ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods

ISO 80369-20:2015 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369‑series.

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé -Partie 20: Méthodes d essai communes

General Information

• Status: Published
• Publication Date: 14-May-2015
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.25 - Syringes, needles an catheters
• ICS: 19.040 - Environmental testing
• 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: 15-Apr-2015
• Completion Date: 11-May-2015

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 80369-20
First edition
2015-05-15
Small-bore connectors for liquids and
gases in healthcare applications —
Part 20:
Common test methods
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 20: Méthodes d’essai communes

Reference number
ISO 80369-20:2015(E)

©
ISO 2015

---------------------- Page: 1 ----------------------
ISO 80369-20:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 80369-20:2015(E)

Contents Page
Foreword .iv
Introduction .v
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test methods for small-bore connectors . 1
Annex A (informative) Rationale and guidance . 3
Annex B (normative) *Leakage by pressure decay test method . 6
Annex C (normative) Falling drop positive-pressure liquid leakage test method .9
Annex D (normative) Subatmospheric-pressure air leakage test method .11
Annex E (normative) Stress cracking test method .15
Annex F (normative) Resistance to separation from axial load test method .17
Annex G (normative) Resistance to separation from unscrewing test method .19
Annex H (normative) Resistance to overriding test method .21
Annex I (normative) Disconnection by unscrewing test method .23
Annex J (informative) Modification of the test methods to generate variable data for
statistical analysis .25
Annex K (informative) Terminology — alphabetized index of defined terms .28
Bibliography .29
© ISO 2015 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 80369-20:2015(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. Internationa
...