SIST 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)
EN-ISO 80601-2-13 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.
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für 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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 80601-2-13:2022
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
SIST EN ISO 80601-2-13:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 80601-2-13:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 80601-2-13:2022
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 80601-2-13:2022
EN ISO 80601-2-13:2022 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 80601-2-13:2022
EN ISO 80601-2-13:2022 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 80601-2-13:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 80601-2-13:2022
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 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 80601-2-13:2022
ISO 80601-2-13:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 80601-2-13:2022
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 2022 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 80601-2-13:2022
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
---------------------- Page: 10 ----------------------
SIST EN ISO 80601-2-13:2022
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 2022 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 80601-2-13:2022
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
---------------------- Page: 12 ----------------------
SIST EN ISO 80601-2-13:2022
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 2022 – All rights reserved vii
---------------------- Page: 13 ----------------------
SIST EN ISO 80601-2-13:2022
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
---------------------- Page: 14 ----------------------
SIST EN ISO 80601-2-13:2022
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 2022 – All rights reserved 1
---------------------- Page: 15 ----------------------
SIST EN ISO 80601-2-13:2022
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
---------------------- Page: 16 ----------------------
SIST EN ISO 80601-2-13:2022
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
2
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-13:2019
01-november-2019
Medicinska električna oprema - 2-13. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti delovnega mesta za anestezijo (ISO/DIS 80601-2-13:2019)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation (ISO/DIS 80601-2-13:2019)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Anästhesie-Arbeitsplätzen
(ISO/DIS 80601-2-13:2019)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performances essentielles pour les postes de travail d'anesthésie (ISO/DIS 80601-2-
13:2019)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-13
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-13:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 80601-2-13:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO 80601-2-13:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-13
ISO/TC 121/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-09-03 2019-11-26
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
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-13:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
---------------------- Page: 3 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
ISO/DIS 80601-2-13:2019(E)
14 Contents
15 Foreword . v
16 Introduction. vii
17 201.1 Scope, object and related standards . 1
18 201.2 Normative references . 3
19 201.3 Terms and definitions. 6
20 201.4 General requirements . 11
21 201.5 General requirements for testing ME equipment . 13
22 201.6 Classification of ME equipment or ME systems . 14
23 201.7 ME equipment identification, marking and documents . 14
24 201.8 Protection against electrical hazards from ME equipment . 19
25 201.9 Protection against mechanical hazards of ME equipment and ME systems . 20
26 201.10 Protection against unwanted and excessive radiation hazards . 21
27 201.11 Protection against excessive temperatures and other hazards . 22
28 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 24
29 201.13 Hazardous situations and fault conditions . 30
30 201.14 Programmable electrical medical systems (PEMS). 30
31 201.15 Construction of ME equipment . 31
32 201.16 ME systems . 31
33 201.17 Electromagnetic compatibility of ME equipment and ME systems . 32
34 201.101 Additional requirements for anaesthetic gas delivery systems . 33
35 201.102 Additional requirements for an anaesthetic breathing system . 39
36 201.103 Additional requirements for an anaesthetic gas scavenging system . 51
37 201.104 Additional requirements for an anaesthetic vapour delivery system . 56
38 201.105 Additional requirements for an anaesthetic ventilator . 61
39 201.106 Display of pressure-volume loops . 68
40 201.107 Clinical evaluation . 68
41 202 Electromagnetic disturbances — Requirements and tests . 68
42 203 General requirements for radiation protection in diagnostic X-ray equipment . 69
43 206 Usability . 69
44 208 General requirements, tests and guidance for alarm systems in medical electrical
45 equipment and medical electrical systems . 70
COPYRIGHT PROTECTED DOCUMENT
46 209 Requirements for environmentally conscious design . 71
© ISO 2019
47 211 Requirements for medical electrical equipment and medical electrical systems used
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
48 in the home healthcare environment . 71
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
49 212 Requirements for medical electrical equipment and medical electrical systems
below or ISO’s member body in the country of the requester.
