SIST EN IEC 61340-6-1:2019

SLOVENSKI STANDARD
SIST EN IEC 61340-6-1:2019
01-januar-2019
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Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for
facilities (IEC 61340-6-1:2018)
Ta slovenski standard je istoveten z: EN IEC 61340-6-1:2018
ICS:
11.020.99 Drugi standardi v zvezi z Other standards related to
zdravstvom na splošno health care in general
17.220.99 Drugi standardi v zvezi z Other standards related to
elektriko in magnetizmom electricity and magnetism
SIST EN IEC 61340-6-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 61340-6-1:2019

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SIST EN IEC 61340-6-1:2019


EUROPEAN STANDARD EN IEC 61340-6-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2018
ICS 11.020.99; 17.220.99; 29.020

English Version
Electrostatics - Part 6-1: Electrostatic control for healthcare -
General requirements for facilities
(IEC 61340-6-1:2018)
Électrostatique - Partie 6-1: Contrôle électrostatique dans le Elektrostatik - Teil 6-1: Überwachung der Elektrostatik im
domaine de la santé - Exigences générales relatives aux Gesundheitswesen - Allgemeine Anforderungen für die
établissements Infrastruktur
(IEC 61340-6-1:2018) (IEC 61340-6-1:2018)
This European Standard was approved by CENELEC on 2018-10-29. 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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 61340-6-1:2018 E

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EN IEC 61340-6-1:2018 (E)
European foreword
The text of document 101/566/FDIS, future edition 1 of IEC 61340-6-1, prepared by IEC/TC 101
"Electrostatics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 61340-6-1:2018.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2019-07-29
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2021-10-29
document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice
The text of the International Standard IEC 61340-6-1:2018 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-1 NOTE Harmonized as EN 60601-1
IEC 61010-2-101 NOTE Harmonized as EN 61010-2-101
IEC 60364 (series) NOTE Harmonized as HD 60364 (series)
IEC 61000-4-2 NOTE Harmonized as EN 61000-4-2
IEC 60079-32-2 NOTE Harmonized as EN 60079-32-2
IEC/TS 60079-32-1 NOTE Harmonized as CLC/TR 60079-32-1


2

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EN IEC 61340-6-1:2018 (E)
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
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.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.

Publication Year Title EN/HD Year
IEC 60364-7-710 -  Electrical installations of buildings - Part 7-710: HD 60364-7-710 -
Requirements for special installations or
locations - Medical locations
IEC/TR 61340-1 -  Electrostatics - Part 1: Electrostatic phenomena - -
- Principles and measurements
IEC 61340-2-1 -  Electrostatics - Part 2-1: Measurement methods EN 61340-2-1 -
- Ability of materials and products to dissipate
static electric charge
IEC 61340-2-3 -  Electrostatics - Part 2-3: Methods of test for EN 61340-2-3 -
determining the resistance and resistivity of
solid materials used to avoid electrostatic
charge accumulation
IEC 61340-4-1 -  Electrostatics - Part 4-1: Standard test methods EN 61340-4-1 -
for specific applications - Electrical resistance of
floor coverings and installed floors
IEC/TS 61340-4-2 2013 Electrostatics - Part 4-2: Standard test methods - -
for specific applications - Electrostatic
properties of garments
IEC 61340-4-3 -  Electrostatics - Part 4-3: Standard test methods EN IEC 61340-4-3 -
for specific applications - Footwear
IEC 61340-4-5 -  Electrostatics - Part 4-5: Standard test methods EN IEC 61340-4-5 -
for specific applications - Methods for
characterizing the electrostatic protection of
footwear and flooring in combination with a
person
IEC 61340-5-1 -  Electrostatics - Part 5-1: Protection of electronic EN 61340-5-1 -
devices from electrostatic phenomena -
General requirements
3

