SIST EN 50385:2018

Product standard to demonstrate the compliance of base station equipment with radiofrequency electromagnetic field exposure limits (110 MHz - 100 GHz), when placed on the market

This product standard is related to human exposure to radiofrequency electromagnetic fields transmitted by base station equipment in the frequency range 110 MHz to 100 GHz.
The object is to assess the compliance of such equipment with the general public basic restrictions (directly or indirectly via compliance with reference levels) and the workers’ exposure limit values (directly or indirectly via compliance with action levels), when it is placed on the market.
For low power devices the applicable product standard is EN 50663:2017.

Produktnorm zur Konformitätsüberprüfung von Mobilfunk-Basisstationen und stationären Teilnehmergeräten für schnurlose Telekommunikationsanlagen im Hinblick auf die Basisgrenz- und Referenzwerte bezüglich der Exposition von Personen gegenüber elektromagnetischen Feldern (110 MHz bis 40 GHz) - Allgemeinbevölkerung

Norme de produit pour démontrer la conformité des équipements de station de base aux limites d’exposition aux champs électromagnétiques radiofréquences (110 MHz - 100 GHz), lors de leur mise sur le marché (110 MHz - 100 GHz)

La présente norme de produit porte sur l’exposition des personnes aux champs électromagnétiques radiofréquences produits par les équipements de station de base dans la plage de fréquences de 110 MHz à 100 GHz.
La présente norme a pour objet de vérifier, lors de leur mise à disposition sur le marché, la conformité de ces équipements aux restrictions de base pour l’exposition du public (directement ou indirectement via la conformité aux niveaux de référence) et aux valeurs limites d’exposition des travailleurs (directement ou indirectement via la conformité aux niveaux d’action).
La norme de produit applicable aux dispositifs de faible puissance est l'EN 50663:2017.

Produktni standard za prikaz skladnosti opreme baznih postaj z mejnimi vrednostmi v povezavi z izpostavljenostjo elektromagnetnim sevanjem (110 MHz - 100 GHz), ko je dana na trg

Ta standard za proizvode obravnava izpostavljenost prebivalstva radiofrekvenčnim elektromagnetnim sevanjem opreme baznih postaj v frekvenčnem območju od 110 MHz do 100 GHz.
Namen tega standarda je ocena skladnosti take opreme z osnovnimi omejitvami za prebivalstvo (neposredno ali posredno na podlagi skladnosti z referenčnimi ravnmi) in mejnimi vrednostmi izpostavljenosti delavcev (neposredno ali posredno na podlagi skladnosti z opozorilnimi vrednostmi) pri dajanju te opreme na trg.
Za naprave majhnih moči se uporablja standard za proizvode prEN 50663:2016.

General Information

• Status: Published
• Publication Date: 10-Dec-2017
• ICS: 13.280 - Radiation protection
• ICS: 33.120.40 - Aerials
• Technical Committee: INIR - Electromagnetic fields in human enviornment
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 27-Nov-2017
• Due Date: 01-Feb-2018
• Completion Date: 11-Dec-2017
• Directive: 1999/5/EC - 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
• Directive: 2014/53/EU - 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 and repealing Directive 1999/5/EC
• Directive: EUR-PUB - European Union - Public Standards
• Mandate: M/536 - [C(2015)536] Standardisation request as regards radio equipment in support of Directive 2014/53/EU
• Ref Project: EN 50385:2017 - Product standard to demonstrate the compliance of base station equipment with radiofrequency electromagnetic field exposure limits (110 MHz - 100 GHz), when placed on the market

Relations

• Replaces: SIST EN 50384:2003 - Product standard to demonstrate the compliance of radio base stations and fixed terminal stations for wireless telecommunication systems with the basic restrictions or the reference levels related to human exposure to radio frequency electromagnetic fields (110 MHz - 40 GHz) - Occupational
• Effective Date: 13-Nov-2017
• Replaces: SIST EN 50385:2003 - Product standard to demonstrate the compliance of radio base stations and fixed terminal stations for wireless telecommunication systems with the basic restrictions or the reference levels related to human exposure to radio frequency electromagnetic fields (110 MHz - 40 GHz) - General public
• Effective Date: 10-Oct-2017
• Revised: SIST EN 50385:2003 - Product standard to demonstrate the compliance of radio base stations and fixed terminal stations for wireless telecommunication systems with the basic restrictions or the reference levels related to human exposure to radio frequency electromagnetic fields (110 MHz - 40 GHz) - General public
• Effective Date: 09-Feb-2016

