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 zum Nachweis der Übereinstimmung von Einrichtungen für Basisstationen bei ihrer Inverkehrbringung mit Grenzwerten für die Exposition von Personen gegenüber hochfrequenten elektromagnetischen Feldern (110 MHz bis 100 GHz)

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
05-Oct-2017
Withdrawal Date
23-Jul-2020
Current Stage
6060 - Document made available - Publishing
Start Date
06-Oct-2017
Due Date
29-Mar-2018
Completion Date
06-Oct-2017

Relations

Effective Date
27-Jan-2023
Effective Date
24-Jan-2023

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.

Frequently Asked Questions

EN 50385:2017 is a standard published by CLC. Its full title is "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 standard covers: 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.

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.

EN 50385:2017 is classified under the following ICS (International Classification for Standards) categories: 33.120.40 - Aerials. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 50385:2017 has the following relationships with other standards: It is inter standard links to EN 50384:2002, EN 50385:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 50385:2017 is associated with the following European legislation: EU Directives/Regulations: 1999/5/EC, 2014/53/EU; Standardization Mandates: M/536. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

You can purchase EN 50385:2017 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.

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
...

Questions, Comments and Discussion

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SIST EN 50385:2018 표준은 110 MHz에서 100 GHz 주파수 범위 내에서 기지국 장비가 발생시키는 전자기파에 대한 인간 노출을 다룹니다. 이 표준의 주요 목적은 기지국 장비가 일반 대중의 기본 제한 사항 및 근로자의 노출 한도 값에 대한 준수를 평가하는 것입니다. 이를 통해 기지국 장비가 시장에 출시될 때 해당 기준에 부합하는지에 대한 검증이 이루어집니다. 이 표준의 강점은 인체의 안전성을 최우선으로 고려하여 설계되었다는 점입니다. EN 50385:2017은 일반 대중과 근로자의 비율에 따라 다양한 제한 및 노출 수준을 설정하고 있으며, 이는 모든 사용자에게 적절한 보호를 제공하는 데 기여합니다. 또한, 기기 제조업체는 이 표준을 준수함으로써 고객들에게 신뢰성과 안전성을 보장할 수 있습니다. EN 50385:2017의 관련성은 급격히 발전하는 통신 기술 환경 속에서 더욱 중요해지고 있습니다. 5G 및 그 이상의 네트워크 확장이 이루어지고 있는 현재, 대중과 근로자를 보호하기 위한 명확한 기준은 필수입니다. 이 표준은 무선 주파수 전자기장 노출에 대한 명확한 지침을 제공함으로써, 기지국 장비의 안전성을 높이고 사회적 책임을 다할 수 있도록 도와줍니다. 결론적으로, SIST EN 50385:2018은 기지국 장비의 전자기파 노출을 효과적으로 관리하고 관련 기준을 준수하도록 하는 중요한 문서입니다.

The document EN 50385:2017 serves as a crucial product standard for ensuring that base station equipment adheres to established safety limits regarding radiofrequency electromagnetic field exposure. Its scope specifically addresses the frequencies ranging from 110 MHz to 100 GHz, which encompasses a significant range of operational parameters for base station technology. This standard’s primary objective is to evaluate the compliance of base station equipment with the basic restrictions set forth for the general public, as well as the exposure limit values designated for workers. One of the strengths of EN 50385:2017 lies in its comprehensive approach to compliance assessment. It establishes clear guidelines for manufacturers and market stakeholders to ensure that any equipment introduced into the market does not exceed the defined electromagnetic field exposure limits. This is essential not only for regulatory compliance but also for protecting public health and maintaining trust in telecommunications technology. The relevance of this standard cannot be overstated, as it aligns with the growing concerns surrounding electromagnetic field exposure amid the increasing proliferation of base station installations. By providing a framework to demonstrate compliance, EN 50385:2017 equips manufacturers with the necessary tools to ensure their products are safe for public use, ultimately enhancing occupational safety for workers who may be directly involved with these technologies. Furthermore, for low power devices, the standard EN 50663:2017 complements EN 50385:2017, ensuring a cohesive regulatory environment that caters to various categories of radiofrequency electromagnetic field exposure and reinforces the commitment to safeguarding both public and occupational health. Thus, EN 50385:2017 stands as a foundational standard in the evolving telecommunications landscape, crucial for fostering responsible manufacturing and deployment practices in base station technology.

