FprEN ISO 18777-1

SLOVENSKI STANDARD
oSIST prEN ISO 18777-1:2024
01-maj-2024
Prenosni sistemi tekočega kisika za medicinsko uporabo - 1. del: Splošne in
posebne zahteve za osnovne enote (ISO/DIS 18777-1:2024)
Transportable liquid oxygen systems for medical use - Part 1: Common requirements
and particular requirements for base units (ISO/DIS 18777-1:2024)
Flüssigsauerstoffsysteme für medizinische Anwendungen - Teil 1: Allgemeine
Anforderungen und besondere Anforderungen für Basiseinheiten (ISO/DIS 18777-
1:2024)
Systèmes transportables d'oxygène liquide à usage médical - Exigences particulières -
Partie 1: unités de base (ISO/DIS 18777-1:2024)
Ta slovenski standard je istoveten z: prEN ISO 18777-1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 18777-1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 18777-1:2024
oSIST prEN ISO 18777-1:2024
DRAFT
International
Standard
ISO/DIS 18777-1
ISO/TC 121/SC 6
Transportable liquid oxygen
Secretariat: ANSI
systems for medical use —
Voting begins on:
Part 1: 2024-03-05
Common requirements and
Voting terminates on:
2024-05-28
particular requirements for base
units
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.
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NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 18777-1:2024(en)
oSIST prEN ISO 18777-1:2024
DRAFT
ISO/DIS 18777-1:2024(en)
International
Standard
ISO/DIS 18777-1
ISO/TC 121/SC 6
Transportable liquid oxygen
Secretariat: ANSI
systems for medical use —
Voting begins on:
Part 1:
Common requirements and
Voting terminates on:
particular requirements for base
units
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 2024
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
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NOTIFICATION OF ANY RELEVANT PATENT
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 18777-1:2024(en)
ii
oSIST prEN ISO 18777-1:2024
ISO/DIS 18777-1:2024(en)
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13 Contents
14 Foreword . v
15 Introduction . vi
16 1 Scope . 7
17 2 Normative references . 7
18 3 Terms and definitions . 8
19 4 General requirements . 9
20 4.1 Risk management . 9
21 4.2 Usability. 9
22 4.3 Materials . 9
23 4.4 Environmental conditions . 10
24 5 Design requirements . 10
25 5.1 Cryogenic vessels . 10
26 5.2 Filling connectors . 10
27 5.3 Interoperability between the base unit and the portable unit . 11
28 5.4 Flow outlets . 11
29 5.5 Oxygen temperature at the flow outlet . 11
30 5.6 Flow control . 11
31 5.7 Pressure at the flow outlet . 12
32 5.8 Oxygen conserving device. 12
33 5.9 Venting of gaseous oxygen . 12
34 5.10 Pressure control . 12
35 5.11 Evaporation rate . 12
36 5.12 Leakage. 12
37 5.13 Excessive temperatures of accessible surfaces . 12
38 5.14 Electrical safety . 13
39 5.15 Fire safety . 13
40 5.16 Protection of components and controls . 13
41 5.17 Stability . 13
42 6 Construction requirements . 13
43 7 Information to be supplied by the manufacturer. 13
44 7.1 General . 13
45 7.2 Marking . 14
46 7.3 Instructions for use . 14
47 Annex A (informative) Rationale . 15
48 A.5.7 Pressure at the flow outlet . 15
49 Annex B (Normative) Test Methods . 16
50 B.1 Transport and storage environmental conditions preconditioning . 16
51 B.2 Test method for transfer of liquid oxygen and leakage when the base unit is connected
52 to a large oxygen source and when connected to a portable unit. (requirement 5.2.3)
53 . 16
54 Annex C (Normative) Transfilling device . 20
55 Annex D (informative) Clearance template . 2
56 Annex E (informative) Guidance on the requirements in IEC 60601-1 that could be
57 applicable . 3
58 Annex F (informative) Hazard identification for risk management assessment . 7
oSIST prEN ISO 18777-1:2024
ISO/DIS 18777-1:2024(en)
ISO 18777-1:202(X)
59 H.1 General . 7
60 H.2 Patient and user harm/lack of therapy associated with the use of transportable liquid
61 oxygen systems: . 7
62 Bibliography . 8
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63 Foreword
64 ISO (the International Organization for Standardization) is a worldwide federation of national standards
65 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
66 through ISO technical committees. Each member body interested in a subject for which a technical
67 committee has been established has the right to be represented on that committee. International
68 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
69 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
70 electrotechnical standardization.
