ISO 18250-7:2018

Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 7: Connectors for intravascular infusion

This document specifies the interface dimensions and requirements for the design and functional performance of connectors intended to be used to connect intravascular infusion sets to intravascular infusion 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. EXAMPLES Medical devices which may use intravascular reservoir connectors are the following: — Administration ports on IV fluid reservoirs and the mating spikes of IV administration/intravascular infusion sets/lines, e.g., IV bags/containers and the spike inlet ends of IV sets; — Devices intended to be connected in series between the administration port of IV fluid reservoirs and the mating spikes of IV administration/giving lines; — Syringes and syringe IV sets utilizing Luer connectors. The following connectors are excluded from the scope of this document: — Stoppers for bottles as specified in ISO 8536-2; — Compounding/admixture ports on IV reservoirs and intended mating devices. EXAMPLES Rubber stoppers used for injection into the reservoir and the mating pharmacy admixture devices (syringes, needles, reconstitution devices, and other ancillary equipment used to access the compounding or admixture ports). — The fill ports of non-powered (i.e. elastomeric) pumps. NOTE 1 Details of alternative spikes that are in common use are located in Annex G for informational purposes. NOTE 2 Manufacturers are encouraged to incorporate the connectors specified in this document into intravascular infusion 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.

Dispositifs médicaux — Connecteurs pour systèmes de livraison de réservoir pour des applications de soins de santé — Partie 7: Connecteurs pour perfusion intravasculaire

General Information

• Status: Published
• Publication Date: 16-Dec-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-Jun-2029

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 18250-7
First edition
2018-12
Medical devices — Connectors
for reservoir delivery systems for
healthcare applications —
Part 7:
Connectors for intravascular infusion
Dispositifs médicaux — Connecteurs pour systèmes de livraison de
réservoir pour des applications de soins de santé —
Partie 7: Connecteurs pour perfusion intravasculaire
Reference number
ISO 18250-7:2018(E)
©
ISO 2018

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ISO 18250-7:2018(E)

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ISO 18250-7:2018(E)

Contents Page
Foreword .iv
Introduction .vi
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 2
4.1 Non-interconnectability through conformance to this document . 2
4.2 * Intravascular Reservoir Connector types . 2
5 Material requirements . 3
5.1 Connector Type 1: spikes and administration ports . 3
5.2 Connector Type 2: Luers . 3
6 Dimensional requirements . 3
6.1 Connector Type 1: Spikes and Administration Ports. 3
6.2 Connector Type 2: Luers . 3
7 Performance requirements . 3
7.1 * Connector Type 1: Spikes and Administration Ports . 3
7.2 Connector Type 2: Luers . 3
Annex A (informative) Rationale and guidance . 4
Annex B (normative) Design of connectors* .13
Annex C (informative) Assessment of reservoir connectors and their attributes with
connections t
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