EN 50527-1:2016
(Main)Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
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
Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren medizinischen Geräten (AIMD) gegenüber elektromagnetischen Feldern - Teil 1: Allgemeine Festlegungen
Procédure pour l’évaluation de l’exposition des travailleurs porteurs de dispositifs médicaux implantables actifs aux champs électromagnétiques - Partie 1 : Généralités
Postopek ocenjevanja izpostavljenosti delavcev z aktivnimi medicinskimi vsadki elektromagnetnim poljem - 1. del: Splošno
Ta evropski standard določa postopek za oceno tveganja za delavce, ki imajo enega ali več aktivnih medicinskih vsadkov, v povezavi z izpostavljenostjo električnim, magnetnim in elektromagnetnim poljem na delovnem mestu. Opisuje način izvajanja splošnega ocenjevanja tveganja in določa, ali je treba izvesti podrobno ocenjevanje tveganja.
OPOMBA 1: Ta evropski standard ne zajema posrednih vplivov, ki jih povzročajo neaktivni vsadki.
OPOMBA 2: Obravnavano je tveganje izpostavljenosti osebe elektromagnetnemu polju, ki je izključno posledica okvare aktivnega medicinskega vsadka. Možnosti aktivnega medicinskega vsadka za povečanje tveganja, npr. lokalne spremembe porazdelitve elektromagnetnega polja, ki jih povzroči zunanji vir, ali ustvarjanje lastnega elektromagnetnega polja, so zajete v ustreznih standardih za aktivne medicinske vsadke. Na podlagi posameznih standardov za delovna mesta je mogoče ugotoviti, ali so za namene skladnosti z določbami Direktive 2013/35/EU potrebni preventivni ukrepi/dejanja. Zajete delovne razmere se obravnavajo kot običajni delovni pogoji, vključno z običajnim delovanjem, vzdrževanjem, čiščenjem in drugimi okoliščinami, ki so del običajnega opravljanja dela.
Zajet frekvenčni razpon je od 0 Hz do 300 GHz.
Direktiva 2013/35/EU Evropskega parlamenta in Sveta bo prenesena v nacionalno zakonodajo vseh držav članic EU. Priporočljivo je, da uporabniki tega standarda upoštevajo nacionalno zakonodajo, povezano s tem prenosom, ter se seznanijo z nacionalni predpisi in zahtevami. Ti nacionalni predpisi in zahteve lahko vključujejo dodatne zahteve, ki niso zajete v tem standardu, in imajo prednost.
OPOMBA 3: Zahtevane lastnosti v zvezi z aktivnimi medicinskimi vsadki so izključene s področja uporabe tega standarda in so opredeljene v ustreznih standardih za aktivne medicinske vsadke.
Ocena tveganja, opisana v tem standardu, je zahtevana samo, če je prisoten uporabnik aktivnega medicinskega vsadka.
Aktivne medicinske vsadke (AIMD) ureja Direktiva 90/385/EGS in njena dopolnila.
OPOMBA 4: Standard za proizvode EN 45502-1 in skupina standardov EN 45502-2-X opisujejo zahteve za različne vrste aktivnih medicinskih vsadkov. Različne vrste aktivnih medicinskih vsadkov so npr. srčni spodbujevalnik (EN 45502-2-1), kardioverter defibrilatorji za vsaditev (EN 45502-2-2), polžasti vsadki (EN 45502-2-3), nevrostimulatorji za vsaditev (ISO 14708-3), infuzijske črpalke za vsaditev (ISO 14708-4).
Če ocena tveganja v skladu s tem standardom ne privede do zaključka, so v posameznih standardih za ustrezne aktivne medicinke vsadke podane dodatne določbe za oceno izpostavljenosti delavcev za te vrste aktivnih medicinskih vsadkov (glej sliko 1).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2017
1DGRPHãþD
SIST EN 50527-1:2010
Postopek ocenjevanja izpostavljenosti delavcev z aktivnimi medicinskimi vsadki
elektromagnetnim poljem - 1. del: Splošno
Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices - Part 1: General
Verfahren zur Beurteilung der Exposition von Arbeitnehmern mit aktiven implantierbaren
medizinischen Geräten (AIMD) gegenüber elektromagnetischen Feldern - Teil 1:
Allgemeine Festlegungen
Procédure pour l’évaluation de l’exposition des travailleurs porteurs de dispositifs
médicaux implantables actifs aux champs électromagnétiques - Partie 1 : Généralités
