SIST EN ISO 80601-2-13:2022/A1:2026

SLOVENSKI STANDARD
01-oktober-2026
Medicinska električna oprema - 2-13. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti delovnega mesta za anestezijo - Dopolnilo A1 (ISO 80601-2-
13:2022/Amd 1:2026)
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and
essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-
13:2022/Amd 1:2026)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anästhesie-Arbeitsplätzen (ISO
80601-2-13:2022/Amd 1:2026)
Appareils électromédicaux - Partie 2-13: Exigences particulières de sécurité de base et
de performances essentielles pour les postes de travail d'anesthésie - Amendement 1
(ISO 80601-2-13:2022/Amd 1:2026)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2022/A1:2026
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-
EUROPEAN STANDARD
13:2022/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2026
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-13: Particular
requirements for basic safety and essential performance of
an anaesthetic workstation - Amendment 1 (ISO 80601-2-
13:2022/Amd 1:2026)
Appareils électromédicaux - Partie 2-13: Exigences Medizinische elektrische Geräte - Teil 2-13: Besondere
particulières de sécurité de base et de performances Festlegungen für die Sicherheit einschließlich der
essentielles pour les postes de travail d'anesthésie - wesentlichen Leistungsmerkmale von Anästhesie-
Amendement 1 (ISO 80601-2-13:2022/Amd 1:2026) Arbeitsplätzen (ISO 80601-2-13:2022/Amd 1:2026)
This amendment A1 modifies the European Standard EN ISO 80601-2-13:2022; it was approved by CEN on 28 May 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-13:2022/A1:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 80601-2-13:2022/A1:2026) 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 Amendment to the European Standard EN ISO 80601-2-13:2022 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by February
2027, and conflicting national standards shall be withdrawn at the latest by February 2027.
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.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-13:2022/Amd 1:2026 has been approved by CEN as EN ISO 80601-2-
13:2022/A1:2026 without any modification.

International
Standard
ISO 80601-2-13
Second edition
Medical electrical equipment —
2022-04
Part 2-13:
AMENDMENT 1
Particular requirements for basic
2026-08
safety and essential performance of
an anaesthetic workstation
AMENDMENT 1
Appareils électromédicaux —
Partie 2-13: Exigences particulières de sécurité de base et de
performances essentielles pour les postes de travail d'anesthésie
AMENDEMENT 1
Reference number
ISO 80601-2-13:2022/Amd.1:2026(en) © ISO 2026

ISO 80601-2-13:2022/Amd.1:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 80601-2-13:2022/Amd 1:2026(en)
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).
ISO and IEC draw attention to the possibility that the implementation of this document may involve the
use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any
claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had
not received notice of (a) patent(s) which may be required to implement this document. However,
implementers are cautioned that this may not represent the latest information, which may be obtained
from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
not be held responsible for identifying any or all such patent rights.
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, Medical equipment, software, and systems, Subcommittee SC 62D, Particular
medical equipment, software, and systems, 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).
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.
AMENDMENT ISO 80601-2-13:2022/Amd 1:2026(en)

Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety and essential
performance of an anaesthetic workstation
AMENDMENT 1
Foreword
Replace the text of the third dash by the following:
- consideration of anaesthetic workstations using Oxygen 90+;

