IEC 80369-5:2016

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
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 10 - TC 62/SC 62D/JWG 10
• Current Stage: PPUB - Publication issued
• Start Date: 31-Mar-2016
• Completion Date: 04-Mar-2016

Relations

• Corrected By: IEC 80369-5:2016/COR2:2021 - Corrigendum 2 - Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
• Effective Date: 05-Sep-2023
• Corrected By: IEC 80369-5:2016/COR1:2017 - Corrigendum 1 - Small bore connectors for liquids and gases in healthcare application - Part 5: Connectors for limb cuff inflation applications
• Effective Date: 05-Sep-2023

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

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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) .
...