
Adoption and submission of revisions of HSs are as explained in clauses 5.1 to 5.4.
5.6 Withdrawal of Harmonized Standards
After consultation of TCAM, the Commission may withdraw the OJEU reference to HSs by publication of a notice to
that effect in the OJEU. Presumption of conformity through that HS will then cease.
For the case where, following the Commission's action, the relevant ETSI TB considers that the HS should be
withdrawn, the ETSI TWP provide the procedures to be followed. The ETSI Secretariat will ensure that the standard is
archived so as to remain available if requested, including traceability that the standard had been published in the OJEU,
with the relevant dates of publication and withdrawal.
ETSI
14 ETSI EG 201 399 V2.2.1 (2010-08)
6 Formulation of technical requirements
6.1 Guiding principles
6.1.1 General
This methodology is based on the evaluation of applicable technical parameters for equipment corresponding to specific
attributes. The parameters and attributes are shown in annex A.
As a matter of principle, the decision of precisely how to demonstrate compliance with an essential requirement should
remain the duty of the applicable TB. However, it is important that a common set of principles be made available to
guide the TB when making decisions on content. Where a TB considers that deviation from the principles of annex A is
desirable, OCG R&TTE should be advised who may develop a formal justification for onward transmission to the EC
or other concerned parties.
6.1.2 Level of technological independence
ETSI technical bodies should take note, as a principal goal, that wherever possible, HSs which are technology
independent are preferred. The level of technological independence should remain the responsibility of the appropriate
TB. Means for judgement could be commonalities in equipment attributes and technical parameters as outlined below.
6.1.3 Equipment attributes
In producing HSs for application under the Directive, ETSI should ensure that the standards do not exceed the degree of
regulation envisaged by the Commission, and should apply discernment in order not to inhibit technological innovation
or the meeting of the needs of a free-market economy. To assist this objective, the present document defines groups of
products sharing similar fundamental attributes.
Equipment attributes are defined in annex A.
A single equipment can have more than one attribute. The rules for specifying attributes are set out below, and are
designed such that, if required, new attributes may be added in the future for as yet unknown applications.
There is not necessarily any fixed relationship between these equipment attributes and the Equipment Classes [i.1]
assigned by the Commission.
The rules for establishing equipment attributes are:
1) Attributes should not exist to support a particular technology. They are technology independent.
2) Attributes should not by their nature provoke questions of intellectual property rights in any form.
3) Attributes are used to categorize fundamental technical differences.
4) Attributes may exist due to fundamental differences in the circumstances of the environment as related to the
essential requirements of the R&TTE Directive [i.1].
5) Attributes may exist for the purpose of differentiating operational properties.
6) Products having the same attribute should have similar technical requirements in respect of that attribute.
Subject to the above constraints, the objective is to establish a small number of attributes which collectively cover all
equipment falling under the R&TTE Directive [i.1].
ETSI
15 ETSI EG 201 399 V2.2.1 (2010-08)
6.1.4 Evaluation of parameters
HSs should be written to address only the technical parameters necessary to allow a presumption of conformity to the
...
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
ETSI Guide
Electromagnetic compatibility
and Radio spectrum Matters (ERM);
A guide to the production of Harmonized Standards
for application under the R&TTE Directive
2 ETSI EG 201 399 V2.2.1 (2010-08)
Reference
REG/ERM-RM-261
Keywords
radio, regulation, terminal
ETSI
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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.
