SIST EN ISO 80601-2-13:2022/oprA1:2025

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
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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
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WHICH REFERENCE MAY BE MADE IN
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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 alarm system to indicate system recovery
156 with a cessation of ventilation or gas delivery.
157 i) The alarm condition for a system recovery with a cessation of ventilation or gas delivery
158 shall be high priority or may be an alternative alarm signal. The type of alternative
159 alarm signal or alarm condition delay and alarm signal generation delay for the alarm
160 signal shall be documented in the risk management file.
161 d) During a system recovery without a cessation of ventilation or gas delivery, the anaesthetic
162 workstation shall be equipped with an alarm system to indicate system recovery without a
163 cessation of ventilation or gas delivery.
164 1) The alarm condition for system recovery without a cessation of ventilation or gas delivery shall
165 be at least low priority with an auditory alarm signal or may be an alternative alarm signal. The
166 type of alternative alarm signal or alarm condition delay and alarm signal generation delay for
167 the alarm signal shall be documented in the risk management file.
ISO 80601-2-13:2022/DAM 1.2:2025(en)
168 e) Following a system recovery without operator intervention, the anaesthetic workstation shall
169 attempt to operate with the same system configuration settings, ventilation or gas delivery
170 settings and alarm settings as before the system recovery.
171 1) If ventilation settings, gas delivery settings or alarm settings are different after the system
172 recovery, the anaesthetic workstation alarm system shall indicate any change in settings.
173  2)   The alarm generated shall be at least medium priority.
174 f) The duration of a system recovery with a cessation of ventilation or gas delivery should be as short
175 as practicable to avoid an unacceptable risk to the patient and shall be documented in the risk
176 management file.
177 g) The maximum duration of a system recovery of ventilation or gas delivery shall be disclosed in the
178 instructions for use.
179 Check conformance by inspection of the instructions for use, inspection of the risk management file and
180 functional testing.
181 201.4
182 Add the following subclause:
183 201.4.5 Alternative risk control measures or test methods for ME equipment or ME system
184 Amendment (add prior to the compliance check):
185 aa) Subsequent revisions of dated references (new editions or amendments) may be used in
186 substitution of a referenced document provided the manufacturer can demonstrate the hazard or
187 hazardous situation addressed in the dated normative reference is adequately resolved in the
188 subsequent revision.
189 201.4.10.101*
190 Add the following new NOTE below NOTE 2:
191 NOTE 3 Anaesthetic workstations can provide the supply gas to drive other devices such as high flow
192 therapy, oxygen flow meters or suction equipment. See also 201.7.9.2.101 qq).
193 201.5.101.4
194 Replace the text of the second dash:
195  with Oxygen 90+ if the anaesthetic workstation is rated compatible or conditionally
196 compatible with Oxygen 90+.
197 Replace the third dash by a NOTE:
198 NOTE The concentration of oxygen and balance gases can vary over time in a gas supply with Oxygen 90+.
199 201.7
200 Add the following subclause:
201 201.7.1.101 Information to be supplied by the manufacturer
202 The information supplied by the manufacturer including marking, labelling and instructions for use
203 shall conform with ISO 20417:2021.
ISO 80601-2-13:2022/DAM 1.2:2025(en)
204 Check conformance by application of ISO 20417:2021.
205 201.7.2.21*
206 Replace the existing text by:
207 This subclause does not apply.
208 201.7.2.101
209 Delete this subclause completely.
210 201.7.2.104
211 Delete this subclause completely.
212 201.7.2
213 Add the following subclause:
214 201.7.2.107 Oxygen 90+
215 The anaesthetic workstation and its components shall be marked whether it is compatible,
216 conditionally compatible or incompatible with Oxygen 90+. A workstation that can be used with
217 Oxygen 90+ with restrictions shall be rated conditionally compatible with Oxygen 90+, see
218 201.7.9.2.101, ii).
219 An Oxygen 90+ compatibility marking shall be placed on the anaesthetic workstation, next to the gas
220 supply connectors. A single marking is sufficient to cover all components that are described in the
221 instructions for use of the anaesthetic workstation.
