SIST EN ISO 18777-2:2026

Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units (ISO 18777-2:2025)

This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE            Requirements that are common to both portable units and base units are specified in ISO 18777-1.

Flüssigsauerstoffsysteme für medizinische Anwendungen - Teil 2: Tragbare Einheiten (ISO 18777-2:2025)

Dieses Dokument legt die besonderen Anforderungen an tragbare Einheiten fest, die Teil eines Flüssigsauerstoffsystems sind und zur Abgabe eines geregelten Sauerstoffflusses zur Inhalation durch den 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 eine 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 18777-2:2025)

Le présent document spécifie les exigences particulières s’appliquant aux unités portables qui font partie d’un système transportable d’oxygène liquide et sont utilisées pour fournir un débit d’oxygène contrôlé inhalé par le patient dans le contexte des soins à domicile.
Une unité portable est destinée à être utilisée sans surveillance professionnelle. Elle est portée par le patient lors de ses déplacements au domicile et lors de ses sorties et se recharge en connectant le dispositif de transvasement d’une unité de base au raccord de remplissage de l’unité portable.
NOTE            Les exigences communes aux unités portables et aux unités de base sont spécifiées dans l’ISO 18777-1.

Prenosni sistemi tekočega kisika za medicinsko uporabo - 2. del: Posebne zahteve za prenosne enote (ISO 18777-2:2025)

General Information

• Status: Published
• Public Enquiry End Date: 27-May-2024
• Publication Date: 07-Dec-2025
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Dec-2025
• Due Date: 09-Feb-2026
• Completion Date: 08-Dec-2025
• 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: EN ISO 18777-2:2025 - Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units (ISO 18777-2:2025)

Relations

• Revised: SIST EN ISO 18777:2009 - Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
• Effective Date: 28-Feb-2018

Overview

EN ISO 18777-2:2025 - "Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for portable units" (approved by CEN November 2025) specifies safety, design and performance requirements unique to portable units used in transportable liquid oxygen systems for home-care medical use. Portable units are lightweight devices carried by patients, refilled from a base unit via a transfilling device, and intended for unsupervised use during daily activities.

Key topics and technical requirements

• Filling port connector: Portable units shall have a standardized filling port connector to ensure compatibility with base-unit transfilling devices and safe liquid oxygen transfer. Connector details (example essential dimensions) include: Øa 16.00 mm ± 0.05 mm, minimum b = 17.0 mm, c = 3.0 mm ± 0.5 mm, spring tension 20–45 N. The connector must be non-user detachable (not removable without tools).
• Maximum mass: Filled portable units (including recommended or integral conserving device) shall weigh less than 4 kg to support portability.
• Conserving devices: Oxygen-conserving devices fitted to portable units shall conform to ISO 80601-2-67 (requirements for oxygen-conserving equipment).
• Mechanical strength and durability: Units must maintain required performance after a 1 m drop onto a hard surface (worst-case orientation). Carrying straps and connections shall withstand a load equal to 2 × the filled mass.
• Position-of-use safety: Portable units shall include an audible alarm that activates when the unit is placed in a position posing a spillage risk.
• Other covered aspects: Design and construction requirements, evaporation rate, marking, instructions for use, and manufacturer-supplied information. Test methods and verification procedures are provided in Annex A (normative).

Practical applications

• Develop compliant portable liquid oxygen units: design engineers and manufacturers use this standard to ensure safe, interoperable components (e.g., filling ports, conserving devices).
• Conformity testing and certification: test laboratories and conformity assessors follow the prescribed tests (drop, connector compatibility, strap load, weighing) to verify compliance.
• Procurement and clinical use: healthcare providers, home-care suppliers and purchasing authorities can specify EN ISO 18777-2:2025 to ensure safe, user-friendly portable oxygen solutions.
• Technical documentation and labeling: instructive content, marking and user instructions aligned with the standard improve patient safety and regulatory acceptance.

Who should use this standard

• Medical device manufacturers and product designers
• Test laboratories and certification bodies
• Respiratory equipment suppliers and home healthcare providers
• Regulatory agencies and procurement teams

Related standards

• ISO 18777-1:2026 - common requirements and particular requirements for base units
• ISO 80601-2-67 - oxygen-conserving equipment requirements

Keywords: EN ISO 18777-2:2025, transportable liquid oxygen systems, portable units, filling port connector, oxygen-conserving device, portable oxygen, home-care oxygen, transfilling device, ISO 18777-1.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2026
Prenosni sistemi tekočega kisika za medicinsko uporabo - 2. del: Posebne zahteve
za prenosne enote (ISO 18777-2:2025)
Transportable liquid oxygen systems for medical use - Part 2: Particular requirements for
portable units (ISO 18777-2:2025)
Flüssigsauerstoffsysteme für medizinische Anwendungen - Teil 2: Tragbare Einheiten
(ISO 18777-2:2025)
Systèmes transportables d'oxygène liquide à usage médical - Partie 2: Exigences
particulières s'appliquant aux unités portables (ISO 18777-2:2025)
Ta slovenski standard je istoveten z: EN ISO 18777-2:2025
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.

EN ISO 18777-2
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2025
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 18777:2009
English Version
Transportable liquid oxygen systems for medical use - Part
2: Particular requirements for portable units (ISO 18777-
2:2025)
Systèmes transportables d'oxygène liquide à usage Flüssigsauerstoffsysteme für medizinische
médical - Partie 2: Exigences particulières s'appliquant Anwendungen - Teil 2: Besondere Anforderungen für
aux unités portables (ISO 18777-2:2025) tragbare Einheiten (ISO 18777-2:2025)
This European Standard was approved by CEN on 22 November 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18777-2:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 18777-2:2025) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2026, and conflicting national standards shall be
withdrawn at the latest by May 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18777:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 18777-2:2025 has been approved by CEN as EN ISO 18777-2:2025 without any
modification.
International
Standard
ISO 18777-2
First edition
Transportable liquid oxygen
2025-11
systems for medical use —
Part 2:
Particular requirements for
portable units
Systèmes transportables d'oxygène liquide à usage médical —
Partie 2: Exigences particulières s'appliquant aux unités
portables
Reference number
ISO 18777-2:2025(en) © ISO 2025

ISO 18777-2:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 18777-2:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 1
5 Design requirements . 1
5.1 General .1
5.2 Filling port connector .2
5.3 Maximum mass .3
5.4 Conserving devices .3
5.5 Mechanical strength .3
5.6 Position of use .3
5.7 Evaporation rate .4
6 Constructional requirements . 4
7 Information supplied by the manufacturer . 4
7.1 General .4
7.2 Marking .4
7.3 Instructions for use .4
Annex A (normative) Test methods . 5

iii
ISO 18777-2:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes
...