ETSI TR 103 879 V1.1.1 (2024-10)

Electromagnetic compatibility and Radio spectrum Matters (ERM); Guidance on risk assessment for radio equipment

DTR/ERM-RM-278

General Information

• Status: Not Published
• Technical Committee: ERM WGRM - ERM Radio Matters
• Current Stage: 12 - Completion
• Due Date: 07-Nov-2024
• Completion Date: 29-Oct-2024

Standards Content (Sample)

TECHNICAL REPORT
Electromagnetic compatibility and
Radio spectrum Matters (ERM);
Guidance on risk assessment
for radio equipment
2 ETSI TR 103 879 V1.1.1 (2024-10)

Reference
DTR/ERM-RM-278
Keywords
Directive 2014/53/EU, EMC, harmonised standard,
OJEU, radio, RED, risk, risk assessment

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3 ETSI TR 103 879 V1.1.1 (2024-10)
Contents
Intellectual Property Rights . 4
Foreword . 4
Modal verbs terminology . 4
Introduction . 4
1 Scope . 6
2 References . 6
2.1 Normative references . 6
2.2 Informative references . 6
3 Definition of terms, symbols and abbreviations . 7
3.1 Terms . 7
3.2 Symbols . 7
3.3 Abbreviations . 7
4 General . 8
4.1 Legal background . 8
4.2 What is risk? . 10
4.3 What is risk assessment? . 10
4.4 What is the relationship between harmonised standards and risk assessment? . 11
5 Guideline of risk assessment and risk reduction . 12
5.1 Iterative process of risk assessment and risk reduction . 12
5.2 Define user, intended use . 14
5.3 Identify possible risks related to EMC and Radio . 14
5.3.1 General . 14
5.3.2 Risks related to EMC (RED article 3.1(b)) . 15
5.3.3 Risks related to Radio (RED article 3.2) . 15
5.4 Define and perform own methods and evaluate the residual risks . 16
5.5 Risk reduction . 16
5.6 Documentation (Checklist) . 17
5.7 Monitor production and product returns as well as any industry 'state of the art' changes . 18
6 Special cases . 18
6.1 Case 1: Multi-radio equipment and combined radio/non radio equipment . 18
Annex A: Guidance on the use of harmonised and non-harmonised standards . 20
Annex B: An example on how a risk assessment could look like. . 21
History . 22

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4 ETSI TR 103 879 V1.1.1 (2024-10)
Intellectual Property Rights
Essential patents
IPRs essential or potentially essential to normative deliverables may have been declared to ETSI. The declarations
pertaining to these essential IPRs, if any, are 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 (https://ipr.etsi.org/).
Pursuant to the ETSI Directives including the ETSI IPR Policy, no investigation regarding the essentiality of IPRs,
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.
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ETSI claims no ownership of these except for any which are indicated as being the property of ETSI, and conveys no
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Organizational Partners. oneM2M™ logo is a trademark of ETSI registered for the benefit of its Members and of the ®
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BLUETOOTH is a trademark registered and owned by Bluetooth SIG, Inc.
Foreword
This Technical Report (TR) has been produced by ETSI Technical Committee Electromagnetic compatibility and Radio
spectrum Matters (ERM).
A technical Report (TR) is an ETSI deliverable, containing only informative elements, approved for publication by a
Technical Body (TB), see ETSI Directives [i.18], clause A.3.
Modal verbs terminology
In the present document "should", "should not", "may", "need not", "will", "will not", "can" and "cannot" are to be
interpreted as described in clause 3.2 of the ETSI Drafting Rules (Verbal forms for the expression of provisions).
"must" and "must not" are NOT allowed in ETSI deliverables except when used in direct citation.
Introduction
The conformity assessment procedure for radio equipment requires manufacturers to adequately analyse and assess the
risk(s) related to the essential requirements of the Radio Equipment Directive 2014/53/EU (RED) [i.1], as set out in its
article 3, even if a harmonised standard is fully applied.
Several guidance documents related to the essential requirements in general and specifically of RED already exist:
• Both Blue Guide [i.2] and the RED Guide [i.3] provide brief guidance on risk assessment.
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5 ETSI TR 103 879 V1.1.1 (2024-10)
• CENELEC has already published the CENELEC GUIDE 32 on Guidelines for Safety Related Risk
Assessment and Risk Reduction for Low Voltage Equipment which is applicable to the risk assessment and
risk reduction related to article 3(1)a (electrical safety and health) of RED [i.7]. ISO/IEC has published a
similar Guide with ISO/IEC Guide 51 [i.8].
• REDCA has published in May 2022 the Technical Guidance Note 30 (TGN30) on Notified Body examination
of a manufacturer's risk assessment under Annex III of Directive 2014/53/EU [i.6]. This guidance is intended
for notified bodies, but may also be useful for manufacturers.
The present document is intended to assist manufacturers in the collection of relevant information for risk assessment
and the subsequent performance of risk assessment and mitigation. This risk assessment should be documented and be
part of the technical documentation required by article 21 of Directive 2014/53/EU [i.6].

