FprEN 50527-2-3:2021

SLOVENSKI STANDARD
oSIST prEN 50527-2-3:2020
01-februar-2020
Postopek ocenjevanja izpostavljenosti delavcev z aktivnimi medicinskimi vsadki

elektromagnetnim poljem - 2-3. del: Specifično ocenjevanje delavcev z vsadljivimi

Procedure for the assessment of the exposure to electromagnetic fields of workers

bearing active implantable medical devices - Part 2-3: Specific assessment for workers

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CENELEC 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

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

European foreword ........................................................................................................................................... 3

1 Scope ........................................................................................................................................................... 4

2 Normative references ................................................................................................................................. 4

3 Terms and definitions ................................................................................................................................ 4

4 Specific assessment .................................................................................................................................. 6

4.1 Description of the assessment process ............................................................................................ 6

4.1.1 General ................................................................................................................................ 6

4.1.2 Exclusion based on history and physician warnings ........................................................... 8

4.1.3 Specific assessment phase 1: Consideration of equipment and SCS therapy type ........... 9

4.1.4 Equipment consideration ................................................................................................... 10

4.1.5 Specific assessment phase 2: Ruling out extrinsic stimulation and tissue damage .......... 11

4.1.6 Specific assessment phase 3: Assessment of clinical effects using in vivo testing .......... 11

4.2 Assessment of extrinsic stimulation and tissue damage risk ......................................................... 12

4.2.1 General .............................................................................................................................. 12

4.2.2 Overview of the Assessments Method given in Annexes D and E .................................... 13

4.2.3 Selection of Parameters Affecting the Assessment ........................................................... 13

4.2.4 Examples of assessment for unipolar configuration .......................................................... 15

4.2.5 Overall Assessment ........................................................................................................... 17

4.2.6 Further Assessment ........................................................................................................... 19

4.2.7 Concluding phase 2 assessment ....................................................................................... 20

4.3 Specific Assessment Phase 3: Clinical Evaluation ......................................................................... 20

4.3.1 Considerations in choosing a clinical method .................................................................... 20

4.3.2 Conducting in vivo tests ..................................................................................................... 21

5 Documentation ......................................................................................................................................... 22

Annex A (normative) Device specific replacement of EN 50527-1:2016, Table 1 ................................... 23

Annex B (informative) Clinical investigation methods .............................................................................. 30

Annex C (informative) Rationale .................................................................................................................. 31

Annex D (informative) Nerve Stimulation for SCS ..................................................................................... 32

Annex E (informative) Modelling Nerve Stimulation for SCS.................................................................... 38

Bibliography .................................................................................................................................................... 70

This document (prEN 50527-2-3:2019) has been prepared by CLC/TC 106X “Electromagnetic fields in the

This document has been prepared under a mandate given to CENELEC by the European Commission and

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

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

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 and takes both transient and long-term exposure within specific areas of the

NOTE 2 This document does not address risks from contact currents or the effects upon any associated external

The techniques described in the different approaches can also be used for the assessment of publicly

The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the devices

NOTE 3 The rationale for limiting the observation range to 3 GHz can be found in ISO 14708-3.

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.

The following documents are referred to in the text in such a way that some or all of their content constitutes

requirements of this document. For dated references, only the edition cited applies. For undated references,

the latest edition of the referenced document (including any amendments) applies.

EN 50527-1:2016, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing

EN ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

For the purposes of this document, the terms and definitions given in EN 50527-1:2016 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

part of the active implantable medical device, including the power supply and electronic circuit that produces

active implantable medical device comprising an implantable pulse generator and includes therapy delivering

electrodes usually part of implanted electrical leads that are intended to deliver therapy to a patient by

electrically stimulating certain nerve structures, along with an associated external patient programming device

electrically conducting part (usually the termination of a lead) which is designed to form an interface with body

Note 1 to entry: For the purposes of this document, the term AIMD-Employee refers to the patient whose implant consists

— employer and if applicable, his occupational health and safety experts and/or occupational physician;

stimulation using a single electrode with reference to the outer shell of the implantable pulse generator

Note 1 to entry: Leads for use with SCS devices typically have a minimum of 8 electrodes.

stimulation using two electrodes located on two separate leads that are implanted in close proximity to one

physical model containing tissue-equivalent material used to simulate the body in an experimental dose

Note 1 to entry: EM phantoms are sometimes also referred to as torso simulator or phantom.

alternating electric field, alternating magnetic field, or radio wave between

static (stationary) or quasi-static (below 1 Hz) electric field or magnetic field whether continuous, pulsed, or

neurostimulator system designed specifically for stimulation of the human spinal cord to treat chronic pain by

