2013/35/EU - 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
Directive 2013/35/EU establishes minimum health and safety requirements for protecting workers from risks associated with exposure to electromagnetic fields (EMF) up to 300 GHz in the workplace. It addresses direct biophysical effects such as thermal heating, nerve and muscle stimulation, sensory disturbances, and limb currents, as well as indirect effects like interference with medical devices and fire hazards. The Directive introduces exposure limit values (ELVs) based on scientifically established short-term effects and action levels (ALs) to simplify compliance assessments. Employers must evaluate risks, ensure exposure remains below ELVs, and implement protective measures, considering situations where temporary ELV exceedances are justified. The Directive excludes long-term effects pending conclusive scientific evidence and does not cover risks from contact with live conductors. Flexibility is allowed for more favorable national provisions and exceptions for specific sectors, including medical imaging and the armed forces. The Directive mandates continuous monitoring of scientific developments and empowers the Commission to update technical annexes. It complements Directive 89/391/EEC, reinforcing worker protection while avoiding excessive burdens on businesses.
Purpose
Directive 2013/35/EU establishes minimum health and safety requirements concerning the exposure of workers to risks resulting from physical agents-specifically electromagnetic fields (EMFs). It aims to protect workers from known direct biophysical and indirect effects caused by EMFs during work. This Directive repeals and replaces Directive 2004/40/EC due to concerns over its impact on medical activities and certain industries, and reflects updated scientific knowledge.
The Directive addresses short-term and acute effects such as thermal heating and electrical stimulation of tissues but does not cover suggested long-term effects, for which scientific evidence remains inconclusive. The European Commission is tasked with monitoring scientific developments and may propose further legislation if new evidence emerges regarding long-term effects.
The Directive respects workers’ fundamental rights to healthy and safe working conditions and provides a high level of protection while avoiding unnecessary administrative or economic burdens on businesses, especially small and medium-sized enterprises.
Key Obligations
Risk Assessment: Employers must conduct effective, proportionate risk assessments related to workers’ exposure to electromagnetic fields at the workplace, based on frequency- and exposure-pattern-dependent criteria.
Exposure Limits: Employers must ensure workers’ exposure does not exceed specified Exposure Limit Values (ELVs), which are derived from international scientific recommendations (mainly ICNIRP). ELVs include:
- Health effects ELVs: thresholds above which adverse health effects (like tissue heating or nerve stimulation) may occur.
- Sensory effects ELVs: thresholds above which transient sensory disturbances or minor brain function changes may occur.
Action Levels (ALs): These operational levels simplify compliance verification. When ALs are not exceeded, compliance with ELVs is presumed. If ALs are exceeded, employers must take measures to assess risks and implement controls unless ELVs are demonstrated not to be exceeded.
Preventive Measures: Employers must prioritize preventive measures including:
- Selecting and designing work equipment and procedures to minimize EMF exposure.
- Implementing specific protective measures when temporary or justified exceedances of ALs or ELVs occur.
Information and Training: Employers must inform and train workers about risks from EMF exposure, especially in circumstances where ALs or ELVs might be exceeded temporarily or permanently.
Special Cases:
- Exposure exceeding ELVs may be possible temporarily if justified by specific work processes but requires immediate action to restore compliance as soon as possible.
- Specific provisions apply for activities such as medical imaging involving magnetic resonance techniques and for the armed forces, which may adopt equivalent or more specific standards (e.g., NATO standards) as long as worker health and safety are maintained.
- Protection must consider workers with medical devices (e.g., pacemakers) due to electromagnetic interference risks.
Compliance and Review: Employers must keep up to date with technical progress and scientific knowledge and adjust measures accordingly. The Directive allows the European Commission to adopt delegated acts for technical updates, including amendments to exposure limit values.
Affected Products and Actors
Employers: Across all sectors with workers potentially exposed to electromagnetic fields, including industrial, medical, and military settings.
Workers: Individuals exposed to static and time-varying electric, magnetic, and electromagnetic fields with frequencies up to 300 GHz.
Work Equipment and Products: Machinery and devices generating electromagnetic fields must comply with relevant safety legislation. Equipment that meets stricter product safety rules may require simplified risk assessments.
Member States: Required to transpose this Directive into national law and can adopt stricter provisions to protect workers.
Implementation Timeline
Transposition Deadline: Member States were required to transpose the Directive into national law by 31 October 2013, replacing Directive 2004/40/EC.
Ongoing Monitoring: The European Commission is to continuously review scientific evidence, particularly about long-term effects, and report to the European Parliament and Council.
Delegated Acts: The Commission can amend technical annexes relating to ELVs and ALs to reflect technical progress or new scientific findings, following consultations with expert advisory committees.
In summary, Directive 2013/35/EU provides a harmonized minimum framework for assessing and managing risks related to electromagnetic fields at work, ensuring a high standard of worker health and safety protection across the European Union.
Directive 2013/35/EU applies to the protection of workers from risks to their health and safety arising from exposure to electromagnetic fields in the workplace. It covers static electric, static magnetic, and time-varying electric, magnetic, and electromagnetic fields with frequencies up to 300 GHz. The Directive addresses all known direct biophysical effects (such as tissue heating and stimulation of muscles or nerves) and indirect effects (including interference with medical electronic devices and risks from ferromagnetic objects). The Directive sets minimum health and safety requirements for all sectors where workers may be exposed to electromagnetic fields during their work activities. It excludes risks from contact with live conductors and does not cover suggested long-term effects given the current lack of conclusive scientific evidence. The Directive allows Member States to maintain or introduce stricter provisions and applies broadly without limiting specific sectors, including medical, industrial, and others, while considering the particularities of certain activities like magnetic resonance in medicine or military operations.
Die Richtlinie 2013/35/EU legt Mindestanforderungen zum Schutz der Sicherheit und Gesundheit von Arbeitnehmern fest, die elektromagnetischen Feldern während der Arbeit ausgesetzt sind. Sie ersetzt die bisherige Richtlinie 2004/40/EG aufgrund neuer wissenschaftlicher Erkenntnisse und berücksichtigt sowohl direkte biophysikalische Wirkungen wie thermische Effekte und Nervenstimulation als auch indirekte Auswirkungen, etwa Störungen medizinischer Geräte. Die Richtlinie definiert Expositionsgrenzwerte und Auslöseschwellen, die auf internationalen Empfehlungen basieren, und schreibt verpflichtende Risikobewertungen sowie Schutzmaßnahmen durch Arbeitgeber vor, um Gefährdungen zu minimieren. Langzeitwirkungen elektromagnetischer Felder werden derzeit nicht berücksichtigt, sollen jedoch künftigen wissenschaftlichen Erkenntnissen folgend neu bewertet werden. Die Mitgliedstaaten können strengere Schutzvorschriften erlassen. Spezielle Regelungen berücksichtigen den Schutz besonders gefährdeter Arbeitnehmergruppen und Besonderheiten bei medizinischen Anwendungen sowie im militärischen Bereich. Die Kommission wird ermächtigt, technische Anpassungen vorzunehmen, um den technischen Fortschritt und neue wissenschaftliche Erkenntnisse einzubeziehen. Insgesamt sichert die Richtlinie ein hohes Schutzniveau für Arbeitnehmer im Kontakt mit elektromagnetischen Feldern innerhalb der EU.
