oSIST prEN ISO 23368:2019
(Main)Anaesthetic and respiratory equipment - Low flow nasal cannulae for oxygen therapy (ISO/DIS 23368:2019)
Anaesthetic and respiratory equipment - Low flow nasal cannulae for oxygen therapy (ISO/DIS 23368:2019)
This device-specific standard specifies requirements for nasal cannulae used in both home-care and hospital environments for the administration of oxygen therapy.
Anästhesie- und Beatmungsgeräte - Nasenbrillen für die Atemtherapie (ISO/DIS 23368:2019)
Matériel d'anesthésie et de réanimation respiratoire - Canules nasales à faible débit pour oxygénothérapie (ISO/DIS 23368:2019)
Anestezijska in dihalna oprema - Nosni kateter za kisikovo terapijo (ISO/DIS 23368:2019)
General Information
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN ISO 23368:2019
01-september-2019
Anestezijska in dihalna oprema - Nosni kateter za kisikovo terapijo (ISO/DIS
23368:2019)
Anaesthetic and respiratory equipment - Low flow nasal cannulae for oxygen therapy
(ISO/DIS 23368:2019)Anästhesie- und Beatmungsgeräte - Nasenbrillen für die Atemtherapie (ISO/DIS
23368:2019)
Matériel d'anesthésie et de réanimation respiratoire - Canules nasales à faible débit pour
oxygénothérapie (ISO/DIS 23368:2019)Ta slovenski standard je istoveten z: prEN ISO 23368
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 23368:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------oSIST prEN ISO 23368:2019
---------------------- Page: 2 ----------------------
oSIST prEN ISO 23368:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23368
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2019-05-23 2019-08-15
Anaesthetic and respiratory equipment — Low flow nasal
cannulae for oxygen therapy
Matériel d'anesthésie et de réanimation respiratoire — Canule nasale pour thérapie oxygène
ICS: 11.040.10THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23368:2019(E)
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. ISO 2019
---------------------- Page: 3 ----------------------
oSIST prEN ISO 23368:2019
ISO/DIS 23368
ISO/DIS 23368:2019(E)
Contents
Foreword ......................................................................................................................................................................... iv
Introduction..................................................................................................................................................................... v
1 Scope .......................................................................................................................................................................... 1
2 Normative references .......................................................................................................................................... 1
3 Terms and definitions .......................................................................................................................................... 1
4 General requirements .......................................................................................................................................... 2
5 Materials ................................................................................................................................................................... 2
6 Design requirements ............................................................................................................................................ 2
6.1 General ...................................................................................................................................................................... 2
6.2 Resistance to flow .................................................................................................................................................. 4
6.3 Inlet connectors ....................................................................................................................................................... 4
6.4 Nasal prongs ............................................................................................................................................................ 4
6.5 Colour coding ..................................................................................................... Error! Bookmark not defined.
7 Sterility ...................................................................................................................................................................... 5
8 Packaging .................................................................................................................................................................. 5
9 Information supplied by the manufacturer ................................................................................................. 5
Annex A (informative) Rationale ............................................................................................................................. 6
Annex B (Normative) Test method for resistance to flow .............................................................................. 7
Annex C (Normative) Test methods for security of connectors and nasal prongs ................................. 8
Bibliography .................................................................................................................................................................... 9
COPYRIGHT PROTECTED DOCUMENT© ISO 2019
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
© ISO #### – All rights reserved iii
---------------------- Page: 4 ----------------------
oSIST prEN ISO 23368:2019
ISO/DIS 23368:2019(E)
Contents
Foreword ......................................................................................................................................................................... iv
Introduction..................................................................................................................................................................... v
1 Scope .......................................................................................................................................................................... 1
2 Normative references .......................................................................................................................................... 1
3 Terms and definitions .......................................................................................................................................... 1
4 General requirements .......................................................................................................................................... 2
5 Materials ................................................................................................................................................................... 2
6 Design requirements ............................................................................................................................................ 2
6.1 General ...................................................................................................................................................................... 2
6.2 Resistance to flow .................................................................................................................................................. 4
6.3 Inlet connectors ....................................................................................................................................................... 4
6.4 Nasal prongs ............................................................................................................................................................ 4
6.5 Colour coding ..................................................................................................... Error! Bookmark not defined.
7 Sterility ...................................................................................................................................................................... 5
8 Packaging .................................................................................................................................................................. 5
9 Information supplied by the manufacturer ................................................................................................. 5
Annex A (informative) Rationale ............................................................................................................................. 6
Annex B (Normative) Test method for resistance to flow .............................................................................. 7
Annex C (Normative) Test methods for security of connectors and nasal prongs ................................. 8
Bibliography .................................................................................................................................................................... 9
© ISO 2019 – All rights reserved---------------------- Page: 5 ----------------------
oSIST prEN ISO 23368:2019
ISO/DIS 23368:2019(E)
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 documents 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).Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html.This document was prepared by Technical Committee 121, Anaesthetic and respiratory equipment
Subcommittee SC 2, Airways and related equipment and is based on the General Standard for airways and
related devices ISO 18190:2016.This is the first edition.
Throughout this International Standard the following print types are used:
Requirements and definitions: roman type;
Test specifications: italic type;
Informative material appearing outside of tables, such as notes, examples and references: smaller type.
The normative text of tables is also in smaller type; terms defined in clause 3: green italics.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.The attention of Member Bodies and National Committees is drawn to the fact that equipment
manufacturers and testing organizations may need a transitional period following publication of a new,
amended or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip themselves for conducting new or revised tests. It is the recommendation of
the committee that the content of this publication be adopted for implementation nationally not earlier
than 3 years from the date of publication for equipment newly designed and not earlier than 5 years
from the date of publication for equipment already in production.© ISO 2019 – All rights reserved
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.