prEN ISO 18777-1

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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IS THEREFORE SUBJECT TO CHANGE
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Reference number
ISO/DIS 18777-1:2024(en)
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
BE CONSIDERED IN THE LIGHT OF THEIR
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 18777-1:2024(en)
ii
ISO/DIS 18777-1:2024(en)
ISO #####-#:####(X)
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
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
iv © ISO 2024 – All rights reserved

ISO/DIS 18777-1:2024(en)
ISO #####-#:####(X)
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 transfillin
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