201.2
Add the following reference:
ISO 20417:2026, Medical devices — Information to be supplied by the manufacturer
201.3
Add the following terms and definitions:
201.3.239
essential function
function or capability that is required to maintain basic safety, essential performance, a minimum of
clinical functionality as specified by the manufacturer, and operational availability for the medical
device
Note 1 to entry: Essential functions include, but are not limited to, the safety instrumented function (basic safety
and essential performance), the control function and the availability of urgently needed functions and such
allowing the operator to view and manipulate the medical device safely with the most urgently needed
performance (operational availability). The loss of essential function is commonly termed loss of protection,
loss of control and loss of view respectively.
Note 2 to entry: The term is derived from IEC 62443-4-2:2019, 3.1.20, and has been refined for the purpose
and scope of this document.
[SOURCE: IEC/TR 60601-4-5:2021, 3.10]
ISO 80601-2-13:2022/Amd 1:2026(en)
201.3.240
firecall
method established to provide emergency access to a secure medical device
Note 1 to entry: In an emergency situation, unprivileged users can gain access to key systems to correct the
problem. When a firecall is used, there is usually a review process to ensure that the access was used properly
to correct a problem. These methods generally either provide a one-time use user identifier (ID) or one-time
password or other suitable measures.
Note 2 to entry: Also referred to as “break glass” feature.
[SOURCE: IEC/TR 60601-4-5:2021, 3.11]
*201.3.241
interchangeable AGSS
anaesthetic gas scavenging system that by design is intended to be used with different models and
manufacturers’ anaesthetic workstations
Note 1 to entry: Connections of interchangeable AGSSs can be non-operator detachable.
201.3.242
Oxygen 90+ (O 90+)
gas mixture that meets the following criteria for composition:
— Oxygen (O₂): volume fraction of no less than 90%
— Argon (Ar): volume fraction of no more than 5%
— Nitrogen (N₂): volume fraction of no more than 10%
— Carbon dioxide (CO₂): volume fraction of no more than 300 ppm
— Carbon monoxide (CO): volume fraction of no more than 10 ppm
— Nitrogen oxides (NOx): volume fraction of no more than 2 ppm
— Sulfur dioxide (SO₂): volume fraction of no more than 1 ppm
— Water (H₂O): volume fraction of no more than 67 ppm
— Oils: no more than 0.1 mg/m
Note 1 to entry: Regional or national regulations can specify the colour coding for Oxygen 90+.
Note 2 to entry: It is expected that the definition of Oxygen 90+ is added to ISO 4135.
201.3.243
security level
level corresponding to the required set of countermeasures and inherent cybersecurity properties
of devices and systems for a zone or conduit based on assessment of risk for the zone or conduit
[SOURCE: IEC/TR 60601-4-5:2021, 3.23]
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ISO 80601-2-13:2022/Amd 1:2026(en)
201.3.244
Target Security Levels
SL-T
Target Security Levels are the desired level of security for a particular system. This is usually
determined by performing a risk assessment on a system and determining that it needs a particular
level of security to ensure its correct operation
[SOURCE: IEC 62443-3-3:2013, 3.3]
201.3.245
system recovery
method for fault handling via an automatic restart of programmable electronic subsystem (PESS) for
parts of the ME equipment or for the complete ME equipment
NOTE 1 to entry: There is guidance or rationale for this definition contained in Clause AA.
[SOURCE: ISO 80601-2-12:2023, 201.3.298]
201.3.246
waste volatile anaesthetic agent capture system
system that collects and stores waste volatile anaesthetic agents from the exhaust port of a breathing
system
201.4
Add the following subclause:
201.4.3.101 System recovery
NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.
a) Following a malfunction, the anaesthetic workstation should perform a system recovery to attempt
to restore essential performance of the anaesthetic workstation.
NOTE 2 An anaesthetic workstation or a subassembly function can become disturbed by a malfunction that
can jeopardize the essential performance of the anaesthetic workstation. Without system recovery, the
patient would have to be disconnected and connected to an alternative means of ventilation or gas delivery.
Ventilation or gas delivery would thus be interrupted until an alternative means of ventilation or gas
delivery is connected. System recovery, as specified in this subclause, attempts to automatically re-establish
ventilation or gas delivery in a shorter period. If necessary, the anaesthetic workstation can be replaced
later when it has fewer consequences for the patient´s therapy.
b) System recovery can result in the temporary:
1) cessation in the ventilation or gas delivery leading to risk of harm; or
2) reduction in the function of anaesthetic workstation subassemblies without cessation of
ventilation or gas delivery.
EXAMPLE The temporary blanking of the display.
ISO 80601-2-13:2022/Amd 1:2026(en)
c) During a system recovery with a cessation of ventilation or gas delivery that can lead to a
hazardous situation:
1) the anaesthetic workstation shall allow spontaneous patient breathing. Manual ventilation shall
be available within 15 s in accordance with 201.102.12; and
NOTE 3 During a system recovery, there can be a short period where manual ventilation is not possible
because the pneumatic system may have to be restarted by the anaesthetic workstation.
2) the anaesthetic workstation shall be equipped with an alarm system to indicate system recovery
with a cessation of ventilation or gas delivery.
i) The alarm condition for a system recovery with a cessation of ventilation or gas delivery
shall be high priority or may be an alternative alarm signal. The type of alternative
alarm signal or alarm condition delay and alarm signal generation delay for the alarm
signal shall be documented in the risk management file.
d) During a system recovery without a cessation of ventilation or gas delivery, the anaesthetic
workstation shall be equipped with an alarm system to indicate system recovery without a
cessation of ventilation or gas delivery.
1) The alarm condition for system recovery without a cessation of ventilation or gas delivery shall
be at least low priority with an auditory alarm signal or may be an alternative alarm signal. The
type of alternative alarm signal or alarm condition delay and alarm signal generation delay for
the alarm signal shall be documented in the risk management file.
e) Following a system recovery without operator intervention, the anaesthetic workstation shall
attempt to operate with the same system configuration settings, ventilation or gas delivery
settings and alarm settings as before the system recovery.
1) If ventilation settings, gas delivery settings or alarm settings are different after the system
recovery, the anaesthetic workstation alarm system shall indicate any change in settings.
2) The alarm generated shall be at least medium priority.
f) The duration of a system recovery with a cessation of ventilation or gas delivery should be as short
as practicable to avoid an unacceptable risk to the patient and shall be documented in the risk
management file.
g) The maximum duration of a system recovery of ventilation or gas delivery shall be disclosed in the
instructions for use.
Check conformance by inspection of the instructions for use, inspection of the risk management file and
functional testing.
4 © ISO 2026 – All rights reserved

