EN 50527-1:2016

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 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 .
• 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.
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.
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
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]
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
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 the workplace. Equipment listed in
Table 1 may be assumed to produce fields that do not exceed the General Public reference levels of
Council Recommendation 1999/519/EC. If there is equipment present that is not listed in Table 1 or is not
used as specified in the remarks in Table 1 it needs to be assumed that the electric, magnetic or
electromagnetic field levels may be too high to ensure uninfluenced behaviour of the AIMD. In this case a
specific assessment following Annex A shall be performed.
If all equipment at the workplace is listed in Table 1 and is used as specified in the remarks in Table 1 it is
necessary to find out whether the AIMD-Employee has received specific warnings from the responsible
physician. Such specific warnings are based on the fact that the immunity of the implant under the condition
of implantation and parameter setting is not compatible with General Public reference levels.
If the AIMD-Employee is being exposed to static magnetic fields of flux density > 1mT, some types of AIMD
such as pacemakers, ICDs, neurostimulator, etc. may respond to the field by switching to a clinically
acceptable behaviour for short exposure. It is not advisable, however, to have the worker exposed to such
fields for long periods of time (i.e. over several seconds) as it may result in unacceptable responses or
changes in intended performance of the AIMD. This 1mT limit also applies for “quasi static“ magnetic fields in
the frequency range from 0 Hz to 1 Hz (or up to a few Hz).
NOTE 2 Such magnetic fields may occur in industries using DC applications (e.g. electrolysis) or may be caused by
equipment using permanent magnets like e.g. loud speakers or ear phones.
NOTE 3 Directive 2013/35/EU states an action level of 0,5 mT for static magnetic fields reasoned by interference of
pacemakers.
4.1.3 Previously uninfluenced behaviour
The assessment effort can be reduced by checking whether or not the AIMD-Employee has worked within
the current role without experiencing clinically significant effects even though not all equipment present at the
workplace is listed in Table 1.
If this is so, proportionate to the risk, it can be assumed that the residual risk is acceptable as long as:
• the AIMD-Employee has experienced all reasonably foreseeable exposure situations and they have
been in their position for a period of at least 12 months,
• no new equipment is brought into the workplace,
• no changes to the AIMD configuration have been made during the last 12 months,
• no changes in the therapy indication are given.
If previously uninfluenced behaviour is concluded, it should be considered that this approach does not
provide any safety margin. Therefore this approach might be suitable only if tolerable interference (e.g.
acoustic sound in a cochlear implant) is expected. If clinically significant interaction might be possible (e.g.
delivery of an inappropriate therapy of an implanted defibrillator) this approach is not recommended.
The period of 12 months is chosen:
• to make sure that at least one follow up clinical visit with the responsible physician has taken place,
• to ensure that all seasonal changes of workplace electromagnetic environment have been accounted
for.
Documentation of the result and AIMD-Employee’s information shall be performed as described in 5.2.
4.1.4 Specific warnings
All AIMD-Employees receive from their responsible physician general warnings to avoid situations in which
risk of interference may occur such as for example mobile phones should not be used closer than a specified
distance from the AIMD and not to use motor-operated equipment immediately adjacent to the implantation
site. Such warnings are not considered specific warnings but nevertheless needs to be followed. Specific
warnings are instructions given by the responsible physician caused by the configuration of the AIMD, its
settings or clinical conditions of the patient which are more stringent than the warnings every AIMD-
Employee receives, including any warning in the manual that the AIMD-Employee receives. Specific
warnings originate from EN 45502-1:2015, 28.22.
When an AIMD-Employee has received such specific warnings a specific assessment following Annex A
shall be performed. If not, documentation of the result and AIMD-Employees information shall be performed
as described in 5.2.
Figure 2 — Risk assessment process
