SIST EN 50527-1:2017
(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).
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
SIST EN 50527-1:2017
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
SIST EN 50527-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 50527-1:2017
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SIST EN 50527-1:2017
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
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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
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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
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EN 50527-1:2016 (E)
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 document supersedes EN 50527-1:2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CENELEC [and/or CEN] 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).
EN 50527 is currently composed with the following parts:
— EN 50527-1, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing
active implantable medical devices — Part 1: General;
— EN 50527-2-1, Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices — Part 2-1: Specific assessment for workers with cardiac
pacemakers;
— prEN 50527-2-2, Procedure for the assessment of the exposure to electromagnetic fields of workers
bearing active implantable medical devices — Part 2-2: Specific assessment for workers with
1)
implantable cardioverter defibrillators .
EN 50527-1:2016 includes the following significant technical changes with respect to EN 50527-1:2010:
• updates to recognize the Occupational Exposure Directive 2013/35/EU;
• inclusion of EN 50527-2-2 within the family of standards for AIMD-Employee assessment;
• former Clause 2 (Relationship to other standards) was removed, subsequent renumbering of all later
clauses;
• update of normative references to the “state of the art”, including the removal of EN 50499;
• clarification of the defined term “transient exposure”;
• numerous editorial changes to improve readability and clarity;
• correction of minor technical issues related to the general and specific assessment procedures;
• update to the Bibliography.
———————
1) Currently at drafting stage.
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The human exposure to electromagnetic fields (EMF) is regulated at European level in a twofold way. For the
general public, Council Recommendation 1999/519/EC stipulates maximum exposure limits based on the
ICNIRP guidelines. Nevertheless, Article 153 of the European treaty grants the member states the right to
set stricter limit values in their obligation to govern public health and safety.
For Occupational Exposure Directive 2013/35/EU as individual physical agents directive issued under the
Occupational Health and Safety Framework Directive 89/391/EEC sets the minimum health and safety
requirements based on the maximum occupational exposure limits of the ICNIRP guidelines.
Common to the European Recommendation and Directive limiting human exposure to EMF and to the
ICNIRP guidelines is the fact that their limit values are based on direct effects of EMF exposure to the human
body. For the low frequency range the induced current density in the nervous system or induced voltages
across membranes are the limiting factors whereas in the higher frequency area tissue heating by absorption
needs to be limited.
The Occupational Exposure Directive 2013/35/EU in Article 4.5 additionally obliges the employer to
investigate during the risk assessment process indirect effects like interference with medical electronic
equipment and devices (including cardiac pacemakers and other implanted devices).
Risks to the bearer may be caused by different effects:
— a conductive implant may directly cause an increase of current density in the body tissue surrounding
the implant, or
— the behaviour of the device may be interfered with (for examples see D.8 in Annex D of this standard).
The possibility of interference to the device depends on the EMF exposure level and the electromagnetic
performance of the device, its settings and the method of implantation. The clinical relevance of interference
may depend on the duration of exposure.
The main objective of this standard is to describe how a risk assessment for an employee bearing one or
more active implantable medical devices (AIMD-Employee) in electromagnetic fields may be performed. A
first step consists of a simplified risk analysis, followed where necessary, by a more extensive risk
assessment.
Directives 90/385/EEC and 2007/47/EC on medical devices requires that AIMDs are designed and
manufactured in such a way as to remove or minimize as far as possible risks connected with reasonably
foreseeable environmental conditions such as magnetic fields, external electromagnetic interference effects,
and electrostatic discharge.
EN 50499 originally introduced a concept of identifying equipment not likely to cause exposure to EMF
above the limit values. This standard follows this approach but some of the identified equipment for general
purpose assessment needs further analysis for AIMD-Employee. For higher frequency exposures, human
body tissue has a time constant with respect to heating effects and a high immunity to pulsating exposure,
whereas the electronic circuitry of an implant may be interfered with even by short pulses.
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EN 50527-1:2016 (E)
1 Scope
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).
