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

Status
Published
Publication Date
23-Sep-2018
Technical Committee
Current Stage
PPUB - Publication issued
Completion Date
24-Sep-2018
Ref Project

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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
IEC 61340-6-1:2018-09(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
---------------------- 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 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

---------------------- Page: 4 ----------------------
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

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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

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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.
---------------------- 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.
---------------------- Page: 6 ----------------------
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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– 6 – IEC 61340-6-1:2018 © IEC 2018
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 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
___________
Numbers in square brackets refer to the bibliography.
---------------------- Page: 8 ----------------------
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.
---------------------- Page: 9 ----------------------
– 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 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.
---------------------- 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.

---------------------- Page: 11 ----------------------
– 10 – IEC 61340-6-1:2018 © IEC 2018
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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