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EN IEC 61340-6-1:2018 (E)
ISO 18080-2 -  Textiles - Test methods for evaluating the - -
electrostatic propensity of fabrics - Part 2: Test
method using rotary mechanical friction
ISO 18080-3 -  Textiles - Test methods for evaluating the - -
electrostatic propensity of fabrics - Part 3: Test
method using manual friction
ISO 18080-4 -  Textiles - Test methods for evaluating the - -
electrostatic propensity of fabrics - Part 4: Test
method using horizontal mechanical friction
ISO 20344 -  Personal protective equipment - Test methods - -
for footwear

4

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SIST EN IEC 61340-6-1:2019



IEC 61340-6-1

®


Edition 1.0 2018-09




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Electrostatics –

Part 6-1: Electrostatic control for healthcare – General requirements for facilities




Électrostatique –

Partie 6-1: Contrôle électrostatique dans le domaine de la santé – Exigences

générales relatives aux établissements















INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.020.99; 17.220.99; 29.020 ISBN 978-2-8322-6036-4




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Electrostatic hazards . 8
4.1 General . 8
4.2 ESD effects on equipment . 9
4.3 Contamination caused by ESA . 9
4.4 Ignition of flammable substances . 10
4.5 Electrostatic shock to people . 10
5 Electrostatic control requirements . 10
5.1 General . 10
5.2 Medical procedures . 10
5.3 Medical locations . 10
5.3.1 Classification by groups . 10
5.3.2 Unclassified rooms . 11
5.3.3 Group 0 – Electrostatic control recommended . 11
5.3.4 Group 1 – Electrostatic control recommended . 11
5.3.5 Group 2 – Electrostatic control required . 11
5.4 Service and maintenance . 12
5.5 Administrative requirements and recommendations. 12
5.5.1 Designing facilities. 12
5.5.2 Operational responsibility . 12
5.5.3 Qualification and verification . 12
5.6 Technical requirements . 12
5.6.1 Electrical safety . 12
5.6.2 Material classification . 12
5.6.3 Selection of materials for static control . 14
5.7 Packaging, containers and other control items . 16
Annex A (normative) Test methods for low charging textiles . 17
A.1 Test methods for clothing and upholstery . 17
A.2 Test methods for bedding, curtains, and surgical drapes . 17
Annex B (informative) Ionization and other considerations . 21
Bibliography . 22

Figure A.1 – Example of test equipment set up for measuring body voltage when
removing item of bedding or surgical drape from person wearing reference clothing . 18
Figure A.2 – Example of test equipment set up for measuring body voltage when
removing item of bedding or surgical drape from bed or examination/operating table . 19
Figure A.3 – Example of test equipment set up for measuring body voltage on two
people when removing item of bedding or surgical drape . 20

Table 1 – Summary of electrostatic control methods for specified locations . 11

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IEC 61340-6-1:2018 © IEC 2018 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ELECTROSTATICS –

Part 6-1: Electrostatic control for healthcare –
General requirements for facilities

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61340-6-1 has been prepared by IEC technical committee 101:
Electrostatics.
The text of this International Standard is based on the following documents:
FDIS Report on voting
101/566/FDIS 101/570/RVD

Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
A list of all parts in the IEC 61340 series, published under the general title Electrostatics, can
be found on the IEC website.

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The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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IEC 61340-6-1:2018 © IEC 2018 – 5 –
INTRODUCTION
Static electricity can be the source of several hazards to patients, staff and equipment in
healthcare facilities. Such hazards include:
• electromagnetic disturbance or electrostatic discharge (ESD) disruption or damage to
medical instrumentation and data processing equipment;
• damage to ESD susceptible electronic components and assemblies during service and
maintenance;
• electrostatic attraction (ESA) and contamination;
• ignition of flammable gases, liquids and other materials, and
• electrostatic shocks to people.
Adequate electrostatic control can eliminate these hazards, or at least reduce residual risk to
tolerable levels.