Zweck
Die Richtlinie 2013/35/EU hat das Ziel, Mindestvorschriften für den Schutz der Sicherheit und Gesundheit der Arbeitnehmer vor den Gefährdungen durch physikalische Einwirkungen elektromagnetischer Felder (EMF) am Arbeitsplatz festzulegen. Sie ersetzt die frühere Richtlinie 2004/40/EG und berücksichtigt sämtliche bekannten direkten biophysikalischen Wirkungen sowie indirekte Auswirkungen elektromagnetischer Felder. Dabei liegt der Fokus auf der Vermeidung kurzfristiger akuter Effekte wie thermischer Erwärmungen und elektrischer Stimulationen sowie auf der Minimierung von Sicherheitsrisiken. Langzeitwirkungen werden derzeit nicht berücksichtigt, sollen aber kontinuierlich von der Kommission überwacht werden. Die Richtlinie dient der Harmonisierung eines hohen Schutzniveaus für alle Arbeitnehmer in der EU und ermöglicht es den Mitgliedstaaten, strengere nationale Regelungen zu erlassen, um die Gesundheit der Beschäftigten noch besser zu schützen.
Wesentliche Verpflichtungen
- Gefährdungsbeurteilung: Arbeitgeber müssen eine wirksame und verhältnismäßige Beurteilung der Exposition gegenüber elektromagnetischen Feldern am Arbeitsplatz durchführen.
- Einhaltung der Expositionsgrenzwerte: Die Exposition der Arbeitnehmer darf die in den Anhängen der Richtlinie festgelegten Expositionsgrenzwerte für gesundheitliche und sensorische Wirkungen sowie Auslöseschwellen nicht überschreiten.
- Schutz- und Präventionsmaßnahmen: Werden die Auslöseschwellen oder Expositionsgrenzwerte überschritten, sind unverzüglich geeignete Maßnahmen zu ergreifen, um die Einhaltung dieser Werte sicherzustellen.
- Berücksichtigung besonderer Gruppen: Besondere Schutzvorkehrungen sind für besonders gefährdete Arbeitnehmer erforderlich, z. B. Personen mit implantierten medizinischen Geräten wie Herzschrittmachern oder Cochlea-Implantaten.
- Arbeitsmittel und Arbeitsverfahren: Arbeitgeber sollen bereits bei Planung und Auswahl der Arbeitsmittel sowie Arbeitsmethoden präventive Maßnahmen zur Minderung der EMF-Exposition umsetzen.
- Aktualisierungspflicht: Arbeitgeber müssen Schutzmaßnahmen regelmäßig an technische und wissenschaftliche Fortschritte anpassen.
- Ausnahmen für militärische Zwecke: Mitgliedstaaten können spezifische oder gleichwertige Schutzsysteme anwenden, z. B. NATO-Standards, sofern ein vergleichbarer Gesundheitsschutz gewährleistet wird.
- Dokumentation und Information: Arbeitgeber sind verpflichtet, Expositionsbewertungen zu dokumentieren und betroffene Arbeitnehmer entsprechend zu informieren.
Betroffene Produkte und Akteure
- Arbeitgeber in sämtlichen Branchen, in denen Beschäftigte elektromagnetischen Feldern ausgesetzt sind, einschließlich Industrie, Medizin (beispielsweise bildgebende Verfahren auf Magnetresonanzbasis) und Forschung.
- Arbeitnehmer, die elektromagnetischen Feldern ausgesetzt sind, einschließlich besonderer Personengruppen mit medizinischen Implantaten oder auf andere Weise besonders empfänglich.
- Hersteller und Anbieter von Arbeitsmitteln und Geräten, die elektromagnetische Felder erzeugen oder beeinflussen, da deren Produkte die Einhaltung der Richtlinienanforderungen erleichtern bzw. beeinflussen.
- Nationale Behörden, die die Einhaltung der Richtlinie überwachen und umsetzen.
- Militärische Organisationen, sofern sie auf spezifische Standards wie NATO-Normen zurückgreifen, die einen gleichwertigen Schutz garantieren.
Umsetzungsfrist
Die Richtlinie wurde am 26. Juni 2013 verabschiedet. Die Mitgliedstaaten sind verpflichtet, die erforderlichen nationalen Rechtsvorschriften so zu erlassen und umzusetzen, dass die Richtlinie bis spätestens zum 1. Juli 2016 vollständig angewendet wird. Sie müssen die Kommission zudem über die Umsetzungsmaßnahmen und dazugehörige erläuternde Dokumente informieren. Die Kommission wird die neuesten wissenschaftlichen Erkenntnisse weiter beobachten und kann technische Anhänge gemäß dem Stand der Technik und neuen Forschungsergebnissen aktualisieren.
Quelle: Auszüge aus der Richtlinie 2013/35/EU über Mindestvorschriften zum Schutz der Arbeitnehmer vor Gefährdungen durch elektromagnetische Felder
Die Richtlinie 2013/35/EU gilt für den Schutz von Arbeitnehmern vor Gefährdungen durch elektromagnetische Felder am Arbeitsplatz. Sie umfasst statische elektrische und magnetische sowie zeitvariable elektrische, magnetische und elektromagnetische Felder mit Frequenzen bis 300 GHz. Die Richtlinie legt Mindestanforderungen fest, die alle bekannten direkten biophysikalischen Wirkungen und indirekten Auswirkungen elektromagnetischer Felder abdecken, insbesondere thermische und nichtthermische Effekte sowie Störungen medizinischer Geräte. Vermutete Langzeitwirkungen sind nicht Gegenstand der Richtlinie. Sie gilt für alle Sektoren und Tätigkeiten, bei denen Arbeitnehmer elektromagnetischen Feldern ausgesetzt sind, schließt jedoch Gefährdungen durch das Berühren unter Spannung stehender Leitungen aus. Besondere Regelungen gelten für medizinische Anwendungen, die bildgebende Verfahren einsetzen, sowie für militärische Tätigkeiten, bei denen gleichwertige oder spezifischere Schutzsysteme angewandt werden können. Ziel ist ein einheitliches Schutzniveau in der Europäischen Union ohne Wettbewerbsverzerrungen.