ISO 80601-2-13:2022/Amd 1:2026(en)
201.4
Add the following subclause:
201.4.5 Alternative risk control measures or test methods for ME equipment or ME system
Amendment (add prior to the compliance check):
aa) Subsequent revisions of dated references (new editions or amendments) may be used in
substitution of a referenced document provided the manufacturer can demonstrate the hazard or
hazardous situation addressed in the dated normative reference is adequately resolved in the
subsequent revision.
201.4.10.101*
Add the following new NOTE below NOTE 2:
NOTE 3 Anaesthetic workstations can provide the supply gas to drive other devices such as high flow
therapy, oxygen flow meters or suction equipment. See also 201.7.9.2.101 qq).
201.5.101.4
Replace the text of the second dash:
 with Oxygen 90+ if the anaesthetic workstation is rated compatible or conditionally
compatible with Oxygen 90+.
Replace the third dash by a NOTE:
NOTE The concentration of oxygen and balance gases can vary over time in a gas supply with Oxygen 90+.
201.7
Add the following subclause:
201.7.1.101 Information to be supplied by the manufacturer
The information supplied by the manufacturer including marking, labelling and instructions for use
shall conform with ISO 20417.
Check conformance by application of ISO 20417.
201.7.2.21*
Replace the existing text by:
This subclause does not apply.
ISO 80601-2-13:2022/Amd 1:2026(en)
201.7.2.101
Delete this subclause completely.
201.7.2.104
Delete this subclause completely.
201.7.2
Add the following subclause:
201.7.2.107 Oxygen 90+
The anaesthetic workstation and its components shall be marked whether it is compatible,
conditionally compatible or incompatible with Oxygen 90+. A workstation that can be used with
Oxygen 90+ with restrictions shall be rated conditionally compatible with Oxygen 90+, see
201.7.9.2.101, ii).
An Oxygen 90+ compatibility marking shall be placed on the anaesthetic workstation, next to the gas
supply connectors. A single marking may be sufficient to cover all components that are described in
the instructions for use of the anaesthetic workstation. Additional markings can be required by risk
management, e.g. to inform the operator.
NOTE Symbols for the marking of compatibility with Oxygen 90+ have been proposed for inclusion in ISO
7000.
201.7.9.1
Replace the existing text by:
This subclause does not apply.
201.7.9.2.101
Replace the text in list item ii) with the following:
ii)
— the type of oxygen the anaesthetic workstation or its individual components are compatible with
(oxygen or Oxygen 90+) and;
— if the anaesthetic workstation or its components is rated conditionally compatible with Oxygen 90+,
a description of the conditions under which it can be used with Oxygen 90+ and;
— if the anaesthetic workstation or its components is rated conditionally compatible or compatible with
Oxygen 90+, the gas composition of Oxygen 90+ as defined in 201.3.242;
Replace the text in list item jj) with the following:
6 © ISO 2026 – All rights reserved

