ISO 18250-6:2019

INTERNATIONAL ISO
STANDARD 18250-6
First edition
2019-03
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 6:
Neural applications
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 6: Applications neurales
Reference number
©
ISO 2019
© ISO 2019
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ii © ISO 2019 – All rights reserved

Contents Page
Foreword .iv
Introduction .vi
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 *Neural reservoir outlet port connector. 1
5 *Neural giving set inlet port connector . 1
Annex A (informative) Rationale . 2
Annex B (informative) Summary of design history of connectors for neural reservoirs .3
Bibliography . 6
Foreword
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This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices.
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Introduction
During the development of the ISO 80369 series of standards for small-bore connectors for liquids and
gases in healthcare applications it became evident that the risk of misconnections was not limited to the
patient access connectors and that the connectors used at the reservoir end of the systems were also
a potential high risk for misconnection. For many reasons these reservoir connectors did not fit well
within the scope of ISO 80369 so it was decided to develop a separate series of standards specifically for
these reservoir connectors. The 18250 series takes into account the risks of misconnections between
the reservoir connectors of different applications including the existing standardized IV spike specified
in ISO 8536-4 and ISO 1135-4.
NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into medical
devices, even if not currently required by the particular device standard. It is expected that when the particular
device standards are revised, requirements for connectors with the dimensions, as specified within this
document, will be included.
vi © ISO 2019 – All rights reserved

INTERNATIONAL STANDARD ISO 18250-6:2019(E)
Medical devices — Connectors for reservoir delivery
systems for healthcare applications —
Part 6:
Neural applications
1 *Scope
This document specifies the connectors recommended for the outlet ports
...