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6 ETSI TR 103 879 V1.1.1 (2024-10)
1 Scope
The present document is to support manufacturers with a systematic and easy-to-understand guidance on how to carry
out a risk assessment.
The present document covers the essential requirements of Directive 2014/53/EU (RED) [i.1], articles 3(1)b and 3(2).
NOTE: The present document provides guidance on risk assessment only for RED articles 3(1)b and 3(2), which
does not mean that manufacturers need to perform risk assessment only for these two articles. The general
approach to risk assessment should apply to all aspects of the essential requirements described in RED
article 3.
2 References
2.1 Normative references
Normative references are not applicable in the present document.
2.2 Informative references
References are either specific (identified by date of publication and/or edition number or version number) or
non-specific. For specific references, only the cited version applies. For non-specific references, the latest version of the
referenced document (including any amendments) applies.
NOTE: The hyperlinks included in this clause were valid at the time of publication, ETSI cannot guarantee their
long-term validity.
The following referenced documents are not necessary for the application of the present document but they assist the
user with regard to a particular subject area.
[i.1] Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
radio equipment (RED).
[i.2] Commission Notice: "The 'Blue Guide' on the implementation of EU product rules 2022".
[i.3] Guide to the Radio Equipment Directive 2014/53/EU ('RED Guide'), Version of 19 December
2018.
[i.4] Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on
market surveillance and compliance of products and amending Directive 2004/42/EC and
Regulations (EC) No 765/2008 and (EU) No 305/2011.
[i.5] 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.6] REDCATechnical Guidance Note 30, V3.1, May 2022: "Notified Body examination of a
manufacturer's risk assessment under Annex III of Directive 2014/53/EU".
[i.7] CENELEC Guide 32, Edition 1, 2014-07: "Guidelines for Safety Related Risk Assessment and
Risk Reduction for Low Voltage Equipment which is applicable to the risk assessment and risk
reduction related to article 3(1)a (electrical safety and health) of the RED".
[i.8] ISO/IEC Guide 51:2014: "Safety aspects -- Guidelines for their inclusion in standards".
[i.9] ETSI EG 203 367 (V1.1.1): "Guide to the application of harmonised standards covering articles
3.1b and 3.2 of the Directive 2014/53/EU (RED) to multi-radio and combined radio and non-radio
equipment".
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[i.10] ETSI EN 303 446-1 (V1.2.1): "ElectroMagnetic Compatibility (EMC) standard for combined
and/or integrated radio and non-radio equipment; Part 1: Requirements for equipment intended to
be used in residential, commercial and light industry locations".
[i.11] ETSI EN 303 446-2 (V1.2.1): "ElectroMagnetic Compatibility (EMC) standard for combined
and/or integrated radio and non-radio equipment; Part 2: Requirements for equipment intended to
be used in industrial locations".
[i.12] ERC Recommendation 70-03 (February 2022): "Relating to the use of Short Range Devices
(SRD)".
[i.13] Guide for the EMCD (Directive 2014/30/EU), Publication date: 24/01/2019.
[i.14] Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the
harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast)
Text with EEA relevance.
[i.15] Recommendation ITU-R SM.329-12 (09/2012): "Unwanted emissions in the spurious domain".
[i.16] ETSI EG 203 336 (V1.2.1): "Guide for the selection of technical parameters for the production of
Harmonised Standards covering article 3.1(b) and article 3.2 of Directive 2014/53/EU".
[i.17] IEC TR 61000-2-5: 2017: "Electromagnetic compatibility (EMC) - Part 2-5: Environment -
Description and classification of electromagnetic environment".
[i.18] ETSI Directives.
3 Definition of terms, symbols and abbreviations
3.1 Terms
For the purposes of the present document, the following terms apply:
combined equipment: equipment consisting of two or more products where at least one of which is radio
communication or radio determination equipment (according to ETSI EG 203 367 [i.9], clause 3.1)
essential requirements: For the purposes of the present document, unless otherwise defined, the term refers to the
essential requirements set out in articles 3.1(b) and 3.2 of the Radio Equipment Directive 2014/53/EU (RED) [i.1].
harmonised standard listed in the OJEU (hEN): European standard adopted on the basis of a request made by the
Commission for the application of Union harmonisation legislation which is cited in the Official Journal for Directive