ISO 80601-2-13:2022/Amd 1:2026(en)
jj) if the anaesthetic workstation or its individual components is rated conditionally compatible or
compatible for use with Oxygen 90+, the consequences of the use of Oxygen 90+, e.g. possible argon
accumulation and varying oxygen concentrations;
Add the following list items and NOTE below oo)*:
pp) list of any component or function that is pneumatically powered, the type of gas needed and its
consumption of gas in l/min;
qq) a description of those components that are pneumatically powered that cannot be used in
parallel;
NOTE If too many devices are used in parallel, the pressure supply to the anaesthetic workstation can be
overloaded.
201.9.2.103*
Delete this subclause completely.
201.9.2.104*
Delete this subclause completely.
201.12.4.101*
Replace the text in list item a) by the following:
a) A means of protection against accidental adjustment of operating controls that can create a
hazardous situation shall be provided. This includes:
 deactivating fresh gas flow to a patient permanently (i.e. not reactivating without user
interaction);
 deactivating the anaesthetic vapour delivery system permanently (i.e. not reactivating
without user interaction);
 activating the standby mode of an anaesthetic workstation;
 accidental turning off of the anaesthetic workstation or its individual components.
The means for preventing an accidental adjustment shall be single fault safe.
The means preventing the accidental adjustment as listed above shall be analysed and documented
in the risk management file.
EXAMPLE 1 Requiring a confirmation step can be one method. The same confirmation step as for any other
adjustment will possibly not be appropriate.
NOTE 1 Logging of each single operator adjustment leading to permanent deactivation of fresh gas flow or
vapour delivery, activation of the standby mode or turning off the anaesthetic workstation or its individual
components can help investigating adverse events.
ISO 80601-2-13:2022/Amd 1:2026(en)
NOTE 2 Detecting patient breathing activity during standby or when no fresh gas is being delivered to the
patient and announcing an alarm signal (e.g. optical and acoustical with a high volume level) can help to prevent
adverse outcomes in such situations.
Add list item d) before the conformance check:
d) If an anaesthetic workstation is equipped with a manual configuration for use with Oxygen 90+,
the configuration shall be protected from unintended use.
NOTE 3 The configuration can be protected e.g. by the use of a password. A configuration that does not match the
input oxygen supply can increase inaccuracy or can lead to unexpected behaviour.
201.12.4.102*
Replace the text in the last row for subclause 201.12.4.108 of Table 201.104 by the following:
protection device for the workplace environment (AGSS) if the anaesthetic workstation is equipped
with means to deliver nitrous oxide or is designed to be equipped with an anaesthetic vapour delivery
system
201.12.4.104
Add the following text:
Anaesthetic workstations equipped with an anaesthetic ventilator shall have a means to monitor the
exhaled volume.
201.12.4.104.1*
Replace Table footnote a in Table 201.105 by the following:
a V is measured by means of a pressure sensor at the test lung, where
T
V = C x (P - P ) and
T insp exp
V is the volume delivered to the test lung
T
C is the Compliance of the test lung
Pinsp is the inspiratory pressure measured in the test lung
is the expiratory pressure measured in the test lung
Pexp
201.12.4.107.3*
Replace the text of the NOTE by the following:
NOTE Oxygen 90+ can have major influence on the output of a hypoxic mixture delivery selection
protection device, as the supply oxygen and balance gas concentrations can vary simultaneously.
8 © ISO 2026 – All rights reserved

