EN ISO 80601-2-13:2022/prA1:2025
(Amendment)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/DAmd1:2025)
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/DAmd1:2025)
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/DAmd1:2025)
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/DAmd1:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2025
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/DAmd1:2025)
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/DAmd1:2025)
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/DAmd1:2025)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2022/prA1:2025
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2- en,fr,de
13:2022/oprA1:2025
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
Amendment
ISO 80601-2-
13:2022/
DAM 1
ISO/TC 121/SC 1
Medical electrical equipment —
Secretariat: DIN
Part 2-13:
Voting begins on:
Particular requirements for basic
2025-02-11
safety and essential performance of
Voting terminates on:
an anaesthetic workstation 2025-05-06
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
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO 80601-2-13:2022/DAM 1:2025(en)
DRAFT
ISO 80601-2-13:2022/DAM 1:2025(en)
Amendment
ISO 80601-2-
13:2022/
DAM 1
ISO/TC 121/SC 1
Medical electrical equipment —
Secretariat: DIN
Part 2-13:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
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
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 80601-2-13:2022/DAM 1:2025(en)
ii
ISO 80601-2-13:2022/DAM 1:2025(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).
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).
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constitute an endorsement.
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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.
Amendment 1 to ISO/IEC 80601-2-13:2022 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).
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.
iii
ISO 80601-2-13:2022/DAM 1:2025(en)
Medical electrical equipment —
Part 2-13:
Particular requirements for basic safety and essential
performance of an anaesthetic workstation
AMENDMENT 1
201.2
Add the following reference:
ISO 20417, Information to be supplied by the manufacturer
201.3
Add the following terms and definitions:
201.3.239
waste volatile anaesthetic agent capture system
system that collects and stores waste volatile anaesthetic agents from the exhaust port of a
breathing system
*201.3.240
interchangeable AGSS
anaesthetic gas scavenging system that by design is intended to be used with different anaesthetic
workstations
NOTE 1 to entry: Connections of interchangeable AGSSs can be non-operator detachable.
201.3.241
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]
201.4
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:
ISO 80601-2-13:2022/DAM 1:2025(en)
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).
201.4
Add the following subclause:
201.4.11* 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 could 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 may 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.
c) During a system recovery with a cessation of ventilation or gas delivery that could lead to a
hazardous situation:
1) the anaesthetic workstation shall allow spontaneous patient breathing and should allow
manual ventilation in accordance with 201.102.12; and
NOTE During a system recovery, there may 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.
ISO 80601-2-13:2022/DAM 1:2025(en)
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 change in settings alarm conditions 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.
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 20417:2021.
Check conformance by application of ISO 20417:2021.
201.7.2.21*
Replace the existing text by:
This subclause does not apply.
201.7.2.101
Replace the existing text by:
This subclause does not apply.
201.7.2.104
Replace the existing text by:
This subclause does not apply.
201.7.9.1
Replace the existing text by:
This subclause does not apply.
201.7.9.2.101
ISO 80601-2-13:2022/DAM 1:2025(en)
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 anae
...
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