4.2 Documentation and information for the AIMD-Employee
The risk assessment shall be documented and the result be communicated to the AIMD-Employee. This
documentation shall follow national regulations. In the absence of national requirements for the
documentation, forms for documenting the risk assessment are suggested in Annex B.
Where applicable, the AIMD-Employee shall be informed about:
• areas for continuous stay,
• areas of transient exposure,
• areas of non-access.
It is recommended to remind the AIMD-Employee that guidelines were provided with the AIMD, that they
were provided by a responsible physician, and that they still apply in the workplace.
4.3 Maintaining the risk assessment
The result of the risk assessment procedures shall be kept up to date. A procedure shall be established to
ensure that the employer is informed about any changes of the risk situation.
Such a change of the risk situation occurs:
• when the AIMD-Employee receives a new AIMD,
• when the clinical situation of the AIMD-Employee changes,
• where the settings of the AIMD-Employee’s AIMD have been changed,
• when the workplace exposure changes in ways not already accounted for in the present assessment.
If the AIMD-Employee reports symptoms that may be related to the exposure in the workplace, the risk
assessment shall be updated.
5 Equipment at workplaces
5.1 General approach
This section describes equipment present at the workplace which is identified as not causing interference
with AIMD. No further assessment is needed if only such equipment is present at the workplace. Other
equipment not listed in this section may cause interference with AIMD and a more detailed assessment is
needed, nevertheless the result of the assessment may be that no risk for the AIMD-Employee is identified.
The basis for the immunity limits set for AIMDs in their product standards is derived from the Reference
Levels from Council Recommendation 1999/519/EC without any time averaging being included. Table 1
reflects these immunity requirements and therefore may be different from the limit values and action values
of Directive 2013/35/EU.
Static magnetic fields with flux density of B > 1 mT, at the region occupied by the AIMD, may cause
influenced behaviour of the implanted AIMD. This 1 mT limit also applies for “quasi static“ magnetic fields in
the frequency range from 0 Hz to 1 Hz. In addition AIMD product standards also include protection
mechanisms for exposure above the reference levels of Council Recommendation 1999/519/EC. These
mechanisms allow interference levels above this basis but only under some circumstances and not for all
types of AIMD. Transient exposure in the order of seconds under those circumstances may be permitted
provided the AIMD-Employee has not received warnings against this from their responsible physician.
Except from some specific cases the electric and magnetic field levels decrease with increasing distance
from any piece of equipment. This is discussed in detail in D.3 and the decrease amount depends on the
size of the source, the type of field and the distance itself. This allows the identification of interference
distances for some equipment, outside of which an AIMD-Employee can work normally. Similarly, if portable
equipment is kept at a distance greater than the interference distance, from the AIMD or attached leads, the
AIMD-Employee can work normally.
The AIMD-Employee should not work inside the interference distance unless a specific risk assessment has
been made for that situation. It may be possible for the AIMD-Employee to pass by equipment closer than
the interference distance in conditions of transient exposure. In any case of doubt further guidance may be
obtained from device or emitter manufacturers, the responsible physician or by the use of the appropriate
device specific standard.
Table 1 may be amended or replaced in vertical standards for the specific needs of different AIMDs.
5.2 Equipment with recommendations restricting use
5.2.1 General recommendations
In all cases where recommendations restricting use of workplace equipment are given with the AIMD, they
should be identified and taken into account as part of the risk assessment. Where these recommendations
cannot be taken into account at the workplace, a specific risk assessment following Annex A is required.
Such recommendations are normally in the form of a minimum separation distance between the equipment
and the AIMD. Those recommendations are given in the patients manual the AIMD-Employee receives from
the implanting institution or by the suppliers of the specific equipment in the workplace.
5.2.2 Compliant workplaces and exceptions
Table 1 — Compliant workplaces and equipment with exceptions
Designation of Examples of equipment Exceptions and remarks