ISO 80601-2-13:2022/Amd 1:2026(en)
201.12.4.108*
Replace the first paragraph by the following text:
If the anaesthetic workstation is equipped with means to deliver nitrous oxide or is designed to be
equipped with an anaesthetic vapour delivery system, the anaesthetic workstation shall either
201.12.4.109
Replace list item a) 2) by the following text:
2) if not so equipped, the instructions for use of the anaesthetic workstation shall contain a
statement to the effect that the anaesthetic workstation is to be provided with airway pressure
monitoring equipment conforming with this document before being put into service; also, it shall
describe how to connect that component. Manufacturers of the airway pressure monitoring
equipment shall make available on request information on how to connect that component to the
anaesthetic workstation, the anaesthetic breathing system and the anaesthetic ventilator.
201.14.101
Replace the headline of this subclause by:
201.14.101 Software life cycle
Delete the EXAMPLE.
Replace the second paragraph with the following:
Check conformance by inspection of the documentation required by IEC 62304:2006+AMD1:2015 for
the software safety class C (see IEC 62304:2006+AMD1:2015, 1.4).
201.14
Add the following subclause:
201.14.102 Cybersecurity capabilities of an anaesthetic workstation
a) An anaesthetic workstation should contribute to the safe operation related to cybersecurity.
b) Risk control measures as specified in IEC/TR 60601-4-5:2021, Clauses 4 to 7, should be implemented, as
appropriate, with the following additions to IEC/TR 60601-4-5:2021, 4.6.3.
1) Essential function: Data interfaces to an IT-network connection can be subject to attack (via
physical or logical disconnection). After disconnection of all data interfaces, if it is necessary to
restart the anaesthetic workstation, all clinical functions except the affected remote functionality
should be in place and operate as intended.
2) Firecall functions: As an anaesthetic workstation is used with healthcare professional operator
supervision, the user interface need not require authentication for operators and thus need not
ISO 80601-2-13:2022/Amd 1:2026(en)
require firecall functions. If authentication for operators to operator accessible settings is in place
also for the user interface, a firecall function should be able to overrule that operator
authentication combined with a log entry protected against modifications by the operator (i.e.
responsible organization log). IT-network interfaces including those for remote access typically
require authentication but should not include firecall functions.
3) Target security level SL-T: For user interfaces and for remote setting of clinical functions, the
expected security level of SL-T, as specified in IEC/TR 60601-4-5:2021, is 1 or better.
Authentication is not required for operators of the user interface of the anaesthetic workstation.
Authentication is required for remote access through a data interface. The expected security
level of SL-T, as specified in IEC/TR 60601-4-5:2021, is 2 or better for secure updates or
restorage of software, remotely or locally.
201.101.4.2.1
Add the following NOTE after item b):
NOTE It can be sufficient to use an Oxygen connector if the device is rated compatible or conditionally
compatible with Oxygen 90+.
201.101.6.1
Replace the text of list item c) by the following:
c) The accuracy of the graduations of any flowmeter or flow rate adjustment control used in the
anaesthetic gas delivery system shall be:
— within ±10 % of the indicated value for flow rates between 10 % and 100 % of full scale with oxygen
>99 %Vol;
— within ±15 % of the indicated value for flow rates between 10 % and 100 % of full scale with Oxygen
90+
when discharged into the ambient atmosphere (see 201.5.101.2).
201.101.7
Replace the text of the first paragraph by the following:
At any flow rate and supply pressure given in normal use, the oxygen concentration shall be:
— within ±5 % volume fraction of the set or indicated value for an anaesthetic workstation which is
designed or configured for use with oxygen >99 %Vol;
— within ± (5 % volume fraction or 10 % of the set or indicated value, the higher value applies), of the
set or indicated value with Oxygen 90+ for an anaesthetic workstation which has a configuration for
use with Oxygen 90+ and has been rated conditionally compatible or compatible with Oxygen 90+;
— within +5 % volume fraction, –(5 % volume fraction or 15 % of the set or indicated value, the higher
value applies) of the set or indicated value with Oxygen 90+ for an anaesthetic workstation which has
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ISO 80601-2-13:2022/Amd 1:2026(en)
no configuration for use with Oxygen 90+ and has been rated conditionally compatible or compatible
with Oxygen 90+.
201.102.1.1.1
Delete this subclause completely.
201.102.1.1.3
Replace the text of the third dash by the following:
— the symbols shown in Figure 201.102 (symbols ISO 7000-3902 and ISO 7000-3903, see Table
201.D.2.101, symbol No. 10 and symbol No. 11).
Add the following Figure as Figure 201.102:

