EN ISO 80601-2-13:2022
(Main)Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
anaesthetic gas delivery system;
anaesthetic breathing system;
anaesthetic gas scavenging system (AGSS);
anaesthetic vapour delivery system;
anaesthetic ventilator;
monitoring equipment;
alarm system;
protection device.
NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.
An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.
NOTE 2 The applicability of this document is indicated in Table AA.2.
This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components including accessories, as relevant.
Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Anästhesie-Arbeitsplätzen (ISO 80601-2-13:2022)
Dieses Dokument gilt für die Basissicherheit und wesentlichen Leistungsmerkmale eines Anästhesie-Arbeitsplatzes für die Applikation einer Inhalationsanästhesie unter ständiger Aufsicht eines fachlich ausgebildeten Bedieners.
Dieses Dokument 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-Arbeitsplatzes eingesetzt werden können:
– Anästhesiegas-Abgabesystem;
– Anästhesie-Atemsystem;
– Anästhesiegas-Fortleitungssystem;
– Anästhesiemitteldampf-Abgabesystem;
– Anästhesie-Beatmungsgerät;
– Überwachungsgerät;
– Alarmsystem;
– Schutzvorrichtung.
ANMERKUNG 1 Die Überwachungsgeräte, Alarmsysteme und Schutzvorrichtungen sind in Tabelle AA.1 zusammengefasst.
Ein als Ganzes bereitgestellter Anästhesie-Arbeitsplatz und dessen einzelne Bauteile werden in Bezug auf die Allgemeinen Festlegungen als ME-Geräte oder ME-Systeme betrachtet.
ANMERKUNG 2 Die Gültigkeit dieses Dokuments ist in Tabelle AA.2 wiedergegeben.
Dieses Dokument gilt auch für das Zubehör, das vom Hersteller für den Anschluss an einen Anästhesie-Arbeitsplatz vorgesehen ist, wenn die Eigenschaften dieses Zubehörs die Basissicherheit und die wesentlichen Leistungsmerkmale eines Anästhesie-Arbeitsplatzes beeinträchtigen können.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf Anästhesie-Arbeitsplatz-Bauteile vorgesehen, ist dies aus Überschrift und Inhalt des Abschnittes oder Unterabschnittes ersichtlich. Ist das nicht der Fall, trifft der Abschnitt oder Unterabschnitt, wo anwendbar, auf den Anästhesie-Arbeitsplatz und auf dessen Bauteile, einschließlich Zubehör, zu.
Die mit der vorgesehenen physiologischen Funktion des Anästhesie-Arbeitsplatzes oder seiner Bauteile innerhalb des Anwendungsbereiches dieses Dokuments direkt verbundenen Gefährdungen bleiben von den spezifischen Anforderungen (Festlegungen) dieses Dokuments unberücksichtigt, mit Ausnahme von 7.2.13 und 8.4.1 der Allgemeinen Festlegungen.
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et de performances essentielles pour les postes de travail d'anesthésie (ISO 80601-2-13:2022)
Le présent document 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.
Le présent document 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 anesthésique;
système d’anesthésie par voie respiratoire;
système d’évacuation des gaz anesthésiques (SEGA);
système d’administration de vapeur anesthésique;
ventilateur d’anesthésie;
appareil de surveillance;
système d’alarme;
dispositif de protection.
NOTE 1 Les appareils de surveillance, les systèmes d’alarme et les dispositifs de protection font l’objet d’un récapitulatif dans le Tableau AA.1.
Un poste de travail d’anesthésie fourni en tant qu’ensemble complet et ses composants individuels sont considérés comme un équipement EM ou des systèmes EM en ce qui concerne la norme générale.
NOTE 2 L’applicabilité du présent document est indiquée dans le Tableau AA.2.
Le présent document s’applique également aux accessoires destinés, selon leur fabricant, à être raccordés à un poste de travail d’anesthésie lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base et les performances essentielles du poste de travail d’anesthésie.
Si un article ou un paragraphe est spécifiquement destiné à être appliqué aux composants d’un poste de travail d’anesthésie ou à ses accessoires uniquement, le titre et le contenu de cet article ou de ce paragraphe le mentionneront. Si cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois à un poste de travail d’anesthésie et à ses composants individuels, y compris ses accessoires, comme il se doit.
Les dangers inhérents à la fonction physiologique prévue d’un poste de travail d’anesthésie et de ses composants individuels, y compris ses accessoires, dans le cadre du domaine d’application du présent document ne sont pas couverts par des exigences particulières contenues dans le présent document, à l’exception de l’IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 et 8.4.1.
NOTE 3 Voir également l’IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
Le présent document ne s’applique pas aux postes de travail d’anesthésie destinés à être utilisés avec des agents anesthésiques inflammables, comme déterminé par l’Annexe BB.