71 The procedures used to develop this document and those intended for its further maintenance are
72 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
73 different types of ISO documents should be noted. This document was drafted in accordance with the
74 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
75 Attention is drawn to the possibility that some of the elements of this document may be the subject of
76 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
77 patent rights identified during the development of the document will be in the Introduction and/or on
78 the ISO list of patent declarations received (see www.iso.org/patents).
79 Any trade name used in this document is information given for the convenience of users and does not
80 constitute an endorsement.
81 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
82 expressions related to conformity assessment, as well as information about ISO's adherence to the World
83 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
84 www.iso.org/iso/foreword.html.
85 This document was prepared by Technical Committee ISO/TC 121 Anaesthetic and respiratory
86 equipment Subcommittee SC 6, Medical gas supply systems in collaboration with the European
87 Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic
88 equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
89 Agreement).
90 This first edition together with ISO 18777-2 cancels and replaces ISO 18777:2005 which has been
91 technically revised.
92 The main changes are as follows:
93 — the standard has been split into two parts:
94 • Part 1 Common requirements and particular requirements for base units; and
95 • Part 2 Particular requirements for Portable units.
96 — part 1 includes requirements that are common to both base units and portable units. Part 2 cross
97 references these common requirements as appropriate;
98 — the format of the document has been changed from the IEC to the ISO format; and
99 — requirements for the transfilling device have been included.
100 A list of all parts in the ISO 18777 series can be found on the ISO website.
101 Any feedback or questions on this document should be directed to the user’s national standards body. A
102 complete listing of these bodies can be found at www.iso.org/members.html.
oSIST prEN ISO 18777-1:2024
ISO/DIS 18777-1:2024(en)
ISO 18777-1:202(X)
103 Introduction
104 Transportable liquid oxygen systems comprise a base unit and a portable unit for use primarily in home-
105 care applications and without professional supervision. This document specifies requirements that
106 are common to both base units and portable units and requirements that are specific to base units.
107 Base units can be used solely to store the liquid oxygen for refilling the portable unit or can, if fitted
108 with a flow outlet and flow control, also be used to provide a controlled flow of oxygen for inhalation
109 by the patient.
110 Base units comprise:
111 — a double-walled vacuum-insulated cryogenic container for storing liquid oxygen (LOX) at
112 approximately –180 °C;
113 — a content level indicator;
114 — a heat exchanger to convert liquid oxygen to gaseous oxygen and warming it to ambient
115 temperature;
116 — a transfilling device; and can also include a separate filling connector.
117 Annex A contains rationale for some of the requirements. It is included to provide additional insight into
118 the committee’s reasoning that led to a particular requirement to address the identified hazards.
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119 Transportable liquid oxygen systems for medical use —
120 Part 1: common requirements and particular requirements for
121 base units
122 1 Scope
123 This document specifies common requirements for transportable liquid oxygen systems and
124 specific requirements for base units. Base units are used as a store for liquid oxygen for refilling
125 portable units. They can also, if fitted with a flow outlet and flow control, be used as a source for
126 the supply of oxygen direct to the patient.
127 Stationary liquid oxygen systems used for oxygen pipeline supply systems are excluded
128 from this document.
129 NOTE 1: Throughout this document the term “units” is used where the requirement applies to both
130 base units and portable units.
131 NOTE 2: ISO 18777 Part 2 specifies those requirements specific to portable units.
132 2 Normative references
133 The following documents are referred to in the text in such a way that some or all of their content
134 constitutes requirements of this document. For dated references, only the edition cited applies.
135 For undated references, the latest edition of the referenced document (including any
136 amendments) applies.