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ETSI
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
4 ETSI EG 201 399 V2.2.1 (2010-08)
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
ETSI
5 ETSI EG 201 399 V2.2.1 (2010-08)
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;
ETSI
6 ETSI EG 201 399 V2.2.1 (2010-08)
• 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
7 ETSI EG 201 399 V2.2.1 (2010-08)
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
8 ETSI EG 201 399 V2.2.1 (2010-08)
[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
9 ETSI EG 201 399 V2.2.1 (2010-08)
[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 accordance
with the applicable Community or national regulations"
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10 ETSI EG 201 399 V2.2.1 (2010-08)
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 whether such test is a member of the essential radio test suite or of the other test suite.
interference: effect of unwanted energy due to one or a combination of emissions, radiation, or induction upon
reception in a radiocommunication system, manifested by any performance degradation, misinterpretation, or loss of
information which could be extracted in the absence of such unwanted energy
manufacturer: manufacturer or his authorized representative established in the Community (R&TTE Directive [i.1],
annex II), or the person responsible for placing the apparatus on the market (R&TTE Directive [i.1], article 6.3)
other test suite: test procedure(s) not referred to in annex III of the R&TTE Directive [i.1]
Radio Equipment (RE): radio equipment as defined in R&TTE Directive [i.1], article 2(c), subject to the general
exclusions within the R&TTE Directive [i.1] (see its annex I)
skeleton document: pre-built deliverable, already laid out as required and containing essential titles and text blocks
TB: unless the context indicates otherwise this refers to the ETSI TB responsible for the development of the HS being
considered
Telecommunications Terminal Equipment (TTE): Telecommunications Terminal Equipment as defined in R&TTE
Directive [i.1], article 2(b) subject to general exclusions within the R&TTE Directive [i.1] (see its annex I)
3.2 Abbreviations
For the purposes of the present document, the following abbreviations apply:
ATM Air Traffic Management
CCF Call Control reception Failure
CCR Control Channel correctly Received
CEN Comité Européen de Normalisation
CENELEC European Committee for Electrotechnical Standardization
CEPT Conference Européenne des Postes et Télécommunications
DOA Date Of Announcement
DOW Date Of Withdrawal
EC European Commission (often refered to as "Commission" in the present document)
ECC Electronic Communications Committee (a committee of CEPT)
ECI Equipment Class Identifier
NOTE: See R&TTE Directive [i.1], articles 4.1 and 11.1 and COMMISSION DECISION
2000/299/EC of 6 April 2000 [i.25].
EEA European Economic Area
EFTA European Free Trade Association
EIRP Equivalent Isotropic Radiated Power
EMC ElectroMagnetic Compatibility
NOTE: See "new" EMC Directive 2004/108/EC [i.4].
EN European Norm
ER Essential Requirement
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11 ETSI EG 201 399 V2.2.1 (2010-08)
ERC European Radiocommunications Committee
NOTE: This committee of CEPT led later to ECC.
ERP Effective Radiated Power
ETSI TWP ETSI Technical Working Procedures
FAQ Frequently Asked Questions
HS Harmonized Standard
HS-RTT HS Requirements and conformance Test specifications Table
ISM Industrial Scientific Medical
LVD Low Voltage Directive
NOTE: See Directive 73/23/EEC [i.2], more recently replaced by 2006/95/EC [i.3].
MoU Memorandum of Understanding
Nb Number
OCG R&TTE ETSI's Operational Co-ordination Group sub-group on Radio Equipment & Telecommunications
Terminal Equipment
OJEU Official Journal of the European Union
PMR Private Mobile Radio
R&TTE Radio Equipment and Telecommunications Terminal Equipment
NOTE: See Directive 1999/5/EC [i.1].
RE Radio Equipment
RIS Radio Interface Specification
RSCom Radio Spectrum Committee
RSPG Radio Spectrum Policy Group
SMF System Monitoring Fail
SMP System Monitoring Pass
TB ETSI Technical Body
TCAM Telecommunication Conformity Assessment and Market surveillance committee
NOTE: See R&TTE Directive [i.1], articles 13, 14 and 15.
TDD Time Division Duplex
TDM Time Division Multiplex
TTCN Testing and Test Control Notation or (previously) Tree and Tabular Combined Notation
NOTE: Both are valid and have been used associated different version of TTCN.
TEDDI TErms and Definitions Database Interactive
TTE Telecommunications Terminal Equipment
TxD Transmission Disable command
TxE Transmission Enable command
4 Role and purpose of Harmonized Standards
4.1 Background to the R&TTE Directive
The R&TTE Directive [i.1] conforms to the EC Council Resolution of 7 May 1985 [i.7]. It introduced a market-led
approach into the Radio and Telecommunications Terminal Equipment sector, and removed the regime of type
approvals.
