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.
Status : PublishedPublication date : 2018-12
Edition : 1Number of pages : 34
Technical Committee:Quality management and corresponding general aspects for medical devices
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