137 ISO 14971, Medical devices — Application of risk management to medical devices
138 ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
139 ISO 17256:202X , Anaesthetic and respiratory equipment — Respiratory therapy tubing and
140 connectors
141 ISO 18562-1, Biocompatibility evaluation of breathing gas pathways in healthcare applications
142 Part 1: Evaluation and testing within a risk management process
143 ISO 20417, Medical devices — Information to be supplied by the manufacturer
144 ISO 21029-1:2018+A1:2019, Cryogenic vessels — Transportable vacuum insulated vessels of
145 not more than 1 000 litres volume — Part 1: Design, fabrication, inspection and tests
146 ISO 21029-2, Cryogenic vessels — Transportable vacuum insulated vessels of not more than 1
147 000 litres volume — Part 2: Operational requirements
148 ISO 23208, Cryogenic vessels — Cleanliness for cryogenic service
149 IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1:
150 General requirements for basic safety and essential performance
151 ISO 80601-2-67, Medical electrical equipment — Part 2-67: Particular requirements for basic
152 safety and essential performance of oxygen conserving equipment
153 EN 837-1:1998, Pressure gauges. Bourdon tube pressure gauges. Dimensions, metrology,
154 requirements, and testing
oSIST prEN ISO 18777-1:2024
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ISO 18777-1:202(X)
155 3 Terms and definitions
156 For the purposes of this document, the following terms and definitions apply.
157 ISO and IEC maintain terminology databases for use in standardization at the following
158 addresses:
159 — ISO Online browsing platform: available at https://www.iso.org/obp
160 — IEC Electropedia: available at https://www.electropedia.org/
161 NOTE: the terms defined in clause 3 are delineated throughout this document by italic font.
162 3.1
163 base unit
164 transportable vacuum insulated cryogenic vessel for storing liquid oxygen, used for refilling the
165 portable unit and can also be used as the supply source for administering oxygen to the patient
166 3.2
167 conserving device
168 device that reduces the amount of oxygen consumed by delivering gas intermittently and
169 synchronized with the patient's inspiratory cycle
170 Note 1 to entry: Conserving devices can be electrically or pneumatically powered.
171 [SOURCE: ISO 80601-2-67:202 (201.3.201) modified by replacing equipment/ME equipment
172 with device and conserving with amount of oxygen consumed]
173 3.3
174 flow control
175 means for setting and indicating the flow
176 3.4
177 maximum allowable working pressure
178 MAWP
179 Ps
180 maximum effective gauge pressure permissible at the top of the vessel in its normal operating
181 position including the highest effective pressure during filling and discharge
182 [SOURCE ISO -21029-1:3.17 modified: note 1 to entry deleted)
183 3.5
184 portable unit
185 refillable, vacuum insulated cryogenic vessel for administering a controlled flow of gaseous
186 oxygen to the patient whilst mobile
187 3.6
188 transfilling device
189 device for transferring liquid oxygen from a base unit to a portable unit
190 NOTE to entry: transfilling devices can also be used as the means to fill base units from large liquid
191 oxygen sources.
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192 4 General requirements
193 4.1 Risk management
194 4.1.1 Manufacturers shall assess the risks, in accordance with ISO 14971, when the
195 units are transported, stored, installed and operated under normal and single fault conditions
196 and maintained according to the manufacturer’s instructions.
197 Check conformance by inspection of the risk management file.
198 4.1.2 Any risks identified shall be reduced to an acceptable level.
199 NOTE 1: A situation in which a fault is not detected is considered a normal condition.
200 NOTE 2: Annex E lists known hazards that should be taken into account during a risk assessment.
201 Check conformance by inspection of the risk management file.
202 4.2 Usability
203 Manufacturers shall apply a usability engineering process, (e.g. IEC 60601-1-6 and IEC
204 62366), to assess and mitigate any risks caused by usability problems associated with
205 correct use (i.e. normal use) and use errors.
206 Check conformance by inspection of the usability engineering file.
207 4.3 Materials
208 NOTE: There is rationale for this clause in A.4.3.
209 4.3.1 Materials, which come in contact with liquid or gaseous oxygen under normal or
210 single fault conditions, shall:
211 a) be resistant to corrosion;
212 b) be compatible with oxygen;
213 c) conform with ISO 15001 and ISO 23208; and
214 d) if liable to shed particles, shall not be used for highly strained components and parts
215 liable to wear, (e.g. springs)
216 NOTE 1: Corrosion resistance includes resistance against moisture and surrounding materials.
217 NOTE 2: Oxygen compatibility is usually defined as the ability of a material to coexist with oxygen and a
218 moderate ignition source.
219 NOTE 3: Many materials which do not burn in air will do so in an oxygen-enriched environment,
220 particularly under pressure. Similarly, materials which can be ignited in air require lower ignition
221 energies to ignite in an oxygen atmosphere. Many such materials can be ignited by friction at a valve seat
222 or by adiabatic compression when oxygen at high pressure is rapidly introduced into a system initially at
223 low pressure.