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12 ETSI EG 201 399 V2.2.1 (2010-08)
The R&TTE Directive [i.1] covers apparatus within its scope that is either TTE (Telecommunications Terminal
Equipment) or RE (Radio Equipment), as defined in its articles 2(b) and 2(c), or that is both TTE and RE, but excludes
equipment listed in its annex I (radio amateur kits, certain marine equipment, cabling and wiring, receive-only
radio/TV, and at the time of the publication of the R&TTE Directive [i.1], certain civil aviation equipment and certain
air-traffic-management equipment), and equipment used exclusively for activities of the State (article 1.5). It applies
only to the communication aspects of certain medical devices (article 1.2) and vehicles (article 1.3). These limitations
on the scope of the Directive apply to all TTE or RE.
4.2 Role of Harmonized Standard in Presumption of Conformity
The Directive identifies essential requirements that are to be met. Conformity with the Essential Requirements in
article 3 of the R&TTE Directive [i.1] is declared by the manufacturer, and may be based on HSs (see R&TTE
Directive [i.1], article 5.1) or using other means.
In principle, HSs relate to equipment when installed, operated as intended, and not under fault conditions nor when
misused by the customer, deliberately or otherwise.
In certain circumstances, the Commission may also publish guidelines on the interpretation of HSs or the conditions
under which compliance with that standard raises a presumption of conformity.
5 Procedure for generation of Harmonized Standards
5.1 Standardization mandate
"Harmonized standards are European standards, which are adopted by European standards organisations, prepared in
accordance with the General Guidelines agreed between the Commission and the European standards organisations, and
follow a mandate issued by the Commission after consultation with the Member States" [i.37].
"Harmonized standard" means "a standard adopted by one of the European standardisation bodies listed in Annex I to
Directive 98/34/EC on the basis of a request made by the Commission in accordance with article 6 of that
Directive" [i.38].
Reference [i.38] states, "Products which are in conformity with harmonized standards or parts thereof the references of
which have been published in the Official Journal of the European Union shall be presumed to be in conformity with
the requirements covered by those standards or parts thereof, set out in … [reference to the relevant part of the
legislation]."
As a result, Harmonized Standards are distinct from other ENs, in particular, in that:
• they are produced under a formally issued standardization mandate through the European Commission's
'98/34/EC procedure';
• when the standard has been adopted, a reference to it is placed in the Official Journal of the European Union
with an indication of the Directive for which the presumption of conformity should apply.
With the advent of the R&TTE Directive [i.1], the European Commission requested ETSI to propose a programme of
standardization work considered necessary under Directive. This programme of work provided the basis for a first
standardization mandate.
ENs cannot be quoted in the OJEU as HSs unless they have been developed under an EC standardization mandate.
Mandates under the R&TTE Directive [i.1] are proposed by the Commission, after consultation with TCAM, and
approved by the Committee established under the terms of Directive 98/34/EC [i.8] before being presented to ETSI.
Where a standardization mandate exists and has been accepted by ETSI, a situation may occur where ETSI technical
bodies consider that there is a need for a HS that is not covered by the mandate.
In such a situation, ETSI should adopt a work item under the ETSI TWP. The ETSI Secretariat will present the work
item to TCAM with a justification covering why the HS is required. If regarded as justified, the EC may decide to
modify the mandate or issue a new one. Such decisions require approval by the Committee established under the terms
of Directive 98/34/EC [i.8].
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13 ETSI EG 201 399 V2.2.1 (2010-08)
5.2 The drafting process
Guidance of the drafting process is addressed separately in clause 7.
5.3 Adoption of Harmonized Standards
HSs are adopted according to specific procedures under the ETSI TWP.
Before a HS is submitted to the voting procedure, the standard should be finally examined to ascertain that the
conditions imposed by the R&TTE Directive [i.1], the conditions of the standardization mandate, and the conditions
stemming from the present document are met.