Spinal Cord Stimulation (SCS) is generally used for chronic pain reduction. The stimulation does not provide

therapy in direct relation to AIMD-Employee safety, so changes to therapy, or turning therapy off, does not

pose a specific risk to the AIMD-Employee. It is noted that an AIMD-Employee can also receive therapy

changes which may appear as a “shock” or “jolt” due to abrupt movements such as coughing and laughing as

well as from postural changes such as standing up from seating, or vice versa. These are not significant direct

risk situations to the AIMD-Employee, but there may be indirect implications due to the nature of the occupation

or positioning. A workplace risk assessment does not need to be based on an absence of risk or effect. It can

be made using a balance of the benefits and the identified possible effects, both direct and indirect, due to the

The risks to an AIMD-Employee resulting from to EMF or SF exposure in the workplace includes the following

— that the implanted SCS may itself be influenced in a way that leads to temporary or permanent loss of

therapy, or delivery of a corrupted form of therapy that might not meet the needs of the patient such that

they might be unable to carry out their employee functions. ISO 14708-3 is the product standard that

addresses the risks of malfunction and damage to the SCS NS when exposed to EMF or SF. The working

group has deemed the risks to the AIMD-Employee related to malfunction and device damage to be

acceptable, and they are therefore not addressed by this document. See C.2 for additional rationale.

— that the AIMD-Employee may experience additional effects upon their nervous system due to extrinsic

stimulation arising from induced currents in their implanted lead system. These effects can include

— that the induced currents are of sufficient magnitude to cause nerve tissue damage. This risk would occur

at higher exposure levels and where the EMF frequencies are high enough that they would not be

To address these risks, this document describes a multi-phase risk assessment as summarized in Figure 1.

— Exclusion from further assessment based upon a survey of the equipment in the workplace

— Exclusion from further assessment if the AIMD-Employee has a stimulator where outputs can be shut off

in high-impedance mode and is able to work with the stimulator in this mode receiving no therapy while at

— Assessment of the likelihood that the extrinsically induced current arising from the EMF environment of

the workplace will exceed the stimulation threshold (i.e. limit of perceived stimulation) for the spinal cord

portion of the human nervous system. Further assessment is prescribed where extrinsic stimulation cannot

— Assessment of the likelihood that the extrinsically induced current arising from the EMF environment of

the workplace could cause damage to the tissues of the spinal cord. This risk is present when the

characteristics of the extrinsically induced currents are such that they are not perceived by the AIMD-

Employee, yet are of sufficient magnitude to result in a level of deposited power as to cause tissue damage

as a result of tissue heating. . The underlying approach is first to allow work without restriction if it can be

— Where the risk of tissue damage has been ruled out, but extrinsic stimulation has not been ruled out,

assessment of actual stimulation effects. Since the consequences of unintended stimulation vary widely

from one individual to another the assessment necessarily involves in vivo testing.

Further risk assessment is not necessary if a history of uninfluenced behaviour at the workplace exists and a

responsible physician has confirmed that this history is sufficient to exclude clinically significant interaction.

When a SCS NS is tested according to ISO 14708-3, the manufacturer is required to provide a warning to the

implanting physician in the accompanying technical information as to any settings available in the device that

if used, afford the device with a reduced immunity to certain types of EMI. A specific warning would only be

given to the patient receiving the implant if they were discharged with one of these settings in effect, or if at

Figure 2 summarizes the situations where further risk assessment is unnecessary, and where a specific

4.1.3 Specific assessment phase 1: Consideration of equipment and SCS therapy type

To minimize the burden on the employer and AIMD-employee, the specific assessment begins with a first

phase in which it is determined if work can be allowed based upon considerations of equipment in the

A specific risk assessment for the AIMD-Employee is required when there is history of influenced behaviour or

a) there is equipment present in the workplace that is neither included in, nor used in accordance with

b) all equipment at the workplace is listed in Table A.1 (see Annex A) and is used accordingly, but the AIMD-

Employee has received warning(s) from the responsible physician that their device might be susceptible

to static fields (SF) or electromagnetic fields (EMF) associated with particular types of equipment, thereby

c) there is equipment present in the workplace that is neither included in, nor used in accordance with

Table A.1 and for which the AIMD-Employee does not have a history of device behaviour (uninfluenced

or otherwise) while in its presence, but the AIMD-Employee has received a specific warning as described

Figure 3 depicts phase 1 of the specific assessment. The steps to be taken are based upon a consideration of

When any of the conditions a) through c) exist, 4.1.4 applies. Otherwise, no further assessment is required,

Information relevant to the equipment or other field generating sources under consideration shall be collected

— can it be determined that clinically significant interference with the device will not occur as a result of

expected exposure to the equipment under consideration? If so, no further assessment is required, and

— can it be determined that the AIMD-Employee can return to the workplace only with restrictions placed on

the work tasks or areas of access? If so, no further assessment is required, and documentation of the

When neither of these questions can be answered positively, the assessment continues to phase 2, as

The intent of this subclause is to find and utilize information that might already exist and that allows the

assessment to be completed without further, costlier and time-consuming effort. It is recommended that

experts who are likely to have such information be contacted. Examples of such experts are the device

manufacturer, equipment manufacturer, employer’s technical department, consultants, or others skilled in EMF

4.1.5 Specific assessment phase 2: Ruling out extrinsic stimulation and tissue damage

When steps of the specific assessment phase 1 shown in Figure 3 have been followed but fail to mitigate or

to dismiss risk to the AIMD-Employee from the effects of workplace EMF or SF, then additional investigation

shall be performed as shown in Figure 4. The goal of Phase 2 investigation is to rule out the risk of extrinsic

The first step of phase 2 is to determine the levels of SF or EMF associated with the equipment in question.