Ta slovenski standard je istoveten z: EN 50527-1:2016
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
13.100 Varnost pri delu. Industrijska Occupational safety.
higiena Industrial hygiene
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 50527-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2016
ICS 11.040.40; 13.100; 13.280 Supersedes EN 50527-1:2010
English Version
Procedure for the assessment of the exposure to
electromagnetic fields of workers bearing active implantable
medical devices - Part 1: General
Procédure pour l'évaluation de l'exposition des travailleurs Verfahren zur Beurteilung der Exposition von
porteurs de dispositifs médicaux implantables actifs aux Arbeitnehmern mit aktiven implantierbaren medizinischen
champs électromagnétiques - Partie 1 : Généralités Geräten (AIMD) gegenüber elektromagnetischen Feldern -
Teil 1: Allgemeine Festlegungen
This European Standard was approved by CENELEC on 2016-07-04. 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, 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
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 50527-1:2016 E
Contents Page
European foreword . 4
1 Scope . 6
2 Normative references . 7
3 Terms and definitions . 7
4 Risk assessment . 8
4.1 Risk assessment procedure . 8
4.1.1 Introduction . 8
4.1.2 Workplace equipment . 9
4.1.3 Previously uninfluenced behaviour . 9
4.1.4 Specific warnings . 10
4.2 Documentation and information for the AIMD-Employee. 11
4.3 Maintaining the risk assessment . 12
5 Equipment at workplaces . 12
5.1 General approach. 12
5.2 Equipment with recommendations restricting use . 13
5.2.1 General recommendations . 13
5.2.2 Compliant workplaces and exceptions . 13
6 Special cases . 17
7 AIMD-Employees with more than one AIMD . 17
8 Documentation . 17
Annex A (normative) Specific risk assessment . 18
A.1 General . 18
A.2 Non-clinical approach . 18
A.2.1 Assessment of the exposure situation . 18
A.2.2 Assessment of the AIMD immunity . 18
A.2.3 Assessment of the compatibility . 18
A.2.4 Assessment of the risk of incompatibility . 19
A.3 Clinical approach . 19
A.4 Documentation of the specific assessment . 19
Annex B (informative) Documenting the risk assessment . 20
B.1 Introduction . 20
B.2 Workplace compliance documentation form . 20
B.2.1 General . 20
B.2.2 Assessment . 21
B.2.3 Conclusion . 21
B.3 Previously uninfluenced behaviour . 22
B.3.1 General information . 22
B.3.2 Assessment . 22
B.3.3 Conclusion . 23
B.4 Documenting the detailed risk assessment . 23
B.4.1 General information . 23
B.4.2 Assessment . 23
B.4.3 Exposure situation (see A.2.1) . 24
B.4.4 Compliance demonstration . 24
Annex C (informative) Specific electromagnetic environments . 25
C.1 Railways . 25
C.2 Workplace power transmission and distribution . 25
C.2.1 General . 25
C.2.2 Field levels in public exposure situations. 25
C.2.3 Sensitivity of AIMDs to 50 Hz fields . 26
C.2.4 Risk assessment in occupational situations . 26
C.3 Broadcasting . 26
Annex D (informative) Theoretical considerations . 27
D.1 Introduction . 27
D.2 Brief summary of exposure limits for persons without implant . 27
D.3 General considerations about electromagnetic fields . 28
D.4 General considerations about AIMDs . 29
D.4.1 General . 29
D.4.2 Devices with sensing leads . 29
D.4.3 Devices with stimulating leads . 29
D.4.4 Devices without leads . 29
D.4.5 Devices using RF or inductive coupling . 29
D.4.6 Considerations for minimizing transient exposure . 30
D.5 Description of electromagnetic interference effects . 30
D.6 Model to assess the possibility of induction of AIMD response . 30
D.7 Possibility of induced AIMD response . 31
D.8 Possible AIMD responses to interference . 32
Bibliography . 34
Figures
Figure 1 — Structure of the EN 50527 family of standards . 6
Figure 2 — Risk assessment process . 11
Figure D.1 — Field strength – Distance ratio . 28
Figure D.2 — Near field – far field transition for sources smaller than half wavelength in size . 28
Figure D.3 — Entire model to assess the possibility of induction of AIMD response . 30
Figure D.4 — Simplified model to assess the possibility of AIMD response in special cases . 31
Tables
Table 1 — Compliant workplaces and equipment with exceptions . 13
Table C.1 — Summary of maximum field values beneath high-voltage overhead lines at 1 m
above ground . 26
European foreword
This document (EN 50527-1:2016) 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 implemented (dop) 2017-07-04
at national level by publication of an identical national
standard or by endorsement
• latest date by which the national standards conflicting with (dow) 2019-07-04
this document have to be withdrawn
This do
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