Guidelines for product committees on the preparation of standards related to human exposure from electromagnetic fields

The purpose of this Technical Report is to give advice on, and explanation of, the preparation of suitable EMF standards. It also aims to ensure that relevant deliverables from all CLC TCs will accurately reflect the current policy and legislative background on EMF exposure.

Leitfaden für Produktkomitees zur Ausarbeitung von Normen in Bezug auf die Sicherheit von Personen in elektromagnetischen Feldern

Lignes directrices pour les comités de produit concernant l'établissement des normes relatives à l'exposition humaine aux champs électromagnétiques

Smernice produktnim tehničnim odborom za pripravo standardov v zvezi z izpostavljenostjo ljudi elektromagnetnim sevanjem

Namen tega tehničnega poročila je podati smernice in razlago za priprave ustreznih standardov v zvezi z izpostavljenostjo elektromagnetnim sevanjem. Njegov cilj je tudi zagotoviti, da bodo ustrezni izsledki odborov CLC TC natančno odražali trenutna pravila in zakonodajno ozadje o izpostavljenosti elektromagnetnim sevanjem.

General Information

Status
Published
Publication Date
06-Feb-2018
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-Jan-2018
Due Date
31-Mar-2018
Completion Date
07-Feb-2018

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SLOVENSKI STANDARD
SIST-TP CLC/TR 50442:2018
01-marec-2018
1DGRPHãþD
SIST-TP CLC/TR 50442:2005
6PHUQLFHSURGXNWQLPWHKQLþQLPRGERURP]DSULSUDYRVWDQGDUGRYY]YH]L]
L]SRVWDYOMHQRVWMROMXGLHOHNWURPDJQHWQLPVHYDQMHP

Guidelines for product committees on the preparation of standards related to human

exposure from electromagnetic fields

Leitfaden für Produktkomitees zur Ausarbeitung von Normen in Bezug auf die Sicherheit

von Personen in elektromagnetischen Feldern

Lignes directrices pour les comités de produit concernant l'établissement des normes

relatives à l'exposition humaine aux champs électromagnétiques
Ta slovenski standard je istoveten z: CLC/TR 50442:2018
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
13.280 Varstvo pred sevanjem Radiation protection
SIST-TP CLC/TR 50442:2018 en

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

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SIST-TP CLC/TR 50442:2018
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SIST-TP CLC/TR 50442:2018
TECHNICAL REPORT CLC/TR 50442
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
January 2018
ICS 01.120; 13.280; 29.020 Supersedes CLC/TR 50442:2005
English Version
Guidelines for product committees on the preparation of
standards related to human exposure from electromagnetic
fields

Lignes directrices pour les comités de produit concernant Leitfaden für Produktkomitees zur Ausarbeitung von

l'établissement des normes relatives à l'exposition humaine Normen in Bezug auf die Sicherheit von Personen in

aux champs électromagnétiques elektromagnetischen Feldern
This Technical Report was approved by CENELEC on 2018-12-25.

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

Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, 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

© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. CLC/TR 50442:2018 E
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CLC/TR 50442:2018 (E)
Contents Page

Contents ............................................................................................................................................................. 2

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

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

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

2 Types of EMF product-related standards ........................................................................................... 5

3 Other types of standard ....................................................................................................................... 6

4 Structure of EMF standards and general quality principles ............................................................ 6

5 Titles of EMF standards ....................................................................................................................... 7

6 Drafting of an EMF product standard ................................................................................................. 7

7 Coordinating role of CENELEC TC 106X for EMF standards prepared by other CENELEC

committees .......................................................................................................................................... 10

Annex A (informative) Example Annexes ZZ ............................................................................................... 11

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CLC/TR 50442:2018 (E)
European foreword

This document (CLC/TR 50442:2018) has been prepared by CLC/TC 106X, "Electromagnetic fields in the

human environment".
This document supersedes CLC/TR 50442:2005.