a)  Symbol for marking “on” b)  Symbol for marking “off”
(bypassed)
Figure 201.102 — Absorbent bypass control markings
201.102.1.2
Replace list item c) by the following text:
c) information on how to connect the anaesthetic breathing system;
Replace list item f) by the following text:
f) information on any means of pressure relief, including pressure/flow rate
characteristics measured with air under STPD conditions;
Replace list item j) by the following text:
j) instructions for use of exhaust valves not integrated into the anaesthetic breathing
system, which shall describe the pressure/flow-rate characteristics of the exhaust valve
including the opening pressure and the pressure drop at a flow rate of 30 l/min air
under STPD conditions;
Replace list item l) by the following text:
ISO 80601-2-13:2022/Amd 1:2026(en)
l) for breathing system components intended to be assembled by the operator, the
resistance at;
 30 l/min if the anaesthetic breathing system is intended for adult patients;
 15 l/min if the anaesthetic breathing system is intended for paediatric patients;
 2,5 l/min if the anaesthetic breathing system is intended for neonatal patients;
at a fresh gas flow rate of (10 ± 1) l/min air under STPD conditions; and state that the data is collected
using air under STPD conditions;
Replace list item n) by the following text:
n) the inspiratory and expiratory pressure/flow rate characteristics of the anaesthetic
breathing system at a fresh gas flow rate of (10 ± 1) l/min air under STPD conditions,
including the pressure at
— 30 l/min if the anaesthetic breathing system is intended for adult patients;
— 15 l/min if the anaesthetic breathing system is intended for paediatric patients;
— 2,5 l/min if the anaesthetic breathing system is intended for neonatal patients.

For all three flow rates it shall be disclosed that the data is collected using air under STPD conditions.
Replace list item p) 2) by the following text:
p) 2) a method for the operator to test an anaesthetic breathing system for maximum pressure
change at the patient connection port for spontaneous breathing mode and inspiratory and
expiratory breathing phases of automatic ventilation;
— for changes of fresh gas flow
— for the use of oxygen flush;
NOTE By using this method the operator can determine if an anaesthetic breathing system is suitable for a
patient.
201.102.2.2
Replace the headline of this subclause by:
201.102.2.2 * Adjustable pressure limit protection devices
Replace list item a) 2) by the following text:
a) 2) if not so equipped, the instructions for use of the anaesthetic breathing system shall
contain a statement to the effect that the anaesthetic breathing system is to be provided
with a protection device to limit the pressure at the patient connection port to an operator-
adjustable pressure conforming with this document before the anaesthetic breathing
system is put into service and shall describe how to connect that component to the
anaesthetic workstation available (e.g. in integration instructions) upon request.
Replace list item b) by the following text:
12 © ISO 2026 – All rights reserved

