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ISO 80369 Small-Bore Connector Standards

What is ISO 80369?

ISO 80369 is a new standard that is being developed by the International Organization for Standardization to improve patient safety and reduce the risk of small-bore misconnections used in liquid and gas healthcare applications. Small-bore connectors convey liquids or gases in a patient-care setting. Such connectors are used in enteral, respiratory, urinary, blood pressure, neuraxial and intravenous systems.

Patients often have multiple lines connected to them to deliver medicine and nutrients. Numerous devices and systems use the universal luer lock connector, which is a type of small-bore connector. A small-bore connector is defined as having an ID of less than 8.5 mm, and a luer is defined by the ISO 594-1 and ISO 594-2 standards as: “a conical fitting with a 6% taper for syringes, needles and certain other medical equipment.”

Through this connector, a healthcare worker or patient could mistakenly connect one device used for one application, such as enteral nutrition, to another device used for another application, such as intravenous therapy.



What are the ISO 80369 standards?

ISO 80369-1
General Requirements and Overview

ISO 80369-20
Common Test Methods

 

ISO 80369-2
Breathing Systems and Driving Gases (Airway)

ISO 80369-4
Urinary Collection (Urethra)

 

ISO 80369-5
Limb Cuff Inflation (Tourniquets and BP Cuffs)

ISO 80369-7
Intravenous (Artery/Veins)*

 

*Note: Section 7 will define the standard luer fitting. This section will replace the current ISO 594-1 and the
ISO 594-2. No physical changes to the current luer specification are anticipated.



How does this affect you?

If you are currently using any small-bore connectors in a kit, set, or line, which drives gas or pressurized fluids to patients and are using luers in non IV applications, this may impact you. This standard will involve some key changes from component suppliers, which may include designing new connectors or modifying existing connectors to meet the specifications in the new standard.

ISO 80369-1 General Requirements and Overview

ISO 80369-1 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. It 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.

ISO 80369-2 Respiratory

Changes Affect Two Designs for Respiratory Connectors
Respiratory connectors involve systems designed to administer breathing systems and driving gas applications. ISO 80369-2 connectors have designs for two small-bore connectors for respiratory applications. One is for use on low-flow equipment such as sample ports on anesthetic and ventilator breathing systems and another is for use on high-flow equipment such as flowmeters, nebulizer therapy face masks, and nasal cannulae.

ISO 80369-3 Enteral Feeding

Enteral is the first clinical application to make the transition to new, safer connectors. The New Enteral Feeding Connectors have been designed to improve patient safety and reduce the risk of enteral feeding misconnections. The new standard has changed the configuration of the male and female connectors. These enteral connectors are larger and will not allow connectivity with the male luer or female luer connectors that meet the ISO 594 standards or any other connectors for any other clinical use. They also provide a locking feature that signals the appropriate connection and stays in place. Administration sets and syringes have a female connector end that fit into a male patient-access feeding tube port.

All enteral connectors including feeding tubes, administration sets, and medication, flush, and bolus feed syringes are expected to comply with the new ISO standard. Enteral-specific syringes will also be required to connect to the new enteral feeding connector for medication, flush, and bolus feed syringes.

Enteral Nutrition Transitions to the New ENFitTM Connector
The Global Enteral Device Suppliers Association (GEDSA.org) was formed to facilitate the transition to the new type of connectors and has created the brand ENFit to represent the new ISO 80369-3 standard.

What does Qosina offer to help you prepare for ISO 80369-3 Enteral Feeding Connectors?

Qosina offers an extensive line of enteral feeding connectors that have been designed to meet the ISO 80369-3 standard. Qosina is offering ENFitTM male and female connectors, caps, stepped adapters, Y connectors, stopcocks, and syringes, as well as the ENFit to ENLock adapters, ENPlus cross spikes and universal bottle adapters for the ENPlus cross spike in various sizes and materials to meet the needs of your enteral project. Please visit our ENFit section at: www.qosina/ENFit

ISO 80369-4 Urinary and Urethral

Future Changes for Urinary Catheters
Urethral applications involve the urinary catheters that are used to drain the bladder.

ISO 80369-5 Limb Cuff

Development process ahead for limb cuff connectors
Limb cuff inflation connectors will join air inflation administration to limb cuffs.

ISO 80369-6 Neuraxial

This standard specifies requirements for small-bore connectors intended to be used in neuraxial applications. These applications involve the use of medical devices used to administer medications to neuraxial sites, wound infiltration anesthesia delivery and other regional anesthesia procedures, or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.

The Global Enteral Device Suppliers Association was formed to promote initiatives surrounding safe and optimal feeding and neuraxial tubing connectivity; therefore, it created the NRFit™ brand of neuraxial connectors to meet the ISO 80369-6 standard. NRFit™ connectors look much like luers, making a tapered seal connection; however, they are slightly smaller so that they cannot be misconnected to male or female luers as specified in the ISO 594 standards. Color is not included in the standard, but many manufacturers are choosing yellow as a plunger color to indicate NRFit™ syringes, which will easily differentiate them in procedural kits used in healthcare settings.

What does Qosina offer to help you comply with ISO 80369-6?
Qosina stocks a line of NRFit™ connectors and caps that are small and lightweight, made of medical-grade acrylic resin, BPA- and latex-free, gamma and EtO sterilization ready, and clear with no colorants added. The connectors are available to fit 0.083 inch (2.1 mm) or 0.122 inch (3.1 mm) outer diameter tubing, and the caps are offered in both vented and non-vented designs. The ergonomic wings on the female connectors and the easy-to-grip hub on the male connectors allow for ease of use. Please visit our NRFit™ selection at www.qosina.com/neuraxial.

ISO 80369-7 Intravenous

Design includes intravascular and hypodermic applications
Connections following the intravenous therapy (IV) design include systems with the purpose of infusion of liquid through intravascular or hypodermic applications. This series will replace the current ISO 594-1 and the ISO 594-2. No physical changes to the current luer specification are anticipated.

ISO 80369-20 Common Test Methods

ISO 80369-20 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369 series. During the development of the ISO 80369 series it became evident that many of the test methods were very similar for each of the applications. It was therefore decided to standardize all the test methods into a separate part of the series to prevent unnecessary duplication and minor differences. It is also recognized that not all connectors can be evaluated using each test method in this part. The test methods applicable to each connector are specified in the respective part of the ISO 80369 series.

How can Qosina help you prepare for the new standards?

Qosina is actively researching the upcoming changes and is a member of GEDSA. Qosina will be adding compliant components to its extensive line as the standards become approved.

Where can one find additional and updated information?

International Organization for Standardization: www.iso.org
Association for the Advancement of Medical Instrumentation (AAMI): www.aami.org
The Global Enteral Device Supplier Association (GEDSA): www.gedsa.org

For additional information, call a Qosina Customer Specialist at 631-242-3000 or email us at info@qosina.com

Note: “This information is solely provided by Qosina based on research done through the ISO, AAMI, and GEDSA websites. These notes have not been endorsed or approved by ISO, AAMI or GEDSA and should not be used to make specific business decisions.”

ENFitTM is a registered trademark of GEDSA used with their permission.