La directive 2013/35/UE fixe des prescriptions minimales pour protéger la santé et la sécurité des travailleurs exposés aux champs électromagnétiques sur le lieu de travail. Elle remplace la directive 2004/40/CE, en s’appuyant sur des données scientifiques actualisées, afin de prévenir les effets biophysiques directs et indirects connus, notamment les effets thermiques et la stimulation nerveuse ou musculaire. La directive ne traite pas des effets à long terme en l’absence de preuves scientifiques solides, mais la Commission européenne s’engage à surveiller les évolutions scientifiques et à proposer des mesures si nécessaire. Les États membres doivent veiller à ce que l’exposition des travailleurs respecte des valeurs limites d’exposition (VLE) basées sur les recommandations de la CIPRNI, tout en permettant l’adoption de normes plus strictes si nécessaire. Les employeurs doivent évaluer les risques et prendre des mesures pour éliminer ou réduire l’exposition, en tenant compte notamment des équipements utilisés et des catégories de travailleurs à risques spécifiques. La directive prévoit aussi des adaptations spéciales pour certaines activités, comme la technique de résonance magnétique, et pour les forces armées.
Objet
La directive 2013/35/UE établit des prescriptions minimales de sécurité et de santé pour protéger les travailleurs contre les risques liés à l’exposition aux champs électromagnétiques sur le lieu de travail. Elle couvre tous les effets biophysiques connus, directs et indirects, produits par des champs électromagnétiques dont la fréquence va jusqu’à 300 GHz. Elle vise à garantir un niveau minimal de protection de la santé et de la sécurité des travailleurs dans toute l’Union européenne.
Obligations principales
- Évaluation des risques : Les employeurs doivent réaliser une évaluation efficace et proportionnée des risques liés aux champs électromagnétiques présents sur le lieu de travail.
- Respect des valeurs limites d’exposition (VLE) : L’exposition des travailleurs doit être limitée aux VLE fixées dans la directive, qui couvrent les effets directs aigus et à court terme (thermiques et de stimulation nerveuse ou musculaire).
- Valeurs déclenchant l’action (VA) : Des niveaux opérationnels appelés VA sont définis pour faciliter l’application des VLE. Si les VA sont dépassées, des mesures de prévention ou de protection doivent être mises en œuvre.
- Mesures de prévention : Favoriser la réduction des risques à la source, notamment lors de la conception des postes de travail et du choix des équipements et méthodes de travail.
- Protection de groupes spécifiques : Prendre en compte des catégories particulières de travailleurs à risques (par exemple porteurs de dispositifs médicaux implantables comme les stimulateurs cardiaques).
- Adaptation et mise à jour : La directive prévoit que la Commission européenne peut adopter des actes délégués pour ajuster les annexes en fonction des progrès scientifiques et techniques.
- Interopérabilité avec d’autres législations : La directive complète et ne remplace pas la directive-cadre 89/391/CEE relative à la sécurité et la santé au travail.
- Cas particuliers : Les États membres peuvent maintenir ou adopter des règles plus strictes, par exemple pour les forces armées ou certaines activités médicales spécifiques (imagerie médicale).
Produits et acteurs concernés
- Champ d’application : Tous les travailleurs exposés à des champs électromagnétiques sur leur lieu de travail, dans tous les secteurs d’activité. Cela inclut les employés dans l’industrie, la santé, la recherche, la défense, etc.
- Champs concernés : Champs électriques statiques, champs magnétiques statiques, et champs électriques, magnétiques et électromagnétiques variant dans le temps (fréquences jusqu’à 300 GHz).
- Types d’effets couverts : Effets biophysiques directs (thermiques, stimulation nerveuse ou musculaire, courants induits) et effets indirects (interférences avec dispositifs médicaux, risques d’incendie, projections d’objets ferromagnétiques, etc.).
- Employeurs : Responsables de la mise en œuvre des mesures de prévention, de la vérification du respect des VLE et VA, et de la protection spécifique des travailleurs à risques.
- Organes nationaux de contrôle : Veillent à la conformité des mesures adoptées et au respect des obligations européennes.
Calendrier de mise en œuvre
- Date d’adoption : 26 juin 2013.
- Transposition en droit national : Les États membres de l'Union européenne devaient transposer les dispositions de cette directive dans leurs législations nationales avant le 1er juillet 2016.
- Entrée en vigueur : À compter de la date de transposition, les employeurs doivent veiller au respect des VLE et prendre les mesures prévues en cas de dépassement.
- Suivi scientifique : La Commission européenne assure un suivi régulier des avancées scientifiques concernant les effets à long terme éventuels, et peut proposer une révision de la directive si nécessaire.
Cette directive constitue un cadre essentiel pour garantir la protection des travailleurs contre les risques liés aux champs électromagnétiques, en harmonisant les règles minimales à l’échelle européenne tout en permettant une flexibilité nationale adaptée.
La directive 2013/35/UE s'applique à la protection des travailleurs contre les risques liés à l'exposition professionnelle aux champs électromagnétiques, y compris les champs électriques et magnétiques statiques ainsi que les champs électriques, magnétiques et électromagnétiques variant dans le temps jusqu'à 300 GHz. Elle couvre tous les effets biophysiques directs et indirects connus résultant de cette exposition, tels que les effets thermiques, la stimulation nerveuse ou musculaire, ainsi que les interférences avec des dispositifs médicaux implantés ou des risques d'incendie et d'explosion. La directive ne traite pas des effets à long terme potentiels faute de preuves scientifiques établies. Elle ne couvre pas non plus les risques liés au contact avec des conducteurs sous tension, qui relèvent d'autres réglementations. Les prescriptions minimales fixées sont applicables à tous les secteurs d’activité professionnelle où les travailleurs peuvent être exposés à ces champs électromagnétiques.