ISO 80601-2-13:2022/Amd 1:2026(en)
b) Adjustable pressure limit protection devices shall ensure that under normal condition the
pressure at the patient connection port does not exceed the operator-set maximum value by
1) during any automatic ventilation mode:
— more than 15 % or 10 hPa (10 cmH2O), whichever is greater, with a fresh gas flow of
air ≤25 l/min (STPD conditions);
— more than 20 % or 15 hPa (15 cmH2O), whichever is greater, with 5 l/min fresh gas
flow of air (STPD conditions) and the maximum oxygen flush of the anaesthetic
workstation;
2) during manual or spontaneous ventilation mode:
2O), whichever is greater, with a fresh gas flow of
— more than 15 % or 10 hPa (10 cmH
air ≤25 l/min (STPD conditions);
— more than 20 % or 20 hPa (20 cmH2O), whichever is greater, with 5 l/min fresh gas
flow of air (STPD conditions) and the maximum oxygen flush of the anaesthetic
workstation.
NOTE 1 25 l/min is considered to be a maximum continuous fresh gas flow.
NOTE 2 During automatic ventilation, the O2 flush is not synchronized with an inspiration or expiration
phase. During manual ventilation, the operator presses the breathing bag to apply an inspiratory breathing
stroke and would have to press the O2 flush at the same time to cause an increase of pressure to the given
maximum pressure.
NOTE 3 The maximum O flush can be 75 l/min Oxygen or Oxygen 90+ (STPD conditions) or can be limited to
a lower value if the anaesthetic gas delivery system is integrated in the anaesthetic workstation.
NOTE 4 A fresh gas flow of 5 l/min is considered to be a high but reasonable fresh gas flow for an adult with
a minute volume of 5 l/min in automatic and manual ventilation (see table 201.105).
Check conformance by functional testing and, if applicable, by inspection of the instructions for use.
201.102.4
Delete this subclause completely.
201.102.5.1
Replace the first paragraph by the following text:
The patient connection port shall be a coaxial 22 mm cone/15 mm socket or a 15 mm socket
connector complying with ISO 5356-1:2015. The patient connection port may swivel.
201.102.5.2
Replace list item b) and the last paragraph by the following text:
ISO 80601-2-13:2022/Amd 1:2026(en)
b) have a 30 mm cone conforming with ISO 5356-1:2015 with a means to prevent
connection of the orifice to anaesthetic breathing system ports conforming with ISO 5356-1:2025
or ISO 5367:2014.
Check conformance by inspection of the manufacturer’s technical documentation.
201.102.5.3.1
Replace the last paragraph by the following text:
Check conformance by inspection.
Replace Figure 201.102 with the following Figure and renumber as Figure 201.103:

a) Arrangement for breathing system b) Arrangement for breathing system
component with a 22 mm socket reservoir component with a 22 mm cone reservoir
bag connector port bag connector port
Key to a) and b)
1 Patient interface with a 15/22 mm coaxial connector
2 Reservoir bag [22 mm socket]
3 inspiratory and expiratory connection ports (22 mm cones)
4 Reservoir bag port (22 mm socket)
5 Circle absorber assembly
6 Flexible bag arm or bag swivel mount with a 22 mm cone (direct connection to the reservoir
bag)
7 22 mm cone on both ends of the tube connecting the breathing system with the breathing bag
Figure 201.103 — Schematic representation of the connectors and the arrangement of the
breathing system in relation to the type of reservoir bag connection port

14 © ISO 2026 – All rights reserved

ISO 80601-2-13:2022/Amd 1:2026(en)
201.102.5.3.2
Replace the first paragraph by the following text:
The reservoir bag connection port shall be marked with the word “bag” or the equivalent in a
language that is acceptable to the intended operator, or symbol ISO 7000-3904 (see Figure
201.104 and Table 201.D.2.101 No. 12).
Add the following Figure as Figure 201.104:

Figure 201.104 — Symbol for the reservoir bag connection port
201.102.5.4
Replace the text in the subclause by the following text:
and not intended to
Anaesthetic ventilators that are operator-detachable, i.e. without the use of a tool
be directly connected to a breathing set shall not engage with connectors conforming with ISO 5356-
1:2015 and breathing tubes conforming with ISO 5367:2023.
NOTE Breathing sets are defined in ISO 5367:2023.
Check conformance by inspection, functional testing and application of the tests of ISO 5356-1:2015,
ISO 5356-2:2012, ISO 5356-2:2012/Amd 1:2019 and ISO 5367:2023.
201.102.5.5
Replace the text in the subclause by the following text:
If an anaesthetic breathing system is operator-detachable without the use of a tool, it shall be a fitting
that does not engage with connectors conforming with ISO 5356-1:2015 and breathing tubes
conforming with ISO 5367:2023.
NOTE This does not apply to the inspiratory and expiratory port connectors. See 201.102.5.6.
Check conformance by inspection of the manufacturer’s technical documentation.

