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
Relations
Overview
EN ISO 80601-2-13:2022 - titled Medical electrical equipment - Particular requirements for basic safety and essential performance of an anaesthetic workstation - specifies safety and performance requirements for anaesthetic workstations used to administer inhalational anaesthesia while continuously attended by a professional operator. Published by CEN and aligned with ISO, this standard covers complete workstations and individual components (e.g., ventilators, gas delivery and scavenging systems, vapourisers, monitoring and alarm systems) and applies to accessories whose characteristics can affect workstation safety or performance. It excludes workstations intended for use with flammable anaesthetic agents (see Annex BB).
Key topics and requirements
- Scope and applicability: Requirements for complete anaesthetic workstations and specified components (anaesthetic gas delivery system, breathing system, AGSS, vapour delivery, ventilator, monitoring, alarms, protection devices).
- Basic safety & essential performance: Tests and criteria to ensure patient and operator safety during normal and fault conditions, including hazardous outputs and fault management.
- Component-specific requirements: Additional clauses for breathing systems, ventilators, scavenging (differentiating active vs non‑active AGSS), vapour delivery, pressure/flow characteristics and reservoir connections.
- Alarms, monitoring and usability: Requirements for alarm systems, clinical monitoring (exhaled volume, pressure-volume loops), marking and instructions for use to support safe operation.
- Electrical, mechanical & EMC protection: Electrical safety, mechanical hazard protection, electromagnetic compatibility (EMC) and marking for MRI suitability.
- Lifecycle and serviceability: Requirements added for expected service life, internal power sources, and behaviour on electrical/pneumatic power interruption.
- Documentation & clinical evaluation: Instructions for use, technical documentation, clinical evaluation guidance and guidance/rationale in informative annexes (Annex AA).
- Normative references: Interaction with general standard IEC/ISO 60601-1 for medical electrical equipment and other series parts (PEMS, usability, EMC).
Practical applications
- Ensures anaesthetic workstations meet internationally harmonized safety and performance criteria for operating theatres, ambulatory surgery and intensive care settings where inhalational anaesthesia is used.
- Guides design, testing and risk mitigation for manufacturers of anaesthetic machines, ventilators, vapourisers, scavenging systems and related accessories.
- Provides test labs and conformity assessment bodies with standardized test requirements for certification and regulatory compliance.
Who should use this standard
- Medical device manufacturers and designers (anaesthetic workstations and components)
- Clinical engineers, hospital procurement and biomedical maintenance teams
- Notified bodies, testing laboratories and regulatory compliance specialists
- Risk managers and usability engineers involved in perioperative equipment
Related standards
- IEC/ISO 60601-1 (general requirements for basic safety of medical electrical equipment)
- Other parts of the ISO/IEC 80601 series addressing ventilators, EMC, usability and home-care variants
Keywords: EN ISO 80601-2-13:2022, anaesthetic workstation, medical electrical equipment, anaesthetic ventilator, anaesthetic gas delivery, AGSS, safety standard, CEN, ISO.
Frequently Asked Questions
EN ISO 80601-2-13:2022 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)". This standard covers: 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.
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.
EN ISO 80601-2-13:2022 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 80601-2-13:2022 has the following relationships with other standards: It is inter standard links to EN ISO 80601-2-13:2012/A1:2019, EN ISO 80601-2-13:2012/A2:2019, EN ISO 80601-2-13:2012, EN ISO 80601-2-13:2022/prA1. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 80601-2-13:2022 is associated with the following European legislation: EU Directives/Regulations: 2017/745; Standardization Mandates: M/565, M/575, M/MDR. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 80601-2-13:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
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 and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
This document was prepared jointly by Technical Committee 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 62D
Electromedical equipment, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with
the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 80601-2-13:2011), which has been
technically revised. It also incorporates the Amendments ISO 80601-2-13:2011/Amd 1:2015 and
ISO 80601-2-13:2011/Amd 2:2018.
