oSIST prEN ISO 18730:2026

SLOVENSKI STANDARD
01-marec-2026
Anestezijska in dihalna oprema - Sistemi za zajem odpadnih hlapnih anestetikov
(ISO/DIS 18730:2026)
Anaesthetic and respiratory equipment - Waste volatile anaesthetic agent capture
systems (ISO/DIS 18730:2026)
Anästhesie- und Beatmungsgeräte - Systeme zum Auffangen von gebrauchten
flüchtigen Anästhesiemitteln (ISO/DIS 18730:2026)
Matériel d'anesthésie et de réanimation respiratoire - Systèmes de capture d'agents
anesthésiques volatils résiduels (ISO/DIS 18730:2026)
Ta slovenski standard je istoveten z: prEN ISO 18730
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.

DRAFT
International
Standard
ISO/DIS 18730
ISO/TC 121/SC 1
Anaesthetic and respiratory
Secretariat: DIN
equipment — Waste volatile
Voting begins on:
anaesthetic agent capture systems
2026-01-13
Matériel d'anesthésie et de réanimation respiratoire — Systèmes
Voting terminates on:
de capture des déchets d'agents anesthésiques volatils
2026-04-07
ICS: 11.040.10
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Reference number
ISO/DIS 18730:2026(en)
DRAFT
ISO/DIS 18730:2026(en)
International
Standard
ISO/DIS 18730
ISO/TC 121/SC 1
Anaesthetic and respiratory
Secretariat: DIN
equipment — Waste volatile
Voting begins on:
anaesthetic agent capture systems
Matériel d'anesthésie et de réanimation respiratoire — Systèmes
Voting terminates on:
de capture des déchets d'agents anesthésiques volatils
ICS: ISO ics
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 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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Published in Switzerland Reference number
ISO/DIS 18730:2026(en)
ii
ISO/DIS 18730:2026(en) ISO 18730 (X)
13 Contents
14 Foreword .iv
15 Introduction . v
16 1 Scope . 1
17 2 Normative references . 1
18 3 Terms and definitions . 1
19 4 General . 5
20 4.1 Risk management . 5
21 4.2 Usability . 5
22 4.3 Mechanical and electrical safety . 6
23 4.4 Test conditions . 6
24 5 Materials . 6
25 5.1 General . 6
26 5.2 Fire prevention . 6
27 5.3 Influences on other devices. 6
28 6 Design . 7
29 6.1 General . 7
30 6.2 Leakage and spillage . 7
31 6.3 Back pressure . 9
32 6.4 Hose assemblies . 9
33 6.5 Connectors . 9
34 6.6 Agent capture media . 9
35 7 Information to be supplied by the manufacturer . 10
36 7.1 General . 10
37 7.2 Marking . 10
38 7.3 Instructions for use . 10
39 7.4 Technical file . 11
40 Annex A (informative) Rationale . 12
41 Annex B (informative)  Hazards associated with waste volatile anaesthetic agent capture
42 systems . 15
43 Bibliography . 16
© ISO #### – All rights reserved iii
iii
ISO 18730 (X) ISO/DIS 18730:2026(en)
45 Foreword
46 ISO (the International Organization for Standardization) is a worldwide federation of national standards
47 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
48 through ISO technical committees. Each member body interested in a subject for which a technical
49 committee has been established has the right to be represented on that committee. International
50 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
51 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
52 electrotechnical standardization.
53 The procedures used to develop this document and those intended for its further maintenance are
54 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
55 different types of ISO documents should be noted. This document was drafted in accordance with the
56 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
57 Attention is drawn to the possibility that some of the elements of this document may be the subject of
58 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
59 patent rights identified during the development of the document will be in the Introduction and/or on
60 the ISO list of patent declarations received (see www.iso.org/patents).
61 Any trade name used in this document is information given for the convenience of users and does not
62 constitute an endorsement.
63 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
64 expressions related to conformity assessment, as well as information about ISO's adherence to the World
65 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
66 www.iso.org/iso/foreword.html.
67 This document was prepared by Technical Committee ISO/TC 121 anaesthetic and respiratory equipment,
68 Subcommittee SC 1, Breathing attachments and anaesthetic machines.
69 Any feedback or questions on this document should be directed to the user’s national standards body. A
70 complete listing of these bodies can be found at www.iso.org/members.html.