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ELECTROSTATICS –

Part 6-1: Electrostatic control for healthcare –
General requirements for facilities



1 Scope
This part of IEC 61340 applies to facilities that provide healthcare including hospitals, care
centres and clinics.
This document provides technical requirements and recommendations for controlling
electrostatic phenomena in healthcare facilities, which includes requirements for equipment,
materials, and products used to control static electricity.
The requirements of this document do not apply to medical electrical equipment specified in
1
IEC 60601-1 [1] and in vitro diagnostic (IVD) medical equipment specified in
IEC 61010-2-101 [2].
2 Normative references
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.
IEC 60364-7-710, Electrical installations of buildings – Part 7-710: Requirements for special
installations or locations – Medical locations
IEC TR 61340-1, Electrostatics – Part 1: Electrostatic phenomena – Principles and
measurements
IEC 61340-2-1, Electrostatics – Part 2-1: Measurement methods – Ability of materials and
products to dissipate static electric charge
IEC 61340-2-3, Electrostatics – Part 2-3: Methods of test for determining the resistance and
resistivity of solid materials used to avoid electrostatic charge accumulation
IEC 61340-4-1, Electrostatics – Part 4-1: Standard test methods for specific applications –
Electrical resistance of floor coverings and installed floors
IEC TS 61340-4-2:2013, Electrostatics – Part 4-2: Standard test methods for specific
applications – Electrostatic properties of garments
IEC 61340-4-3, Electrostatics – Part 4-3: Standard test methods for specific applications –
Footwear
IEC 61340-4-5, Electrostatics – Part 4-5: Standard test methods for specific applications –
Methods for characterizing the electrostatic protection of footwear and flooring in combination
with a person
___________
1
Numbers in square brackets refer to the bibliography.

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IEC 61340-6-1:2018 © IEC 2018 – 7 –
IEC 61340-5-1, Electrostatics – Part 5-1: Protection of electronic devices from electrostatic
phenomena – General requirements
ISO 18080-2, Textiles – Test methods for evaluating the electrostatic propensity of fabrics –
Part 2: Test method using rotary mechanical friction
ISO 18080-3, Textiles – Test methods for evaluating the electrostatic propensity of fabrics –
Part 3: Test method using manual friction
ISO 18080-4, Textiles – Test methods for evaluating the electrostatic propensity of fabrics –
Part 4: Test method using horizontal mechanical friction
ISO 20344, Personal protective equipment – Test methods for footwear
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC TR 61340-1 and the
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
acceptance test
test used to determine if systems or products meet specified requirements prior to installation
or first use
Note 1 to entry: Acceptance tests may be the same as those used for qualification, or can be simpler tests more
appropriate for use in a facility rather than a controlled test laboratory.
3.2
electrostatic attraction
ESA
force between two or more oppositely charged objects resulting in an increased deposition
rate of particles onto charged surfaces or movement of charged particles
Note 1 to entry: This note applies to the French language only.
3.3
electrostatic discharge
ESD
transfer of electric charge between bodies of different electric potential in proximity or through
direct contact
3.4
electrostatic discharge sensitive device
ESDS
sensitive devices, integrated circuit or assembly that can be damaged by electrostatic fields or
electrostatic discharge
Note 1 to entry: This note applies to the French language only.

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3.5
ESD protected area
EPA
area in which an ESDS can be handled with acceptable risk of damage as a result of
electrostatic discharge or fields
Note 1 to entry: This note applies to the French language only.
3.6
electromagnetic compatibility
EMC
ability of an equipment or system to function satisfactorily in its electromagnetic environment
without introducing intolerable electromagnetic disturbances to anything in that environment
3.7
functional ground
terminal used to connect parts to ground for reasons other than safety
Note 1 to entry: A functional ground can be a ground rod, stake or a separate wiring system that is bonded to the
AC ground at the main service panel.
Note 2 to entry: In the absence of a dedicated functional ground, a protective earth can be used as a functional
ground.
3.8
isolated conductors
non-grounded conductors
3.9
low charging material
materials with a tendency to minimize charge generation when contacting and rubbing against
other materials
Note 1 to entry: As contact electrification and triboelectric charging are dependent on the nature of both
contacting surfaces and the local environment, materials qualified as low charging under specific test conditions
are not necessarily low charging under all possible conditions.
3.10
protective earth
terminal used to connect parts to earth for safety reasons
Note 1 to entry: Protective earth is also known as equipment grounding conductor.
3.11
qualification
process of evaluating test data or system/product data sheets to ensure that systems,
materials or finished products meet specified requirements
4 Electrostatic hazards
4.1 General
Four different hazards of static electricity are generally recognized: ESD damaging or
disrupting electrical equipment, contamination caused by ESA, ignition of flammable
substances and electrostatic shock to people.

