Reasonably Foreseeable Use Conditions when referring to EMF Exposure Assessment

This Technical Report illustrates good practice and provides guidance with regard to the term "reasonably foreseeable use" as it relate to product compliance assessment standards concerning the exposure of humans to electric, magnetic and electromagnetic fields (EMF) as required in the Radio Equipment Directive (RED) and Low Voltage Directive (LVD). Other safety aspects and requirements from other directives are not covered by this Technical Report.
This report uses the term "reasonably foreseeable use". In this context of this TR the terms "reasonably foreseeable conditions" and "conditions of use which can be reasonably foreseen" are interchangeable. The report provides guidance that is not specific to individual equipment. The report covers both occupational and general public use of equipment and also provides a rationale for the distinction between occupational use and use by the general public.

Vernünftigerweise vorhersehbare Gebrauchsbedingungen, auf die bei EMF-Bewertungen Bezug genommen wird

Conditions d'utilisation raisonnablement prévisibles dans le cadre de l'évaluation de l'exposition aux champs électromagnétiques

Razumno predvidljivi pogoji uporabe pri sklicevanju na oceno izpostavljenosti elektromagnetnim poljem (EMF)

General Information

Status
Published
Publication Date
12-Sep-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
20-Jul-2021
Due Date
24-Sep-2021
Completion Date
13-Sep-2021

Buy Standard

Technical report
SIST-TP CLC/TR 50713:2021 - BARVE na PDF-str 16,17,18
English language
24 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST-TP CLC/TR 50713:2021
01-oktober-2021
Razumno predvidljivi pogoji uporabe pri sklicevanju na oceno izpostavljenosti
elektromagnetnim poljem (EMF)
Reasonably Foreseeable Use Conditions when referring to EMF Exposure Assessment
Ta slovenski standard je istoveten z: CLC/TR 50713:2021
ICS:
13.280 Varstvo pred sevanjem Radiation protection
SIST-TP CLC/TR 50713:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST-TP CLC/TR 50713:2021
---------------------- Page: 2 ----------------------
SIST-TP CLC/TR 50713:2021
TECHNICAL REPORT CLC/TR 50713
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
July 2021
ICS 13.280
English Version
Reasonably Foreseeable Use Conditions when referring to EMF
Exposure Assessment

Conditions d'utilisation raisonnablement prévisibles dans le Vernünftigerweise vorhersehbare Gebrauchsbedingungen,

cadre de l'évaluation de l'exposition aux champs auf die bei EMF-Bewertungen Bezug genommen wird

électromagnétiques
This Technical Report was approved by CENELEC on 2021-07-13.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. CLC/TR 50713:2021 E
---------------------- Page: 3 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)
Contents

European foreword .................................................................................................................................... 3

Introduction ................................................................................................................................................ 4

1 Scope ............................................................................................................................................. 5

2 Normative references ................................................................................................................... 5

3 Terms and definitions .................................................................................................................. 5

4 Distinction between general public and workers ...................................................................... 6

5 Intended Use ................................................................................................................................. 7

6 Reasonably foreseeable use ....................................................................................................... 7

6.1 Fundamental elements of reasonably foreseeable use ............................................................ 7

6.2 The device/equipment .................................................................................................................. 7

6.2.1 General ........................................................................................................................................... 7

6.2.2 The user ......................................................................................................................................... 7

6.2.3 The device use .............................................................................................................................. 8

6.3 Reasonably Foreseeable Use for the general public ................................................................ 8

6.4 Reasonably Foreseeable Use for workers ................................................................................. 9

6.5 Reasonably foreseeable misuse and unreasonable use .......................................................... 9

6.6 Realistic exposure scenarios ...................................................................................................... 9

7 Conclusions and Recommendations concerning EMF exposure assessment ...................10

Annex A (informative) Exemplary List of Studies investigating the actual EMF exposure under

reasonably foreseeable use conditions ...................................................................................11

Bibliography .............................................................................................................................................24

---------------------- Page: 4 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)
European foreword

This document (CLC/TR 50713:2021) has been prepared by CLC/TC 106X “Electromagnetic fields in the human

environment”.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission and the

European Free Trade Association.
---------------------- Page: 5 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)
Introduction

Directive 2014/53/EU (Radio Equipment Directive, RED) and Directive 2014/35/EU (Low Voltage Directive,

LVD) require that equipment meets the electromagnetic fields (EMF) exposure requirements when used as

intended as well as under reasonably foreseeable conditions. Consequently, all relevant product standards are

to be revised to meet the new requirements introduced in these directives.