222 NOTE Symbols for the marking of compatibility with Oxygen 90+ will be defined in ISO 7000.
223 201.7.9.1
224 Replace the existing text by:
225 This subclause does not apply.
226 201.7.9.2.101
227 Replace the text in list item ii) with the following:
228 ii)
229 — the type of oxygen the anaesthetic workstation or its individual components are compatible with
230 (oxygen or Oxygen 90+) and;
231 — if the anaesthetic workstation or its components is rated conditionally compatible with Oxygen 90+,
232 a description of the conditions under which it can be used with Oxygen 90+ and;
233 — if the anaesthetic workstation or its components is rated conditionally compatible or compatible with
234 Oxygen 90+, the gas composition of Oxygen 90+ as defined in 201.3.245;
235 Replace the text in list item jj) with the following:
236 jj) if the anaesthetic workstation or its individual components is rated conditionally compatible or
237 compatible for use with Oxygen 90+, the consequences of the use of Oxygen 90+, e.g. possible argon
238 accumulation and varying oxygen concentrations;
ISO 80601-2-13:2022/DAM 1.2:2025(en)
239 Add the following list items and NOTE below oo)*:
240 pp) list of any component or function that is pneumatically powered, the type of gas needed and its
241 consumption of gas in l/min;
242 qq) a description of those components that are pneumatically powered that cannot be used in
243 parallel;
244 NOTE If too many devices are used in parallel the pressure supply to the anaesthetic workstation can be
245 overloaded.
246 201.9.2.103*
247 Delete this subclause completely.
248 201.9.2.104*
249 Delete this subclause completely.
250 201.12.4.101*
251 Replace the text in list item a) by the following:
252 a) A means of protection against accidental adjustment of operating controls that can create a
253 hazardous situation shall be provided. This includes:
254  deactivating fresh gas flow to a patient permanently (i.e. not reactivating without user
255 interaction);
256  deactivating the anaesthetic vapour delivery system permanently (i.e. not reactivating
257 without user interaction);
258  activating the standby mode of an anaesthetic workstation;
259  accidental turning off of the anaesthetic workstation or its individual components.
260 The means for preventing an accidental adjustment shall be single fault safe.
261 The means preventing the accidental adjustment as listed above shall be analysed and documented
262 in the risk management file.
263 EXAMPLE 1 Requiring a confirmation step can be one method. The same confirmation step as for any
264 other adjustment might not be appropriate.
265 NOTE 1  Logging of each single operator adjustment leading to permanent deactivation of fresh gas
266 flow or vapour delivery, activation of the standby mode or turning off the anaesthetic workstation or its
267 individual components can help investigating adverse events.
268 NOTE 2 Detecting patient breathing activity during standby or when no fresh gas is being delivered
269 to the patient and announcing an alarm signal (e.g. optical and acoustical with a high volume level) can help to
270 prevent adverse outcomes in such situations.
271 Add list item d) before the conformance check:
272 d) If an anaesthetic workstation is equipped with a manual configuration for use with Oxygen 90+,
273 the configuration shall be protected from unintended use.
274 NOTE 3 The configuration can be protected e.g. by the use of a password. A configuration that does not match the
275 input oxygen supply can increase inaccuracy or may lead to unexpected behaviour.
ISO 80601-2-13:2022/DAM 1.2:2025(en)
276 201.12.4.102*
277 Replace the text in the last row for subclause 201.12.4.108 of Table 201.104 by the following:
278 protection device for the workplace environment (AGSS) if the anaesthetic workstation is equipped
279 with means to deliver nitrous oxide or is designed to be equipped with an anaesthetic vapour delivery
280 system
281 201.12.4.104
282 Add the following text:
283 Anaesthetic workstations equipped with an anaesthetic ventilator shall have a means to monitor the
284 exhaled volume.
285 201.12.4.104.1*
286 Replace Table footnote a in Table 201.105 by the following:
287  a V  is measured by means of a pressure sensor at the test lung, where
T
288   V = C x (P - P ) and
T insp exp
289  V is the volume delivered to the test lung
T
290  C is the Compliance of the test lung
291  P is the inspiratory pressure measured in the test lung
insp
292  P is the expiratory pressure measured in the test lung
exp
294 201.12.4.107.3*
295 Replace the text of the NOTE by the following:
296 NOTE Oxygen 90+ can have major influence on the output of a hypoxic mixture delivery selection
297 protection device, as the supply oxygen and balance gas concentrations can vary simultaneously.