Direktiva 2013/35/EU določa minimalne zdravstvene in varnostne zahteve za zaščito delavcev pred tveganji, ki nastajajo zaradi izpostavljenosti elektromagnetnim sevanjem na delovnem mestu. Namen direktive je zagotoviti varnost in zdravje delavcev z obravnavo vseh znanih neposrednih biofizikalnih in posrednih vplivov elektromagnetnega sevanja, hkrati pa preprečiti izkrivljanje konkurence med državami članicami EU. Direktiva določa mejne vrednosti izpostavljenosti in opozorilne vrednosti za elektromagnetna polja z namenom preprečevanja termičnih in atermičnih učinkov, kot so segrevanje tkiv in stimulacija živcev ter mišic. Delodajalci morajo izvajati ocenjevanje tveganj in sprejeti ustrezne ukrepe za zmanjšanje izpostavljenosti, obveznosti pa vključujejo tudi informiranje delavcev. Direktiva ne obravnava domnevnih dolgoročnih učinkov zaradi pomanjkanja znanstvenih dokazov, a predvideva spremljanje znanstvenih dognanj in morebitno prilagoditev zakonodaje. Posebne določbe veljajo za vojaške sile in uporabo medicinskih naprav, pri čemer se posamezne države lahko odločijo za strožje ukrepe za varstvo delavcev.
Namen
Direktiva 2013/35/EU določa minimalne zdravstvene in varnostne zahteve za varstvo delavcev pred tveganji, ki izhajajo iz izpostavljenosti elektromagnetnim sevanjem na delovnem mestu. Glavni cilj je zagotoviti varnost in zdravje delavcev pred poznanimi neposrednimi biofizikalnimi vplivi (termičnimi in atermičnimi) ter posrednimi vplivi elektromagnetnega sevanja, hkrati pa preprečiti izkrivljanje konkurence med državami članicami EU.
Direktiva ne zajema domnevnih dolgoročnih učinkov elektormagnetnih sevanj, saj trenutno ni trdnih znanstvenih dokazov o vzročni povezavi. Komisija spremlja znanstveni razvoj in bo v primeru novih dokazov pripravila potrebne zakonodajne predloge in o njih poročala Evropskemu parlamentu in Svetu.
Ključne obveznosti
- Ocenjevanje tveganj: Delodajalci morajo oceniti tveganja zaradi elektromagnetnih sevanj na delovnem mestu, vključno z merjenjem ali izračunom ravni izpostavljenosti (člen 4).
- Mejne vrednosti izpostavljenosti: Delodajalci zagotavljajo, da izpostavljenost delavcev ne presega mejnih vrednosti, določjenih na podlagi biofizikalnih in bioloških znanstvenih dognanj, ki zajemajo neposredne kratkoročne vplive na zdravje (člen 3).
- Opozorilne vrednosti: V primeru preseganja opozorilnih vrednosti morajo delodajalci sprejeti ustrezne varnostne ukrepe.
- Prilagajanje ukrepov: Ukrepi morajo biti sorazmerni in upoštevati specifike posameznih delovnih praks, vključno z izjemo primerov, kot so medicinski postopki z magnetno resonanco.
- Posebne skupine: Posebni ukrepi so predvideni za posebej ogrožene delavce in za preprečevanje vplivov na delovanje medicinskih naprav, kot so srčni spodbujevalniki in drugi vsadki.
- Nujni postopki: V izjemnih primerih neposrednega tveganja lahko pristojni organi sprožijo nujne ukrepe.
- Spremljanje znanstvenega razvoja: Komisija ima pooblastila za sprejemanje tehničnih sprememb prilog, ki odražajo nove standarde in znanstvene ugotovitve.
Vplivani izdelki in akterji
- Delavci: Vse skupine delavcev izpostavljene elektromagnetnim sevanjem v okviru evropske unije.
- Delodajalci: Imenovani za izvajanje ocene tveganj in izvajanje ukrepov za zmanjševanje izpostavljenosti.
- Proizvajalci delovne opreme: Oprema mora biti skladna z ustreznimi evropskimi standardi o izpostavljenosti elektromagnetnim sevanjem.
- Zdravstveni sektor: Zaradi vplivov na medicinske postopke in opremo, kot so magnetna resonanca in medicinske elektronske naprave, so predvidene posebne izjeme in varovalni mehanizmi.
- Pristojni organi držav članic: Za nadzor upoštevanja direktive in izvajanje nujnih postopkov.
Časovna shema izvajanja
- Direktiva je bila sprejeta 26. junija 2013.
- Rok za prenos direktive v nacionalno zakonodajo držav članic je bil 31. oktober 2013.
- Po prenosu države članice nadzirajo izvajanje ukrepov in izvajajo potrebne spremembe na podlagi navodil direktive ter spremljajo znanstvene spremembe.
- Komisija spremlja razvoj in lahko po potrebi sprejema delegirane akte za posodobitev mejnih in opozorilnih vrednosti.
- O izvedbi in učinkih direktive mora Komisija obveščati Evropski parlament in Svet, posebej ob pojavu relevantnih novih znanstvenih dokazov.
Direktiva tako predstavlja pomembno pravno podlago za zaščito zdravja delavcev v EU pred tveganji elektromagnetnih sevanj in ureja sorazmerne ukrepe, ki spodbujajo varno delovno okolje brez nepotrebnih omejitev razvoja podjetij.
Direktiva 2013/35/EU določa minimalne zdravstvene in varnostne zahteve za varovanje delavcev pred tveganji zaradi izpostavljenosti elektromagnetnim sevanjem pri delu. Vključuje vse poznane neposredne biofizikalne vplive in posredne vplive elektromagnetnega sevanja s frekvencami do 300 GHz. Namenjena je zaščiti zdravja in varnosti delavcev v različnih sektorjih, ki so izpostavljeni takšnim fizikalnim dejavnikom, pri čemer ne zajema domnevnih dolgoročnih učinkov, za katere trenutno ni znanstvenih dokazov. Direktiva se uporablja za vsa delovna mesta, kjer so delavci lahko izpostavljeni elektromagnetnim poljem, in zajema različne dejavnosti, vključno z medicinskimi postopki, industrijskimi dejavnostmi ter posebnimi primeri, kot so oborožene sile, ob upoštevanju ustreznih standardov. Prav tako izvzema tveganja, ki nastanejo zaradi stika z aktivnimi prevodniki.
General Information
This document provides general methods for measurement and calculation of quantities associated with human exposure to electromagnetic fields in the frequency range from 0 Hz to 300 GHz. It is intended specifically to be used for the assessment of emissions from products and comparison of these with the exposure limits for the general public given in Council Recommendation 1999/519/EC, and those given for workers in Directive 2013/35/EU, as appropriate. It also is intended to be used for assessment of human exposure to electromagnetic fields in the workplace to determine compliance with the requirements of Directive 2013/35/EU.
This standard deals with quantities that can be measured or calculated external to the body, notably electric and magnetic field strength or power density, and includes the measurement and calculation of quantities inside the body that form the basis for protection guidelines. In particular the standard provides information on:
- definitions and terminology,
- characteristics of electromagnetic fields,
- measurement of exposure quantities,
- instrumentation requirements,
- methods of calibration,
- measurement techniques and procedures for evaluating exposure,
- calculation methods for exposure assessment.