The main changes are as follows:
update of normative references;
update of terms and definitions;
consideration of anaesthetic workstations using Oxygen 93;
addition of requirements for expected service life;
amendment of the requirements on test equipment;
amendment of the requirements on warning and safety notices, on the instructions for use and on
the technical description as well as design documentation;
ISO 80601-2-13:2022(E)
addition of marking requirements regarding the suitability of anaesthetic workstations and its
components for use in a magnetic resonance environment;
amendment of the requirements on compatibility with substances used with the anaesthetic
workstation and its components;
amendment of the requirements on internal electrical power source;
amendment of the requirements on the exhaled volume monitoring equipment;
amendment of the requirements on detachable, flow-direction-sensitive parts and accessories;
amendment of the requirements on multiple socket-outlets;
amendment of the requirements and recommendations for signal input/signal output part;
amendment of the requirements on the flow-rate adjustment control;
amendment of the requirements on the maximum limited pressure protection device;
amendment of the requirements on the reservoir bag port connection port connector;
amendment of the requirements on the inspiratory and expiratory pressure/flow rate characteristics
amendment of the requirements on breathing tubes and breathing tube sets;
amendment of the requirements on circle absorber assemblies;
addition of requirements on ventilation modes;
amendment of the requirements on anaesthetic gas scavenging systems by differentiation between
active and non-active systems;
amendment of the requirements on anaesthetic ventilators in case of interruption of the electrical or
pneumatic power supply.
A list of all parts in the ISO 80601 and the IEC 80601 series can be found on the ISO and IEC websites.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html and www.iec.ch/national-
committees.
vi © ISO 2022 – All rights reserved
ISO 80601-2-13:2022(E)
Introduction
In this document, the following print types are used:
Requirements and definitions: roman type.
Terms defined in Clause 3 of the general standard, in this particular standard and test specifications:
italic type.
Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
In referring to the structure of this document, the term
“clause” means one of the eight numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
“subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.12 are all
subclauses of Clause 201.7).
References to clauses within this document are preceded by the term “Clause” followed by the clause
number. References to subclauses within this document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
For the purposes of this document, the auxiliary verb:
“shall” means that conformance with a requirement or a test is mandatory for conformity with this
document;
“should” means that conformance with a requirement or a test is recommended but is not mandatory
for conformance with this document;
“may” is used to describe permission (e. g. a permissible way to achieve conformance with a
requirement or test);
"can" is used to describe a possibility or capability; and
"must" is used to express an external constraint.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex AA.
This document considers both an anaesthetic workstation supplied complete and its individual
components in combination with its accessories. It has been structured to allow responsible organizations
to configure an anaesthetic workstation from individual components in conformance with professional
guidelines and to meet the needs of their clinical practice. In order to achieve this aim, this document
identifies particular requirements pertinent to specific anaesthetic workstation components, including
associated monitoring equipment, alarm system(s) and protection device(s), and defines the interfaces.
Thus this document also defines requirements for individual components that can be used to form an
anaesthetic workstation.
ISO 80601-2-13:2022(E)
The following table identifies the individual components of an anaesthetic workstation and provides an
overview of the structure of this document.
Table 201.101 — Configuration of an anaesthetic workstation and corresponding organization of this
document
anaesthetic workstation
General requirements
Clauses 201.1 – 201.17, 201.106,
201.107, 202-212
including associated
These are mandatory
monitoring equipment,
anaesthetic gas delivery system components;
alarm systems and
Clause 201.101 see also Table AA.1
protection devices
anaesthetic breathing system
Clause 201.102
anaesthetic gas scavenging system
(AGSS)
Clause 201.103
including associated
These are optional
monitoring equipment,
anaesthetic vapour delivery system components;
alarm systems and
Clause 201.104 see also Table AA.1
protection devices
anaesthetic ventilator
Clause 201.105
viii © ISO 2022 – All rights reserved
INTERNATIONAL STANDARD ISO 80601-2-13:2022(E)
Medical electrical equipment — Part 2-13: Particular
requirements for basic safety and essential performance of an
anaesthetic workstation
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 * Scope
Replacement:
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,
ISO 80601-2-13:2022(E)
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.