Overview

EN 50385:2017 (CLC) is a European product standard for demonstrating that base station equipment complies with regulatory limits for radiofrequency (RF) electromagnetic field exposure in the frequency range 110 MHz – 100 GHz when placed on the market. The standard defines how to evaluate exposure against the relevant general public basic restrictions (and/or reference levels) and workers’ exposure limit values (and/or action levels). It is intended as a means to support conformity with EU requirements for radio equipment (Directive 2014/53/EU).

Key topics and requirements

• Scope and frequency range: Covers base stations and similar fixed radio-transmitting equipment operating 110 MHz–100 GHz. Low‑power devices are covered by EN 50663:2017.
• Exposure conditions: All reasonably foreseeable operating and installation conditions must be considered, including time‑varying power, simultaneous bands and exposure durations.
• Normative limits: Applies Council Recommendation 1999/519/EC limits for the general public and Directive 2013/35/EU limits for workers (basic restrictions/reference levels; exposure limit values/action levels).
• Evaluation methods: Compliance boundary and exposure assessment are performed by calculation and/or measurement in accordance with EN 62232:2017 using maximum transmitted power per transmit band.
• Documentation requirements: Manufacturers must supply maximum transmitted power, antenna characteristics and EIRP, representative external‑antenna configurations (if applicable), compliance boundaries, methodology and uncertainty of the RF evaluation, and installation/worker safety guidelines.
• Uncertainty and comparison: Assessment uncertainty must be calculated (per EN 62232) and used when comparing results to limits.
• Presumption of conformity: Annex ZZ explains how this standard supports essential requirements of Directive 2014/53/EU and can provide a presumption of conformity when cited in the Official Journal.

Applications and who uses it

• Manufacturers and integrators of mobile base stations, fixed wireless access points, radio relays, WLAN access points and other fixed transmitters use EN 50385:2017 to demonstrate RF exposure compliance before placing products on the EU market.
• Test laboratories and RF engineers apply the standard to perform calculations and measurements, define compliance boundaries and report uncertainties.
• Regulatory and compliance teams use the required documentation to support CE marking and to demonstrate conformity with exposure-related essential requirements.
• Site planners and installers use installation guidance and compliance boundaries to ensure public and worker safety during deployment and maintenance.

Related standards

• EN 62232:2017 (RF field strength, power density and SAR determination for base stations) - normative reference for evaluation methods.
• EN 50663:2017 - generic standard for low‑power equipment (0 Hz–300 GHz).
• Council Recommendation 1999/519/EC and Directive 2013/35/EU - exposure limits referenced by EN 50385:2017.