Both the above-mentioned directives introduce new wordings such as “conditions of use which can be

reasonably foreseen” as well as “reasonably foreseeable conditions” which are considered synonymous

phrases. These new wordings could be open to different interpretations. Therefore, there is a need for

clarification of what “conditions of use which can be reasonably foreseen” and its synonyms “reasonably

foreseeable conditions” as well as “reasonably foreseeable use” mean when dealing with the EMF compliance

of different product categories and applications.

Reasonably foreseeable conditions not only take into account the user behaviour but also exposure conditions

representative of all readily-predictable human and system behaviour including parameters such as the duration

of exposure, time variability of transmitted power, simultaneously operated frequency bands, availability of

manufacturer-approved accessories, and time averaging as defined in normative limits and exposure guidelines.

This document addresses only the EMF assessment perspective (both measurement and calculation).

This document refers to the wording of the underlying directives. The considerations are restricted to the EMF

exposure assessment and not intended to be applied beyond EMF exposure assessment.

---------------------- Page: 6 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)
1 Scope

This document illustrates good practices and provides guidance with regard to the term “reasonably foreseeable

use” as it relates to product compliance assessment standards concerning the exposure of humans to electric,

magnetic and electromagnetic fields (EMF) as required in the Radio Equipment Directive (RED) and Low

Voltage Directive (LVD). Other safety aspects and requirements from other directives are not covered by this

document.

This document uses the term “reasonably foreseeable use”, which in the context of this document is

interchangeable with the terms “reasonably foreseeable conditions” and “conditions of use which can be

reasonably foreseen”. The document provides guidance that is not specific to individual equipment.

The document covers both occupational and general public use of equipment and also provides a rationale for

the distinction between occupational use and use by the general public.
This document is limited to the standards in the scope of TC106X.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
intended use

use of equipment in accordance with the information for use or user training provided by the manufacturer

Note1 to entry: According to the RED, intended use requires proper installation and maintenance of radio equipment and

that radio equipment has to be used for its intended purpose.

Note 2 to entry: Some usage of a product, shown for advertising purpose only, might not be intended to be repeated by

the user and is therefore not part of the intended use.

[SOURCE: CENELEC Guide 32:2016, definition 4.8, modified; IEV 903-01-13, modified]

3.2
reasonably foreseeable use

intended use as well as use of equipment in conditions, which results from lawful and readily predictable human

and system behaviour that can be anticipated by the manufacturer

Note 1 to entry: Use conditions explicitly excluded by the manufacturer in the information for use or user training, but

nevertheless reasonably foreseeable under the assumption that the user has not read the information for use or has not

followed training instructions, are deemed to represent reasonably foreseeable misuse and such conditions fall outside this

definition.

Note 2 to entry: This document uses the term “reasonably foreseeable use”. In this context, the terms “reasonably

foreseeable conditions”, “reasonably foreseeable use” and “conditions of use which can be reasonably foreseen” are

interchangeable.
---------------------- Page: 7 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)
3.3
reasonably foreseeable misuse

any use conditions not included in “reasonably foreseeable use” or “unreasonable misuse”, including use

conditions which contradict the information for intended use or user training, even if considered reasonably

predictable human behaviour

Note 1 to entry: Any potential misuse shall not be considered for the compliance assessment of equipment regarding

human exposure to EMF.

[SOURCE: CENELEC Guide 32:2016, definition 4.11, modified; IEV 903-01-14, modified]

3.4
unreasonable misuse
use conditions, which are based on not predictable or unlawful human behaviour
3.5
general public

individuals of all ages and of differing health statuses, which may include particularly vulnerable groups or

individuals, and who might have no knowledge of or control over their exposure to EMF

Note 1 to entry: In many cases, members of the general public are unaware of their exposure to EMF. These

considerations underlie the adoption of more stringent exposure restrictions for the public than for workers while they are

occupationally exposed.
Note 2 to entry: Consumers are considered to be members of general public.
Note 3 to entry: Conscious medical treatment to a maximum dosage is excluded.
3.6
professional use
use conditions intended only for trained experts or instructed persons
[SOURCE: IEV 851-11-12 modified]
3.7
worker

any person employed by an employer, including trainees and apprentices but excluding domestic servants

Note 1 to entry: The formal distinction between general public and worker is often given in national legislation.

