prEN ISO 18777-2

Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units (ISO/DIS 18777-2:2024)

This document specifies requirements for portable units which are part of a transportable liquid oxygen system. These are used as a supply source for oxygen therapy in home-care and in health-care facilities.
Portable units are intended to be carried by patients whilst moving around and during their off-site activities and can be refilled from a base unit through a transfilling connector. Portable units are used without professional supervision.

Flüssigsauerstoffsysteme für medizinische Anwendungen - Teil 2: Tragbare Einheiten (ISO/DIS 18777-2:2024)

Dieses Dokument legt Anforderungen an tragbare Einheiten fest, die Teil eines Flüssigsauerstoffsystems sind und als Versorgungsquelle für die Sauerstofftherapie insbesondere für Patienten bei der medizinischen Versorgung in häuslicher Umgebung verwendet werden.
Tragbare Einheiten sind für die Verwendung ohne Überwachung durch Fachpersonal vorgesehen, werden von Patienten in Bewegung und während ihrer außerhäuslichen Aktivitäten getragen und aus einer Basiseinheit über einer Umfüllvorrichtung durch den Füllöffnungsanschluss der tragbaren Einheit aufgefüllt.
ANMERKUNG   Anforderungen, die sowohl für Basiseinheiten als auch für tragbare Einheiten gelten, sind in ISO 18777 1 festgelegt.

Systèmes transportables d'oxygène liquide à usage médical - Partie 2: Exigences particulières s'appliquant aux unités portables (ISO/DIS 18777-2:2024)

Prenosni sistemi tekočega kisika za medicinsko uporabo - 2. del: Prenosne enote (ISO/DIS 18777-2:2024)

General Information

• Status: Not Published
• Publication Date: 30-Sep-2025
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 14-Nov-2024
• Completion Date: 14-Nov-2024
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/086 - Mandate to CEN for standardization in the field of transport of dangerous goods
• Ref Project: oSIST prEN ISO 18777-2:2024 - Transportable liquid oxygen systems for medical use - Part 2: Portable units (ISO/DIS 18777-2:2024)

Relations

• Revises: EN ISO 18777:2009 - Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
• Effective Date: 07-Dec-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2024
Prenosni sistemi tekočega kisika za medicinsko uporabo - 2. del: Prenosne enote
(ISO/DIS 18777-2:2024)
Transportable liquid oxygen systems for medical use - Part 2: Portable units (ISO/DIS
18777-2:2024)
Flüssigsauerstoffsysteme für medizinische Anwendungen - Teil 2: Tragbare Einheiten
(ISO/DIS 18777-2:2024)
Systèmes transportables d'oxygène liquide à usage médical - Partie 2: Exigences
particulières s'appliquant aux unités portables (ISO/DIS 18777-2:2024)
Ta slovenski standard je istoveten z: prEN ISO 18777-2
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 18777-2
ISO/TC 121/SC 6
Transportable liquid oxygen
Secretariat: ANSI
systems for medical use —
Voting begins on:
Part 2: 2024-03-05
Portable units
Voting terminates on:
2024-05-28
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,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
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/DIS 18777-2:2024(en)
DRAFT
ISO/DIS 18777-2:2024(en)
International
Standard
ISO/DIS 18777-2
ISO/TC 121/SC 6
Transportable liquid oxygen
Secretariat: ANSI
systems for medical use —
Voting begins on:
Part 2:
Portable units
Voting terminates on:
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
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
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: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 18777-2:2024(en)
ii
ISO/DIS 18777-2:2024(en)
ISO 18777-2:202(X)
22 Contents
23 Foreword . iv
24 Introduction . v
25 1 Scope . 1
26 2 Normative references . 1
27 3 Terms and definitions . 1
28 4 General requirements . 1
29 5 Design requirements . 1
30 5.1 General . 1
31 5.2 Filling port connector . 1
32 5.3 Maximum mass . 2
33 5.4 Conserving devices . 2
34 5.5 Mechanical strength . 2
35 5.6 Position of use . 3
36 6 Constructional requirements . 3
37 7 Information supplied by the manufacturer . 3
38 7.1 General . 3
39 7.2 Marking . 3
40 7.3 Instructions for use . 3
41 Annex A (normative) Test methods . 4
42 A.1 Mechanical strength test methods (requirement 5.5) . 4
43 A.2 Position of use test method (requirement 5.6) . 4
44 Bibliography . 6
ISO/DIS 18777-2:2024(en)
ISO #####-#:####(X)
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 6, Medical gas supply systems in collaboration with the European Committee for
69 Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
70 accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
71 This first edition together with ISO 18777-1 replaces ISO 18777:2005, which has been technically revised.
72 The main changes are as follows:
73 ⎯ The standard has been split into two distinct parts:
74 • Part 1 - Common requirements and particular requirements for base units and
75 • Part 2 – Particular requirements for Portable units.
76 ⎯ Requirements that are common to both base units and portable units are specified in part 1
77 and cross referred to in this document.
78 ⎯ The format of the document has been changed from the IEC to the ISO format.
79 ⎯ Requirements for the filling port connector have been included.
80 A list of all parts in the ISO 18777 series can be found on the ISO website.
81 Any feedback or quest
...