201.1.2 Object
Replacement:
The object of this document is to establish particular basic safety and essential performance requirements
for an anaesthetic workstation and its individual components designed for use in the anaesthetic
workstation (as defined in 201.3.210) and its accessories.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of the general
standard and Clause 201.2 of this document.
IEC 60601-1-3:2008+AMD1:2013+AMD2:2021, IEC 60601-1-9:2007+AMD1:2013+AMD2:2020,
IEC 60601-1-11:2015+A1:2020 do not apply.
201.1.4 *Particular standards
Addition:
The numbering of clauses and subclauses of this document corresponds to that of IEC 60601-1 (the
general standard) with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of
the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s)
of the collateral standard document number (e.g. 202.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-2 collateral standard, 206.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-6 collateral standard, etc.). The changes to the text of the general standard
are specified by the use of the following words:
“Replacement” means that the clause or subclause of the general standard or applicable collateral
standard is replaced completely by the text of this document.
“Addition” means that the text of this document is additional to the requirements of the general standard
or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of the general standard are numbered starting
from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 to 3.154,
additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are
lettered AA, BB, etc., and additional items aa), bb), etc.
2 © ISO 2022 – All rights reserved
ISO 80601-2-13:2022(E)
Subclauses or figures which are additional to those of a collateral standard are numbered starting from
20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 206 for IEC 60601-1-6,
etc.
The term “this document” is used to make reference to the general standard, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of the
general standard or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this document.
If an anaesthetic workstation is supplied with physiological monitoring, having more than one applied
part on the patient, then IEC 80601-2-49:2018 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 parameters such as
2 2
spontaneous ventilation volume or CO production, are not considered to be a physiological monitoring
unit as per IEC 80601-2-49.
201.2 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.
Clause 2 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows:
Addition:
ISO 407:2021, Small medical gas cylinders — Pin-index yoke-type valve connections
ISO 5145:2017, Gas cylinders — Cylinder valve outlets for gases and gas mixtures — Selection and
dimensioning
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 5356-2:2012+AMD1:2019, Anaesthetic and respiratory equipment — Conical connectors — Part 2:
Screw-threaded weight-bearing connectors
ISO 5359:2014 +AMD1:2017, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for
use with medical gases
ISO 5360:2016, Anaesthetic vaporizers — Agent-specific filling systems
ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7396-1:2016+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed
medical gases and vacuum
ISO 7396-2:2007, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
ISO 9170-1:2017, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 80601-2-13:2022(E)
ISO 9170-2:2008, Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic
gas scavenging systems
ISO 10524-1:2018, Pressure regulators for use with medical gases — Part 1: Pressure regulators and
pressure regulators with flow-metering devices
ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 18082:2014+AMD1:2017, Anaesthetic and respiratory equipment — Dimensions of non-
interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —
Part 1: Evaluation and testing within a risk management process
ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 7:
Connectors for intravascular or hypodermic applications
ISO 80601-2-55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the basic
safety and essential performance of respiratory gas monitors
ISO/IEC 80079-20-1:2017, Explosive atmospheres — Part 20-1: Material characteristics for gas and
vapour classification — Test methods and data
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-10:2007+AMD1:2013+AMD2:2020, 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
IEC 60601-1-12:2014+AMD1:2020, Medical electrical equipment — Part 1-12: General requirements for
basic safety and essential performance — Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the emergency medical services environment
IEC 62570:2014, Standard practice for marking medical devices and other items for safety in the magnetic
resonance environment
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in,
IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020,
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
NOTE An index of defined terms is found in Annex CC.
201.3.201
active anaesthetic gas scavenging system
active AGSS
AGSS in which gas flow in the disposal system results from a power device
4 © ISO 2022 – All rights reserved
ISO 80601-2-13:2022(E)
[SOURCE: ISO 4135:2022, 3.9.1.2]
201.3.202
AGSS disposal system
part of an AGSS which conveys gas from a receiving system to a point of discharge
Note 1 to entry: The point of discharge can be, for example, the exterior of a building or a non-recirculating extract
ventilation system.
[SOURCE: ISO 4135:2022, 3.9.1.3, modified by adding Note 1 to entry.]