50 intended for use in the emergency medical services environment . 71
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
© ISO 2018 – All rights reserved iii
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
14 Contents
15 Foreword . v
16 Introduction. vii
17 201.1 Scope, object and related standards . 1
18 201.2 Normative references . 3
19 201.3 Terms and definitions. 6
20 201.4 General requirements . 11
21 201.5 General requirements for testing ME equipment . 13
22 201.6 Classification of ME equipment or ME systems . 14
23 201.7 ME equipment identification, marking and documents . 14
24 201.8 Protection against electrical hazards from ME equipment . 19
25 201.9 Protection against mechanical hazards of ME equipment and ME systems . 20
26 201.10 Protection against unwanted and excessive radiation hazards . 21
27 201.11 Protection against excessive temperatures and other hazards . 22
28 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 24
29 201.13 Hazardous situations and fault conditions . 30
30 201.14 Programmable electrical medical systems (PEMS). 30
31 201.15 Construction of ME equipment . 31
32 201.16 ME systems . 31
33 201.17 Electromagnetic compatibility of ME equipment and ME systems . 32
34 201.101 Additional requirements for anaesthetic gas delivery systems . 33
35 201.102 Additional requirements for an anaesthetic breathing system . 39
36 201.103 Additional requirements for an anaesthetic gas scavenging system . 51
37 201.104 Additional requirements for an anaesthetic vapour delivery system . 56
38 201.105 Additional requirements for an anaesthetic ventilator . 61
39 201.106 Display of pressure-volume loops . 68
40 201.107 Clinical evaluation . 68
41 202 Electromagnetic disturbances — Requirements and tests . 68
42 203 General requirements for radiation protection in diagnostic X-ray equipment . 69
43 206 Usability . 69
44 208 General requirements, tests and guidance for alarm systems in medical electrical
45 equipment and medical electrical systems . 70
46 209 Requirements for environmentally conscious design . 71
47 211 Requirements for medical electrical equipment and medical electrical systems used
48 in the home healthcare environment . 71
49 212 Requirements for medical electrical equipment and medical electrical systems
50 intended for use in the emergency medical services environment . 71
© ISO 2018 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
51 Annex C (informative) Guide to marking and labelling requirements for ME equipment and
52 ME systems or their parts. 72
53 Annex D (informative) Symbols on marking . 82
54 Annex AA (informative) Particular guidance and rationale . 85
55 Annex BB (normative) Test for flammability of anaesthetic agent . 102
56 Annex CC (informative) Terminology — alphabetized index of defined terms . 103
57 Bibliography . 107
58 Annex ZA (informative) . 108
59
iv © ISO 2019 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
60 Foreword
61 ISO (the International Organization for Standardization) is a worldwide federation of national
62 standards bodies (ISO member bodies). The work of preparing International Standards is normally
63 carried out through ISO technical committees. Each member body interested in a subject for which a
64 technical committee has been established has the right to be represented on that committee.
65 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
66 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
67 matters of electrotechnical standardization.
68 The procedures used to develop this document and those intended for its further maintenance are
69 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
70 different types of ISO documents should be noted. This document was drafted in accordance with the
71 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
72 Attention is drawn to the possibility that some of the elements of this document may be the subject of
73 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
74 any patent rights identified during the development of the document will be in the Introduction and/or
75 on the ISO list of patent declarations received (see www.iso.org/patents).
76 Any trade name used in this document is information given for the convenience of users and does not
77 constitute an endorsement.
78 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
79 expressions related to conformity assessment, as well as information about ISO's adherence to the
80 World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
81 www.iso.org/iso/foreword.html.
