ISO 18250-3:2018

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 3: Enteral applications

This document specifies dimensions and requirements for the design and functional performance of connectors intended to be used on enteral reservoirs. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Manufacturers are encouraged to incorporate the connectors specified in this document into enteral medical devices or accessories, even if not currently required by the particular medical device Standards. It is expected that when the particular medical device Standards are revised, requirements for reservoir connectors, as specified in ISO 18250, will be included. This document does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. They rather belong to the food and beverage packaging domain despite often enteral giving sets are required to connect with them. NOTE 2 Examples of screw caps and necks are defined in DIN 55525:1988, ASTM D2911-94 (reapproved 2001), DIN 6063-1:2004, DIN 6063-2:2004, DIN 168-1:1998. Examples of crown cork caps and necks are defined in DIN 6094-1:1998, ISO 12821:2013, EN 14635:2010.

Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 3: Applications entérales

General Information

• Status: Published
• Publication Date: 25-Jun-2018
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: ISO/TC 210 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: ISO/TC 210/WG 5 - Connectors for reservoir delivery systems
• Current Stage: 9092 - International Standard to be revised
• Completion Date: 18-Dec-2023

Relations

• Consolidated By: ISO 12957-1:2018 - Geosynthetics — Determination of friction characteristics — Part 1: Direct shear test
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18250-3
First edition
2018-06
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 3:
Enteral applications
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 3: Applications entérales
Reference number
ISO 18250-3:2018(E)
©
ISO 2018

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ISO 18250-3:2018(E)

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ii © ISO 2018 – All rights reserved

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ISO 18250-3:2018(E)

Contents Page
Foreword .iv
Introduction .v
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 non-interconnectable characteristics . 2
4.2 *Materials . 2
5 *Dimensional requirements . 3
6 Performance requirements . 3
6.1 General performance requirements . 3
6.2 Positive pressure liquid leakage . 3
6.3 Subatmospheric-pressure air leakage . 3
6.4 Stress cracking . 4
6.5 Resistance to separation from axial load. 4
6.6 Resistance to separation from unscrewing . 4
6.7 Resistance to overriding . 4
6.8 Disconnection by unscrewing . 4
Annex A (informative) Rationale and guidance .
...