La norme SIST EN 50385:2018 est un document essentiel qui vise à établir des critères clairs pour démontrer la conformité des équipements de stations de base en ce qui concerne les limites d'exposition aux champs électromagnétiques radiofréquence. S'étendant sur une plage de fréquences de 110 MHz à 100 GHz, cette norme est particulièrement pertinente dans le contexte actuel où les préoccupations liées aux effets des champs électromagnétiques sur la santé humaine sont en constante augmentation. L'un des principaux points forts de cette norme réside dans sa capacité à évaluer de manière rigoureuse la conformité des équipements aux restrictions fondamentales applicables au grand public, ainsi qu'aux valeurs limites d'exposition pour les travailleurs. En intégrant des niveaux de référence clairs et des niveaux d'action, la norme permet d'assurer une protection adéquate vis-à-vis des émissions radiologiques tout en facilitant l'innovation dans le domaine des technologies de communication sans fil. De plus, la norme SIST EN 50385:2018 se démarque par sa méthodologie d'évaluation, qui prend en compte non seulement les appareils à faible puissance, pour lesquels la norme EN 50663:2017 est applicable, mais également ceux qui fonctionnent à des puissances plus élevées. Cela en fait un outil précieux pour les fabricants, les régulateurs et les chercheurs, qui bénéficient d'une référence standardisée pour évaluer et garantir la sécurité des équipements avant leur mise sur le marché. En résumé, la norme SIST EN 50385:2018 est d'une grande importance pour assurer la conformité des équipements de stations de base aux limites d'exposition aux champs électromagnétiques. Sa portée, ses forces et sa pertinence en font un document incontournable pour la protection de la santé publique et l'avancement des technologies radio.

Die Norm EN 50385:2017 ist eine entscheidende Produktstandardisierung, die sich mit der Einhaltung von Grenzwerten für die Exposition gegenüber hochfrequenter elektromagnetischer Strahlung befasst, die von Basisstationen in einem Frequenzbereich von 110 MHz bis 100 GHz ausgeht. Diese Norm ist besonders relevant, da sie sicherstellt, dass beim Inverkehrbringen von Basistationenausrüstung die grundlegenden Sicherheitsanforderungen für die allgemeine Öffentlichkeit und für Arbeiter eingehalten werden. Ein wesentlicher Stärke dieser Norm liegt in ihrer umfassenden Anwendbarkeit. Sie bewertet die Konformität der Geräte sowohl direkt als auch indirekt, indem sie die allgemeinen öffentlichen Grundsätze und die Grenzwerte für die Exposition von Arbeitnehmern berücksichtigt. Dadurch hilft die Norm, die Risiken für die menschliche Gesundheit zu minimieren und ein sicheres Umfeld sowohl für Verbraucher als auch für Fachkräfte zu schaffen. Ein weiterer positiver Aspekt der EN 50385:2017 ist ihre Klarheit und Struktur. Sie bietet Herstellern klare Richtlinien zur Bewertung der elektromagnetischen Felder, die von ihren Produkten ausgehen. Außerdem ermöglicht die Norm, dass Unternehmen, die Geräte mit niedrigem Stromverbrauch herstellen, auf die EN 50663:2017 Bezug nehmen können, was die Anwendbarkeit und Flexibilität in der Produktentwicklung erhöht. Die Relevanz der Norm wird durch die steigende Nutzung von Mobilfunktechnologien und drahtlosen Kommunikationssystemen verstärkt. Da diese Technologien nach wie vor rasant wachsen, gewinnt der Schutz der Benutzer vor potenziellen Gesundheitsrisiken durch elektromagnetische Felder an Bedeutung. EN 50385:2017 unterstützt die Industrie dabei, vertrauenswürdige Produktstandards einzuhalten und fördert somit das Verbraucherbewusstsein und -vertrauen in der Technologiebranche.

標準 EN 50385:2017 は、110 MHz から 100 GHz の周波数範囲における無線周波数電磁場の曝露制限に関して、基地局設備の適合性を示すための製品基準です。この標準は、人々が基地局設備からの無線周波数電磁場に曝露される際の基準を設定しており、公共の基礎制限(参照レベルを通じて直接または間接的に)および作業者の曝露限度値(行動レベルを通じて直接または間接的に)に対する適合性の評価を目的としています。 この標準の範囲は、基地局設備が市場に出される際の公衆の健康と安全に関連する重要な側面に焦点を当てており、製品が法律や規制に従っていることを確認するための具体的なガイドラインを提供しています。特に、周波数帯域が110 MHzから100 GHzの範囲であり、さまざまなデバイスがこの基準の適用を受けることになります。これは、無線通信技術が普及する中で、一般市民と労働者が安全に利用できるようにするための重要なフレームワークです。 標準の強みは、その包括性と具体性にあります。安全な電磁場曝露の基準を設定することにより、基準は製品開発や評価における信頼性のある指針となります。さらに、低出力デバイスに対しては、EN 50663:2017 が適用されることが明示されており、誤解を避けるための明確な区分も行われています。 この標準は、技術の進化に伴い、無線通信機器の設計者、メーカー、規制当局にとって非常に関連性が高く、必要不可欠なものとなっています。国際的な視点からも、EU 内での基準設定が他国にも影響を与える可能性があり、安全性を確保するための基盤が提供されています。