82 This document was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic
83 and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines and
84 Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62 D,
85 Electromedical equipment.
86 This second edition cancels and replaces the first edition (ISO 80601-2-13:2011 including ISO 80601-2-
87 13:2011/AMD 1:2015 and ISO 80601-2-13:2011/AMD 2:2018), which has been technically revised
88 The main technical changes compared to the previous edition are as follows:
89 - incorporation of the texts of the amendments AMD 1:2015 and AMD 2:2018;
90 - consideration of anaesthetic workstations using Oxygen 93;
91 - updates of the normative references;
92 - inclusion of a normative reference to the series of standards ISO 18562 and to the standard
93 ISO 10993-1 on biocompatibility evaluation of breathing gas pathways and on biological evaluation
94 of medical devices respectively;
95 - amendments of the requirements on test equipment;
96 - amendments to the requirements on marking on the outside of the equipment;
97 - amendments to the requirements in the instructions for use, the technical description and design
98 documentation for anaesthetic equipment and its components;
© ISO 2018 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
99 - amendments to the alarm condition for power supply;
100 - for the determination of the A-weighted sound pressure, replacement of the normative reference
101 ISO 3746 by ISO 3744:2010;
102 - amendments to the requirements on the internal electrical power source;
103 - amendments to the requirement on the connection for remote control;
104 - amendments to the requirements on the flow rate adjustment control;
105 - revision of the requirements on the reservoir bag connector;
106 - amendments of the requirements of the circle absorber assembly;
107 - amendments of the requirements of the accuracy on exhaled volume monitoring equipment;
108 - amendments to the requirements on timed ventilatory pause (expiratory pause);
109 - amendments of the pressure and flow-rate characteristics of the inspiratory and expiratory valves;
110 - addition of requirements on ventilation modes;
111 - amendments to the requirements on the adjustable pressure limitation protection device;
112 - addition of the normative reference to IEC 60601-1-12 for an anaesthetic workstation that is used
113 in an emergency medical services environment.
114 A list of all parts in the ISO 80601 series can be found on the ISO website.
115 Any feedback or questions on this document should be directed to the user’s national standards body. A
116 complete listing of these bodies can be found at www.iso.org/members.html.
vi © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
117 Introduction
118 In this document, the following print types are used:
119 Requirements and definitions: roman type.
120 Terms defined in Clause 3 of the general standard, in this particular standard and test
121 specifications: italic type.
122 Informative material appearing outside of tables, such as notes, examples and references: in smaller
123 type. Normative text of tables is also in a smaller type.
124 In referring to the structure of this document, the term
125 “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of
126 all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
127 “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
128 subclauses of Clause 201.7).
129 References to clauses within this document are preceded by the term “Clause” followed by the clause
130 number. References to subclauses within this document are by number only.
131 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
132 combination of the conditions is true.
133 The verbal forms used in this document conform to usage described in Clause 7 of the
134 ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
135 “shall” means that conformance with a requirement or a test is mandatory for conformity with this
136 document;
137 “should” means that conformance with a requirement or a test is recommended but is not
138 mandatory for conformance with this document;
139 “may” is used to describe permission (e. g. a permissible way to achieve conformance with a
140 requirement or test);
141 "can" is used to describe a possibility or capability; and
142 "must" is used to express an external constraint.
143 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
144 that there is guidance or rationale related to that item in Annex AA.
145 This document considers both an anaesthetic workstation supplied complete and its individual
146 components in combination with its accessories. It has been structured to allow responsible
147 organizations to configure an anaesthetic workstation from individual components in conformance with
148 professional guidelines and to meet the needs of their clinical practice. In order to achieve this aim, this
149 document identifies particular requirements pertinent to specific anaesthetic workstation components,
150 including associated monitoring equipment, alarm system(s) and protection device(s), and defines the
151 interfaces.
152 Thus this document also defines requirements for individual components that can be used to form an
153 anaesthetic workstation.
© ISO 2018 – All rights reserved vii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
154 The following table identifies the individual components of an anaesthetic workstation and provides an
155 overview of the structure of this document.
156 Table 201.101 — Configuration of an anaesthetic workstation and corresponding organization of this
157 document
anaesthetic workstation
General requirements
Clauses 201.1 – 201.17, 201.106,
201.107, 202-212
including associated monitoring
These are mandatory
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
Clause 201.103
including associated monitoring
These are optional
anaesthetic vapour delivery system equipment,
components;
Clause 201.104 alarm systems and
see also Table AA.1
protection devices
anaesthetic ventilator
Clause 201.105
158
159
160
viii © ISO 2019 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO DIS 80601-2-13:2018
161 Medical electrical equipment — Part 2-13: Particular
162 requirements for basic safety and essential performance of an
163 anaesthetic workstation
164 201.1 Scope, object and related standards
165 IEC 60601-1:2005 + AMD 1:2012, Clause 1 applies, except as follows:
166 201.1.1 * Scope
167 Replacement:
168 This document is applicable to the basic safety and essential performance of an anaesthetic
169 workstation for administering inhalational anaesthesia whilst continuously attended by a
170 professional operator.