ISO 80601-2-13:2022/Amd 1:2026(en)
201.102.5.6
Replace the second paragraph by the following text:
Check conformance by inspection of the manufacturer’s technical documentation.
201.102.5.7
Replace the headline of this subclause by:
201.102.5.7 Access ports for breathing sets
Replace the text in the subclause by the following text:
a) Access ports shall be socket (female) L2 Luer lock connectors complying with ISO 80369-7:2021.
NOTE These ports provide access to the gas within the breathing set for the purposes of:
i) monitoring the composition and the pressure of the breathing gas, and
ii) administering a drug into the breathing system via a hypodermic syringe.
b) Access ports shall be provided with a means to prevent leakage to the atmosphere when not in
use. If the means is via a cap or plug, the cap or plug shall be captive.
c) Access ports should be marked with the appropriate words or symbol, e.g.
1) “access port” or IEC 60417-5448; or
2) “sample port” or ISO 7000-0795; or
3) “input port” or ISO 7000-0794.
d) Include in the instructions for use a Warning to the effect: “As this [insert name of medical device
here] uses a Luer connector for other than intravascular or hypodermic access, there is a possibility
that an inadvertent connection can occur between this [insert name of medical device here] and
another medical device or accessory using a Luer connector, which can result in a hazardous situation
causing harm to the patient.”
Check conformance by visual inspection and functional testing.

16 © ISO 2026 – All rights reserved

ISO 80601-2-13:2022/Amd 1:2026(en)
201.102.5
Add the following subclause:
201.102.5.8 Sampling gas return ports
a) Sampling gas return ports shall not engage with connectors as specified in ISO 5356-1:2015 or ISO
80369-7.
b) Sampling gas return ports shall be provided with a means to prevent leakage to atmosphere when
not in use. If this means is via a cap or plug, the cap or plug shall be captive.
c) Sampling gas return ports shall be marked with the words “gas return” or symbol ISO 7000-0794.
Check conformance by visual inspection and functional testing.
201.102.8.1
Replace list item b) and the last paragraph by the following text:
b) other connectors compatible with a breathing tube conforming with ISO 5367:2023.
Check conformance by inspection and application of the tests of ISO 5356-1:2015.
201.102.8.3
Replace the text in the subclause by the following text:
a) Breathing tubes shall comply with ISO 5367:2023.
b) Breathing tubes connecting the patient with the inspiratory and expiratory port connectors of a
circle absorber assembly shall prevent a misconnection of the patient or make it detectable.
This may be achieved by e.g.
1) a pre-assembled set of breathing tubes that cannot be disassembled by the operator (this includes
e. g. co-axial systems, double-D-systems) (see Figure 201.105.1);
2) creating a fixed connection of both ends of a pair of breathing tubes, where the distance between
the ends of this pair of breathing tubes then shall not exceed 300 mm (see Figure 201.105.2).

ISO 80601-2-13:2022/Amd 1:2026(en)
Add the following Figure and key as Figure 201.105.1

a) Correct connection
b) Incorrect connection
c) Incorrect connection
Key to a) and b) and c)
1 Patient interface device (e.g. tracheal tube, facemask) with a 15 mm cone or 22 mm socket connector
2 Inspiratory breathing tubes with 22 mm sockets on both ends
3 Expiratory breathing tubes with 22 mm sockets on both ends
4 Anaesthetic workstation
5 A permanent connection between the T-piece and expiratory breathing tube prevents incorrect connection
Figure 201.105.1 — Pre-assembled set of breathing tubes that cannot be disassembled by
...