2014/53/EU
multi-radio equipment: combined equipment consisting of two or more radio products (according to ETSI
EG 203 367 [i.9], clause 3.1)
3.2 Symbols
Void.
3.3 Abbreviations
For the purposes of the present document, the following abbreviations apply:
AFA Adaptive Frequency Agility
CAP Conformity Assessment Procedures
DFS Dynamic Frequency Selection
DoC Declaration of Conformity
EAU Electrical Aggregation Unit
EMC ElectroMagnetic Compatibility
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8 ETSI TR 103 879 V1.1.1 (2024-10)
EMCD ElectroMagnetic Compatibility Directive
EN European standard
ESOs European Standardization Organizations
EU/EEA European Union / European Economic Area
EUA Equipment Under Assessment
EUT Equipment Under Test
GPS Global Positioning System
GSM General System for Mobile communication
hEN harmonised European standard (listed in the OJEU)
LBT Listen Before Talk
LTE 3GPP Long Term Evolution (4G)
MU Measurement Uncertainty
NB Notified Body
OJEU Official Journal of the European Union
OJEU-RED Official Journal - Directive 2014/53/EU
NOTE: See https://ec.europa.eu/docsroom/documents/51934.
RED Radio Equipment Directive (Directive 2014/53/EU)
RF Radio Frequency
TD Technical Documentation
TX Transmitter ®
Wireless Fidelity
Wi-Fi
4 General
4.1 Legal background
The legal references to a manufacturer's risk assessment are spread across multiple documents, some of which are not
easily accessible. Therefore, some of the relevant legal documents related to the risk assessment are listed here, as
information to the manufacturer. These documents may be updated at any time and therefore any manufacturer wishing
to reference these documents should check for new versions.
The RED Guide [i.3]: Clause 2.6b (Conformity assessment procedures (CAP)):
"…Under the Modules mentioned above, an assessment needs to be performed for ensuring that radio equipment
complies with the essential requirements set out in Article 3 of the RED (that includes an assessment of the risks and
aspects covered by Article 3). Based on the wording of Article 21 and Annex V of the RED, this assessment (whether
Module A, B+C or H has been followed) shall be included in the technical documentation…."
Directive 2014/53/EU (RED) [i.1]: Annex III Module B paragraph 3c (Conformity assessment modules B and C):
"…The technical documentation shall make it possible to assess the radio equipment's conformity with the
applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The
technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment,
the design, manufacture and operation of the radio equipment…"
The RED Guide [i.3]: Clause 2.6d (Technical Documentation (TD)):
"…Annex III of the RED asks to include "an adequate analysis and assessment of the risk(s)" in the TD. Chapter 4.3
of the Blue Guide provides clarification on how such assessment shall be documented…"
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The Blue Guide [i.2]: Clause 4.1.1 (Definitions of essential requirements):
"Essential requirements must be applied as a function of the hazard inherent to a given product. Therefore,
manufacturers have to carry out a risk analysis to first identify all possible risks that the product may pose and
determine the essential requirements relevant for the product. This analysis implies that the manufacturer should
assess all the different elements of the products and determine which Union harmonisation legislation applies to it,
and which specific essential requirements as set out therein. This analysis has to be documented and included in
the technical documentation. In addition, the manufacturer needs to document the assessment of how the risks
identified are addressed to ensure that the product complies with the relevant essential requirements (for example,
by applying harmonised standards). If only part of the harmonised standard is applied or it does not cover all
relevant essential requirements, then the way relevant essential requirements not covered by it are dealt with,
should be documented (179).
(179) Even where the manufacturer uses a harmonised standard (where its reference is published in the OJEU and
which aims to cover certain risks) to satisfy essential requirements, the risk assessment has to be carried out and he
must check whether the harmonised standard covers all risks of the product. This is because it cannot be assumed
that the harmonised standard covers all requirements of all legislative acts applicable to a given product (or,
indeed, all the requirements of the specific act under which it has been developed) or whether the product in
question introduces also other risks not considered in the harmonised standard."
The Blue Guide [i.2]: Clause 4.1.2.2 (Role of harmonised standards):