298 201.12.4.108*
299 Replace the first paragraph by the following text:
300 If the anaesthetic workstation is equipped with means to deliver nitrous oxide or is designed to be
301 equipped with an anaesthetic vapour delivery system, the anaesthetic workstation shall either
302 201.12.4.109
303 Replace list item a) 2) by the following text:
304 2) if not so equipped, the instructions for use of the anaesthetic workstation shall contain a
305 statement to the effect that the anaesthetic workstation is to be provided with airway pressure
306 monitoring equipment conforming with this document before being put into service; also, it shall
307 describe how to connect that component. Manufacturers of the airway pressure monitoring
308 equipment shall make available on request information on how to connect that component to the
309 anaesthetic workstation, the anaesthetic breathing system and the anaesthetic ventilator.
310 201.14.101
ISO 80601-2-13:2022/DAM 1.2:2025(en)
311 Replace the headline of this subclause by:
312 201.14.101 Software life cycle
313 Delete the EXAMPLE.
314 Replace the second paragraph with the following:
315 Check conformance by inspection of the documentation required by IEC 62304:2006+AMD1:2015 for
316 the software safety class C (see IEC 62304:2006+AMD1:2015, 1.4).
317 201.14
318 Add the following subclause:
319 201.14.102 Cybersecurity capabilities of an anaesthetic workstation
320 a) An anaesthetic workstation should contribute to the safe operation related to cybersecurity.
321 b) Risk control measures as specified in IEC/TR 60601-4-5:2021, Clauses 4 to 7, should be implemented, as
322 appropriate, with the following additions to IEC/TR 60601-4-5:2021, 4.6.3.
323 1) Essential function: Data interfaces to an IT-network connection may be subject to attack (via
324 physical or logical disconnection). After disconnection of all data interfaces, if it is necessary to
325 restart the anaesthetic workstation, all clinical functions except the affected remote functionality
326 should be in place and operate as intended.
327 2) Firecall functions: As an anaesthetic workstation is used with healthcare professional operator
328 supervision, the user interface need not require authentication for operators and thus need not
329 require firecall functions. If authentication for operators to operator accessible settings is in place
330 also for the user interface, a firecall function should be able to overrule that operator
331 authentication combined with a log entry protected against modifications by the operator (i.e.
332 responsible organization log). IT-network interfaces including those for remote access typically
333 require authentication but should not include firecall functions.
334 3) Target security level SL-T: For user interfaces and for remote setting of clinical functions, the
335 expected security level of SL-T, as specified in IEC/TR 60601-4-5:2021, is 1 or better.
336 Authentication is not required for operators of the user interface of the anaesthetic workstation.
337 Authentication is required for remote access through a data interface. The expected security
338 level of SL-T, as specified in IEC/TR 60601-4-5:2021, is 2 or better for secure updates or
339 restorage of software, remotely or locally.
340 201.101.4.2.1
341 Add the following NOTE after item b):
342 NOTE It can be sufficient to use an Oxygen connector if the device is rated compatible or conditionally
343 compatible with Oxygen 90+.
344 201.101.6.1
345 Replace the text of list item c) by the following:
346 c) The accuracy of the graduations of any flowmeter or flow rate adjustment control used in the
347 anaesthetic gas delivery system shall be:
ISO 80601-2-13:2022/DAM 1.2:2025(en)
348 — within ±10 % of the indicated value for flow rates between 10 % and 100 % of full scale with pure
349 oxygen
350 — within ±15 % of the indicated value for flow rates between 10 % and 100 % of full scale with Oxygen
351 90+
352 when discharged into the ambient atmosphere (see 201.5.101.2).
353 201.101.7
354 Replace the text of the first paragraph by the following:
355 At any flow rate and supply pressure given in normal use, the oxygen concentration shall be:
356 — within ±5 % volume fraction of the set or indicated value for an anaesthetic workstation which is
357 designed or configured for use with pure oxygen;
358 — within ± (5 % volume fraction or 10 % of the set or indicated value, the higher value applies), of the
359 set or indicated value with Oxygen 90+ for an anaesthetic workstation which has a configuration for
360 use with Oxygen 90+;
361 — within +5 % volume fraction, -(5 % volume fraction or 15 % of the set or indicated value, the higher
362 value applies) of the set or indicated value with Oxygen 90+ for an anaesthetic workstation which has
363 no configuration for use with Oxygen 90+.