Medicinska električna oprema - 2-13. del: Posebne zahteve za osnovno varnost in bistvene lastnosti delovnega mesta za anestezijo (ISO 80601-2-13:2022)
Standard EN-ISO 80601-2-13 se uporablja za osnovno varnost in bistvene lastnosti delovnega mesta za anestezijo za dovajanje inhalacijske anestezije, ki ga vedno upravlja profesionalni upravljavec. Ta dokument določa posebne zahteve za celotno delovno mesto za anestezijo in naslednje sestavne dele delovnega mesta za anestezijo, ki se lahko kljub temu, da so samostojne naprave, uporabljajo skupaj z drugimi ustreznimi sestavnimi deli delovnega mesta za anestezijo in z njimi sestavljajo delovno mesto za anestezijo za določeno specifikacijo: – sistem za dovajanje anestetičnih plinov; – sistem za vdihavanje anestetika; – sistem za povratni anestetični plin (AGSS); – sistem za dovajanje anestetičnih hlapov; – anestetični ventilator; – oprema za spremljanje; – sistem alarmov; – zaščitna naprava.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2022
Nadomešča:
SIST EN ISO 80601-2-13:2013
SIST EN ISO 80601-2-13:2013/A1:2020
SIST EN ISO 80601-2-13:2013/A2:2020
Medicinska električna oprema - 2-13. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti delovnega mesta za anestezijo (ISO 80601-2-13:2022)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen (ISO
80601-2-13:2022)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performances essentielles pour les postes de travail d'anesthésie (ISO 80601-2-
13:2022)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 80601-2-13
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2022
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-13:2012
English Version
Medical electrical equipment - Part 2-13: Particular
requirements for basic safety and essential performance of
an anaesthetic workstation (ISO 80601-2-13:2022)
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 (ISO wesentlichen Leistungsmerkmale für Anästhesie-
80601-2-13:2022) Arbeitsplätzen (ISO 80601-2-13:2022)
This European Standard was approved by CEN on 25 May 2022.
CEN 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 CEN
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 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-13:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-13:2022) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2022, and conflicting national standards
shall be withdrawn at the latest by June 2025.
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.
This document supersedes EN ISO 80601-2-13:2012.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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 80601-2-13:2022 has been approved by CEN as EN ISO 80601-2-13:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-13
Second edition
2022-04
Medical electrical equipment —
Part 2-13:
Particular requirements for basic
safety and essential performance of an
anaesthetic workstation
Appareils électromédicaux —
Partie 2-13: Exigences particulières de sécurité de base et de
performances essentielles pour les postes de travail d'anesthésie
Reference number
ISO 80601-2-13:2022(E)
ISO 80601-2-13:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80601-2-13:2022(E)
Contents
Foreword . v
Introduction. vii
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 10
201.5 General requirements for testing ME equipment . 11
201.6 Classification of ME equipment or ME systems . 12
201.7 ME equipment identification, marking and documents . 12
201.8 Protection against electrical hazards from ME equipment . 17
201.9 Protection against mechanical hazards of ME equipment and ME systems . 18
201.10 Protection against unwanted and excessive radiation hazards . 19
201.11 Protection against excessive temperatures and other hazards . 19
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 22
201.13 Hazardous situations and fault conditions . 28
201.14 Programmable electrical medical systems (PEMS). 28
201.15 Construction of ME equipment . 29
201.16 ME systems . 29
201.17 Electromagnetic compatibility of ME equipment and ME systems . 31
201.101 Additional requirements for anaesthetic gas delivery systems . 31
201.102 Additional requirements for an anaesthetic breathing system . 37
201.103 Additional requirements for an AGSS . 48
201.104 Additional requirements for interchangeable and non-interchangeable
anaesthetic vapour delivery systems . 53
201.105 Additional requirements for an anaesthetic ventilator . 58
201.106 Display of pressure-volume loops . 64
201.107 Clinical evaluation . 64
202 Electromagnetic disturbances — Requirements and tests . 65
203 General requirements for radiation protection in diagnostic X-ray equipment . 65
206 Usability . 65
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 66
209 Requirements for environmentally conscious design . 66
210 Process requirements for the development of physiologic closed-loop controllers . 67
211 Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment . 67
ISO 80601-2-13:2022(E)
212 Requirements for medical electrical equipment and medical electrical systems intended
for use in the emergency medical services environment . 67
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems or their parts . 68
Annex D (informative) Symbols on marking . 78
Annex AA (informative) Particular guidance and rationale . 80
Annex BB (normative) Test for flammability of anaesthetic agent . 97
Annex CC (informative) Terminology — alphabetized index of defined terms . 98
Bibliography . 102
iv © ISO 2022 – All rights reserved
ISO 80601-2-13:2022(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.
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 or
www.iec.ch/members_experts/refdocs).
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) or the IEC list of patent
declarations received (see patents.iec.ch).
Any trade name used in this document is information given for the convenience of users
...
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