EN ISO 80601-2-13:2022/prA1
(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/DAM 1:2025)
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/DAM 1:2025)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Anästhesie-Arbeitsplätzen (ISO 80601-2-13:2022/DAM 1:2025)
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/DAM 1:2025)
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/DAM 1:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-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/DAM 1:2025)
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/DAM 1:2025)
Medizinische elektrische Geräte - Teil 2-13: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Anästhesie-Arbeitsplätzen (ISO
80601-2-13:2022/DAM 1:2025)
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/DAM 1:2025)
Ta slovenski standard je istoveten z: EN ISO 80601-2-13:2022/prA1
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 1.2
ISO/TC 121/SC 1
Medical electrical equipment —
Secretariat: DIN
Part 2-13:
Voting begins on:
Particular requirements for basic
2025-09-17
safety and essential performance of
Voting terminates on:
an anaesthetic workstation 2025-11-12
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
Member bodies are requested to consult relevant national interests in IEC/SC AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
62D before casting their ballot to the e-Balloting application.
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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 80601-2-13.2:2022/DAM
1:2025(en)
DRAFT
ISO 80601-2-13.2:2022/DAM 1:2025(en)
Amendment
ISO 80601-2-
13:2022/
DAM 1.2
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
Member bodies are requested to consult relevant national interests in IEC/SC AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
62D before casting their ballot to the e-Balloting application.
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
This document is circulated as received from the committee secretariat.
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
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
ISO/CEN PARALLEL PROCESSING
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
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Reference number
Published in Switzerland ISO 80601-2-13.2:2022/DAM
1:2025(en)
ii
ISO 80601-2-13:2022/DAM 1:2025(en)
21 Foreword
22 ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
23 Commission) form the specialized system for worldwide standardization. National bodies that are
24 members of ISO or IEC participate in the development of International Standards through technical
25 committees established by the respective organization to deal with particular fields of technical activity.
26 ISO and IEC technical committees collaborate in fields of mutual interest. Other international
27 organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
28 work.
29 The procedures used to develop this document and those intended for its further maintenance are
30 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
31 different types of document should be noted. This document was drafted in accordance with the editorial
32 rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives or
33 www.iec.ch/members_experts/refdocs).
34 Attention is drawn to the possibility that some of the elements of this document may be the subject of
35 patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent rights. Details
36 of any patent rights identified during the development of the document will be in the Introduction and/or
37 on the ISO list of patent declarations received (see www.iso.org/patents) or the IEC list of patent
38 declarations received (see patents.iec.ch).
39 Any trade name used in this document is information given for the convenience of users and does not
40 constitute an endorsement.
41 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
42 expressions related to conformity assessment, as well as information about ISO's adherence to the World
43 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
44 www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
45 Amendment 1 to ISO/IEC 80601-2-13:2022 was prepared jointly by Technical Committee ISO/TC 121,
46 Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic
47 machines, and Technical Committee IEC/TC 62 Electrical equipment in medical practice, Subcommittee SC
48 62D Electromedical equipment, in collaboration with the European Committee for Standardization (CEN)
49 Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
50 Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
51 A list of all parts in the ISO 80601 and the IEC 80601 series can be found on the ISO and IEC websites.
52 Any feedback or questions on this document should be directed to the user’s national standards body. A
53 complete listing of these bodies can be found at www.iso.org/members.html and www.iec.ch/national-
54 committees.
iii
Internal
ISO 80601-2-13:2022/DAM 1.2:2025(en)
56 Medical electrical equipment —
57 Part 2-13:
58 Particular requirements for basic safety and essential
59 performance of an anaesthetic workstation
60 AMENDMENT 1
61 Foreword
62 Replace the text of the third dash by the following:
63 - consideration of anaesthetic workstations using Oxygen 90+;
64 201.2
65 Add the following reference:
66 ISO 20417:2021, Medical devices - Information to be supplied by the manufacturer
67 201.3
68 Add the following terms and definitions:
69 201.3.239
70 essential function
71 function or capability that is required to maintain basic safety, essential performance, a minimum of
72 clinical functionality as specified by the manufacturer, and operational availability for the medical
73 device
74 NOTE 1 to entry: Essential functions include, but are not limited to, the safety instrumented function (basic
75 safety and essential performance), the control function and the availability of urgently needed functions and
76 such allowing the operator to view and manipulate the medical device safely with the most urgently needed
77 performance (operational availability). The loss of essential function is commonly termed loss of protection,
78 loss of control and loss of view respectively.
79 NOTE 2 to entry: The term is derived from IEC 62443-4-2:2019, 3.1.20, and has been refined for the purpose
80 and scope of this document.