NOTE: ETSI may establish procedures to ensure that this is always the case.
5.4 Submission to EC and Publication in the OJEU
Once adopted by ETSI, HSs developed under a R&TTE Directive [i.1] mandate are presented to the Commission by the
ETSI Secretariat. It has been agreed between the Commission and ETSI that the presentation will be accompanied by
the translation of the title of the document into the official languages of the EU and EFTA.
The Commission will decide whether or not the HS is acceptable in whole or in part as suitable for establishing a
presumption of conformity against the relevant essential requirements. The EC may decide whether or not to cite the HS
or its revision (the whole or parts thereof) in the OJEU.
The ETSI Technical Working Procedures, clause 2.4 states, "ENs shall be transposed by the National Standards
Organizations (see article 13.7 of the Rules of Procedure)." [i.39].
The ETSI Secretariat will set the Date Of Withdrawal (DOW) to eighteen months after Date Of Announcement (DOA)
unless the relevant ETSI TB advises otherwise.
ETSI TBs may add a note in the OJEU listing of HS (e.g. for explaining the transfer of one (set of) standard(s) to
another number). The note will appear across a whole row of the OJEU. The ETSI TB should provide this information
to the ETSI Secretariat if this possibility is chosen.
5.5 Revision of Harmonized Standards
Revisions of HSs developed under R&TTE Directive [i.1] mandate do not require a specific modification to the
standardization mandate. However, publication of the revised standard in the OJEU is necessary to amend the
requirements which give a presumption of conformity with the R&TTE Directive [i.1].
The TB should consider the cost and other implications on industry and other parties before proposing revisions to HSs.
If an ETSI TB considers that technical modifications to a HS are required, it should raise a work item according to the
ETSI TWP.
According to the MoU [i.19] between CEPT-ECC and ETSI, any modification of the HS which would require a
modification of ECC deliverables should lead to a coordination process between the two bodies. The same would apply
if ECC envisages a change in its regulation which would require a modification of HSs.
Adoption and submission of revisions of HSs are as explained in clauses 5.1 to 5.4.
5.6 Withdrawal of Harmonized Standards
After consultation of TCAM, the Commission may withdraw the OJEU reference to HSs by publication of a notice to
that effect in the OJEU. Presumption of conformity through that HS will then cease.
For the case where, following the Commission's action, the relevant ETSI TB considers that the HS should be
withdrawn, the ETSI TWP provide the procedures to be followed. The ETSI Secretariat will ensure that the standard is
archived so as to remain available if requested, including traceability that the standard had been published in the OJEU,
with the relevant dates of publication and withdrawal.
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14 ETSI EG 201 399 V2.2.1 (2010-08)
6 Formulation of technical requirements
6.1 Guiding principles
6.1.1 General
This methodology is based on the evaluation of applicable technical parameters for equipment corresponding to specific
attributes. The parameters and attributes are shown in annex A.
As a matter of principle, the decision of precisely how to demonstrate compliance with an essential requirement should
remain the duty of the applicable TB. However, it is important that a common set of principles be made available to
guide the TB when making decisions on content. Where a TB considers that deviation from the principles of annex A is
desirable, OCG R&TTE should be advised who may develop a formal justification for onward transmission to the EC
or other concerned parties.
6.1.2 Level of technological independence
ETSI technical bodies should take note, as a principal goal, that wherever possible, HSs which are technology
independent are preferred. The level of technological independence should remain the responsibility of the appropriate
TB. Means for judgement could be commonalities in equipment attributes and technical parameters as outlined below.
6.1.3 Equipment attributes
In producing HSs for application under the Directive, ETSI should ensure that the standards do not exceed the degree of
regulation envisaged by the Commission, and should apply discernment in order not to inhibit technological innovation
or the meeting of the needs of a free-market economy. To assist this objective, the present document defines groups of
products sharing similar fundamental attributes.
Equipment attributes are defined in annex A.
A single equipment can have more
...
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