EN 50527-1:2010

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General

The scope of this European Standard is to provide a procedure in order 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 specifies how to perform a general risk assessment and to determine 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 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 must be taken to comply with the provisions of Directive 2004/40/EC. 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. NOTE 3 The European Parliament and Council Directive 2004/40/EC 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 4 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. NOTE 5 This standard is written under mandate M/351 and relates to the exposure limits as specified in the Directive 2004/40/EC which is intended to protect workers from risks to their health and safety arising or likely to arise from exposure to electromagnetic fields (0 Hz to 300 GHz) during their work. However, this and other directives may include additional measures for the protection of specific groups of workers and/or specific workplaces for which the employer is required to investigate other protective measures as a part of the overall risk assessment.

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

Področje uporabe tega standarda je zagotoviti postopek za ocenjevanje tveganja za delavce z aktivnih medicinskih vsadkov, ki so izpostavljeni električnim, magnetnim in elektromagnetnim poljem na delovnem prostoru. Določa, kako izvesti splošno oceno tveganja in presoditi, ali je potrebno izvesti podrobno oceno tveganja.

General Information

• Status: Withdrawn
• Publication Date: 22-Apr-2010
• Withdrawal Date: 31-Jan-2013
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• ICS: 13.100 - Occupational safety. Industrial hygiene
• ICS: 13.280 - Radiation protection
• Technical Committee: CLC/TC 106X - Electromagnetic fields in the human environment
• Parallel Committee: IEC/TC 106 - IEC_TC_106
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Jul-2019
• Completion Date: 04-Jul-2019
• Directive: 2004/40/EC - Directive 2004/40/EC of the European Parliament and of the Council of 29 April 2004 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
• Mandate: M/351 - Standardisation mandate addressed to CEN, CENELEC and ETSI to develop harmonized standards for the assessment, measurement and calculation of worker's exposure to static magnetic and varying electric, magnetic and electromagnetic fields with frequencies from 0Hz to 300 GHz
• Ref Project: SIST EN 50527-1:2010 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General

Relations

• Replaced By: EN 50527-1:2016 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General
• Effective Date: 06-Dec-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-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 50527-1:2010
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
17.240 Merjenje sevanja Radiation measurements
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 50527-1
NORME EUROPÉENNE
April 2010
EUROPÄISCHE NORM
ICS 11.040.40; 13.100; 13.280
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 Verfahren zur Beurteilung der Exposition
des travailleurs porteurs de dispositifs von Arbeitnehmern mit aktiven
médicaux implantables actifs aux champs implantierbaren medizinischen Geräten
électromagnétiques - (AIMD) gegenüber elektromagnetischen
Partie 1 : Généralités Feldern -
Teil 1: Allgemeine Festlegungen

This European Standard was approved by CENELEC on 2010-02-01. 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 Central Secretariat 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 Central Secretariat 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 50527-1:2010 E
Foreword
This European Standard was prepared by the Technical Committee CENELEC TC 106X,
Electromagnetic fields in the human environment. The text of the draft was submitted to the formal vote
and was approved by CENELEC as EN 50527-1 on 2010-02-01.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2011-02-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2013-02-01
This European Standard has been prepared under Mandate M/351 given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 2004/40/EC.
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 (2004/40/EC) 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 both directives 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 is the limiting factor whereas in the higher
frequency area tissue heating by absorption has to be limited.
The occupational exposure directive 2004/40/EC in Article 4.5 additionally obliges the employer to
investigate during the risk assessment process also 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).
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.
– 3 – EN 50527-1:2010
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 introduces 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 may need 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.
__________
Contents
1 Scope . 6
2 Relationship to other standards . 6
3 References . 7
3.1 Normative references . 7
3.2 Regulatory references . 7
4 Terms and definitions . 8
5 Risk assessment . 9
5.1 Risk assessment procedure . 9
5.2 Documentation and information for the AIMD-Employee . 13
5.3 Maintaining the risk assessment . 13
6 Equipment at workplaces . 13
7 Special cases . 18
8 AIMD-Employees with more than one AIMD . 18
9 Documentation . 18
Annex A (normative) Specific risk assessment . 19
A.1 General . 19
A.2 Non-clinical approach. 19
A.3 Clinical approach . 20
A.4 Documentation of the specific assessment. . 20
Annex B (informative) Documenting the risk assessment . 22
B.1 Introduction . 22
B.2 Workplace compliance documentation form . 22
B.3 Previously uninfluenced behaviour . 24
B.4 Documenting the detailed risk assessment . 25
Annex C (informative) Specific electromagnetic environments. 28
C.1 Railways . 28
C.2 Workplace power transmission and distribution . 28
C.3 Broadcasting . 30
Annex D (informative) Theoretical considerations . 31
D.1 Introduction . 31
D.2 Brief summary of exposure limits for persons without implant . 31
D.3 General considerations about electromagnetic fields . 34
D.4 General considerations about AIMDs . 35
D.5 Description of electromagnetic interference effects . 36
D.6 Model to assess the possibility of induction of AIMD response . 36
D.7 Possibility of induced AIMD response. 37
D.8 Clinical relevance of AIMD response . 38
Bibliography . 39

– 5 – EN 50527-1:2010
Figures
Figure 1 – Relationship of standards . 7
Figure 2 – Risk assessment process . 12
Figure D.1 – Reference levels for whole body exposure according to 1999/519/EC. 33
Figure D.2 – Field strength – Distance ratio . 34
Figure D.3 – Near field – far field transition for sources smaller than half wavelength in size . 34
Figure D.4 – Entire model to assess the possibility of induction of AIMD response . 36
Figure D.5 – Simplified model to assess the possibility of AIMD response in special cases . 37

Tables
Table 1 – Compliant workplaces and equipment with exceptions. 14
Table C.1 – Summary of maximum field values beneath high-voltage overhead lines . 29

1 Scope
The scope of this European Standard is to provide a procedure in order 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 specifies how to perform a general risk assessment and to
determine 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 the risk of human ex
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