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4.2 ESD effects on equipment
Electrostatic discharges can cause losses of the functions of instrumentation during patient
care increasing the risks to human safety. Insufficient electrostatic control may also cause
unnecessary repair costs of medical equipment, as well as corruption of data affecting the
quality and reliability of medical operation.
Electrical installation requirements for medical equipment and locations are provided in the
electrical safety rules specified in IEC 60364 (all parts) [3]. It is essential to recognize that
electrical safety does not necessarily provide precautions for prevention of the risks of static
electricity and electrostatic discharge (ESD). Local safety regulations shall be taken into
account.
ESD immunity testing does not cover all the real discharge scenarios, such as those where
metal parts having different electric potentials are touched together. A current limiting resistor
used in the ESD testing specified in IEC 61000-4-2 [4] does not necessarily exist in such
situations, resulting in higher discharge power in equipment under real stress. Charge
accumulation in a mobile metal object can also result in high energies in uncontrolled
environments. Especially in low humidity, discharge energies can exceed the stress levels
used in IEC 61000-4-2 [4].
A completely integrated system in medical care is not necessarily tested against transients
caused by ESD, although individual parts of the system have passed EMC qualification.
Therefore, it does not always take into account all the realistic coupling and failure scenarios
of the whole system.
Discharges from isolated conductors or from a human body can be prevented with grounding.
Conductive parts of patient beds, intravenous stands, trolleys, delivery carts, over-bed tables,
chairs, and other mobile metal objects are not normally connected to the protective earth.
Therefore, grounding all conductive parts of every item through the flooring or with direct
electrical connection to a functional ground becomes essential for static control.
The probability of ESD can efficiently be reduced by optimization of humidity levels, bipolar
ionization, adequate material selection, personnel grounding, and grounding of mobile metal
objects. In general, the prevention of static charge generation and ESD is preferable
compared to enhancing medical equipment EMC immunity.
If a functional ground is used for electrostatic control purposes, it should be electrically
bonded to protective earth where possible so as to avoid potential differences between the
two systems.
4.3 Contamination caused by ESA
Electrostatically charged surfaces attract airborne particles. Increased deposition of
microorganisms onto charged surfaces, including the airways, human skin, and open wounds,
can contribute to the incidence of hospital infections. Electrostatic sources of contamination
and nosocomial infection can be healthcare personnel, patients, or the environment. All
objects that come into contact with patients can be considered as potentially contaminated.
Cleaning, disinfection and sterilizing can prevent transmission of infective agents. However,
because of the human factor, complete certainty in cleanliness cannot be achieved without
adequate control of the environment. Avoidance of electrostatic attraction (ESA) decreases
airborne microbe contamination and improves overall cleanliness in healthcare. The reduction
in charge carried by airborne submicron contaminants will additionally reduce the deposition
of such contaminants in the airways, thereby reducing the load placed on the body’s immune
system. Charge accumulation and high surface charge densities can be reduced to tolerable
levels by grounding of personnel and other conductors, and by correct selection of materials.

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4.4 Ignition of flammable substances
The use of flammable substances in healthcare facilities has decreased, but the risk of fires
and explosions can still occur especially in laboratories, intensive care units and operating
rooms. For example, using alcohol based sterilizing substances has caused fires due to
electrostatic discharge. ESD can be an ignition source in hyperbaric oxygen facilities and
other locations where the oxygen concentration exceeds 23,5 % by volume.
The risk of incendiary ESD can
...