[SOURCE: Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage

improvements in the safety and health of workers at work]
4 Distinction between general public and workers

Directive 89/391/EEC defines worker as any person employed by an employer, including trainees and

apprentices but excluding domestic servants; an employer is any natural or legal person who has an

employment relationship with the worker and has responsibility for the undertaking and/ or establishment.

Directive 89/391/ECC as well as Directive 2013/35/EU require information and training for workers who are

likely to be exposed to risks from EMF at work.

Thus, the exposure guidelines distinguish whether the worker is aware of the EMF exposure or not and whether

the person is professionally trained. What can be presumed as reasonably foreseeable use regarding a worker

who is aware of the EMF exposure and professionally trained about the EMF exposure is different from what

can be expected from an unaware and untrained worker. If workers are unaware of their exposure to EMF they

are treated like members of the general public. The reference levels and basic restrictions for the exposure of

the general public to electric, magnetic, and electromagnetic fields are stricter than for occupational exposure.

---------------------- Page: 8 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)

Equipment that is compliant with the requirements for general public is deemed to be usable for workers.

5 Intended Use

This document considers mainly the placing on the market of equipment. The intended use implies proper

installation and maintenance as well as using equipment for its intended purpose.

NOTE 1 The use of the equipment includes relevant accessories and components, as long as the mode of operation is

approved by the manufacturer.

The manufacturer should provide sufficient documentation on the intended use of the equipment in a clear,

understandable and intelligible language for general public and workers. Any labelling should be clear and

understandable. Such user documentation may include a description of manufacturer-approved accessories

and components, including software, which allow the equipment to operate as intended.

NOTE 2 The Blue Guide, in Chapter 3.1.4, provides more details on how the instructions and safety information is

expected to be provided.
6 Reasonably foreseeable use
6.1 Fundamental elements of reasonably foreseeable use

Reasonably foreseeable use includes the reasonably foreseeable conditions under which a device is used.

The devices are required to meet applicable regulatory standards including EMF compliance. In the case of

electromagnetic fields (EMF) exposure assessment, when the equipment operated by the user, three

fundamental elements can easily be recognized:
1) The Device/Equipment,
2) The User,
3) The way the device is used, i.e. the way that user interacts with the device.
6.2 The device/equipment
6.2.1 General

Regarding the device/equipment, sometimes called the device under test (DUT), two relevant parameters stand

out;

1) The fixed elements (e.g. mechanical construction, software, etc.) of the device with its own possible

environmental and safety considerations;

2) The variable elements that influence the actual EMF exposure of the user (eg., transmitted power, antenna

tuning, etc.).

The actual device/equipment operation represents a key aspect of reasonably foreseeable use of the device.

Therefore, both the actual operation of the device and the user behaviour should be taken into account when

defining the “use”.
6.2.2 The user

The user’s inherent characteristics or behaviours contribute to setting the reasonably foreseeable use

conditions. These user-related parameters, such as physiology, anatomy and behaviours are considered in the

product EMF compliance assessment, where very conservative test conditions are defined.

The user is not always the person who is exposed to EMF from the product. The user is responsible for reading

the product manual and to ensure that the use conditions are followed as stated by the manufacturer in the

information for use.
---------------------- Page: 9 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)
6.2.3 The device use

The use of the device/equipment is very closely related to defining the “reasonably foreseeable use-condition”.

The following aspects should be taken into account when determining the ”use-condition”:

— Intended use defined by the manufacturer which usually represents the “normal” use;

— Other reasonably foreseeable use conditions explained in this document.
6.3 Reasonably Foreseeable Use for the general public

Reasonably foreseeable use, including use conditions, considers use of an equipment that is

— properly installed and maintained;
— used for its intended purpose;
— based on actual system behaviour;

— used in a different way than the intended use stated by the manufacturer as long as this results from lawful

and readily predictable human and system behaviour.

Specific usage cases and applicable assessments of individual equipment may be considered in the product

standards.

A behaviour is lawful when it is in line with applicable legislation or does not deliberately or negligently create

non-compliance. There could be a number of unlawful behaviours which are not related to EMF; these

behaviours should not be considered.

A behaviour is readily predictable when the behaviour is reasonable and normal but not reckless.

The realm of reasonably foreseeable uses comprises usages and exposure conditions that are realistically

possible when using the equipment for its intended purpose. The consideration of reasonably foreseeable

conditions should take into account the following:
— the technical and functional characteristics of the equipment,
— the realistic exposure conditions as well as
— the duration of exposure,
— time and spatial averaging as defined in normative limits,
— actual equipment power level behaviour,
— lawful and readily predicable human behaviour,
— installation and operation parameters such as
— time variability of transmitted power,
— simultaneously operated frequency bands,
— availability of manufacturer-approved accessories.

