ISO DIS 18250-7

Description / Abstract: This part of ISO 18250 specifies dimensions and requirements for the design and functional performance of CONNECTORS intended to be used on INTRAVASCULAR INFUSION RESERVOIRS.

This part of ISO 18250 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 standard:

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  Administration ports on IV fluid RESERVOIRS and the mating spikes of IV administration/giving sets/lines. e.g. IV bags/container and the spike inlet ends of IV sets

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  Devices intended to be connected in series between the administration port of IV Fluid RESERVOIRS and the mating spikes of IV administration/giving lines/etc

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  Syringes and syringe IV sets utilizing LUER CONNECTORS

The following MEDICAL DEVICES have CONNECTORS that are considered outside the scope of this standard:

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  Stoppers for bottles per ISO 8536-2

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  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)

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  The fill ports of non-powered (i.e. elastomeric) pumps

NOTE: MANUFACTURERS are encouraged to incorporate the CONNECTORS specified in this part of ISO 18250 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.