Where an applicable electromagnetic field standard specific to a product or technology exists it is expected to be used rather than this document. EN 62311:-, Table 1 gives a list of relevant standards.
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This document provides general methods for measurement and calculation of quantities associated with human exposure to electromagnetic fields in the frequency range from 0 Hz to 300 GHz. It is intended specifically to be used for the assessment of emissions from products and comparison of these with the exposure limits for the general public given in Council Recommendation 1999/519/EC, and those given for workers in Directive 2013/35/EU, as appropriate. It also is intended to be used for assessment of human exposure to electromagnetic fields in the workplace to determine compliance with the requirements of Directive 2013/35/EU. This standard deals with quantities that can be measured or calculated external to the body, notably electric and magnetic field strength or power density, and includes the measurement and calculation of quantities inside the body that form the basis for protection guidelines. In particular the standard provides information on: - definitions and terminology, - characteristics of electromagnetic fields, - measurement of exposure quantities, - instrumentation requirements, - methods of calibration, - measurement techniques and procedures for evaluating exposure, - calculation methods for exposure assessment. Where an applicable electromagnetic field standard specific to a product or technology exists it is expected to be used rather than this document. EN 62311:-, Table 1 gives a list of relevant standards.
- Amendment9 pagesEnglish languagee-Library read for1 day
This document provides general methods for measurement and calculation of quantities associated with human exposure to electromagnetic fields in the frequency range from 0 Hz to 300 GHz. It is intended specifically to be used for the assessment of emissions from products and comparison of these with the exposure limits for the general public given in Council Recommendation 1999/519/EC, and those given for workers in Directive 2013/35/EU, as appropriate. It also is intended to be used for assessment of human exposure to electromagnetic fields in the workplace to determine compliance with the requirements of Directive 2013/35/EU. This standard deals with quantities that can be measured or calculated external to the body, notably electric and magnetic field strength or power density, and includes the measurement and calculation of quantities inside the body that form the basis for protection guidelines. In particular the standard provides information on: — definitions and terminology, — characteristics of electromagnetic fields, — measurement of exposure quantities, — instrumentation requirements, — methods of calibration, — measurement techniques and procedures for evaluating exposure, — calculation methods for exposure assessment. Where an applicable electromagnetic field standard specific to a product or technology exists it is expected to be used rather than this document. EN 62311:—, Table 1 gives a list of relevant standards.
- Standard27 pagesEnglish languagee-Library read for1 day
The scope of this document is to provide a general procedure for the assessment of workers’ exposure to electric, magnetic and electromagnetic fields in a workplace in order to determine compliance with exposure limit values and/or action levels as stated in European Directive 2013/35/EU. The purpose of this document is to — specify how to perform an initial assessment of the levels of workers' exposure to electromagnetic fields (EMF), if necessary, including specific exposure assessment of such levels by measurements and/or calculations, — determine whether it is necessary to carry out a detailed risk assessment of EMF exposure. This document can be used by employers for the risk assessment and, where required, measurement and/or calculation of the exposure of workers. Based on specific workplace and other standards, it can be determined whether preventive measures/actions have to be taken to comply with the provisions of the Directive. The frequencies covered are from 0 Hz to 300 GHz. NOTE 1 This document relates to the exposure limits as specified in the Directive 2013/35/EU. It is intended to protect workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields (0 Hz to 300 GHz) during their work. However, this and other Directives can include additional measures for the protection of specific groups of workers and/or specific workplaces for which the employer is required to investigate other protective measures as a part of the overall risk assessment. See Annex A. NOTE 2 Directive 2013/35/EU has been transposed into national legislation in all the EU member countries. It is intended that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements can have additional requirements that are not covered by this standard.
- Standard38 pagesEnglish languagee-Library read for1 day
This document provides the procedure for the specific assessment required in EN 50527 1:2016, Annex A, for workers with implanted neurostimulator systems (NS), specifically of the type used for spinal cord stimulation (SCS).
It is recognized that implantable neurostimulators have been developed for a wide variety of clinical applications, however the SCS devices within the scope of this document represent the largest segment of the implantable neurostimulator applications thus far.
NOTE 1 If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they are assessed separately according to EN 50527 1 or other particular standards within the EN 50527 series.
The purpose of the specific assessment is to determine the risk for workers with implanted SCS devices arising from exposure to electromagnetic fields (EMF) at the workplace. The assessment includes the likelihood of clinically significant effects.
NOTE 2 This document does not address risks from contact currents, or the effects upon any associated non-implantable devices (e.g. Patient Programmers).
The techniques described in the different approaches can also be used for the assessment of publicly accessible areas.
The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the devices within the scope of this document is expected to occur.
NOTE 3 The rationale for limiting the observation range to 3 GHz can be found in ISO 14708 3 [1].
NOTE 4 Further information concerning the functions of neurostimulator systems can be found at https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Cord-Stimulation.
- Standard106 pagesEnglish languagee-Library read for1 day
This document provides the procedure for the specific assessment required in EN 50527 1:2016, Annex A, for workers with implanted neurostimulator systems (NS), specifically of the type used for spinal cord stimulation (SCS). It is recognized that implantable neurostimulators have been developed for a wide variety of clinical applications, however the SCS devices within the scope of this document represent the largest segment of the implantable neurostimulator applications thus far. NOTE 1 If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they are assessed separately according to EN 50527 1 or other particular standards within the EN 50527 series. The purpose of the specific assessment is to determine the risk for workers with implanted SCS devices arising from exposure to electromagnetic fields (EMF) at the workplace. The assessment includes the likelihood of clinically significant effects. NOTE 2 This document does not address risks from contact currents, or the effects upon any associated non-implantable devices (e.g. Patient Programmers). The techniques described in the different approaches can also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the devices within the scope of this document is expected to occur. NOTE 3 The rationale for limiting the observation range to 3 GHz can be found in ISO 14708 3 [1]. NOTE 4 Further information concerning the functions of neurostimulator systems can be found at https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spinal-Cord-Stimulation.
- Standard106 pagesEnglish languagee-Library read for1 day
IEC 62822-1:2016 is a product family standard, applies to equipment for resistance welding, arc welding and allied processes designed for occupational use by professionals and for use by laymen.
- Standard32 pagesEnglish languagee-Library read for1 day
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.
- Technical report24 pagesEnglish languagee-Library read for1 day
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.
