IEC 61340-6-1:2018
(Main)Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities
Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities
IEC 61340-6-1:2018 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 IEC 60601-1 and in vitro diagnostic (IVD) medical equipment specified in IEC 61010‑2‑101.
Electrostatique - Partie 6-1: Contrôle électrostatique dans le domaine de la santé - Exigences générales relatives aux établissements
L'IEC 61340-6-1:2018 s'applique aux établissements qui proposent des services de santé, y compris les hôpitaux, les centres de soins et les cliniques. Le présent document fournit des recommandations et des exigences techniques pour contrôler les phénomènes électrostatiques dans les établissements de santé, y compris les exigences relatives aux dispositifs, matériaux et produits utilisés pour contrôler l'électricité statique. Les exigences du présent document ne sont applicables ni au matériel électromédical répertorié dans l'IEC 60601-1 ni au matériel médical de diagnostic in vitro (DIV) spécifié dans l'IEC 61010-2-101.
General Information
Standards Content (sample)
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
IEC 61340-6-1:2018-09(en-fr)
---------------------- Page: 1 ----------------------
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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.
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® Registered trademark of the International Electrotechnical CommissionMarque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 61340-6-1:2018 © IEC 2018
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 whenremoving 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 whenremoving 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 twopeople when removing item of bedding or surgical drape ...................................................... 20
Table 1 – Summary of electrostatic control methods for specified locations .......................... 11
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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
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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.---------------------- Page: 5 ----------------------
– 4 – IEC 61340-6-1:2018 © IEC 2018
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.---------------------- Page: 7 ----------------------
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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
IEC 60601-1 [1] and in vitro diagnostic (IVD) medical equipment specified inIEC 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 locationsIEC TR 61340-1, Electrostatics – Part 1: Electrostatic phenomena – Principles and
measurementsIEC 61340-2-1, Electrostatics – Part 2-1: Measurement methods – Ability of materials and
products to dissipate static electric chargeIEC 61340-2-3, Electrostatics – Part 2-3: Methods of test for determining the resistance and
resistivity of solid materials used to avoid electrostatic charge accumulationIEC 61340-4-1, Electrostatics – Part 4-1: Standard test methods for specific applications –
Electrical resistance of floor coverings and installed floorsIEC TS 61340-4-2:2013, Electrostatics – Part 4-2: Standard test methods for specific
applications – Electrostatic properties of garmentsIEC 61340-4-3, Electrostatics – Part 4-3: Standard test methods for specific applications –
FootwearIEC 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___________
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 requirementsISO 18080-2, Textiles – Test methods for evaluating the electrostatic propensity of fabrics –
Part 2: Test method using rotary mechanical frictionISO 18080-3, Textiles – Test methods for evaluating the electrostatic propensity of fabrics –
Part 3: Test method using manual frictionISO 18080-4, Textiles – Test methods for evaluating the electrostatic propensity of fabrics –
Part 4: Test method using horizontal mechanical frictionISO 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 useNote 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 particlesNote 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 contact3.4
electrostatic discharge sensitive device
ESDS
sensitive devices, integrated circuit or assembly that can be damaged by electrostatic fields or
electrostatic dischargeNote 1 to entry: This note applies to the French language only.
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– 8 – IEC 61340-6-1:2018 © IEC 2018
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 fieldsNote 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
3.7functional 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 materialsNote 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.
3.11qualification
process of evaluating test data or system/product data sheets to ensure that systems,
materials or finished products meet specified requirements4 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.---------------------- Page: 10 ----------------------
IEC 61340-6-1:2018 © IEC 2018 – 9 –
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 be reduced to tolerable levels by grounding of personnel and
other conductors, and by correct selection of materials.4.5 Electrostatic shock to people
The incidence of unpleasant electrostatic shocks to people has increased due to the
increased use of highly insulating materials such as plastics. An electrostatic discharge
occurs when a human body approaches close enough to an object with different electric
potential to exceed the electric breakdown field strength. ESD energy can be high enough to
cause painful sensations to patients and healthcare personnel, resulting in involuntary
movements, which can lead to accidents.The risk of electrostatic shock can be reduced to tolerable levels by grounding of personnel
and other conductors, and by correct selection of materials.5 Electrostatic control requirements
5.1 General
Electrostatic control requirements in healthcare depend on the medical procedures, locations
and activities such as service and maintenance of medical equipment.5.2 Medical procedures
To ensure safety of patients from electrostatic hazards, protective measures shall be applied
during medical examination and treatment.Medical procedures can require specific electrostatic control actions that are dependent on
the particular requirements of instrumentation, electric equipment or cleanliness. When
protective measures have not otherwise been specified, the requirements in 5.3 to 5.7 shall
be applied. Consideration shall also be given to applying the recommendations in 5.3 to 5.7
and Annex B.5.3 Medical locations
5.3.1 Classification by groups
Locations that are intended for purposes of diagnosis, treatment, monitoring and care of
patients shall be classified in the following groups, as defined in IEC 60364-7-710:
unclassified, G0, G1 and G2.Selection of materials to reduce residual charge levels is recommended in all locations.
Grounding of personnel and other conductors is recommended in G0 and G1 locations, and is
required in G2 lo...
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