EN 50527-1
General part covering indirect effects caused by interference with all kinds of
AIMD and generic items for subsequent standards for specific AIMD
EN 50527-2-1 EN 50527-2-2 EN 50527-2-x
Cardiac Pacemaker ICD specific Part specific part for
specific Part other AIMD
Figure 1 — Structure of the EN 50527 family of standards
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EN 50527-1:2016 (E)
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 45502-1:2015, Implants for surgery — Active implantable medical devices — Part 1: General
requirements for safety, marking and for information to be provided by the manufacturer
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
AIMD-Employee
employee bearing one or more AIMDs
3.2
interference distance
distance identified for a piece of equipment, outside of which distance an AIMD-Employee can work normally
Note 1 to entry: This is also used in the same way to identify the closest distance an item of portable equipment can
be, while the AIMD-Employee can work normally. At closer distances the AIMD-Employee may still be allowed to work
normally, but this requires a specific assessment for that situation; or transient exposure may be possible provided no
warnings against this have been received by the AIMD-Employee.
Note 2 to entry: Sometimes this distance is quoted as a “safety distance” but it should not be confused with the safety
distances identified for general EMF exposure of all employees in the workplace. At these general EMF safety distances
the fields may be high enough to cause response changes or other effects to an AIMD.
3.3
medical device
instrument, apparatus, appliance, software, material or other article, whether used alone or in combination,
together with any accessories, including the software intended by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the
manufacturer to be used for human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[SOURCE: Directive 2007/47/EC]
3.4
active medical device
medical device relying for its functioning on a source of electrical energy or any source of power other than
that directly generated by the human body or gravity
[SOURCE: Directive 90/385/EEC]
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3.5
active implantable medical device
AIMD
active medical device which is intended to be totally or partially introduced, surgically or medically, into the
human body or by medical intervention into a natural orifice, and which is intended to remain after the
procedure
[SOURCE: Directive 90/385/EEC]
3.6
responsible physician
physician responsible for the implantation and/or follow up monitoring of the AIMD
3.7
transient exposure
exposure to electromagnetic fields in the order of seconds which:
• is not continuous; i.e. comes to an end or reduces to non-influential levels;
• does not damage the AIMD;
• only leads to acceptable response of the AIMD based on the advice from the responsible physician (for
example by general guidance or by a specific warning) and/or described in the documentation
accompanying the AIMD
Note 1 to entry: Such exposure may be caused by the electromagnetic field being temporary or by the exposed person
moving within, or through, an electromagnetic field.
3.8
workplace
location where workers have access as part of their duties or during their breaks and all pathways that need
to be used to reach these
4 Risk assessment
4.1 Risk assessment procedure
4.1.1 Introduction
The Occupational Health and Safety Framework Directive 89/391/EEC requires in Article 15 about Risk
groups:
“Particularly sensitive risk groups must be protected against the dangers which specifically affect them.”
The interference of EMF with an implanted AIMD is identified as being an indirect effect causing particular
risk within the scope of Article 4.5 of Directive 2013/35/EU.
Figure 2 gives a schematic overview of the risk assessment process.
For some types of workplaces the EMF risk assessment is covered by a specific workplace standard. If such
a standard is used for risk assessment then the presentation of the result should normally be done in
accordance with that standard.
Special considerations are often needed when it comes to the assessment of work that takes place outside
the employer’s premises. It is generally advised that the employer trains AIMD-Employees to be aware of
particular risks that they might encounter during their work. This could be, for example, in situations where
craftsmen like bricklayers, plumbers and carpenters do maintenance work on chimneys, rooftops, etc. where
radio transmission or other transmitting antennas could be installed.
AIMD-Employees should be instructed on how to deal with such equipment in a safe manner. Generally this
means that AIMD-Employees are informed about the interference distances or zones of such equipment. If
the safety information is not provided in a sign at the site, it can be requested from the owner of the
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equipment. However, it is the employer’s responsibility that AIMD-employees have the right information on
every workplace that they visit.
4.1.2 Workplace equipment
The risk assessment is based on the approach that AIMDs are expected to function as described in their
product standards as long as the General Public Reference levels of Council Recommendation 1999/519/EC
(except for static magnetic fields) are not exceeded [Directive 2007/47/EC] [1] [2] [3] and where no specific
warnings have been issued to the AIMD-Employee.
NOTE 1 Such specific warnings are rarely required. Examples include combinations of unipolar sensing in
conjunction with the most sensitive settings available.
This risk assessment therefore checks both for fields present at the workplace that exceed these levels and
for AIMD-Employees that are subject to lower immunity of their AIMD due to clinical reasons.
The risk assessment continues by checking the equipment present at
...
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