iv © ISO #### – All rights reserved
iv
ISO/DIS 18730:2026(en) ISO 18730 (X)
71 Introduction
72 Volatile anaesthetic agents and some anaesthetic gases (e.g. nitrous oxide) have, for some time, been
73 considered pollutants within the operating room environment and have therefore been extracted out of
74 the operating room and into the atmosphere via anaesthetic gas scavenging systems (AGSS). These volatile
75 anaesthetic agents and anaesthetic gases are now recognised as a significant cause of pollution of the
76 atmosphere.
78 In an attempt to address atmospheric contamination, some waste volatile anaesthetic agent capture
79 systems have appeared on the market. Some of these systems enable reuse of the waste volatile
80 anaesthetic agents. However, some of these systems collect only part of the expired waste volatile
81 anaesthetic agent, and spill the remainder into the operator environment.
83 This document aims to provide requirements for waste volatile anaesthetic agent capture systems that
84 reduce pollution both in the operator environment and in the general atmosphere and describes test
85 methods to ensure performance and safety.
87 Please note that even if these systems capture all of the exhaust volatile anaesthetic agents, there will still
88 be some pollution of the operator environment due to the leaks from the breathing circuit and patient
89 uptake of volatile anaesthetic agents.The International Organization for Standardization (ISO) draws
90 attention to the fact that it is claimed that compliance with this document may involve the use of a patent.
91 ISO takes no position concerning the evidence, validity and scope of this patent right.
92 The holder of this patent right has assured ISO that he/she is willing to negotiate licences under
93 reasonable and non-discriminatory terms and conditions with applicants throughout the world. In this
94 respect, the statement of the holder of this patent right is registered with ISO. Information may be
95 obtained from the patent database available at www.iso.org/patents.
96 Attention is drawn to the possibility that some of the elements of this document may be the subject of
97 patent rights other than those in the patent database. ISO shall not be held responsible for identifying any
98 or all such patent rights.
© ISO #### – All rights reserved v
v
ISO/DIS 18730:2026(en) ISO 18730 (X)
99 Anaesthetic and respiratory equipment - Waste volatile
100 anaesthetic agent capture systems
101 1 Scope
102 This document specifies requirements for waste volatile anaesthetic agent capture systems that may or
103 may not include the recycling of the collected volatile anaesthetic agent for reuse.
104 NOTE 1: Waste volatile agent capture systems, that are part of a medical gas pipeline system as specified in ISO
105 7396-1, are outside the scope of this document.
106 NOTE 2: Nitrous oxide is not considered to be a volatile anaesthetic agent.
107 2 Normative references
108 The following documents are referred to in the text in such a way that some or all of their content
109 constitutes requirements of this document. For dated references, only the edition cited applies. For
110 undated references, the latest edition of the referenced document (including any amendments) applies.
111 ISO 5359:2014 +A1:2017, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use
112 with medical gases
113 ISO 20417:2021, Medical devices — information to be supplied by the manufacturer
114 ISO 80601-2-13:2022+A1:202x, Medical electrical equipment — Part 2-13: Particular requirements for
115 basic safety and essential performance of an anaesthetic workstation
116 ISO 80601-2-55:2018, Medical electrical equipment — Part 2-55 Particular requirements for the basic
117 safety and essential performance of respiratory gas monitors
118 IEC 60601-1:2015+A1:2012+A2:2020, Medical electrical equipment — Part 1: General requirements for
119 basic safety and essential performance
120 IEC 60601-1-8:2007+A2:2021, Medical electrical equipment - Part 1-8: General requirements for basic
121 safety and essential performance -Collateral Standard: General requirements, tests and guidance for alarm
122 systems in medical electrical equipment and medical electrical systems
123 3 Terms and definitions
124 For the purposes of this document, the terms and definitions given in ISO 4135:2022 and the following
125 apply.
