Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

IEC 80369-5:2016 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in limb cuff inflation applications of medical devices and accessoires. Limb cuff inflation applications include connections between a sphygmomanometer and its cuff. The contents of the corrigenda 1 (2017) and 2 (2021) have been included in this copy.

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 5: Raccords destinés à des applications au gonflage de brassard

L'IEC 80369-5:2016 spécifie les dimensions et les exigences relatives à la conception et aux performances fonctionnelles des raccords de petite taille destinés à être utilisés pour les raccordements dans des applications au gonflage de brassard des dispositifs médicaux et des accessoires. Les applications au gonflage de brassard comprennent les raccordements entre un sphygmomanomètre et son brassard. Le contenu des corrigenda 1 (2017) et 2 (2021) a été pris en considération dans cet exemplaire.

General Information

Status
Published
Publication Date
03-Mar-2016
Current Stage
PPUB - Publication issued
Start Date
31-Mar-2016
Completion Date
04-Mar-2016
Ref Project

Relations

Buy Standard

Standard
IEC 80369-5:2016 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
English and French language
89 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)


IEC 80369-5
Edition 1.0 2016-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Small-bore connectors for liquids and gases in healthcare applications –
Part 5: Connectors for limb cuff inflation applications

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la
santé –
Partie 5: Raccords destinés à des applications au gonflage de brassard

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the

latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,

77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished

Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.

Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient plus de 30 000 termes et définitions en
Spécifications techniques, Rapports techniques et autres
anglais et en français, ainsi que les termes équivalents dans
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
15 langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.

Recherche de publications IEC - www.iec.ch/searchpub
Glossaire IEC - std.iec.ch/glossary
La recherche avancée permet de trouver des publications IEC Plus de 60 000 entrées terminologiques électrotechniques, en
en utilisant différents critères (numéro de référence, texte, anglais et en français, extraites des articles Termes et
comité d’études,…). Elle donne aussi des informations sur les Définitions des publications IEC parues depuis 2002. Plus
projets et les publications remplacées ou retirées. certaines entrées antérieures extraites des publications des

CE 37, 77, 86 et CISPR de l'IEC.
IEC Just Published - webstore.iec.ch/justpublished

Service Clients - webstore.iec.ch/csc
Restez informé sur les nouvelles publications IEC. Just
Published détaille les nouvelles publications parues. Si vous désirez nous donner des commentaires sur cette
Disponible en ligne et aussi une fois par mois par email. publication ou si vous avez des questions contactez-nous:
csc@iec.ch.
IEC 80369-5
Edition 1.0 2016-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Small-bore connectors for liquids and gases in healthcare applications –

Part 5: Connectors for limb cuff inflation applications

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la

santé –
Partie 5: Raccords destinés à des applications au gonflage de brassard

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.20 ISBN 978-2-8322-3211-8

– 2 – IEC 80369-5:2016 © IEC 2016
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 * Scope . 7
2 Normative references. 7
3 Terms and definitions . 8
4 General requirements . 9
4.1 General requirements for the limb cuff inflation APPLICATION . 9
4.2 Materials used for SMALL-BORE CONNECTORS . 9
4.3 TYPE TESTS . 10
5 Dimensional requirements for sphygmomanometer and cuff SMALL-BORE
CONNECTORS . 10
5.1 * Requirements for adult or paediatric PATIENT SMALL-BORE CONNECTORS (S1) . 10
5.2 Void . 10
6 Performance requirements . 10
6.1 Air leakage. 10
6.2 * Resistance to separation from axial load . 10
Annex A (informative) Rationale and guidance . 11
A.1 General guidance . 11
A.2 Rationale for particular clauses and subclauses . 11
Annex B (normative) SMALL-BORE CONNECTORS for the limb cuff inflation APPLICATION . 13
Annex C (normative) Reference CONNECTORS . 17
C.1 General requirements for reference CONNECTORS . 17
C.2 * Sphygmomanometer and cuff S1 reference CONNECTORS . 17
Annex D (informative) Assessment of MEDICAL DEVICES and their attributes with
CONNECTIONS within this APPLICATION . 18
Annex E (informative) Summary of the usability requirements for SMALL-BORE
CONNECTORS for limb cuff inflation APPLICATIONS . 19
E.1 USER PROFILE . 19
E.2 Use scenarios . 19
E.3 Use environments and scenarios . 20
E.4 Generic USER needs . 20
Annex F (informative) Summary of SMALL-BORE CONNECTOR design requirements for
limb cuff inflation APPLICATIONS . 21
Annex G (informative) Summary of assessment of the design of the CONNECTORS for
limb cuff inflation APPLICATION . 29
G.1 General . 29
G.2 Summary of the engineering analysis of the design . 29
G.2.1 NON-INTERCONNECTABLE analysis . 29
G.2.2 S1 male to N1 male . 29
G.3 Summary of the design VERIFICATION . 29
G.4 Summary of the design validation . 30
G.5 Summary of the design review . 30
Annex H (informative) Obsolete limb cuff inflation CONNECTOR . 31
Annex I (informative) Air leakage by pressure decay TEST METHOD . 34
I.1 Principle . 34

I.2 * Test conditions . 34
I.2.1 Test sample preconditioning . 34
I.2.2 Environmental test conditions . 34
I.3 Apparatus . 34
I.4 PROCEDURE . 34
I.5 Test report . 35
Annex J (informative) Resistance to separation from axial load TEST METHOD . 36
J.1 Principle . 36
J.2 * Test conditions . 36
J.2.1 Test sample preconditioning . 36
J.2.2 Environmental test conditions . 36
J.3 Apparatus . 36
J.4 PROCEDURE . 36
J.5 Test report . 36
Annex K (informative) Reference to the essential principles . 37
Index of defined terms . 39
Bibliography . 40

Figure B.1 – Male cuff S1 SMALL-BORE CONNECTOR . 13
Figure B.2 – Female sphygmomanometer S1 SMALL-BORE CONNECTOR . 15
Figure B.3 – Sphygmomanometer and cuff SMALL-BORE CONNECTOR (S1) assembly . 15
Figure H.1 – Obsolete sphygmomanometer and cuff SMALL-BORE CONNECTOR . 32

Table B.1 – Male cuff S1 SMALL-BORE CONNECTOR dimensions . 14
Table B.2 – Female sphygmomanometer S1 SMALL-BORE CONNECTOR dimensions . 16
Table E.1 – USER PROFILE . 19
Table F.1 – Adult or paediatric PATIENT sphygmomanometer and cuff S1 CONNECTOR-
specific design requirements (1 of 4) .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.