201.3.203
airway pressure
pressure at the patient connection port, relative to ambient pressure unless otherwise specified
[SOURCE: ISO 19223:2019, 3.6.1, modified by deleting the notes 1 to 7.]
201.3.204
anaesthetic breathing system
breathing system intended for use with volatile or gaseous anaesthetic agents
[SOURCE: ISO 4135:2022, 3.6.1.8]
201.3.205
anaesthetic gas
gases and, if present, vapour of a volatile anaesthetic agent, used in anaesthesia
Note 1 to entry: In parts of an anaesthetic breathing system, anaesthetic gas includes gases exhaled by the patient.
[SOURCE: ISO 4135:2022, 3.1.1.5]
201.3.206
anaesthetic gas delivery system
anaesthetic workstation component that receives separate supplies of medical gases and delivers mixed
gases in concentrations or individual flow rates adjustable by the operator
Note 1 to entry: An anaesthetic gas delivery system can include a means of flow rate adjustment control, flowmeters or
a gas mixer and anaesthetic gas delivery system piping but does not include vaporizers.
[SOURCE: ISO 4135:2022, 3.3.2.1]
201.3.207
anaesthetic gas scavenging system
AGSS
system which is connected to the exhaust ports of a breathing system or of other equipment for the
purpose of conveying excess gases to an appropriate point of discharge
Note 1 to entry: Functionally, an AGSS comprises three parts: a transfer system, a receiving system and an AGSS disposal
system. These three functionally discrete parts may be either separate or sequentially combined in part or in total. One or
more parts of an AGSS may be combined with an anaesthetic breathing system component or other equipment.
Note 2 to entry: The excess gases can contain anaesthetic gases and vapours.
[SOURCE: ISO 4135:2022, 3.9.1.1, modified by replacing "excess anaesthetic gases and vapours" by
"excess gases" and by adding note 2 to entry.]
ISO 80601-2-13:2022(E)
201.3.208
anaesthetic vapour delivery system
anaesthetic vapourizer
anaesthetic workstation component that provides the vapour of a volatile anaesthetic agent in a
controllable concentration
[SOURCE: ISO 4135:2022, 3.3.2.2, modified by adding “anaesthetic” before “agent”.]
201.3.209
anaesthetic ventilator
anaesthetic workstation component that is connected via the anaesthetic breathing system to the patient’s
airway and automatically augments or provides ventilation during anaesthesia
[SOURCE: ISO 4135:2022, 3.4.1.3]
201.3.210
anaesthetic workstation
system for administering inhalational anaesthesia that contains an anaesthetic gas delivery system, an
anaesthetic breathing system and any required monitoring equipment, alarm systems, and protection
devices
Note 1 to entry: An anaesthetic workstation can also include, but is not limited to, one or more of the following:
anaesthetic vapour delivery system, anaesthetic ventilator, parts of an anaesthetic gas scavenging system, and any
associated monitoring equipment, alarm systems and protection devices.
[SOURCE: ISO 4135:2022, 3.3.1.2]
201.3.211
breathing tube
non-rigid tube used to convey gases between parts of an anaesthetic breathing system
201.3.212
circle absorber assembly
part of a circle breathing system that comprises one or more carbon-dioxide-absorbent containers,
inspiratory and expiratory valves or other means of ensuring unidirectional gas flow, two ports for
connection to breathing tubes, a fresh-gas inlet, and a reservoir bag port or an anaesthetic ventilator port
or both
[SOURCE: ISO 4135:2022, 3.6.1.8.2]
201.3.213
circle breathing system
anaesthetic circle breathing system
breathing system in which the direction of gas flow through inspiratory and expiratory pathways is
unidirectional and in which the two pathways form a loop
Note 1 to entry: In context of anaesthesia, the breathing system is a circle breathing system.