126 ISO and IEC maintain terminology databases for use in standardization at the following addresses:
127 — ISO Online browsing platform: available at https://www.iso.org/obp
128 — IEC Electropedia: available at https://www.electropedia.org/
129 NOTE: The terms defined in clause 3 are delineated throughout this document in italic type.
130 3.1
131 breathing system
132 pathways through which gas flows at respiratory pressures between the inspiratory port and the exhaust
133 port
134 [SOURCE: ISO 4135:2022, 3.6.1.1, modified - deleted ´and continuously or intermittently in fluid
135 communication with the patient´s respiratory tract during any form of artificial ventilation or respiratory
136 therapy´, deleted notes 1 to 5]
© ISO #### – All rights reserved 1
ISO 18730 (X) ISO/DIS 18730:2026(en)
137 3.2
138 anaesthetic gas scavenging system (AGSS)
139 protection device that is connected to an anaesthetic breathing system (3.1) or to associated equipment
140 for the purpose of conveying excess anaesthetic gas to an appropriate place of discharge
141 [SOURCE: ISO 80601-2-13:2022+A1:20xx, 201.3.207 modified – deleted notes]
142 3.3
143 risk management
144 systematic application of management policies, procedures and practices to the tasks of analysing,
145 evaluating, controlling and monitoring risk
146 [SOURCE: ISO 14971:2019, 3.24]
147 3.4
148 securely attached
149 not detachable without the use of a tool
150 3.5
151 waste volatile anaesthetic agent capture system
152 system that collects and stores waste volatile anaesthetic agents from a breathing system (3.1)
153 3.6
154 active waste volatile anaesthetic agent capture system
155 system including a waste volatile anaesthetic agent capture system in which the exhaust gas is actively
156 discharged from the operating room
157 NOTE 1 to entry: The source of power for discharging the exhaust gas is normally from an active AGSS
158 system.
159 Example 1 to entry:
161 Key:
162 1 Anaesthetic workstation according to ISO 80601-2-13:2022+A1:20xx
163 2 Exhaust of an anaesthetic workstation
164 3 Breathing System
165 4 Capture system
166 5 Active AGSS (as per ISO 80601-2-13: 2022+A1:20xx)
167 6 Infrastructure
168 7 Discharging System
169 8 Optional (0 … n)
170 9 Active AGSS Systems Wall Inlet
171 Figure 1 - System with an active waste volatile anaesthetic agent capture system
172 within the transfer system of an active AGSS
2 © ISO #### – All rights reserved
ISO/DIS 18730:2026(en) ISO 18730 (X)
173 Example 2 to entry:
175 Key:
176 1 Anaesthetic workstation according to ISO 80601-2-13:2022+A1:20xx
177 2 Exhaust of an anaesthetic workstation
178 3 Breathing System
179 4 Active AGSS (as per ISO 80601-2-13: 2022+A1:20xx)
180 5 Capture system
181 6 Infrastructure
182 7 Discharging System
183 8 Optional (0 … n)
184 9 Active AGSS Systems Wall Inlet
185 Figure 2 - System with an active waste volatile anaesthetic agent capture system
186 within the disposal system of an active AGSS
188 Example 3 to entry:
190 Key:
191 1 Anaesthetic workstation according to ISO 80601-2-13:2022+A1:20xx
192 2 Exhaust of an anaesthetic workstation
193 3 Breathing System
194 4 Active AGSS (as per ISO 80601-2-13: 2022+A1:20xx)
195 5 Capture system
196 6 Infrastructure
197 7 Discharging System
198 8 Optional (0 … n)
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ISO 18730 (X) ISO/DIS 18730:2026(en)
199 9 Active AGSS Systems Wall Inlet
200 Figure 3 - System with an active waste volatile anaesthetic agent capture system
201 integrated in an active AGSS; within the AGSS the integration can take place
202 in the transfer line, or the disposal line or within the receiving system
203 3.7
204 passive waste volatile anaesthetic agent capture system
205 system including a waste volatile anaesthetic agent capture system in which the exhaust gas flows into the
206 operating room
207 NOTE 1 to entry: The flow in a passive system relies on the expired flow from the patient and on an excess
208 gas from a medical device or can be based on an active drive to support discharging the exhaust gas from the
209 anaesthetic workstation. The active drive can be part of the capture system (4 in example 1) or the hose (5 in
210 example 2).