Keywords: EN 50385:2017, base station equipment, RF exposure, electromagnetic fields, 110 MHz–100 GHz, compliance boundary, EN 62232, Directive 2014/53/EU, CE marking.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2018
1DGRPHãþD
SIST EN 50384:2003
SIST EN 50385:2003
Produktni standard za prikaz skladnosti opreme baznih postaj z mejnimi
vrednostmi v povezavi z izpostavljenostjo elektromagnetnim sevanjem (110 MHz -
100 GHz), ko je dana na trg
Product standard to demonstrate the compliance of base station equipment with
radiofrequency electromagnetic field exposure limits (110 MHz - 100 GHz), when placed
on the market
Produktnorm zur Konformitätsüberprüfung von Mobilfunk-Basisstationen und stationären
Teilnehmergeräten für schnurlose Telekommunikationsanlagen im Hinblick auf die
Basisgrenz- und Referenzwerte bezüglich der Exposition von Personen gegenüber
elektromagnetischen Feldern (110 MHz bis 40 GHz) - Allgemeinbevölkerung
Norme de produit pour démontrer la conformité des équipements de station de base aux
limites d’exposition aux champs électromagnétiques radiofréquences (110 MHz - 100
GHz), lors de leur mise sur le marché (110 MHz - 100 GHz)
Ta slovenski standard je istoveten z: EN 50385:2017
ICS:
13.280 Varstvo pred sevanjem Radiation protection
33.120.40 Antene Aerials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 50385
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2017
ICS 33.120.40 Supersedes EN 50385:2002
English Version
Product standard to demonstrate the compliance of base station
equipment with radiofrequency electromagnetic field exposure
limits (110 MHz - 100 GHz), when placed on the market
Norme de produit pour démontrer la conformité des Produktnorm zum Nachweis der Übereinstimmung von
équipements de station de base aux limites d'exposition Einrichtungen für Basisstationen bei ihrer Inverkehrbringung
aux champs électromagnétiques radiofréquences (110 MHz mit Grenzwerten für die Exposition von Personen
- 100 GHz), lors de leur mise sur le marché (110 MHz - 100 gegenüber hochfrequenten elektromagnetischen Feldern
GHz) (110 MHz bis 100 GHz)
This European Standard was approved by CENELEC on 2017-07-24. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
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: Avenue Marnix 17, B-1000 Brussels
© 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 50385:2017 E
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Exposure conditions . 5
5 Normative limits . 6
6 Evaluation of compliance . 6
7 Assessment uncertainty . 6
8 Documentation . 6
9 Assessment of compliance . 7
Annex ZZ (informative) Relationship between this European standard and the essential
requirements of Directive 2014/53/EU [2014 OJ L153] aimed to be covered . 8
Bibliography . 9

European foreword
This document (EN 50385:2017) has been prepared by CLC/TC 106X “Electromagnetic fields in the
human environment”.
The following dates are fixed:
• latest date by which this document has to be (dop) 2018-07-24
implemented at national level by publication of an
identical national standard or by endorsement
• latest date by which the national standards conflicting (dow) 2020-07-24
with this document have to be withdrawn
This document supersedes EN 50385:2002.
1) the standard requires that the assessment has to take into account all reasonably foreseeable
operating conditions (Clause 4);
2) the standard covers equipment intended for use only by workers as well as equipment intended
for use by the general public and different limits are given for each case (Clause 5).
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, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this
document.
1 Scope
This product standard is related to human exposure to radiofrequency electromagnetic fields
transmitted by base station equipment in the frequency range 110 MHz to 100 GHz.
The object is to assess the compliance of such equipment with the general public basic restrictions
(directly or indirectly via compliance with reference levels) and the workers’ exposure limit values
(directly or indirectly via compliance with action levels), when it is placed on the market.
For low power devices the applicable product standard is EN 50663:2017.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN 62232:2017, Determination of RF field strength, power density and SAR in the vicinity of
radiocommunication base stations for the purpose of evaluating human exposure (IEC 62232:2017)
Council Recommendation 1999/519/EC of 12 July 1999 on the limitation of exposure of the general
public to electromagnetic fields (0 Hz to 300 GHz) (Official Journal L 199, 30.6.1999, p. 59-70)
Directive 2013/35/EU of the European Parliament and of the Council 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) (20th individual Directive within the meaning of Article 16(1) of
Directive 89/391/EEC) and repealing Directive 2004/40/EC (Official Journal L 179, 29.6.2013, p. 1–21)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
action levels
levels which are provided for practical exposure assessment purposes and which are derived from
exposure limit values
Note 1 to entry: Respect of the action level will ensure respect of the relevant exposure limit value. If the action
level is exceeded, it does not necessarily follow that the exposure limit value will be exceeded.
3.2
basic restrictions
restrictions on exposure of the general public to electric, magnetic, and electromagnetic fields that are
based directly on established health effects and biological considerations
3.3
base station
BS
fixed equipment including the radio transmitter and associated antenna(s) as used in wireless
telecommunications networks
Note 1 to entry: A base station comprises the hardware, including transceivers, necessary to transmit and
receive radio signals. Base stations with integrated antennas, base stations with connectors for external antennas
and base stations intended for use with external antennas not supplied by the same manufacturer are covered.
Note 2 to entry: Examples of BS equipment include base stations for mobile communications, radio-relays,
wireless local
...