The Blue Guide [i.2]: Clause 4.3 (Technical Documentation):
"…the requirement for an 'adequate analysis and assessment of the risk(s)' requires the manufacturer to first
identify all possible risks of the product and determine the essential requirements applicable. This analysis has to be
documented and included in the technical documentation. In addition, the manufacturer needs to document the
assessment of how he is addressing the risks identified to ensure that the product complies with the applicable
essential requirements (for example, by applying harmonised standards). If only part of the harmonised standard is
applied or it does not cover all applicable essential requirements, then also the way applicable essential
requirements not covered by it are dealt with should be documented in the technical documentation…"
Decision 768/2008/EC [i.5]: Annex II Module A Paragraph 2 (Module A)
"The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess
the product's conformity to the relevant requirements, and shall include an adequate analysis and assessment of the
risk(s)…"
Decision 768/2008/EC [i.5]: Annex II Module B Paragraph 3 (Module B)
"The technical documentation shall make it possible to assess the product's conformity with the applicable
requirements of the legislative instrument and shall include an adequate analysis and assessment of the risk(s)…"
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4.2 What is risk?
Traditionally, 'risk' means the combination of the probability of an occurrence of a hazard causing harm and the degree
of severity of that harm, according to article 3 (18) of Regulation (EU) 2019/1020 [i.4]. The determination of the related
risk requires then assumptions for the probability of an occurrence of such a harm A, and the degree of severity of the
relevant harm B. In theory the related risk is then calculated as A x B. However, this is in practice mostly not a simple
multiplication.
y
t
i
l
i
b
a
b
o
r
P
Severity
Figure 1: Risk = f (Probability, Severity) in the traditional way
The risk within the scope of the present document is interference/immunity related to the essential requirements in:
• RED article 3.1b (EMC): For example, electromagnetic interference due to the EUT's radiation into the radio
spectrum (radiation) and Degradation of performance or loss of functionality of the EUT due to the
electromagnetic environment in which the EUT is located (immunity).
• RED article 3.2 (Radio): For example, radio interference due to the EUT's emissions into the radio spectrum
and insufficient receiver requirements (e.g. sensitivity, selectivity).
4.3 What is risk assessment?
Risk assessment is the systematic process of determining all potential risks linked with the use of the product as
intended. It is followed by the phase of the risk reduction and finally the phase to determine if the residual risk could be
acceptable. As a first step, the manufacturer should determine all legislation(s) applicable to his product and extract the
applicable essential requirements.
Risk assessment accompanies the whole development process of a new product. Unlike the DoC, which should be
established and signed at the end of the development process, the risk assessment should be considered as a 'live'
document during the whole lifecycle of the product since the risks/hazards may change over time. The risk assessment
should therefore be regularly updated.
A risk assessment should, at least, contain the following elements:
• Identification of applicable legislation and associated essential requirements.
• Identification of intended user.
• Identification of intended use including the environmental conditions.
• Identification of all possible risks associated with the essential requirements, taking into account the defined
user and intended use.
• Assessment of the identified risks by applying standards (harmonised or non-harmonised, see Annex A) or
their own technical specifications to test their radio equipment and ensure that it meets the essential
requirements as specified in article 3 of the RED [i.1].
• Measures / Solutions to mitigate the risks that are non-compliant according to the test result.
• Monitor and review the (new) risks.
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The final objective of the risk assessment is to ensure that all possible risks posed by radio equipment are identified and
mitigated so that the radio equipment complies with the essential requirements.
Identify
risks
Monitor Assess
risks risks
Mitigate
risks
Figure 2: Risk assessment process
Risk assessment also provides an alternative way for the case that some measurements related to the essential
requirements cannot practically be carried out. For example, radiated measurements at extreme temperatures cannot
normally be performed in anechoic chambers. Risk assessment allows the manufacturer to assess the product on this
point in their own manner, e.g. through various tests, calculations, analyses, etc.
4.4 What is the relationship between harmonised standards and
risk assessment?
If a harmonised standard cited in the OJEU gives presumption of conformity, why is it necessary to carry out an
additional risk assessment? What is the relationship between harmonised standards and risk assessment?
The Blue Guide [i.2] provides a brief explanation in clause 4.1.1:
"(179) Even where the manufacturer uses a harmonised standard (where it
...