SIST EN ISO 80601-2-13:2013/A1:2020
(Amendment)Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)
EN ISO 80601-2-13 was published in 2011. Amendment 1 to EN ISO 80601-2-13:2011 will update this standard with regard to references to IEC 60601-1:2005 (EN 60601-1:2006) and applicable collateral standards. The Amendment 1 also introduces technical modifications to clarify the relationship between this standard and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following aspects, in part due to the publication of amendments that have been published in 2012 and 2013 respectively to IEC 60601-1:2005 and its collateral standards:
— addition of a definition on interchangeable anaesthetic vapour delivery system;
— marking the mass of mobile me equipment;
— movement over a threshold;
— rough handling test;
— multiple socket-outlets;
— specific requirements on anaesthetic gas delivery systems and anaesthetic breathing systems including instructions for use;
— vapour concentration during and after oxygen flush;
— inspiratory pause.
Where appropriate, amendment 1 also includes modifications of specific informative annexes related to the amended requirements as listed above. Finally, minor editorial updates were made.
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen - Änderung 1 (ISO 80601-2-13:2011/Amd 1:2015)
Diese Internationale Norm gilt für die BASISSICHERHEIT und einschließlich der WESENTLICHEN LEISTUNGS-MERKMALE eines ANÄSTHESIE-ARBEITSPLATZES für die Applikation einer Inhalationsanästhesie unter ständiger Aufsicht eines fachlich ausgebildeten BEDIENERS.
Diese Internationale Norm legt die besonderen Anforderungen an einen vollständigen ANÄSTHESIE-ARBEITSPLATZ und an nachfolgend angeführte Bauteile von ANÄSTHESIE-ARBEITSPLÄTZEN fest, die, obwohl sie als einzelne „selbstständige“ Geräte zu betrachten sind, auch in Verbindung mit anderen relevanten ANÄSTHESIE-ARBEITSPLATZ-Bauteilen unter Bildung eines entsprechend festgelegten ANÄSTHESIE-ARBEITS-PLATZES eingesetzt werden können:
- ANÄSTHESIEGAS-ABGABESYSTEM;
- ANÄSTHESIE-ATEMSYSTEM;
- ANÄSTHESIEGAS-FORTLEITUNGSSYSTEM;
- ANÄSTHESIEMITTELDAMPF-ABGABESYSTEM;
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendement 1 (ISO 80601-2-13:2011/Amd 1:2015)
L'ISO/CEI 80601-2-13:2011 s'applique à la sécurité de base et aux performances essentielles d'un poste de travail d'anesthésie pour l'administration d'un anesthésiant par inhalation tout en étant assisté en continu par un opérateur professionnel.
L'ISO/CEI 80601-2-13:2011 spécifie les exigences particulières pour un poste de travail d'anesthésie complet et les composants suivants d'un poste de travail d'anesthésie qui, bien qu'ils soient considérés comme des dispositifs individuels à part entière, peuvent être utilisés en association avec d'autres composants appropriés d'un poste de travail d'anesthésie afin de former un poste de travail d'anesthésie selon une spécification donnée:
système d'administration de gaz anesthesique,
système d'anesthesie par voie respiratoire,
système d'évacuation des gaz anesthesiques,
système d'administration de vapeur anesthesique
ventilateur d'anesthesie,
Medicinska električna oprema - 2-13. del: Posebne zahteve za osnovno varnost in bistvene lastnosti delovnega mesta za anestezijo - Dopolnilo A1 (ISO 80601-2-13:2011/Amd 1:2015)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 80601-2-13:2013/A1:2020
01-februar-2020
Medicinska električna oprema - 2-13. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti delovnega mesta za anestezijo - Dopolnilo A1 (ISO 80601-2-
13:2011/Amd 1:2015)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-
13:2011/Amd 1:2015)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation - Amendement 1 (ISO 80601-2-
13:2011/Amd 1:2015)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2012/A1:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-13:2013/A1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 80601-2-13:2013/A1:2020
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SIST EN ISO 80601-2-13:2013/A1:2020
EN ISO 80601-2-
EUROPEAN STANDARD
13:2012/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2019
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-13: Particular
requirements for basic safety and essential performance of
an anaesthetic workstation - Amendment 1 (ISO 80601-2-
13:2011/Amd 1:2015)
Appareils électromédicaux - Partie 2-13: Exigences Medizinische elektrische Geräte - Teil 2-13: Besondere
particulières de sécurité de base et de performances Festlegungen für die Sicherheit einschließlich der
essentielles pour les postes de travail d'anesthésie - wesentlichen Leistungsmerkmale für Anästhesie-
Amendement 1 (ISO 80601-2-13:2011/Amd 1:2015) Arbeitsplätzen - Änderung 1 (ISO 80601-2-
13:2011/Amd 1:2015)
This amendment A1 modifies the European Standard EN ISO 80601-2-13:2012; it was approved by CEN on 4 November 2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-13:2012/A1:2019 E
worldwide for CEN national Members.