This report has been accepted by ETSI and CEN as the basis for the development of electromagnetic fields

(EMF) standards.
The main changes with respect to the previous edition of CLC/TR 50442 are:

a) Update of the introduction to take into account Directive 2014/53/EU, Directive 2014/35/EU and

Directive 2013/35/EU;
b) Replacement of Clause 1 "Purpose" with new Clause 1 "Scope";
c) Replacement of Clause 2 with new Clause 2;
d) Replacement of Subclause 2.6 with new Clause 4;
e) Replacement of Clause 3 with new Clause 6;
f) Replacement of Clause 4 with new Clause 3;

g) Added requirements of Directives 2013/35/EU and 2014/53/EU to Clause 5 and renumbered Clauses 5 to

h) Added new Clause 5 – "Titles of EMF standards";
i) Added new Annex A with examples of Annexes ZZ.

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.

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CLC/TR 50442:2018 (E)
Introduction

Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonization of

the laws of the Member States relating to the making available on the market of radio equipment and repealing

Directive 1999/5/EC Text with EEA relevance [OJ L 153, 22.5.2014] is applicable from 13 June 2016.

Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonization

of the laws of the Member States relating to the making available on the market of electrical equipment designed

for use within certain voltage limits (recast) [OJ L 96, 29 March 2014] is applicable from 20 April 2016.

The European Commission has given CENELEC, the task of preparing harmonized standards for the

implementation of these Directives under Mandate M/536 and M/511 to provide a presumption of conformity to

their Essential Safety Requirements.

The Essential Safety Requirements of the Directives include safety in relation to human exposure to

electromagnetic fields.

In addition, Directive 2013/35/EU of 26 June 2013, on the minimum health and safety requirements regarding

the exposure of workers to the risks arising from physical agents (electromagnetic fields). Official Journal, L179,

of 2013-6-29, p. 1–21 is applicable from 29 June 2013. The European Commission has given CENELEC, the

task of preparing standards for the implementation of this Directive under Mandate M/351.

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1 Scope

The purpose of this Technical Report is to give advice on, and explanation of, the preparation of suitable EMF

standards. It also aims to ensure that relevant deliverables from all CLC TCs will accurately reflect the current

policy and legislative background on EMF exposure.
2 Types of EMF product-related standards

There are two types of EMF standards that are related to the assessment of EMF emissions from products:

basic standards and product standards.

Basic EMF standards define measurement and calculation methods, test instrumentation and test set-ups to be

used for the evaluation of compliance with limits on human exposure to electromagnetic fields. General types

or ranges of assessment criteria appropriate to specific evaluation methods or procedures may be given, but a

basic standard includes neither prescribed limits nor compliance criteria. Since basic standards define the

applicable measurement and calculation methods, they constitute the broad foundation on which product

standards are based on.

In general, product standards do not include applicable measurement or calculation methods, test

instrumentation or test set-ups but refer for that purpose to the applicable basic standard or standards. Some

product standards may determine that only certain parts of a basic standard apply while other parts of that basic

standard do not. All EMF product standards shall include normative references to limits on human exposure to

electromagnetic fields, and compliance assessment criteria applicable to products covered by Directives

2013/35/EU and 2014/53/EU.

Both basic standards and product standards can be either product-specific or generic (covering a number of

different products). Moreover, they can address ‘placing-on-the-market’, ‘putting-into-service’ or ‘in-situ’ (i.e.

dedicated to serve a special purpose or situation).