There are several studies on the actual performance of the power levels of the device/equipment in real use

condition. Information to determine realistic or reasonably foreseeable exposure conditions can be found in

studies in Annex A. The informative Annex A provides an exemplary list of studies investigating actual EMF

exposure under reasonably foreseeable use conditions.
---------------------- Page: 10 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)

Repair and refurbishment are reasonably foreseeable use and after repair and refurbishment the requirements

for the exposure of humans to electromagnetic fields should still be fulfilled.

Use conditions not in accordance with the intended purpose of equipment as well as conditions, explicitly

excluded by the manufacturer in the documentation for use but nevertheless reasonably foreseeable under the

assumption that the user has not read the documentation for use, are termed in the context of this TR

‘reasonably foreseeable misuse’ and should not be considered for EMF exposure assessment.

The product standard committees may determine the relevance of reasonably foreseeable misuse for their

standards.

Equipment which is intended exclusively for professional use by trained workers but have subsequently

migrated to the consumer market have to meet the requirements for the general public at the time they are

made available to the general public.
6.4 Reasonably Foreseeable Use for workers

This document differentiates the case of general public and the case of workers at work who are likely to be

exposed to risks from electromagnetic fields. The employer carries out a risk assessment for workers arising

from EMF exposure at the workplace. The employer ensures that workers who are likely to be exposed to risks

from EMF exposure at work receive any necessary documentation and training relating to the outcome of the

risk assessment. It is anticipated that the employer specifies how the worker may use the equipment within the

employees work instructions by relying on the manufacturer definition of intended use and any associated user

training documentation. These work instructions shall include the use parameters (such as the mandated use

of manufacturer-approved accessories) defined according to the equipment intended use as defined by the

equipment manufacturer. The employer cannot specify how the worker could use the equipment in ways that

do not conform with the manufacturer’s user documentation, since employees could be subjected to EMF

exposures in excess of normative limits as a result. Workers shall follow the workplace instructions so devised

provided by the employer. Use conditions shall be avoided by the employer if explicitly excluded by the

manufacturer in the equipment user documentation.

Use conditions, explicitly excluded by the manufacturer or employer in the documentation or training for use,

are considered to be misuse. In this document it is expected that the worker follows the instructions provided

by the employer.
6.5 Reasonably foreseeable misuse and unreasonable use

It is noted that the Radio Equipment Directive and the Low Voltage Directive address reasonably foreseeable

use defined as resulting from lawful and readily predictable human behaviour, but both directives do not cover

misuse. Thus, only reasonably foreseeable use but not misuse should be considered for EMF exposure

assessment under the RED or the LVD. Unreasonable misuse is also excluded from EMF exposure

assessment.
6.6 Realistic exposure scenarios

Reasonably foreseen conditions of use are not only relevant to the equipment user behaviour, but they are also

related to the realistic function and performance of the equipment affecting users' exposure. The realistic

exposure is defined as the exposure conditions representative of all readily-predictable human and system

behaviour including parameters such as the duration of exposure, time variability of transmitted power,

simultaneously operated frequency bands and time averaging as defined in normative limits.

Since the realistic exposure levels are reliably predictable under reasonably foreseeable conditions, the realistic

power levels should be considered in compliance assessments. The assessment of realistic power levels should

be based on realistic exposure scenarios.

In the case when compliance assessment standards require the equipment under test to be operated at

maximum power levels, highly conservative assessment could result. As a consequence, all other exposure

scenarios may be considered as covered.

Workers shall follow the workplace instructions provided by the employer. The employer can enforce equipment

use instructions. Workers conduct misuse if they are likely to be exposed to risks from electromagnetic fields at

work and neglect safety documentation or equipment user training.
---------------------- Page: 11 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)
7 Conclusions and Recommendations concerning EMF exposure assessment
This document:

— Reiterates that equipment put on the market for the first time as well as repaired or refurbished equipment

requires EMF risk assessment under reasonably foreseeable conditions of use and compliance with EMF

exposure requirements as laid down in Council Recommendation 1999/519/EC;

— Recommends that for EMF risk assessment and EMF exposure compliance occupational use of equipment

and use by general public should be distinguished;

— Recommends that for EMF risk assessment and EMF compliance evaluations the term “reasonably

foreseeable use” should be understood covering reasonably foreseeable conditions of use which embrace

e.g. the realistic exposure conditions representative of all readily-predictable human and system behaviour

including parameters such as the duration of exposure, distance to the source, time variability of transmitted

power, simultaneously operated frequency bands, manufacturer-approved accessories, and time and

spatial averaging as defined in applicable limits;

— Emphasizes that the limitations for human exposure to electromagnetic fields, given in the Council

Recommendation 1999/519/EC, already include a significant margin between recommended basic

restrictions and the established biological effects, and therefore considerations about reasonably

foreseeable use for EMF-measurements for human exposure are different from other safety considerations.

