ISO 18250-8:2018

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 8: Citrate-based anticoagulant solution for apheresis applications

This document specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. 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. The following examples of medical devices are intended to use the connectors of this document: — Apheresis tubing sets and mating reservoirs containing citrate-based anticoagulant solution. — Apheresis tubing sets may include, but are not limited to those for use in blood collection, therapeutic applications, and plasma collection. Some apheresis sets are manufactured with a pre-connected reservoir containing citrate-based anticoagulant solution. These medical devices are not intended to use the connectors of this document. NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into apheresis 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 apheresis AC reservoir connectors, will be included.

Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 8: Solution anticoagulante à base de citrate pour les applications d'aphérèse

General Information

• Status: Published
• Publication Date: 20-Aug-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: 9060 - Close of review
• Start Date: 04-Mar-2029

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18250-8
First edition
2018-08
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 8:
Citrate-based anticoagulant solution
for apheresis applications
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 8: Solution anticoagulante à base de citrate pour les
applications d'aphérèse
Reference number
ISO 18250-8:2018(E)
©
ISO 2018

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ISO 18250-8:2018(E)

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ISO 18250-8:2018(E)

Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Non-Interconnectability through conformance to ISO 18250-8 . 3
4.2 *Materials . 3
4.3 Apheresis AC reservoir connector Descriptions . 3
4.4 *Design . 4
4.5 Reference connectors . 4
5 Performance requirements . 4
5.1 General . 4
5.2 *Positive pressure liquid leakage. 4
5.3 Stress-cracking . 4
5.4 Resistance to separation from axial load. 4
5.5 Resistance to separation from unscrewing . 4
5.6 Resistance to overriding . 5
5.7 *Subatmospheric pressure air leakage .
...