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SIST EN ISO 80601-2-13:2013/A1:2020
EN ISO 80601-2-13:2012/A1:2019 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 80601-2-13:2013/A1:2020
EN ISO 80601-2-13:2012/A1:2019 (E)
European foreword
The text of ISO 80601-2-13:2011/Amd 1:2015 has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO)
and has been taken over as EN ISO 80601-2-13:2012/A1:2019 by Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 80601-2-13:2012 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by May
2020, and conflicting national standards shall be withdrawn at the latest by May 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-13:2011/Amd 1:2015 has been approved by CEN as EN ISO 80601-2-
13:2012/A1:2019 without any modification.
3
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SIST EN ISO 80601-2-13:2013/A1:2020
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SIST EN ISO 80601-2-13:2013/A1:2020
INTERNATIONAL ISO
STANDARD 80601-2-13
First edition
2011-08-01
AMENDMENT 1
2015-03-01
Medical electrical equipment —
Part 2-13:
Particular requirements for basic
safety and essential performance of an
anaesthetic workstation
AMENDMENT 1
Appareils électromédicaux —
Partie 2-13: Exigences particulières de sécurité de base et de
performances essentielles pour les postes de travail d’anesthésie
AMENDEMENT 1
Reference number
ISO 80601-2-13:2011/Amd.1:2015(E)
©
ISO 2015
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SIST EN ISO 80601-2-13:2013/A1:2020
ISO 80601-2-13:2011/Amd.1:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved
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SIST EN ISO 80601-2-13:2013/A1:2020
ISO 80601-2-13:2011/Amd.1:2015(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical
activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work. In the field of information technology, ISO and IEC have established a joint technical committee,
ISO/IEC JTC 1.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for
the different types of document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights.
Details of any patent rights identified during the development of the document will be in the Introduction
and/or on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT), see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines and Technical Committee IEC/TC
62, Electrical equipment in medical practice, Subcommittee SC D, Electromedical equipment.
© ISO 2015 – All rights reserved iii
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SIST EN ISO 80601-2-13:2013/A1:2020
ISO 80601-2-13:2011/Amd.1:2015(E)
Introduction
The first edition of IEC 80601-2-13 was published in 2011. This amendment is intended to update the
references to IEC 60601-1:2005 to include Amendment 1:2012, to update the references to IEC 60601-
1-6:2010 to include Amendment 1:2013, to update the references to IEC 60601-1-8:2006 to include
Amendment 1:2012 and to update the references to IEC 60601-1-10 to include Amendment 1:2012. This
amendment also introduces technical modifications to clarify the relationship between this standard
and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following
aspects, in part due to the publication of the before-mentioned amendments:
— addition of a definition on interchangeable anaesthetic vapour delivery system;
— marking the mass of mobile me equipment;
— movement over a threshold;
— rough handling test;
— multiple socket-outlets;
— specific requirements on anaesthetic gas delivery systems and anaesthetic breathing
systems including instructions for use;
— vapour concentration during and after oxygen flush;
— inspiratory pause.
Where appropriate, this amendment also includes modifications of specific informative annexes related
to the amended requirements as listed above. Finally, minor editorial updates were made.
iv © ISO 2015 – All rights reserved
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SIST EN ISO 80601-2-13:2013/A1:2020
ISO 80601-2-13:2011/Amd.1:2015(E)
Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety and essential
performance of an anaesthetic workstation
AMENDMENT 1
201.1 Scope, object and related standards
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.1.4 * Particular standards
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
Add the following paragraph at the end of this subclause:
If an anaesthetic workstation is supplied with physiological monitoring, having more than one
applied part on the patient, then IEC 60601-2-49 applies. Measured parameters related to the
inherent function of an anaesthetic workstation (i.e. airway pressure, ventilation volume, oxygen
concentration, volatile anaesthetic agent concentration, CO /N O), including derived and related
2 2
parameters such as spontaneous ventilation volume or CO production, are not considered to be a
2
physiological monitoring unit as per IEC 60601-2-49.