364 201.102.1.1.1
365 Delete this subclause completely.
366 201.102.1.1.3
367 Replace the text of the third dash by the following:
368 — the symbols shown in Figure 201.102 (symbols ISO 7000-3902 and ISO 7000-3903, see Table
369 201.D.2.101, symbol No. 10 and symbol No. 11).
370 Add the following Figure as Figure 201.102:

a)  Symbol for marking “on” b)  Symbol for marking “off”
371 Figure 201.102 — Absorbent bypass control markings
372 201.102.1.2
373 Replace list item c) by the following text:
374 c) information on how to connect the anaesthetic breathing system;
375 Replace list item f) by the following text:
376 f) information on any means of pressure relief, including pressure/flow rate
377 characteristics measured with air under STPD conditions;
ISO 80601-2-13:2022/DAM 1.2:2025(en)
378 Replace list item j) by the following text:
379 j) instructions for use of exhaust valves not integrated into the anaesthetic breathing
380 system, which shall describe the pressure/flow-rate characteristics of the exhaust valve
381 including the opening pressure and the pressure drop at a flow rate of 30 l/min air
382 under STPD conditions;
383 Replace list item l) by the following text:
384 l) for breathing system components intended to be assembled by the operator, the
385 resistance at 2,5 l/min, 15 l/min and 30 l/min measured with air under STPD
386 conditions; and compliance of those components;
387 Replace list item n) by the following text:
388 n) the inspiratory and expiratory pressure/flow rate characteristics of the anaesthetic
389 breathing system, including the pressure at
390 — 30 l/min if the anaesthetic breathing system is intended for adult patients;
391 — 15 l/min if the anaesthetic breathing system is intended for paediatric patients;
392 — 2,5 l/min if the anaesthetic breathing system is intended for neonatal patients;
393 at a fresh gas flow rate of (10 ± 1) l/min air under STPD conditions; and state that the data is
394 generated using air under STPD conditions;
395 Replace list item p) 2) by the following text:
396 p) 2) a method for the operator to test an anaesthetic breathing system for maximum pressure
397 fluctuation at the patient connection port for spontaneous breathing mode and inspiratory
398 and expiratory breathing phases of automatic ventilation;
399 — for changes of fresh gas flow
400 — for the use of oxygen flush;
401 NOTE By using this method the operator can determine if an anaesthetic breathing system is suitable for a
402 patient.
403 201.102.2.2
404 Replace the headline of this subclause by:
405 201.102.2.2 * Adjustable pressure limit protection devices
406 Replace list item a) 2) by the following text:
407 a) 2) if not so equipped, the instructions for use of the anaesthetic breathing system shall
408 contain a statement to the effect that the anaesthetic breathing system is to be provided
409 with a protection device to limit the pressure at the patient connection port to an operator-
410 adjustable pressure conforming with this document before the anaesthetic breathing
411 system is put into service and shall describe how to connect that component to the
412 anaesthetic workstation available (e.g. in integration instructions) upon request.
413 Replace list item b) 2) by the following text:
414 b) Adjustable pressure limit protection devices shall ensure that under normal condition the
415 pressure at the patient connection port does not exceed the operator-set maximum value by
416  1) during any automatic ventilation mode:
ISO 80601-2-13:2022/DAM 1.2:2025(en)
417 — more than 15 % or 10 hPa (10 cmH2O), whichever is greater, with a fresh gas flow of
418 air ≤ 25 l/min (STPD conditions);
419 — more than 20 % or 15 hPa (15 cmH2O), whichever is greater, with 5 l/min fresh gas
420 flow of air (STPD conditions) and the maximum oxygen flush of the anaesthetic
421 workstation;
422  2) during manual or spontaneous ventilation mode:
423 — more than 15 % or 10 hPa (10 cmH2O), whichever is greater, with a fresh gas flow of
424 air ≤ 25 l/min (STPD conditions);
425 — more than 20 % or 20 hPa (20 cmH2O), whichever is greater, with 5 l/min fresh gas
426 flow of air (STPD conditions) and the maximum oxygen flush of the anaesthetic
427 workstation.