211 Example 1 to entry:
213 Key:
214 1 Anaesthetic workstation according to ISO 80601-2-13:2022+A1:20xx
215 2 Exhaust of an anaesthetic workstation
216 3 Breathing System
217 4 Capture system
218 5 Infrastructure
219 6 Discharging System
220 7 Operation Room Ventilation System Inlet
221 Figure - 4 System with a passive waste volatile anaesthetic agent capture system
222 emitting the exhaust gas in the direct vicinity of an anaesthetic workstation
223 Example 2 to entry:
225 Key:
226 1 Anaesthetic workstation according to ISO 80601-2-13:2022+A1:20xx
4 © ISO #### – All rights reserved
ISO/DIS 18730:2026(en) ISO 18730 (X)
227 2 Exhaust of an anaesthetic workstation
228 3 Breathing System
229 4 Capture system
230 5 (flexible) hose
231 6 Infrastructure
232 7 Discharging System
233 8 Operation Room Ventilation System Inlet
235 Figure 5 - System with a passive waste volatile anaesthetic agent capture system
236 routing the exhaust gas away from an anaesthetic workstation to a distal place of discharge
238 3.8
239 interchangeable waste volatile anaesthetic agent capture system
240 waste volatile anaesthetic agent capture system that by design is intended to be used with different models
241 and manufacturers’ anaesthetic workstations
242 NOTE 1 to entry: Connections of interchangeable waste volatile anaesthetic agent capture systems can be non-
243 operator detachable.
244 NOTE 2 to entry: Interchangeable waste volatile anaesthetic agent capture systems can be passive or active.
245 4 General
246 4.1 Risk management
247 Manufacturers shall apply an established risk management process to the design of waste volatile
248 anaesthetic agent capture systems. The risk management process shall include the following elements:
249 — risk analysis;
250 — risk evaluation;
251 — risk control; and
252 — production and post-production information.
253 (EXAMPLE: ISO 14971:2019).
254 NOTE: A list of known hazards associated with waste volatile anaesthetic agent capture systems is given in Annex
255 B.
256 Check conformance by inspection of the manufacturer’s risk management file.
257 4.2 Usability
258 Manufacturers shall apply a usability engineering process to assess and mitigate any risks caused by
259 usability problems associated with correct use (i.e. normal use) and use errors.
260 (Example: IEC 60601-1-6:2010+A1:2013+A2:2020, or IEC 62366-1:2015+A1:2020).
261 Check conformance by inspection of the manufacturer’s usability engineering file.
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ISO 18730 (X) ISO/DIS 18730:2026(en)
262 4.3 Mechanical and electrical safety
263 Waste volatile anaesthetic agent capture systems shall, in addition to the requirements given in this
264 document, meet the relevant requirements for mechanical and electrical safety given in IEC 60601-
265 1:2015 +A1:2012 +A2:2020.
266 Check conformance by inspection of the manufacturer’s technical file.
267 4.4 Test conditions
268 The ambient temperature for the duration of each test should be between 20 °C and 25 °C, except where
269 otherwise stated. Gas flow rate, volume and leakage specifications in this document are expressed at
270 STPD.
271 NOTE: For the purposes of this document, STPD is 101,3 kPa at an operating temperature of 20 °C.
272 Pressure measuring equipment for functional testing shall have a response time of 200 ms maximum
273 (200 ms to reach 90% of the final reading) and a minimum sample rate of 10 ms.
274 5 Materials
275 5.1 General
276 Materials used in the waste volatile anaesthetic agent capture systems shall:
277 a) be compatible with the volatile agents and anaesthetic gases with which they will come into
278 contact and shall be suitable for use in an oxygen rich environment;
279 b) not be detrimentally affected when subjected to cleaning/disinfecting/sterilizing methods and
280 substances with which they can foreseeably come into contact with.
281 Check conformance by inspection of the manufacturer’s risk management file.
282 5.2 Fire prevention
283 NOTE 1: There is rational for this requirement in A.1.
284 Components used in waste volatile anaesthetic agent capture systems that create heat shall be safe for use
285 in an oxygen-enriched atmosphere according to IEC 60601-1:2005+Amd1:2012+Amd2:2020, clause
286 11.2.2.
287 NOTE 2: Adsorbing material itself can be a source of heat.
288 Check conformance by inspection of the technical documentation.
289 5.3 Influences on other devices
290 NOTE 1:  There is rational for this requirement in A.2.
291 Passive and active waste volatile anaesthetic agent capture systems shall be:
292 a) provided with a means to prevent exhaust gases from affec
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