oSIST prEN ISO 18777-2:2024

Transportable liquid oxygen systems for medical use - Part 2: 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)

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
• Public Enquiry End Date: 27-May-2024
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 04-Apr-2024
• Due Date: 22-Aug-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: prEN ISO 18777-2 - Transportable liquid oxygen systems for medical use - Part 2: Portable units (ISO/DIS 18777-2:2024)

Relations

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

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 18777-2:2024
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
oSIST prEN ISO 18777-2:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 18777-2:2024

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oSIST prEN ISO 18777-2:2024
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)
© ISO 2024

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oSIST prEN ISO 18777-2:2024
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.
COPYRIGHT PROTECTED DOCUMENT
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)
© ISO 2024
© ISO 2024 – All rights reserved
ii

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oSIST prEN ISO 18777-2:2024
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 .
...