EN 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.
Elektrostatik - Teil 6-1: Überwachung der Elektrostatik im Gesundheitswesen - Allgemeine Anforderungen für die Infrastruktur
Électrostatique - 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.
Elektrostatika - 6-1. del: Elektrostatični nadzor na področju zdravstvenega varstva - Splošne zahteve za ustanove (IEC 61340-6-1:2018)
Ta del standarda IEC 61340 se uporablja za ustanove, ki zagotavljajo zdravstveno oskrbo, vključno z bolnišnicami, centri za oskrbo in klinikami.
Ta dokument določa tehnične zahteve in priporočila za nadzor elektrostatičnih pojavov v zdravstvenih ustanovah, vključno z zahtevami glede opreme, materialov in izdelkov, ki se uporabljajo za nadzor statične elektrike.
Zahteve tega dokumenta ne veljajo za medicinsko električno opremo, opredeljeno v standardu IEC 60601-1 [1] in diagnostično medicinsko opremo in vitro, opredeljeno v standardu IEC 61010-2-101 [2].
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2019
(OHNWURVWDWLNDGHO (OHNWURVWDWLþQLQDG]RUQDSRGURþMX]GUDYVWYHQHJDYDUVWYD
6SORãQH]DKWHYH]DXVWDQRYH ,(&
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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
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
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
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
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
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 o
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