[SOURCE: ISO 4135:2022, 3.6.1.8.1]
201.3.214
danger zone
any zone within and/or around an anaesthetic workstation in which a person is subject to a risk to their
health or safety from the powered movement of the anaesthetic workstation or its components
6 © ISO 2022 – All rights reserved
ISO 80601-2-13:2022(E)
201.3.215
delivered volume
V
DEL
volume of gas delivered through a patient connection port during a breath
Note 1 to entry: Delivered volume is also referred to as inspiratory tidal volume when all of the delivered volume enters
the patient’s respiratory tract. This is frequently not the case when there is significant tracheal tube cuff leakage (as in
neonates) or in non-invasive ventilation.
201.3.216
disposal flowrate
flow rate of gas from the receiving system at the entry to the AGSS disposal system
[SOURCE: ISO 4135:2022, 3.9.1.3.6]
201.3.217
disposal hose
part of an AGSS that is intended to convey gas from the receiving system to the AGSS disposal system
[SOURCE: ISO 4135:2022, 3.9.1.3.1, modified by replacing "flexible tube that conveys" by "part of an AGSS
that is intended to convey" and by removing "exhaust" before "gas".]
201.3.218
exhaust port
port of the medical equipment or device from which gas is discharged to the atmosphere during normal
use, either directly or via an anaesthetic gas scavenging system
[SOURCE: ISO 19223:2019, 3.14.2]
201.3.219
exhaust valve
valve with an outlet connected to an exhaust port
EXAMPLE An adjustable pressure-limiting valve.
[SOURCE: ISO 4135:2022, 3.1.4.12]
201.3.220
fresh gas
respirable gas delivered to a breathing system
Note 1 to entry: In a circle system, the fresh gas is all respirable gas delivered into the circle system (including anaesthetic
gases and vapours).
[SOURCE: ISO 4135:2022, 3.1.1.16, modified by deleting the last sentence in Note 1 to entry and by
deleting Note 2 to entry.]
201.3.221
fresh-gas inlet
port through which fresh gas enters the anaesthetic breathing system
[SOURCE: ISO 4135:2022, 3.1.4.20, modified by adding "anaesthetic" before “breathing system”.]
201.3.222
fresh-gas outlet
port through which fresh gas is delivered from the anaesthetic gas delivery system
ISO 80601-2-13:2022(E)
[SOURCE: ISO 4135:2022, 3.3.2.6]
201.3.223
high-flow transfer and receiving system
transfer system and receiving system that connects to a high-flow-rate disposal system
[SOURCE: ISO 4135:2022, 3.9.1.3.8, modified by deleting note 1 to entry.]
201.3.224
induced flow rate
flow rate at the inlet of the transfer system, that is generated by the disposal system in an AGSS
*201.3.225
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
201.3.226
low-flow transfer and receiving system
transfer system and receiving system that connects to a low-flow-rate disposal system
Note 2 to entry: Terminal units of type 1L (as specified in ISO 9170-2 are intended for use with low-flow transfer and
receiving systems.
[SOURCE: ISO 4135:2022, 3.9.1.3.10, modified by deleting Note 1 to entry.]
201.3.227
maximum disposal flowrate
DEPRECATED: maximum exhaust flow rate
largest disposal flowrate that can be accommodated without exceeding the specified limitations for
induced flow rate
[SOURCE: ISO 4135:2022, 3.9.1.3.6.1, modified by adding "for induced flow rate" after "specified
limitations".]
201.3.228
maximum limited pressure
highest airway pressure that can occur during normal use or under a single fault condition
201.3.229
minimum disposal flowrate
disposal flowrate that ensures that the specified limit of spillage to atmosphere is not exceeded
201.3.230
monitoring equipment
medical electrical equipment or part that continuously or continually measures and indicates the value of
a variable to the operator
[SOURCE: ISO 4135:2022, 3.11.1.3, modified by replacing "equipment" with "medical electrical
equipment", adding "continuously or continually" before "measures" and by replacing "user" with
"operator".]
8 © ISO 2022 – All rights reserved
ISO 80601-2-13:2022(E)
201.3.231
patient connection port
port of a breathing system intended for connection to an airway device
EXAMPLE A tracheal tube, tracheostomy tube, face mask and supraglottic airway are all airway devices
Note 1 to entry: The patient connection port is the end of the breathing system proximal to the patient.
