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.

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.

General Information

Status
Published
Publication Date
28-Apr-2022
Current Stage
PPUB - Publication issued
Completion Date
03-May-2022
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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
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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
© ISO 2022 – All rights reserved
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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

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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

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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;
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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.
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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.
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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
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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,

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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.
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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
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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
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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 2022 – All rights reserved 5
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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
...

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