171 This document specifies particular requirements for a complete anaesthetic workstation and the
172 following anaesthetic workstation components which, although considered as individual devices
173 in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation
174 components, to form an anaesthetic workstation to a given specification:
175 anaesthetic gas delivery system;
176 anaesthetic breathing system;
177 anaesthetic gas scavenging system;
178 anaesthetic vapour delivery system;
179 anaesthetic ventilator;
180 monitoring equipment;
181 alarm system;
182 protection device.
183 NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.
184 An anaesthetic workstation supplied complete and its individual components are considered as
185 ME equipment or ME systems with regard to the general standard.
186 NOTE 2 The applicability of this document is indicated in Table AA.2.
187 This document is also applicable to those accessories intended by their manufacturer to be
188 connected to an anaesthetic workstation where the characteristics of those accessories can affect
189 the basic safety and essential performance of the anaesthetic workstation.
© ISO 2018 1
---------------------- Page: 11 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
190 If a clause or subclause is specifically intended to be applicable to anaesthetic workstation
191 components or its accessories only, the title and content of that clause or subclause will say so. If
192 that is not the case, the clause or subclause applies both to an anaesthetic workstation and its
193 individual components including accessories, as relevant.
194 Hazards inherent in the intended physiological function of an anaesthetic workstation and its
195 individual components including accessories within the scope of this document are not covered by
196 specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
197 NOTE 3 See also 4.2 of the general standard.
198 This document is not applicable to any anaesthetic workstation intended for use with flammable
199 anaesthetic agents, as determined by Annex BB.
200 201.1.2 Object
201 Replacement:
202 The object of this document is to establish particular basic safety and essential performance
203 requirements for an anaesthetic workstation and its individual components designed for use in
204 the anaesthetic workstation (as defined in 201.3.209) and its accessories.
205 201.1.3 Collateral standards
206 Addition:
207 This document refers to those applicable collateral standards that are listed in Clause 2 of the
208 general standard and Clause 201.2 of this document.
209 IEC 60601-1-3:2008, IEC 60601-1-9 + AMD 1:2013, IEC 60601-1-11:2010 + AMD 1: 2018 do not
210 apply.
211 201.1.4 *Particular standards
212 Addition:
213 The numbering of clauses and subclauses of this document corresponds to that of IEC 60601-1
214 (the general standard) with the prefix “201” (e.g. 201.1 in this document addresses the content of
215 Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is
216 the final digit(s) of the collateral standard document number (e.g. 202.4 in this document
217 addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 206.4 in this
218 document addresses the content of Clause 4 of the IEC 60601-1-6 collateral standard, etc.). The
219 changes to the text of the general standard are specified by the use of the following words:
220 “Replacement” means that the clause or subclause of the general standard or applicable collateral
221 standard is replaced completely by the text of this document.
222 “Addition” means that the text of this document is additional to the requirements of the general
223 standard or applicable collateral standard.
224 “Amendment” means that the clause or subclause of the general standard or applicable collateral
225 standard is amended as indicated by the text of this document.
2 © ISO 2019 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 80601-2-13:2019
ISO/DIS 80601-2-13:2019 (E)
226 Subclauses, figures or tables which are additional to those of the general standard are numbered
227 starting from 201.101. However, due to the fact that definitions in the general standard are
228 numbered 3.1 to 3.154, additional definitions in this document are numbered beginning from
229 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
230 Subclauses or figures which are additional to those of a collateral standard are numbered starting
231 from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 206 for
232 IEC 60601-1-6, etc.
233 The term “this document” is used to make reference to the general standard, any applicable
234 collateral standards and this particular standard taken together.
235 Where there is no corresponding clause or subclause in this document, the clause or subclause of
236 the general standard or applicable collateral standard, although possibly not relevant, applies
237 without modification; where it is intended that any part of the general standard or applicable
238 collateral standard, although possibly relevant, is not to be applied, a statement to that effect is
239
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.