81 [SOURCE: IEC/TR 60601-4-5:2021, 3.10]
82 201.3.240
83 firecall
84 method established to provide emergency access to a secure medical device
85 NOTE 1 to entry: In an emergency situation, unprivileged users can gain access to key systems to correct the
86 problem. When a firecall is used, there is usually a review process to ensure that the access was used properly
87 to correct a problem. These methods generally either provide a one-time use user identifier (ID) or one-time
88 password or other suitable measures.
89 NOTE 2 to entry: Also referred to as "break glass" feature.
90 [SOURCE: IEC/TR 60601-4-5:2021, 3.11]
ISO 80601-2-13:2022/DAM 1.2:2025(en)
91 *201.3.241
92 interchangeable AGSS
93 anaesthetic gas scavenging system that by design is intended to be used with different models and
94 manufacturers’ anaesthetic workstations
95 NOTE 1 to entry: Connections of interchangeable AGSSs can be non-operator detachable.
96 201.3.242
97 Oxygen 90+ (O 90+)
98 a gas mixture that meets the following criteria for composition:
99 - Oxygen (O₂): volume fraction of no less than 90%
100 - Argon (Ar): volume fraction of no more than 5%
101 - Nitrogen (N₂): volume fraction of no more than 10%
102 - Carbon dioxide (CO₂): volume fraction of less than 300 ppm
103 - Carbon monoxide (CO): volume fraction of less than 10 ppm
104 - Nitrogen oxides (NOx): volume fraction of less than 2 ppm
105 - Sulfur dioxide (SO₂): volume fraction of less than 1 ppm
106 - Water (H₂O): volume fraction of less than 67 ppm
107 - Oils: less then 0.1 mg/m
108 NOTE 1 to entry: Regional or national regulations might specify the colour coding for Oxygen 90+.
109 [SOURCE: ISO/DIS 4135 Amd1:-, 3.1.1.22.2]
110 201.3.243
111 security level
112 level corresponding to the required set of countermeasures and inherent cybersecurity properties
113 of devices and systems for a zone or conduit based on assessment of risk for the zone or conduit
114 [SOURCE: IEC/TR 60601-4-5:2021, 3.23]
115 201.3.244
116 SL-T
117 Target Security Levels (SL-T) are the desired level of security for a particular system. This is usually
118 determined by performing a risk assessment on a system and determining that it needs a particular
119 level of security to ensure its correct operation
120 [SOURCE: ISO 602443-3-3:2013, 3.3]
121 201.3.245
122 system recovery
123 method for fault handling via an automatic restart of programmable electronic subsystem (PESS) for
124 parts of the ME equipment or for the complete ME equipment
125 NOTE 1 to entry: There is guidance or rationale for this definition contained in Clause AA.
126 [SOURCE: ISO 80601-2-12:2023, 201.3.298]
ISO 80601-2-13:2022/DAM 1.2:2025(en)
127 201.3.246
128 waste volatile anaesthetic agent capture system
129 system that collects and stores waste volatile anaesthetic agents from the exhaust port of a breathing
130 system
131 201.4
132 Add the following subclause:
133 201.4.3.101 System recovery
134 NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.
135 a) Following a malfunction, the anaesthetic workstation should perform a system recovery to attempt
136 to restore essential performance of the anaesthetic workstation.
137 NOTE 2 An anaesthetic workstation or a subassembly function can become disturbed by a malfunction that
138 could jeopardize the essential performance of the anaesthetic workstation. Without system recovery, the patient
139 would have to be disconnected and connected to an alternative means of ventilation or gas delivery. Ventilation
140 or gas delivery would thus be interrupted until an alternative means of ventilation or gas delivery is connected.
141 System recovery, as specified in this subclause, attempts to automatically re-establish ventilation or gas delivery
142 in a shorter period. If necessary, the anaesthetic workstation can be replaced later when it has fewer
143 consequences for the patient´s therapy.
144 b) System recovery may result in the temporary:
145 1) cessation in the ventilation or gas delivery leading to risk of harm; or
146 2) reduction in the function of anaesthetic workstation subassemblies without cessation of
147 ventilation or gas delivery.
148 EXAMPLE The temporary blanking of the display.
149 c) During a system recovery with a cessation of ventilation or gas delivery that could lead to a
150 hazardous situation:
151 1) the anaesthetic workstation shall allow spontaneous patient breathing. Manual ventilation shall
152 be available within 15 s in accordance with 201.102.12; and
153 NOTE 3 During a system recovery, there can be a short period where manual ventilation is not possible
154 because the pneumatic system may have to be restarted by the anaesthetic workstation.
155 2) the anaesthetic workstation shall be equipped with an alar
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.