This is ordinarily done by performing an EMF site survey wherein the fields are measured directly in the

workplace at the separation distances expected in daily exposure for the AIMD-Employee. Such

measurements should account for seasonal variations (if any), as well as measurement at lesser distances to

better understand the boundaries where higher exposures might occur. The results are then assessed using

Coincident with the workplace site survey, it is necessary to collect information concerning the specific implant

situation. As a minimum, it is necessary to know the type of stimulation in use (unipolar, bipolar or multipolar

single lead, or bipolar two-lead). Additional information that is useful includes an approximation of the

implanted loop area, proximity of lead electrodes to the spinal cord, the electrode area(s) for the specific leads

implanted, and whether the implantable pulse generator carries an MRI conditional approval. These items of

information might be available from the implanting physician. Otherwise, in the absence of such information, it

should be assumed that the nominal conditions of implant as described in 4.2 apply.

If it is learned that the AIMD-employee is receiving unipolar stimulation and SCS device re-programming to

bipolar stimulation is not possible, and the AIMD-Employee has a stimulator whose outputs can be shut off in

high-impedance mode, and the AIMD-Employee is able to work with the stimulator in this mode receiving no

4.1.6 Specific assessment phase 3: Assessment of clinical effects using in vivo testing

There can exist situations where the results from 4.2 indicate that the risk of tissue damage is negligible, yet

the EMF exposure levels are such that perception of them by the AIMD-Employee cannot be ruled out. In these

situations, the specific assessment continues with the consideration of applying in vivo testing. The

Figure 4 — Specific assessment phase 2 — Ruling out malfunction and extrinsic stimulation

Assessment of the risk of extrinsic induced stimulation that might exceed the threshold of perception is a

complex topic. Annex E together with Annex D, has been developed to provide an analysis methodology for

determination of whether or not an external EMF will be of sufficient magnitude to result in stimulation of the

The risk of extrinsic induced voltages that might result in damage to tissue adjacent to the electrodes is also a

Annex D introduces the SCS devices and important parameters associated with their use.

The SENN model (Spatially Extended Nonlinear Node model), which is used for modelling stimulation of

nerves by internal electric fields in the body, is introduced in E.1 and E.2 and based on the work of J.P Reilly.

The values of the ICNIRP internal electric field Basic Restriction for nerve stimulation is used for assessing

nerve stimulation that may arise from external magnetic and electric fields. In E.3 the values of the ICNIRP

internal electric field Basic Restriction for local heating in the body, are used in the assessment of whether or

The method for assessing whether nerve stimulation will be caused by external fields is based on evaluating

the quantity which is referred to as the Nerve Stimulation Ratio (NSR). If the NSR is greater than 1 then nerve

stimulation may occur, and if it is less than 1 nerve stimulation is not expected.

The stages of the method for assessing nerve stimulation are set out in E.5.1, and the results of the

The method for assessing whether tissue damage will be caused by external fields is based on evaluating the

quantity which is referred to as the Tissue Damage Ratio (TDR). If the TDR is greater than one then nerve

The stages of the method for assessing tissue damage are set out in E.6.1, and the results of the assessment

The methods for assessing whether nerve stimulation and tissue damage occurs both depend on calculating

the voltage induced by the external fields between the electrodes by the external fields (electric and magnetic),

and the current flowing in the tissue between the electrodes. These are presented in E.4.

In some situations, further assessment is required. The approach for this is given in E.8 and reproduced here.

The outcome of the assessment depends on many different parameters. To simplify this, assessments have

been carried out for a few particular sets of parameters representative of worst cases.

The leads between the IPG and electrode site form a loop in which voltages may be induced by magnetic

fields. The lead configuration affects loop area which in turn affects the induced voltage. The areas used are

as follows: 612 cm for unipolar, 140 cm for bipolar (using two leads) and 10 cm for bipolar (using one lead).

The spacing of implanted electrodes affects the voltage induced between them. The spacings used are 50 cm

Values of electric and magnetic fields for this assessment are shown in Figure 5 and Figure 6, respectively.

Two sets of values are used for frequencies between 1 Hz and 10 GHz. The two lines used are:

— the Reference Level from the EU EMF Recommendation for exposures to the General Public.