201.2 Normative references
In the existing introductory paragraph, replace the first sentence with:
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application.
Add the following reference:
IEC 60601-2-49:2011, Medical electrical equipment — Part 2-49: Particular requirements for the basic
safety and essential performance of multifunction patient monitoring equipment
Amend the following existing references:
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
+Amendment 1:2012
IEC 60601-1-6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
+Amendment 1:2013
IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral Standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
+Amendment 1:2012
© ISO 2015 – All rights reserved 1
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SIST EN ISO 80601-2-13:2013/A1:2020
ISO 80601-2-13:2011/Amd.1:2015(E)
IEC 60601-1-10:2007, Medical electrical equipment — Part 1-10: General requirements for basic safety and
essential performance — Collateral standard: Requirements for the development of physiologic closed-loop
controllers
+Amendment 1:2012
201.3 Terms and definitions
Replace the introductory sentence by the following sentence:
For the purposes of this document, the terms and definitions given in ISO 4135:2001, IEC 60601-
1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2010+A1:2013, IEC 60601-1-8:2006+A1:2012 and
the following apply.
Add the following new term and definition:
201.3.240
* interchangeable anaesthetic vapour delivery system
anaesthetic vapour delivery system that
— by design is intended to be used with different anaesthetic workstations, and
— can be exchanged by the clinical user without the use of tools and without the need for specific tests
201.4 General requirements
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
Table 201.101 — Distributed essential performance requirements
In the second column, fourth line, replace “reserve flow” by “reverse flow”.
201.5 General requirements for testing me equipment
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.7 Me equipment identification, marking and documents
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
Add the following subclause:
201.7.2.21 * Mass of mobile equipment
Replacement:
The anaesthetic workstation shall be legibly marked with its maximum mass in kilograms [see also
201.101.1.1 k)].
201.7.2.106 * Marking with mass
Delete this subclause completely.
201.7.9.3.101 Components
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.8 Protection against electrical hazards from me equipment
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
2 © ISO 2015 – All rights reserved
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SIST EN ISO 80601-2-13:2013/A1:2020
ISO 80601-2-13:2011/Amd.1:2015(E)
201.9 Protection against mechanical hazards of me equipment and me systems
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.9.4 Instability hazards
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.9.4.2.4.3 Movement over a threshold
Replace the text by the following text:
Amendment:
anaesthetic workstations that are intended only to be used when mounted to a wall or pendant, but
may need to be removed from the wall or pendant for service or at initial installation, are not considered
mobile equipment and the threshold test specified in IEC 60601-1:2005+A1:2012, 9.4.2.4.3 does not
apply. Such non-mobile machines can use small casters to aid service and installation of the device. See
also 201.7.9.3.102.
The first paragraph
(“In the requirement replace the height of the threshold by 10 mm (instead of 20 mm) and in the test method
replace the height of the solid vertical plane obstruction by 10 mm (instead of 20 mm.”)
is deleted.
201.10 Protection against unwanted and excessive radiation hazards
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.11 Protection against excessive temperatures and other hazards
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.12 Accuracy of controls and instruments and protection against hazardous outputs
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.12.4.102 * Additional requirements for anaesthetic workstations
th
Correct the reference in the 9 list item and correct the corresponding text in Table 201.C.103 (accompanying
documents, general) to read:
— anaesthetic breathing system continuing-positive-pressure alarm condition complying with
201.12.4.106;
201.13 Hazardous situations and fault conditions
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.14 Programmable electrical medical systems (PEMS)
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.15 Construction of me equipment
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
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SIST EN ISO 80601-2-13:2013/A1:2020
ISO 80601-2-13:2011/Amd.1:2015(E)
Add the following subclause:
201.15.3.5 Rough handling test
Amend as follows:
For an anaesthetic workstation with a weight exceeding 125 kg in its nominal configuration and
only movable manually, the speed in a) ascending step shock and b) descending step shock shall be
reduced from 0,8 m/s to 0,4 m/s.
201.16 Me systems
Replace IEC 60601-1:2005 by IEC 60601-1:2005+A1:2012.
201.16.9.2.1 Multiple socket-outlet
Replace the existing text by the following:
Delete the second dash of 16.9.2.1 a) and add the following text under the last list item in 16.9.2.1 a):
An anaesthetic workstation may provide multiple socket-outlets that can accept standard mains
plugs of the kind specified in IEC/TR 60083.
Addition:
Add the following list item:
ee) The anaesthetic workstation and each multiple soc
...
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