ISO/TC 210/JWG 4 - Joint ISO/TC 210 - IEC/SC 62D WG: Small bore connectors

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 See Annex A. NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); - infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields include, but are not limited to: — breathing systems and driving gases; — enteral; — limb cuff inflation; — neuraxial; — intravascular or hypodermic. This document provides the methodology to assess non-interconnectable characteristics of small-bore 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 as specified in this document as well as those that will be developed under future parts of the ISO 80369 series. This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 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, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered. NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur. NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

ISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories. NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports. It 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. It does not specify requirements for small-bore connectors that are used for the following: - gastric suction-only medical devices; - oral-only medical devices; EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth. - pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place; - medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device; - gastrointestinal endoscopy equipment; - skin level gastrostomy medical devices. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices 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 small-bore connectors, as specified in ISO 80369, will be included.

ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. NOTE 2 For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application. EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics. This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices. This part of ISO 80369 does not specify 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 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 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 small-bore connectors, as specified in this part of ISO 80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices used for neuraxial applications. NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for small-bore connectors intended for use with neuraxial application medical devices or accessories, which do not comply with this part of ISO 80369.

IEC 80369-5:2016 specifies dimensions and requirements for the design and functional performance of SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in limb cuff inflation APPLICATIONS of MEDICAL DEVICES and ACCESSORIES. Limb cuff inflation APPLICATIONS include CONNECTIONS between a sphygmomanometer and its cuff.

ISO 80369-20:2015 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369‑ series.

ISO 80369-7:2016 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female luer slip connectors and luer lock connectors. NOTE 1 The luer connector was originally designed for use at pressures up to 300 kPa. ISO 80369-7:2016 does not specify 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. ISO 80369-7:2016 does not specify requirements for the following small-bore connectors, which are specified in other International Standards: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637); - infusion system closure piercing connectors (ISO 8536‑4). NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices 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 small-bore connectors, as specified in ISO 80369, will be included. NOTE 3 ISO 80369‑1:2010, 5.8, specifies alternative methods of compliance with ISO 80369‑1:2010, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not comply with this part of ISO 80369.

ISO 80369-1:2010 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for: breathing systems and driving gases, enteral and gastric, urethral and urinary, limb cuff inflation, neuraxial devices, and intravascular or hypodermic. Small-bore connectors as specified in ISO 80369-1:2010 are non-interconnectable with: the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; the temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and the nipples of EN 13544-2:2002. ISO 80369-1:2010 provides the methodology to assess non-interconnectable characteristics of small-bore 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 and to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed under future parts of this series of standards. It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.