[SOURCE: ISO 4135:2022, 3.1.4.41, modified by removing Notes to entry 2, 3 and 4, and by adding an
example.]
201.3.232
power device
part of the disposal system of an active AGSS that generates the disposal flowrate
201.3.233
power supply
source of energy other than that generated directly by the human body or by gravity that makes the
device function
EXAMPLE Supply mains, internal electrical power source, compressed gas from a medical gas pipeline system or
cylinder.
201.3.234
protection device
part or function of a medical device or accessory that, without intervention by the operator, protects the
patient, other people or the environment from hazardous output due to incorrect delivery of energy or
substances
[SOURCE: ISO 4135:2022, 3.1.4.48, modified by replacing "user" by "operator".]
201.3.235
receiving system
part of an AGSS that conveys gases from an interface of the breathing system to a disposal hose
[SOURCE: ISO 4135:2022, 3.9.1.3.4, modified by removing Notes to entry 1 and 2.]
201.3.236
spillage
volume of anaesthetic gas that cannot be accommodated by the AGSS over a specified period
201.3.237
transfer system
part of an AGSS, which can incorporate a transfer tube, that transfers anaesthetic gas from the exhaust
port of an anaesthetic breathing system, or associated equipment to the receiving system
[SOURCE: ISO 4135:2022, 3.9.1.3.5, modified by replacing "transfer hose" with "transfer tube" and by
replacing "exhaust gas" with "anaesthetic gas".]
201.3.238
y-piece
adaptor comprising a patient connection port and two ports for connection to breathing tubes
[SOURCE: ISO 4135:2022, 3.1.4.53]
ISO 80601-2-13:2022(E)
201.4 General requirements
Clause 4 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows:
201.4.3 * Essential performance
Addition:
Additional essential performance requirements are identified in the subclauses listed in Table 201.102.
Table 201.102 — Distributed essential performance requirements
Requirement Subclause
Oxygen flow under all conditions except 201.12.4.107.1 (oxygen supply failure alarm)
the failure of the oxygen supply (pipeline 201.12.4.107.2 (oxygen supply failure protection device)
or cylinder) to the anaesthetic 201.101.2 (inter
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La norme EN ISO 80601-2-13:2022 est un document fondamental qui s'applique à la sécurité de base et à la performance essentielle des postes d'anesthésie destinés à l'administration de l'anesthésie inhalatoire, en présence continue d'un professionnel. Ce document définit des exigences particulières pour une station d'anesthésie complète et pour certains composants, tels que le système de livraison de gaz anesthésique, le système de respiration anesthésique et le système de scavenging de gaz anesthésiques (AGSS). Un des points forts de cette norme est son approche exhaustive, qui couvre non seulement les équipements de base des postes d’anesthésie, mais également leurs composants individuels, facilitant ainsi leur intégration pour former une station d'anesthésie selon des spécifications précises. La norme précise également la pertinence des équipements de surveillance, des systèmes d'alarme et des dispositifs de protection, mis en relief dans le tableau AA.1, ce qui permet une meilleure compréhension de l’interconnexion entre ces éléments et leur influence sur la sécurité et la performance essentielle de la station. La norme est particulièrement pertinente pour les fabricants et les opérateurs d'équipements médicaux, car elle établit des critères clairs qui doivent être respectés pour garantir la sécurité de base lors de l'utilisation des postes d'anesthésie. Ceci est d'importance cruciale, non seulement pour assurer la sécurité des patients, mais aussi pour minimiser les risques associés à l'utilisation d'agents anesthésiques. La norme exclut les stations destinées à être utilisées avec des agents anesthésiques inflammables, ce qui souligne son engagement envers la sécurité des opérations anesthésiques, comme indiqué à l’Annexe BB. Enfin, la norme souligne l'importance de la compatibilité des accessoires avec les postes d'anesthésie, ce qui renforce la sécurité globale en garantissant que ces accessoires n'affectent pas négativement la performance essentielle des équipements concernés. Cela démontre le souci d'une norme complète et bien structurée qui non seulement répond aux exigences de sécurité, mais également aux besoins des professionnels de la santé.
