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  • BSI
    BS ISO 18250-7:2018 Medical devices. Connectors for reservoir delivery systems for healthcare applications - Connectors for intravascular infusion
    Edition: 2018
    $418.55
    / user per year

Description of BS ISO 18250-7:2018 2018

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.



Standard NumberBS ISO 18250-7:2018
TitleMedical devices. Connectors for reservoir delivery systems for healthcare applications - Connectors for intravascular infusion
StatusDefinitive
Publication Date2018-12-20
Identical National Standard OfISO 18250-7:2018
DescriptorsDelivery, Health services, Testing methods, Electric connectors, Hydraulic fluid reservoirs
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/210/5
ISBN978 0 580 95285 2
PublisherBSI
Pages40

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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