- Technical report24 pagesEnglish languagee-Library read for1 day
This document provides general methods for measurement and calculation of quantities associated with human exposure to electromagnetic fields in the frequency range from 0 Hz to 300 GHz. It is intended specifically to be used for the assessment of emissions from products and comparison of these with the exposure limits for the general public given in Council Recommendation 1999/519/EC, and those given for workers in Directive 2013/35/EU, as appropriate. It also is intended to be used for assessment of human exposure to electromagnetic fields in the workplace to determine compliance with the requirements of Directive 2013/35/EU.
This standard deals with quantities that can be measured or calculated external to the body, notably electric and magnetic field strength or power density, and includes the measurement and calculation of quantities inside the body that form the basis for protection guidelines. In particular the standard provides information on:
— definitions and terminology,
— characteristics of electromagnetic fields,
— measurement of exposure quantities,
— instrumentation requirements,
— methods of calibration,
— measurement techniques and procedures for evaluating exposure,
— calculation methods for exposure assessment.
Where an applicable electromagnetic field standard specific to a product or technology exists it is expected to be used rather than this document. EN 62311:—, Table 1 gives a list of relevant standards.
- Standard27 pagesEnglish languagee-Library read for1 day
The scope of this document is to provide a general procedure for the assessment of workers’ exposure to electric, magnetic and electromagnetic fields in a workplace in order to determine compliance with exposure limit values and/or action levels as stated in European Directive 2013/35/EU.
The purpose of this document is to
— specify how to perform an initial assessment of the levels of workers' exposure to electromagnetic fields (EMF), if necessary, including specific exposure assessment of such levels by measurements and/or calculations,
— determine whether it is necessary to carry out a detailed risk assessment of EMF exposure.
This document can be used by employers for the risk assessment and, where required, measurement and/or calculation of the exposure of workers. Based on specific workplace and other standards, it can be determined whether preventive measures/actions have to be taken to comply with the provisions of the Directive.
The frequencies covered are from 0 Hz to 300 GHz.
NOTE 1 This document relates to the exposure limits as specified in the Directive 2013/35/EU. It is intended to protect workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields (0 Hz to 300 GHz) during their work. However, this and other Directives can include additional measures for the protection of specific groups of workers and/or specific workplaces for which the employer is required to investigate other protective measures as a part of the overall risk assessment. See Annex A.
NOTE 2 Directive 2013/35/EU has been transposed into national legislation in all the EU member countries. It is intended that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements can have additional requirements that are not covered by this standard.
- Standard38 pagesEnglish languagee-Library read for1 day
This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527 1:2015 for workers with implanted cardioverter defibrillators. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they have to be assessed separately.
- Standard62 pagesEnglish languagee-Library read for1 day
The object of this generic standard is to provide a route for evaluation of equipment used by workers against limits on human exposure to electric, magnetic and electromagnetic fields, and induced and contact current when it is put into service in its operational environment, and also for in situ or post-market evaluation of such equipment. The frequency range covered is 0 Hz to 300 GHz. Other standards can apply to products covered by this document. In particular this document is not designed to evaluate the electromagnetic compatibility with other equipment; nor does it reflect any product safety requirements other than those specifically related to human exposure to electromagnetic fields. This standard applies to electronic and electrical equipment for which no dedicated put into service or in situ product or product family standard regarding worker exposure to electromagnetic fields exists. If such a standard does exist then it shall be used and this standard shall not.
- Standard10 pagesEnglish languagee-Library read for1 day
The object of this generic standard is to provide a route for evaluation of such equipment against limits on human exposure to electric, magnetic and electromagnetic fields, and induced and contact current. This standard applies to electronic and electrical equipment for which no dedicated product- or product family standard, or standard relating to low power equipment, regarding human exposure to electromagnetic fields exists. If such a standard does exist then it shall be used and this standard shall not. The frequency range covered is 0 Hz to 300 GHz. This standard is intended to cover both intentional and non-intentional radiators. It should be noted that the supplier of a specific piece of equipment might not know the overall exposure environment in which the equipment is being used. This product standard can only assess the human exposure from the specific equipment under evaluation. Other standards can apply to products covered by this document. In particular this document is not designed to evaluate the electromagnetic compatibility with other equipment; nor does it reflect any product safety requirements other than those specifically related to human exposure to electromagnetic fields.
- Standard10 pagesEnglish languagee-Library read for1 day
This European standard provides simple conformity assessment methods for low-power electronic and electrical equipment operating at frequencies between 10 MHz and 300 GHz to an electromagnetic field (EMF) exposure limit. If such equipment cannot be shown to comply with the applicable EMF exposure requirements using the exposure assessment methods in this standard, then other EMF product standards may be used for conformity assessment. Other standards can apply to products covered by this document. In particular this document is not designed to evaluate the electromagnetic compatibility with other equipment; nor does it reflect any product safety requirements other than those specifically related to human exposure to electromagnetic fields.
- Standard9 pagesEnglish languagee-Library read for1 day
This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one will be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they need to be assessed separately. The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace. NOTE 1 This standard does not address risks from contact currents. The techniques described in the different approaches may also be used for the assessment of publicly accessible areas. The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the pacemaker occurs when the exposure limits are not exceeded. NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.
- Standard70 pagesEnglish languagee-Library read for1 day
IEC 62822-1:2016 is a product family standard, applies to equipment for resistance welding, arc welding and allied processes designed for occupational use by professionals and for use by laymen.
- Standard32 pagesEnglish languagee-Library read for1 day
ISO 15084:2003 specifies requirements for strong points for attaching chains, cables and lines for anchoring, mooring and towing small craft. It does not specify the requirement for the strong point from which the craft can tow other vessels. This standard is applicable to small craft with a hull length up to 24 m.
ISO 15084:2003 does not define anchor weights or the length of chains and lines.
- Standard15 pagesEnglish languagee-Library read for1 day
This European standard provides methods for assessing compliance with the requirements of the Directive 2013/35/EU] at a site operating one or more broadcast transmitters.
This standard covers the frequency range up to 40 GHz.
NOTE The Council and European Parliament Directive 2013/35/EU will be transposed into national legislation in all the EU member countries. Users of this standard shall consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements can have additional requirements that are not covered by this standard.
- Standard25 pagesEnglish languagee-Library read for1 day
This European Standard provides the procedure for the specific assessment required in Annex A of EN 50527 1:2015 for workers with implanted cardioverter defibrillators. It offers different approaches for doing the risk assessment. The most suitable one shall be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they have to be assessed separately.
- Standard62 pagesEnglish languagee-Library read for1 day
This European standard provides methods for assessing compliance with the requirements of the Directive 2013/35/EU] at a site operating one or more broadcast transmitters. This standard covers the frequency range up to 40 GHz. NOTE The Council and European Parliament Directive 2013/35/EU will be transposed into national legislation in all the EU member countries. Users of this standard shall consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements can have additional requirements that are not covered by this standard.