Table 1 gives an overview of the characteristics of the different types of product-related standards. They are

described more fully in Annex I.
Table 1 — Basic vs product standards
Type Contents Aims
Basic Measurement and calculation methods Reference documents
Instrumentation Called up by product standards or
freestanding
Test set-up
No conformance criteria, e.g. limits for
Types and ranges of assessment criteria
products
No limits or compliance criteria
(Not capable of being referenced in the
OJEU list)

Product Scope describing to which products they apply Conformance criteria for products

Intended to be referenced in the OJEU list
Normative limits
for the relevant Directive
Compliance criteria
Refer to basic standards for assessment methods (no
repetition)
Table 2 — Product specific vs generic standards
Type Aim Nature

Product- Specific to a particular product, family of products or range May be a basic or product standard

specific of products
Generic

Can apply to a range of different products e.g. low power May be a basic or product standard

products or products not covered by any other product
standard
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Table 3 — Placing-on-the-market, putting-into-service and in situ standards
Type Purpose Nature

Placing-on-the- Assessment of a product to allow it to be placed on May be a basic or product standard

market
the market, i.e. made available for the first time to
May be product-specific or generic
end-users
Assessment of a single product, usually in isolation.

Putting-into- Assessment of an installed product in its operating May be a basic or product standard

service environment at the point at which it is put-into-service,
May be product-specific or generic
taking account of other EMF sources already present.
Where applicable, to give guidance on installation
practices in order not to have accessible areas where
the exposure limits are exceeded
In- situ

Assessment of an already-installed product in its May be a basic or product standard

operating environment at any time.
May be product-specific or generic
3 Other types of standard

Other EMF standards that are not directly related to product performance include those written to support the

implementation of Directive 2013/35/EU (The Occupational EMF Directive). These are not harmonized and may

have structures and content other than as defined for product or basic standards in Clause 2.

4 Structure of EMF standards and general quality principles

It is intended that product standards should make reference to the basic standards without repeating their

detailed contents. Basic standards should not contain compliance criteria and will not be referenced in the list

of harmonized standards published in the Official Journal of the European Union (OJEU). The OJEU list will

include only references to product standards, i.e. standards that are capable of providing a direct presumption

of conformity of products with the Essential Safety Requirements of Directives 2014/35/EU and 2014/53/EU.

The following general quality principles for standards are emphasized:

• Overall requirement: the title and scope of a standard shall indicate whether it is a basic or a product

standard and if is a product standard, further determination of the purpose as defined in Clause 2 above is

required.

• A standard shall lead to reproducible results: it shall be robust against usual variations in the measuring

set-up or measuring devices.

• A standard shall be unambiguous: It shall not be possible to give multiple interpretations to the standard.

• All types of standards shall take uncertainty into consideration, e.g. by giving maximum allowed uncertainty.

Measurement uncertainties shall be treated in line with the ISO "Guide to the expression of uncertainty in

measurement" [ISO/IEC GUIDE 98-3:2008 Edition 1.0 (2008-09-30) - Uncertainty of measurement – Part 3:

Guide to the expression of uncertainty in measurement (GUM:1995)]. According to the common practice in

EMC standards, the expanded uncertainty shall be evaluated using a confidence interval of 95 %.

• The measurement method shall be as simple as possible for fulfilling the requirements of what needs to be

measured. Sophisticated methods or equipment shall be avoided where possible. Methods easily

applicable have the lowest chance of errors.

• Measurement methods shall be as economical and time-saving as possible for their purpose.

• The method shall be tested in practice by multiple test houses before the standard be subject to voting.

• Overall requirement: the method shall be valid for its purpose. The method shall be such that its outcome

leads to a conclusion whether the EMF exposure from the apparatus falls within the specified limits.

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• The standard shall acknowledge the requirements of all stakeholders including those organizations

representing interests of specific societal groups, e.g. people with disabilities or those needing other

particular considerations and including authorities representing public health. To this end, Partner

Organizations shall be encouraged strongly to nominate experts to CENELEC WGs.
5 Titles of EMF standards

The title of any EMF standard shall reflect clearly whether it is a ‘Basic standard’ or a ‘Product standard’. If it is

a basic standard, the words ‘Basic standard’ shall be preceded by the word “generic” if applicable, and followed

by one of either “plac
...

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