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
17-Oct-2024
Technical Committee
Drafting Committee
Current Stage
PPUB - Publication issued
Start Date
07-Sep-2018
Completion Date
24-Sep-2018
Ref Project

Relations

Buy Standard

Standard
IEC 61340-6-1:2018+AMD1:2024 CSV - Electrostatics - Part 6-1: Electrostatic control in healthcare, commercial and public facilities - Healthcare Released:18. 10. 2024 Isbn:9782832299135
English language
46 pages
sale 15% off
Preview
sale 15% off
Preview
Standard
IEC 61340-6-1:2018 - Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities
English and French language
45 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)


IEC 61340-6-1 ®
Edition 1.1 2024-10
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Electrostatics –
Part 6-1: Electrostatic control for healthcare – General requirements for
facilities Electrostatic control in healthcare, commercial and public facilities –
Healthcare
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews, graphical symbols and the glossary.
committee, …). It also gives information on projects, replaced With a subscription you will always have access to up to date
and withdrawn publications. content tailored to your needs.

IEC Just Published - webstore.iec.ch/justpublished
Electropedia - www.electropedia.org
Stay up to date on all new IEC publications. Just Published
The world's leading online dictionary on electrotechnology,
details all new publications released. Available online and once
containing more than 22 500 terminological entries in English
a month by email.
and French, with equivalent terms in 25 additional languages.

Also known as the International Electrotechnical Vocabulary
IEC Customer Service Centre - webstore.iec.ch/csc
(IEV) online.
If you wish to give us your feedback on this publication or need

further assistance, please contact the Customer Service
Centre: sales@iec.ch.
IEC 61340-6-1 ®
Edition 1.1 2024-10
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Electrostatics –
Part 6-1: Electrostatic control for healthcare – General requirements for
facilities Electrostatic control in healthcare, commercial and public facilities –
Healthcare
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 17.220.99, 29.020, 11.020.99 ISBN 978-2-8322-9913-5
REDLINE VERSION – 2 – IEC 61340-6-1:2018+AMD1:2024 CSV
© IEC 2024
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 conditionally required . 11
5.3.5 Group 2 – Electrostatic control required . 12
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 . 13
5.6.1 Electrical safety . 13
5.6.2 Material classification . 13
5.6.3 Selection of materials for electrostatic control . 14
5.7 Packaging, containers and other electrostatic 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

© IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTROSTATICS –
Part 6-1: Electrostatic control for healthcare –
General requirements for facilities
Electrostatic control in healthcare,
commercial and public facilities – Healthcare

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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s),
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
https://patents.iec.ch. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendment has been
prepared for user convenience.
IEC 61340-6-1 edition 1.1 contains the first edition (2018-09) [documents 101/566/FDIS
and 101/570/RVD] and its amendment 1 (2024-10) [documents 101/713/FDIS and
101/720/RVD].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendment 1. Additions are in green text, deletions are in strikethrough

REDLINE VERSION – 4 – IEC 61340-6-1:2018+AMD1:2024 CSV
© IEC 2024
red text. A separate Final version with all changes accepted is available in this
publication.
International Standard IEC 61340-6-1 has been prepared by IEC technical committee 101:
Electrostatics.
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.
The committee has decided that the contents of this document and its amendment will remain
unchanged until the stability date indicated on the IEC website under webstore.iec.ch in the
data related to the specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
© IEC 2024
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.
REDLINE VERSION – 6 – IEC 61340-6-1:2018+AMD1:2024 CSV
© IEC 2024
ELECTROSTATICS –
Part 6-1: Electrostatic control for healthcare
...


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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 21 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.

IEC publications search - webstore.iec.ch/advsearchform IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
IEC Just Published - webstore.iec.ch/justpublished

Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient 21 000 termes et définitions en anglais
Spécifications techniques, Rapports techniques et autres
et en français, ainsi que les termes équivalents dans 16
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.

Recherche de publications IEC -
Glossaire IEC - std.iec.ch/glossary
webstore.iec.ch/advsearchform
67 000 entrées terminologiques électrotechniques, en anglais
La recherche avancée permet de trouver des publications IEC et en français, extraites des articles Termes et Définitions des
en utilisant différents critères (numéro de référence, texte, publications IEC parues depuis 2002. Plus certaines entrées
comité d’études,…). Elle donne aussi des informations sur les antérieures extraites des publications des CE 37, 77, 86 et
projets et les publications remplacées ou retirées. CISPR de l'IEC.

IEC Just Published - webstore.iec.ch/justpublished Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications IEC. Just Si vous désirez nous donner des commentaires sur cette
Published détaille les nouvelles publications parues. publication ou si vous avez des questions contactez-nous:
Disponible en ligne et aussi une fois par mois par email. sales@iec.ch.

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

– 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

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 applica
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.