workplace
All places Lighting equipment Excluding specialized lighting for
industrial purposes where the energy
is deployed by microwave or radio
frequency fields.
All places Computer and IT equipment Provided that such equipment does not
contain radio transmission equipment
such as RadioLANs, Bluetooth or
Mobile Telephony. If such items are
included in the equipment,see 5.2.1.
Hard disks (other than solid state
harddiscs) of portable computers and
external harddisks should be treated
as equipment producing static
magnetic fields and be used only with
minimum distance of 15 cm between
the hard disk and the AIMD.
All places Computer, tablets and ITE equipment See 5.2.1.
including wireless communication
Hard disks (other than solid state
harddiscs) of portable computers and
external harddisks should be treated
as equipment producing static
magnetic fields and be used only with
minimum distance of 15 cm between
the hard disk and the AIMD.
All places Office equipment Excluding tape erasers.
All places Mobile phones, smart phones and See 5.2.1 As example for pacemakers
cordless phones and defibrillators the interference
distance between source and AIMD is

15 cm for peak powers up to 2 W.
All places Two-way radios See 5.2.1.
All places Base stations for DECT cordless See 5.2.1 As example for pacemakers
phones and WLAN (e.g. Wi-Fi) and defibrillators the interference
distance between source and AIMD is
15 cm for peak powers up to 2 W.
All places Non - wireless communication
equipment and networks
Designation of Examples of equipment Exceptions and remarks
workplace
All places Electric hand-held and transportable Areas containing such equipment are

tools deemed to comply without further
assessment.
If the AIMD-Employee operates the
tools see 5.2.1.
All places Portable heating tools (e.g. glue guns, Areas containing such equipment are
heat guns) deemed to comply without further
assessment.
If the AIMD-Employee operates the
tools see 5.2.1.
All places Small battery chargers for household Large chargers (for professional use)
use require further assessment.
For chargers using inductive coupling
or proximity coupling further
information from the manufacturer is

needed.
All places Electric operated garden appliances Areas containing such equipment are
deemed to comply without further
assessment.
If the AIMD-Employee operates the
tools see 5.2.1.
All places Audio and video equipment If the equipment uses wireless
transmission see 5.2.1.
External harddisks (other than solid
state harddiscs) should be treated as
equipment producing static magnetic
fields and be used only with minimum
distance of 15 cm between the hard
disk and the AIMD.
Loudspeakers and earphones should
be considered equipment producing
static magnetic fields.
All places Portable battery powered equipment
not including radio frequency
transmitters
All places Electrical room heating equipment In general no restrictions. For workers
very close to large industrial heating
systems further information from the
manufacturer is required.
All places All non-electrical equipment Some non-electrical equipment may
include high static magnetic fields (for
example permanent magnets). In this
case see 5.2.1.
All places All equipment producing static Equipment capable of producing static
magnetic fields magnetic flux density of B > 1 mT, at
the region occupied by the AIMD, may
cause influenced behaviour of the
implanted AIMD. This 1 mT peak limit
also applies for “quasi static“ magnetic
fields in the frequency range from 0 Hz
up to a few Hz.
Designation of Examples of equipment Exceptions and remarks
workplace
All places Electricity supply networks in the The criteria given in the middle column
workplace and electricity distribution here for demonstrating that fields are
and transmission circuits passing low enough to avoid interfering with
through or over the workplace. The AIMDs are based on demonstrating
magnetic and electric field exposure that the exposures are lower than the
are considered separately. reference levels given in the
Council Recommendation 1999/519/EC
For magnetic field exposures the
of EMF exposures for the general
following are compliant:
public. It states that for magnetic fields
• any electrical installation with a
all overhead lines satisfy this criterion
phase current rating of 100 A or
but for electric fields only lines with a
less;
rated voltage up to 150 kV satisfy it.
• any individual circuit within an
However for an overhead line whose
installation, with a phase current
voltage is greater than 150 kV the
rating of 100 A or less;
electric field will usually, but not
• any circuit where the conductors always, be lower than the public
reference level.
are close together and having a net
current of 100 A or less;
Clause C.2 gives more information
about this, and as a result a risk
• all components of the networks
satisfying the criteria above are assessment for a workplace
...