428 NOTE 1 25 l/min is considered to be a maximum continuous fresh gas flow.
429 NOTE 2 During automatic ventilation, the O2 flush is not synchronized with an inspiration or expiration
430 phase. During manual ventilation, the operator presses the breathing bag to apply an inspiratory breathing
431 stroke and would have to press the O2 flush at the same time to cause an increase of pressure to the given
432 maximum pressure.
433 NOTE 3 The maximum O2 flush can be 75 l/min Oxygen or Oxygen 90+ (STPD conditions) or can be limited
434 to a lower value if the anaesthetic gas delivery system is integrated in the anaesthetic workstation.
435 NOTE 4 A fresh gas flow of 5 l/min is considered to be a high but reasonable fresh gas flow for an adult
436 with a minute volume of 5 l/min in automatic and manual ventilation (see table 201.105).
437 Check conformance by functional testing and, if applicable, by inspection of the instructions for use.
438 201.102.4
439 Delete this subclause completely.
440 201.102.5.1
441 Replace the first paragraph by the following text:
442 The patient connection port shall be a coaxial 22 mm cone/15 mm socket or a 15 mm socket
443 connector complying with ISO 5356-1:2015. The patient connection port may swivel.
444 201.102.5.2
445 Replace list item b) and the last paragraph by the following text:
446 b) have a 30 mm cone conforming with ISO 5356-1:2015 with a means to prevent
447 connection of the orifice to any anaesthetic breathing system port or component.
448 Check conformance by inspection of the manufacturer´s technical documentation.
449 201.102.5.3.1
450 Replace the last paragraph by the following text:
451 Check conformance by inspection.
452 Replace Figure 201.102 with the following Figure and renumber as Figure 201.103:
ISO 80601-2-13:2022/DAM 1.2:2025(en)

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

453 Figure 201.103 — Schematic representation of the connectors and the arrangement of the
454 breathing system in relation to the type of reservoir bag connection port
455 201.102.5.3.2
456 Replace the first paragraph by the following text:
457 The reservoir bag connection port shall be marked with the word “bag” or the equivalent in a
458 language that is acceptable to the intended operator, or symbol ISO 7000-3904 (see Figure
459 201.104 and Table 201.D.2.101 No. 12).
461 Add the following Figure as Figure 201.104:
464 Figure 201.104 — Symbol for the reservoir bag connection port
465 201.102.5.4
466 Replace the text in the subclause by the following text:
467 Anaesthetic ventilators that are operator-detachable, i.e. without the use of a tool and not intended to
468 be directly connected to a breathing set shall not engage with connectors conforming with
469 ISO 5356-1:2015 and breathing tubes conforming with ISO 5367:2023.
470 NOTE Breathing sets are defined in ISO 5367:2023.
471 Check conformance by inspection, functional testing and application of the tests of ISO 5356-1:2015,
472 ISO 5356-2:2015+AMD1:2019 and ISO 5367:2023.
ISO 80601-2-13:2022/DAM 1.2:2025(en)
473 201.102.5.5
474 Replace the text in the subclause by the following text:
475 If an anaesthetic breathing system is operator-detachable without the use of a tool, it shall be a fitting
476 that does not engage with connectors conforming with ISO 5356-1:2015 and breathing tubes
477 conforming with ISO 5367:2023.
478 NOTE This does not apply to the inspiratory and expiratory port connectors. See 201.102.5.6.
479 Check conformance by inspection of the manufacturer´s technical documentation.
480 201.102.5.6
481 Replace the second paragraph by the following text:
482 Check conformance by inspection of the manufacturer’s technical documentation.
483 201.102.5.7
484 Replace the headline of this subclause by:
485 201.102.5.7 Access ports for breathing sets
487 Replace the text in the subclause by the following text:
488 a) Access ports shall be socket (female) L2 Luer lock connectors complying with ISO 80369-7:2021.
489 NOTE These ports provide access to the gas within the breathing set for the purposes of:
490 i) monitoring the composition and the pressure of the breathing gas, and
491 ii) administering a drug into the breathing system via a hypodermic syringe.
492 b) Access ports shall be provided with a means to prevent leakage to the atmosphere when not in
493 use. If the means is via a cap or plug, the cap or plug shall be captive.
494 c) Access ports should be marked with the appropriate words or symbol, e. g.