Die Norm EN ISO 80601-2-13:2022 stellt spezifische Anforderungen an die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Anästhesiearbeitsplätzen, die für die Verabreichung von Inhalationsanästhesie genutzt werden. Diese Norm ist besonders relevant für Fachleute im Gesundheitswesen, die dafür verantwortlich sind, Anästhesiearbeiten in einem sicheren und effektiven Umfeld durchzuführen. Der Anwendungsbereich dieser Norm umfasst nicht nur den Anästhesiearbeitsplatz als Ganzes, sondern auch die einzelnen Komponenten, die zusammen einen voll funktionsfähigen Anästhesiearbeitsplatz bilden. Dazu gehören Systemkomponenten wie das Anästhesiegasabgabesystem, das Anästhesiebeatmungsgerät sowie Alarm- und Überwachungssysteme. Die Norm definiert die Anforderungen für diese Komponenten, was sicherstellt, dass sie sowohl einzeln als auch in Kombination zuverlässig arbeiten. Dies stärkt die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale des gesamten Anästhesiearbeitsplatzes. Ein herausragendes Merkmal der Norm ist ihre umfassende Betrachtung der Wechselwirkungen zwischen den einzelnen Komponenten und den Anästhesiearbeitsplatz in seiner Gesamtheit. Sie stellt sicher, dass auch Zubehörteile, die eventuell an den Anästhesiearbeitsplatz angeschlossen werden, den Anforderungen an Sicherheit und Leistung gerecht werden. Dies ist entscheidend, da selbst kleine Zubehörteile potenziell einen signifikanten Einfluss auf die Sicherheit des Anästhesieprozesses haben können. Zusätzlich wird darauf hingewiesen, dass die Norm nicht für Anästhesiearbeitsplätze gilt, die mit brennbaren Anästhetika betrieben werden, was ein echter Sicherheitsfaktor in der Anwendung ist. Durch diese klare Abgrenzung trägt die Norm dazu bei, potenzielle Risiken in Verbindung mit der Nutzung von entzündlichen Substanzen zu minimieren. Insgesamt bietet die EN ISO 80601-2-13:2022 eine klare und detaillierte Richtlinie für die Anforderung an Anästhesiearbeitsplätze. Sie gewährleistet, dass alle relevanten Komponenten und Zubehörteile die notwendigen Sicherheitsstandards erfüllen, was zu einer verbesserten Patientenversorgung und -sicherheit führt. Diese Norm ist somit von großer Bedeutung für alle in der Anästhesie tätigen Fachleute, da sie ein sicheres Arbeiten und die Integrität des gesamten Anästhesiesystems fokussiert.
EN ISO 80601-2-13:2022 문서는 마취 작업대의 기본 안전성과 필수 성능에 대한 특정 요구사항을 정의하고 있습니다. 이 표준은 지속적으로 전문 운영자가 참석하는 상태에서 흡입 마취를 제공하기 위해 필요한 마취 작업대의 안전성을 보장하는 데 중점을 둡니다. 이 문서의 강점 중 하나는 마취 작업대의 전체 구성 요소 및 개별 장치에 대한 요구사항을 상세히 설명하고 있다는 점입니다. 여기에는 마취가스 전달 시스템, 호흡 시스템, 가스 스캐빈징 시스템(AGSS), 마취 증기 전달 시스템, 마취 기계, 모니터링 장비, 경고 시스템, 보호 장치가 포함됩니다. 이러한 구성 요소들은 개별적으로도 기능하지만, 특정 규격에 따라 함께 사용되어 통합된 마취 작업대를 형성할 수 있습니다. 또한, 이 표준은 연결될 수 있는 액세서리의 특성이 마취 작업대의 기본 안전성과 필수 성능에 미치는 영향까지 포함하여, 사용자에게 제공되는 마취 작업대의 안전성을 더욱 강화하고 있습니다. 이는 의료기기와 같은 일반 표준에 대한 명확한 가이드라인을 제공함으로써, 사용자가 제품의 안전성을 평가하고 개선하는 데 기여합니다. 본 문서는 구체적인 요구사항을 통해 마취 작업대 및 그 구성 요소의 안전성을 보장하고, 간략한 표 형식으로 모니터링 장비나 경고 시스템과 같은 필수 장치들을 요약하여 신속한 이해를 가능하게 합니다. 따라서 EN ISO 80601-2-13:2022는 의료 환경에서 마취 안전을 보장하는 것을 목표로 하며, 특정 구성 요소와 액세서리에 대한 규정을 통해 의료기기의 품질 향상에도 중대한 영향을 미칩니다. 결론적으로, EN ISO 80601-2-13:2022 표준은 마취 작업대의 안전성과 성능을 보장하고, 관련 기술의 발전에 발맞추어 변화를 수용할 수 있는 유용한 기준으로 자리잡고 있으며, 최신 의료 관행과 기술적 요구 사항을 반영하여 사용자에게 신뢰성을 제공합니다.