- Standard25 pagesEnglish languagee-Library read for1 day
The object of this generic standard is to provide a route for evaluation of such equipment against limits on human exposure to electric, magnetic and electromagnetic fields, and induced and contact current.
This standard applies to electronic and electrical equipment for which no dedicated product- or product family standard, or standard relating to low power equipment, regarding human exposure to electromagnetic fields exists. If such a standard does exist then it shall be used and this standard shall not.
The frequency range covered is 0 Hz to 300 GHz.
This standard is intended to cover both intentional and non-intentional radiators.
It should be noted that the supplier of a specific piece of equipment might not know the overall exposure environment in which the equipment is being used. This product standard can only assess the human exposure from the specific equipment under evaluation.
Other standards can apply to products covered by this document. In particular this document is not designed to evaluate the electromagnetic compatibility with other equipment; nor does it reflect any product safety requirements other than those specifically related to human exposure to electromagnetic fields.
- Standard10 pagesEnglish languagee-Library read for1 day
The object of this generic standard is to provide a route for evaluation of equipment used by workers against limits on human exposure to electric, magnetic and electromagnetic fields, and induced and contact current when it is put into service in its operational environment, and also for in situ or post-market evaluation of such equipment.
The frequency range covered is 0 Hz to 300 GHz.
Other standards can apply to products covered by this document. In particular this document is not designed to evaluate the electromagnetic compatibility with other equipment; nor does it reflect any product safety requirements other than those specifically related to human exposure to electromagnetic fields.
This standard applies to electronic and electrical equipment for which no dedicated put into service or in situ product or product family standard regarding worker exposure to electromagnetic fields exists. If such a standard does exist then it shall be used and this standard shall not.
- Standard10 pagesEnglish languagee-Library read for1 day
This European standard provides simple conformity assessment methods for low-power electronic and electrical equipment operating at frequencies between 10 MHz and 300 GHz to an electromagnetic field (EMF) exposure limit. If such equipment cannot be shown to comply with the applicable EMF exposure requirements using the exposure assessment methods in this standard, then other EMF product standards may be used for conformity assessment.
Other standards can apply to products covered by this document. In particular this document is not designed to evaluate the electromagnetic compatibility with other equipment; nor does it reflect any product safety requirements other than those specifically related to human exposure to electromagnetic fields.
- Standard9 pagesEnglish languagee-Library read for1 day
This European Standard provides a general procedure to assess workers’ exposure to electric and magnetic fields (EMF) in work places associated with the production, transmission and distribution of electric energy, and to demonstrate compliance with exposure limit values and action levels as stated in the Council and European Parliament "EMF" Directive 2013/35/EU [12].
NOTE 1 The Council and European Parliament Directive 2013/35/EU will be transposed into national legislation in all the EU member countries. It is important that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements may have additional requirements that are not covered by this standard
It has the role of a specific workplace standard. It takes into account the non-binding application guide for implementing the EMF Directive [11] and it defines the assessment procedures and compliance criteria applicable to the electric industry.
The frequency range of this standard covers from DC to 20 kHz, which is sufficient to include the power frequency used for electric power supply systems throughout Europe (50 Hz) and the various harmonics and inter-harmonics occurring in the supply system. In this extremely low frequency range, electric and magnetic fields are independent and, therefore, they both have to be addressed in the exposure assessment.
NOTE 2 Electrical companies also use radio frequency transmissions to operate and maintain their networks and power plants. Similarly, other exposures to EMF may occur during maintenance operations, for instance, due to the use of hand-held electrical tools. All these EMF sources are outside the scope of this standard.
NOTE 3 Regarding EMF in the low frequency range, the scientific basis of the EMF directive is the ICNIRP health guidelines published in 2010 [14]. Reference is made to this scientific basis when necessary for justifying or clarifying some of the technical statements of the present document.
- Standard54 pagesEnglish languagee-Library read for1 day
This European Standard provides a general procedure to assess workers’ exposure to electric and magnetic fields (EMF) in work places associated with the production, transmission and distribution of electric energy, and to demonstrate compliance with exposure limit values and action levels as stated in the Council and European Parliament "EMF" Directive 2013/35/EU [12]. NOTE 1 The Council and European Parliament Directive 2013/35/EU will be transposed into national legislation in all the EU member countries. It is important that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements may have additional requirements that are not covered by this standard It has the role of a specific workplace standard. It takes into account the non-binding application guide for implementing the EMF Directive [11] and it defines the assessment procedures and compliance criteria applicable to the electric industry. The frequency range of this standard covers from DC to 20 kHz, which is sufficient to include the power frequency used for electric power supply systems throughout Europe (50 Hz) and the various harmonics and inter-harmonics occurring in the supply system. In this extremely low frequency range, electric and magnetic fields are independent and, therefore, they both have to be addressed in the exposure assessment. NOTE 2 Electrical companies also use radio frequency transmissions to operate and maintain their networks and power plants. Similarly, other exposures to EMF may occur during maintenance operations, for instance, due to the use of hand-held electrical tools. All these EMF sources are outside the scope of this standard. NOTE 3 Regarding EMF in the low frequency range, the scientific basis of the EMF directive is the ICNIRP health guidelines published in 2010 [14]. Reference is made to this scientific basis when necessary for justifying or clarifying some of the technical statements of the present document.
- Standard54 pagesEnglish languagee-Library read for1 day
This European Standard provides a procedure to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a workplace. It describes how a general risk assessment should be performed and determines whether it is necessary to carry out a detailed risk assessment.
NOTE 1 This European Standard does not cover indirect effects caused by non active implants.
NOTE 2 The risk of human exposure to EMF considered is only due to malfunctioning of AIMD. Possibilities of AIMD contribution to the risk, e.g. local modification of the distribution of EMF produced by external source or production of own EMF, are covered by the respective product standards for the AIMD.
Based on specific workplace standards it can be determined whether preventive measures/actions need to be taken to comply with the provisions of Directive 2013/35/EU. The work situation covered is considered to be under normal working conditions including normal operation, maintenance, cleaning and other situations being part of the normal work.
The frequencies covered are from 0 Hz to 300 GHz.
The European Parliament and Council Directive 2013/35/EU will be transposed into national legislation in all the EU member countries. It is recommended that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements may have additional requirements that are not covered by this standard and take precedence.
NOTE 3 Performance requirements with respect to active implantable medical devices are excluded from the Scope of this standard. These are defined in the relevant particular standards for active implantable medical devices.
The risk assessment described in this standard is only required if an AIMD-Employee is present.