For example, misuse should not be considered reasonably foreseeable use for EMF exposure compliance

assessments;

— Recommends using those most representative test positions and test distances as well as installation

parameters in EMF risk assessment and EMF compliance testing which lead to a conservative estimation

in the EMF exposure assessment; recommends that end-users should be provided with sufficient

information on the intended use of the equipment and all accessories relevant for the EMF compliance of

the equipment in a clear, understandable, and intelligible language for end-users;

— Reminds that a manufacturer should provide a description of manufacturer-approved accessories and

components, including software, which allow the equipment to operate as intended; in particular, when they

have an influence on the conformity of the equipment.
---------------------- Page: 12 ----------------------
SIST-TP CLC/TR 50713:2021
CLC/TR 50713:2021 (E)
Annex A
(informative)
Exemplary List of Studies investigating the actual EMF exposure under
reasonably foreseeable use conditions
A1. Output power distributions of terminals in a 3G mobile communication network

(https://www.ncbi.nlm.nih.gov/pubmed/22012866) which highlights in the abstract: “The objective of this

study was to examine the distribution of the output power of mobile phones and other terminals connected

to a 3G network in Sweden. It is well known that 3G terminals can operate with very low output power,

particularly for voice calls. Measurements of terminal output power were conducted in the Swedish

TeliaSonera 3G network in November 2008 by recording network statistics. In the analysis, discrimination

was made between rural, suburban, urban, and dedicated indoor networks. In addition, information about

terminal output power was possible to collect separately for voice and data traffic. Information from six

different Radio Network Controllers (RNCs) was collected during at least 1 week. In total, more than

800000 h of voice calls were collected and in addition to that a substantial amount of data traffic. The

average terminal output power for 3G voice calls was below 1 mW for any environment including rural,

urban, and dedicated indoor networks. This is < 1 % of the maximum available output power. For data

applications the average output power was about 6-8 dB higher than for voice calls. For rural areas the

output power was about 2 dB higher, on average, than in urban areas. Bioelectromagnetics.”

A2. Output power levels from mobile phones in different geographical areas; implications for exposure

assessment (https://pubmed.ncbi.nlm.nih.gov/15317918/) which states in the abstract: “The output power

for all mobile phone calls managed by the GSM operator Telia Mobile was recorded during one week in

four defined areas (rural, small urban, suburban, and city area) in Sweden. The recording included output

power for the 900 MHz and the 1800 MHz frequency band.

Results: In the rural area, the highest power level was used about 50 % of the time, while the lowest power

was used only 3 % of the time. The corresponding numbers for the city area were approximately 25 % and

22 %. The output power distribution in all defined urban areas was similar.”

A3. Determinants of mobile phone output power in a multinational study: implications for exposure

assessment (https://pubmed.ncbi.nlm.nih.gov/19465409/) which revealed:

“More than 500 volunteers in 12 countries used Global System for Mobile communications software-

modified phones (GSM SMPs) for approximately 1 month each. The SMPs recorded date, time, and

duration of each call, and the frequency band and output power at fixed sampling intervals throughout each

call. Questionnaires provided information on the typical circumstances of an individual's phone use. Linear

regression models were used to analyse the influence of possible explanatory variables on the average

output power and the percentage call time at maximum power for each call. Results: Measurements of over

60 000 phone calls showed that the average output power was approximately 50% of the maximum, and

that output power varied by a factor of up to 2 to 3 between study centres and network operators. Maximum

power was used during a considerable proportion of call time (39 % on average). Output power decreased

with increasing call duration, but showed little variation in relation to reported frequency of use while in a

moving vehicle or inside buildings. Higher output powers for rural compared with urban use of the SMP

were observed principally in Sweden where the study covered very sparsely populated areas.

Conclusions: Average power levels are substantially higher than the minimum levels theoretically

achievable in GSM networks. Exposure indices could be improved by accounting for average power levels

of different telecommunications systems. There appears to be little value in gathering information on

circumstances of phone use other than use i
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.