495 1) “access port” or IEC 60417-5448; or
496 2) “sample port” or ISO 7000-0795; or
497 3) “input port” or ISO 7000-0794.
498     d) Include in the instructions for use a Warning to the effect: “As this [insert name of medical device
499 here] uses a Luer connector for other than intravascular or hypodermic access, there is a possibility
500 that an inadvertent connection can occur between this [insert name of medical device here] and
501 another medical device or accessory using a Luer connector, which can result in a hazardous situation
502 causing harm to the patient.”
503 Check conformance by visual inspection and functional testing.
504 201.102.5
ISO 80601-2-13:2022/DAM 1.2:2025(en)
505 Add the following subclause:
506  201.102.5.8 Sampling gas return ports
507 a) Sampling gas return ports shall not engage with connectors as specified in ISO 5356-1:2015 or ISO
508 80369-7.
509 b) Sampling gas return ports shall be provided with a means to prevent leakage to atmosphere when
510 not in use. If this means is via a cap or plug, the cap or plug shall be captive.
511 c) Sampling gas return ports shall be marked with the words “gas return” or symbol ISO 7000-0794.
512 Check conformance by visual inspection and functional testing.
513 201.102.8.1
514 Replace list item b) and the last paragraph by the following text:
515 b) other connectors compatible with a breathing tube conforming with ISO 5367:2023.
516 Check conformance by inspection and application of the tests of ISO 5356-1:2015.
517 201.102.8.3
518 Replace the text in the subclause by the following text:
519 a) Breathing tubes shall comply with ISO 5367:2023.
520 b) Breathing tubes connecting the patient with the inspiratory and expiratory port connectors of a
521 circle absorber assembly shall prevent a misconnection of the patient or make it detectable.
522 This may be achieved by e.g.
523 1)  a pre-assembled set of breathing tubes that cannot be disassembled by the operator (this includes
524 e. g. co-axial systems, double-D-systems)(see Figure 201.105.1);
525 2) creating a fixed connection of both ends of a pair of breathing tubes, where the distance between
526 the ends of this pair of breathing tubes then shall not exceed 300 mm (see Figure 201.105.2).
527 Add the following Figure and key as Figure 201.105.1
530 a) correct connection
ISO 80601-2-13:2022/DAM 1.2:2025(en)
532 b) Incorrect connection
534 c) Incorrect connection
536 Key to a) and b) and c)
537 1 Patient interface device (e.g. tracheal tube, facemask) with a 15 mm cone or 22 mm socket connector
538 2 Inspiratory breathing tubes with 22 mm sockets on both ends
539 3 Expiratory breathing tubes with 22 mm sockets on both ends
540 4 Anaesthetic workstation
541 5 A permanent connection between the T-piece and expiratory breathing tube prevents incorrect
542 connection
543 Figure 201.105.1 — pre-assembled set of breathing tubes that cannot be disassembled by the
544 operator
546 Renumber Figure 201.103 as Figure 201.105.2
548 Renumber the following Figures throughout the text.
549 201.102.10
550 Replace the thirdline in the text of the Key of Figure 201.104 by the following text:
551 3 rigid container (optional)
553 201.102.11
554 Replace the text in the subclause by the following text:
555 An operator-accessible fresh-gas inlet should have a means to prevent unintentional disconnection.
556 In a circle absorber assembly, the fresh-gas inlet should be placed between the absorbent container
557 and the inspiratory valve.
ISO 80601-2-13:2022/DAM 1.2:2025(en)
558 201.103.1.1
559 Add the following items below EXAMPLE 2:
560 c) Interchangeable AGSS´s shall be marked with the symbol for the mandatory action: “Refer to
561 instruction manual/booklet”, given in IEC 60601-1:2005+AMD1:2012+AMD2:2020, Table D.2,
562 number 10).
563 d) Interchangeable AGSS´s shall be marked with symbol 6, 7, 8 or 9 as appropriate, according to Table
564 201.D.2.101
565 201.103.1.2
566 Add the following below item b):
567 c) Information on whether or not an interchangeable AGSS or its individual components and
568 accessories can be used in a magnetic resonance imaging (MRI) environment and any related
569 restrictions and, where applicable, the maximum safe magnetic field strength.
570 201.103.3.1.1
571 Replace the t
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