EN ISO 80601-2-13:2022は、麻酔ワークステーションの基本的な安全性および必須性能に関する特定要件を規定した標準です。この標準は、吸入麻酔を施行する間、専門のオペレーターによる継続的な監視が必要な麻酔ワークステーションに適用されます。特に、麻酔ガス供給システム、麻酔呼吸システム、麻酔ガス排気システム（AGSS）、麻酔蒸気供給システム、麻酔 ventilator、モニタリング装置、警報システム、および保護装置が含まれるすべてのコンポーネントに対して特定の要件を指定しています。 この標準の強みは、麻酔ワークステーション全体に関する包括的なガイドラインを提供することで、安全な運用を確保するための基盤を形成している点です。特に、モニタリング装置や警報システム、保護装置についての要件が明確にまとめられ、ユーザーがシステム全体の安全性を評価する際に役立ちます。また、付属品が麻酔ワークステーションの基本的な安全性および必須性能に影響を与える可能性がある場合、それらの接続に関する要件も明示されており、適切な構造を保証します。 標準がカバーする内容は、麻酔ワークステーション及びその個々のコンポーネントに関するリスク管理の重要性を強調しており、特に患者の安全に直接関連する分野での信頼性を高める役割を果たします。このように、EN ISO 80601-2-13:2022は麻酔手技の分野における医療機器の安全基準を確立する上で、極めて重要な文書です。
The EN ISO 80601-2-13:2022 standard provides crucial guidelines for the basic safety and essential performance of anaesthetic workstations, specifically focusing on the administration of inhalational anaesthesia while under the continuous supervision of a qualified operator. Its comprehensive scope includes all necessary components that make up a complete anaesthetic workstation, such as the anaesthetic gas delivery system, anaesthetic breathing system, anaesthetic gas scavenging system (AGSS), anaesthetic vapour delivery system, anaesthetic ventilator, monitoring equipment, alarm systems, and protection devices. A significant strength of this standard is its detailed specification for the individual components of the anaesthetic workstation, emphasizing their collective interaction and functionality as an integrated ME (Medical Electrical) system. Additionally, it establishes clear applicability not only for the workstation itself but extends to accessories manufactured to connect with the workstation that could impact its basic safety and essential performance. This inclusivity solidifies the standard's relevance in contemporary medical practice, ensuring that all elements contributing to anaesthetic safety are rigorously addressed. Another notable aspect is the consideration of potential hazards inherent in the intended physiological functions of the anaesthetic workstation. While specific requirements for these hazards are not covered in detail within this document, the standard acknowledges the necessity of compliance with IEC 60601-1:2005+AMD1:2012+AMD2:2020 for these considerations, thus promoting a robust safety framework. The standard also wisely delineates the exceptions, clarifying that it does not apply to anaesthetic workstations intended for use with flammable anaesthetic agents, which is crucial for maintaining safety standards in environments where such agents are utilized. Overall, EN ISO 80601-2-13:2022 stands out for its structured approach to defining essential performance criteria and safety requirements for anaesthetic workstations, ensuring that both operators and patients are safeguarded during medical procedures. Its detailed specifications and clear applicability underline its importance in advancing the standards within the healthcare sector related to anaesthesia practices.
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