224 NOTE 4: Design considerations and criteria for the selection of metallic and non-metallic materials
225 that are compatible with oxygen are given in Annexes C and D of ISO 15001.
226 Check conformance by inspection of the technical documentation.
227 4.3.2 Components with breathing gas pathways shall be evaluated for biocompatibility
228 according to ISO 18562-1. Any identified risks shall be reduced to an acceptable level.
229 4.3.3 Units and parts thereof shall be designed and manufactured to minimize health
230 risks due to substances leached from the unit or its components during normal use.
231 Check conformance by inspection of the technical documentation.
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232 4.4 Environmental conditions
233 4.4.1 Transport and storage
234 Units shall meet the performance requirements of this document after being exposed to the
235 following environmental conditions unless a different range of environmental conditions is stated
236 by the manufacturer in their information for users [see 7.3.e)]:
237 a) an ambient temperature range of (−40 to +70) °C; and
238 b) a relative humidity range of (15 to 90) %, non-condensing.
239 Check conformance by exposing test samples to these conditions prior to performing the tests
240 given in Annex B.
241 4.4.2 Operational
242 Units shall conform with the requirements of this document and the performance
243 specified by the manufacturer when operated under the following environmental conditions
244 unless a different range of environmental conditions is stated by the manufacturer in their
245 information for users [see 7.3.e)]:
246 a) an ambient temperature range of (−10 to + 40) °C; and
247 b) a relative humidity range of (15 to 90) %, non-condensing.
248 Check conformance by performing the tests specified in Annex B.
249 5 Design requirements
250 5.1 Cryogenic vessels
251 5.1.1 Units shall be equipped with cryogenic vessels conforming with ISO 21029-
252 1:2018+A1:2019 and ISO 21029-2.
253 Check conformance by inspection of the technical documentation.
254 5.1.2 Units shall have a means to indicate the level at which the vessel should be refilled. This
255 means should ideally express the hours of remaining gaseous oxygen supply based on the flow
256 setting. [See 7.3.h)].
257 Check conformance by visual inspection.
258 5.1.3 Contents indicators shall be non-user detachable (i.e. not detachable without the use of
259 a tool).
260 Check conformance by applying a torque of (50 ±1) N m to the contents indicator and verifying
261 that it does not detach from the unit.
262 5.1.4 A visual alarm shall be activated when the contents reach the minimum content level
263 specified by the manufacturer, [see 7.3 h)].
264 Check conformance by functional testing.
265 5.2 Transfilling devices and filling connectors
266 NOTE 1: Figure C.2 shows the base unit transfilling device connected to the filling port connector of a
267 portable unit.
268 NOTE 2: Figure C.3 shows the opening sequence for the base unit transfilling device and the portable unit
269 filling port connector.
270 5.2.1 Base units shall be equipped with a transfilling device conforming with Figure C.1.
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271 NOTE: Transfilling devices are designed primarily for transferring liquid oxygen from a base unit to a
272 portable unit but can also be used as the means for filling the base unit from a large oxygen supply.
273 Check conformance by visual inspection and functional testing.
274 5.2.2 If a base unit is equipped with an additional connection for filling the base unit from a
275 large liquid oxygen source that connection shall:
276 a) be manufacturer specific; and
277 b) permit the safe transfer of liquid oxygen from a large liquid oxygen supply without
278 causing a spillage of excess gas or liquid oxygen under normal and single fault conditions.
279 Check conformance by visual inspection and the test given in B.2.
280 5.2.4 Transfilling devices and filling connectors shall be non-user detachable from the
281 base unit (i.e. not detachable without the use of a tool).
282 Check conformance by applying a torque of (50 ± 1) N m to the Transfilling device and filling
283 connector and verifying that it does not detach from the base unit.
284 5.2.5 Means shall be provided to reduce the risk of contamination of the transfilling device or
285 filling connector either in storage or in use. (e.g. removable plug, cap, or cover),
286 Check conformance by inspection of the risk management file.
287 5.2.6 Units shall be fitted with a means to reduce the risk of operators receiving cryogenic
288 burns during the filling process, (e.g. protective cover).
289 Check conformance by inspection of the risk management file.
290 5.3 Interoperability between the base unit and the portable unit
291 There shall be a radius of space around the transfilling device of at least 150 mm to allow the
292 portable unit to be attached to enable refilling.
293 Check conformance by functional testing using the clearan
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