ISO/TC 210/WG 5 - Connectors for reservoir delivery systems

This document specifies the connectors recommended for the outlet ports of neural reservoirs and inlet ports of neural giving sets.

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.

This document specifies general requirements for reservoir connectors, which convey fluids in healthcare applications. These reservoir connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these reservoir connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for — respiratory, — enteral, — neural, — intravascular, — citrate-based anticoagulant solution, and — irrigation. Reservoir connectors as specified in this document are non-interconnectable with: — the reservoir connectors of every other application specified in the ISO 18250 series; — removable temperature sensor port specified in Annex EE of ISO 80601-2-74:2017; — the nipples specified in Annex B of ISO 17256[1]; unless otherwise specified in the ISO 18250 series. Application parts of the ISO 18250 series can specify additional connectors with which reservoir connectors (as specified in those application parts) are to be non-interconnectable. This document provides the methodology to assess non-interconnectable characteristics of reservoir connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications. This document does not specify requirements for the medical devices or accessories that use these reservoir connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Manufacturers are encouraged to incorporate the reservoir connectors specified in the ISO 18250 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for reservoir connectors as specified in the series of standards will be included. NOTE 2 The ISO 18250 series does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. Examples of screw caps and necks are defined in DIN 55525, ASTM D2911/D2911M, DIN 6063-1, DIN 6063-2, DIN 168-1. Examples of crown cork caps and necks are defined in DIN 6094, ISO 12821, EN 14635. This document also specifies the test methods to verify the common performance requirements for reservoir connectors. The performance requirements for these common test methods are specified in the application parts and not in the general part. [1] Under preparation. Stage at the time of publication: ISO/DIS 17256:2017.

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.

This document specifies dimensions and requirements for the design and functional performance of connectors intended to be used on enteral 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. NOTE 1 Manufacturers are encouraged to incorporate the connectors specified in this document into enteral 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. This document does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. They rather belong to the food and beverage packaging domain despite often enteral giving sets are required to connect with them. NOTE 2 Examples of screw caps and necks are defined in DIN 55525:1988, ASTM D2911-94 (reapproved 2001), DIN 6063-1:2004, DIN 6063-2:2004, DIN 168-1:1998. Examples of crown cork caps and necks are defined in DIN 6094-1:1998, ISO 12821:2013, EN 14635:2010.