Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods

This document specifies general requirements for reservoir connectors, which convey fluids in healthcare applications. These reservoir connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these reservoir connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for — respiratory, — enteral, — neural, — intravascular, — citrate-based anticoagulant solution, and — irrigation. Reservoir connectors as specified in this document are non-interconnectable with: — the reservoir connectors of every other application specified in the ISO 18250 series; — removable temperature sensor port specified in Annex EE of ISO 80601-2-74:2017; — the nipples specified in Annex B of ISO 17256[1]; unless otherwise specified in the ISO 18250 series. Application parts of the ISO 18250 series can specify additional connectors with which reservoir connectors (as specified in those application parts) are to be non-interconnectable. This document provides the methodology to assess non-interconnectable characteristics of reservoir connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications. This document does not specify requirements for the medical devices or accessories that use these reservoir connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Manufacturers are encouraged to incorporate the reservoir connectors specified in the ISO 18250 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for reservoir connectors as specified in the series of standards will be included. NOTE 2 The ISO 18250 series does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. Examples of screw caps and necks are defined in DIN 55525, ASTM D2911/D2911M, DIN 6063-1, DIN 6063-2, DIN 168-1. Examples of crown cork caps and necks are defined in DIN 6094, ISO 12821, EN 14635. This document also specifies the test methods to verify the common performance requirements for reservoir connectors. The performance requirements for these common test methods are specified in the application parts and not in the general part. [1] Under preparation. Stage at the time of publication: ISO/DIS 17256:2017.

Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 1: Exigences générales et méthodes d'essai courantes

General Information

Status
Published
Publication Date
02-Dec-2018
Current Stage
9060 - Close of review
Start Date
04-Jun-2029
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ISO 18250-1:2018 - Medical devices -- Connectors for reservoir delivery systems for healthcare applications
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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18250-1
First edition
2018-12
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 1:
General requirements and common
test methods
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 1: Exigences générales et méthodes d'essai courantes
Reference number
ISO 18250-1:2018(E)
©
ISO 2018

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ISO 18250-1:2018(E)

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ii © ISO 2018 – All rights reserved

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ISO 18250-1:2018(E)

Contents Page
Foreword .iv
Introduction .vi
1 *Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Materials used for reservoir connectors . 4
4.1 *General . 4
4.2 Alternative test methods . 4
5 *Requirements for reservoir connectors for specific applications .4
5.1 *Reservoir connector incompatibility . 4
5.2 Enteral applications . 5
5.3 Neural applications . 5
5.4 Intravascular applications . 5
5.5 Citrate-based anticoagulant solution for apheresis applications . 5
6 *reservoir connectors for applications not already covered in the ISO 18250 series .5
7 *Performance requirements . 5
7.1 Leakage . 5
7.1.1 Positive-pressure liquid leakage . 5
7.1.2 Sub atmospheric pressure air leakage . 6
7.2 Stress-cracking .
...

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