Active Implantable Medical Devices (AIMDs) are regulated by Directive 90/385/EEC and the amendments to it.
NOTE 4 Product standards EN 45502-1 and of the EN 45502-2-X series describe the product requirements for different kinds of AIMDs. Different kinds of AIMDs are e.g. pacemaker (EN 45502-2-1), implantable cardioverter defibrillators (EN 45502-2-2), cochlear implants (EN 45502-2-3), implantable neurostimulators (ISO 14708-3), implantable infusion pumps (ISO 14708-4).
In situations where the risk assessment following this standard does not lead to a conclusion, complementary provisions for the assessment of workers exposure for different kinds of AIMDs are given in particular standards for these specific AIMDs (see Figure 1).
(...)
Figure 1 - Structure of the EN 50527 family of standards
- Standard34 pagesEnglish languagee-Library read for1 day
This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted pacemakers. It offers different approaches for doing the risk assessment. The most suitable one will be used. If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they need to be assessed separately.
The purpose of the specific assessment is to determine the risk for workers with implanted pacemakers arising from exposure to electromagnetic fields at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace.
NOTE 1 This standard does not address risks from contact currents.
The techniques described in the different approaches may also be used for the assessment of publicly accessible areas.
The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the pacemaker occurs when the exposure limits are not exceeded.
NOTE 2 The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.
- Standard70 pagesEnglish languagee-Library read for1 day
This European Standard provides a procedure to assess the risk to workers bearing one or more active implantable medical devices from exposure to electric, magnetic and electromagnetic fields at a workplace. It describes how a general risk assessment should be performed and determines whether it is necessary to carry out a detailed risk assessment. NOTE 1 This European Standard does not cover indirect effects caused by non active implants. NOTE 2 The risk of human exposure to EMF considered is only due to malfunctioning of AIMD. Possibilities of AIMD contribution to the risk, e.g. local modification of the distribution of EMF produced by external source or production of own EMF, are covered by the respective product standards for the AIMD. Based on specific workplace standards it can be determined whether preventive measures/actions need to be taken to comply with the provisions of Directive 2013/35/EU. The work situation covered is considered to be under normal working conditions including normal operation, maintenance, cleaning and other situations being part of the normal work. The frequencies covered are from 0 Hz to 300 GHz. The European Parliament and Council Directive 2013/35/EU will be transposed into national legislation in all the EU member countries. It is recommended that users of this standard consult the national legislation related to this transposition in order to identify the national regulations and requirements. These national regulations and requirements may have additional requirements that are not covered by this standard and take precedence. NOTE 3 Performance requirements with respect to active implantable medical devices are excluded from the Scope of this standard. These are defined in the relevant particular standards for active implantable medical devices. The risk assessment described in this standard is only required if an AIMD-Employee is present. Active Implantable Medical Devices (AIMDs) are regulated by Directive 90/385/EEC and the amendments to it. NOTE 4 Product standards EN 45502-1 and of the EN 45502-2-X series describe the product requirements for different kinds of AIMDs. Different kinds of AIMDs are e.g. pacemaker (EN 45502-2-1), implantable cardioverter defibrillators (EN 45502-2-2), cochlear implants (EN 45502-2-3), implantable neurostimulators (ISO 14708-3), implantable infusion pumps (ISO 14708-4). In situations where the risk assessment following this standard does not lead to a conclusion, complementary provisions for the assessment of workers exposure for different kinds of AIMDs are given in particular standards for these specific AIMDs (see Figure 1). (...) Figure 1 - Structure of the EN 50527 family of standards
- Standard34 pagesEnglish languagee-Library read for1 day
This document specifies methods for evaluating the stability and buoyancy of intact (i.e. undamaged) boats. The flotation characteristics of boats susceptible to swamping are also encompassed.
The evaluation of stability and buoyancy properties using this document will enable the boat to be assigned to a design category (A, B, C or D) appropriate to its design and maximum load.
This document is principally applicable to boats propelled primarily by sail (even if fitted with an auxiliary engine) of 6 m up to and including 24 m hull length. However, it can also be applied to boats less than 6 m if they are habitable multihulls or can be applied if they do not attain the desired design category specified in ISO 12217‑3 and they are decked and have quick-draining recesses which comply with ISO 11812.
In relation to habitable multihulls, this document includes assessment of susceptibility to inversion, definition of viable means of escape and requirements for inverted flotation.
This document excludes:
— inflatable and rigid-inflatable boats covered by the ISO 6185 series, except for references made in the ISO 6185 series to specific clauses of the ISO 12217 series;
— gondolas and pedalos;
— surfboards including sailing surfboards; and
— hydrofoils and foil stabilized boats when not operating in the displacement mode.
NOTE Displacement mode means that the boat is only supported by hydrostatic forces.
It does not include or evaluate the effects on stability of towing, fishing, dredging or lifting operations, which need to be separately considered if appropriate.
- Draft77 pagesEnglish languagee-Library read for1 day
This document specifies methods for evaluating the stability and buoyancy of intact (i.e. undamaged) boats. The flotation characteristics of boats susceptible to swamping are also encompassed.
The evaluation of stability and buoyancy properties using this document will enable the boat to be assigned to a design category (A, B, C or D) appropriate to its design and maximum load.
This document is principally applicable to boats propelled primarily by sail (even if fitted with an auxiliary engine) of 6 m up to and including 24 m hull length. However, it can also be applied to boats less than 6 m if they are habitable multihulls or can be applied if they do not attain the desired design category specified in ISO 12217‑3 and they are decked and have quick-draining recesses which comply with ISO 11812.
In relation to habitable multihulls, this document includes assessment of susceptibility to inversion, definition of viable means of escape and requirements for inverted flotation.
This document excludes:
— inflatable and rigid-inflatable boats covered by the ISO 6185 series, except for references made in the ISO 6185 series to specific clauses of the ISO 12217 series;
— gondolas and pedalos;
— surfboards including sailing surfboards; and
— hydrofoils and foil stabilized boats when not operating in the displacement mode.
NOTE Displacement mode means that the boat is only supported by hydrostatic forces.
It does not include or evaluate the effects on stability of towing, fishing, dredging or lifting operations, which need to be separately considered if appropriate.
- Draft77 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
An EU Directive is a legislative act of the European Union that sets out goals that all EU member states must achieve. However, it is up to each member state to devise their own laws on how to reach these goals through national transposition. Directives are used to harmonize laws across the EU, particularly for the functioning of the single market.
Directive 2013/35/EU covers "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". There are 31 standards associated with this directive.
Harmonized standards under 2013/35/EU are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of 2013/35/EU, facilitating CE marking and free movement within the European Economic Area.