EN ISO 80369 Small Diameter Connectors for Liquids and Gases in Healthcare Applications

The standard “EN ISO 80369 Small diameter connectors for liquids and gases in healthcare applications”, which is based on a European standard and subsequently published by the International Organization for Standardization (ISO), consists of the following subsections published under the same title:

• The standard "EN ISO 80369-1 Part 1: General requirements" describes the general requirements for small-diameter connectors that conduct liquids or gases in healthcare applications. These small-diameter connectors are used in medical devices or accessories designed for use with a patient. This standard also specifies the healthcare areas in which these small-diameter connectors are intended to be used. These healthcare areas include, but are not limited to:
  • Respiratory systems and propellants
  • enteral
  • Limb cuff inflation
  • Neuraxial
  • Intravascular or hypodermic

This standard provides a methodology for reducing the risk of incorrect connections between medical devices or accessories for the various applications specified herein, as well as for evaluating the non-interconnectability characteristics of small-diameter connectors, based on their inherent design and dimensions, as developed in future installments of the ISO 80369 series of standards. This standard does not specify requirements for medical devices or accessories that use these small-diameter connectors. Such requirements are specifically provided in international standards for specific medical devices or accessories.

Manufacturers are encouraged to incorporate the small-diameter connectors specified in the ISO 80369 series of standards into medical devices, medical systems, or accessories, even if they are not currently required by the relevant medical device standards. It is expected that the risks associated with switching to the new small-diameter connectors specified in the ISO 80369 series will be considered when the relevant medical device standards are revised.

The connectors specified in the ISO 80369 series of standards are intended for use only in the specified applications. Use of these connectors in any other application increases the risk of a hazardous misconnection.

• The standard "EN ISO 80369-2 Part 2: Connectors for respiratory applications" describes the design and dimensions of two small-diameter connectors intended for use in connecting medical devices and accessories in respiratory applications. One connector (R1) is designed for use in medical devices and accessories subjected to pressures up to 15 kPa (e.g., a breathing system). The other connector (R2) is designed for use in medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g., oxygen therapy tubing).

The pressure refers to the pressure at the source to which the medical device is connected. The intended application does not preclude the use of other connectors on medical devices or accessories within that application. Requirements for alternative connectors for this intended application are specified in ISO 80369-1. This standard does not specify requirements for medical devices or accessories that use these connectors. Such requirements are provided in device-specific standards. If a device-specific standard is not available, the performance and material requirements specified in ISO 80369-1 can be used as a guide.

• The standard "EN ISO 80369-3 Part 3: Connectors for enteral applications" describes the dimensions and requirements for the design and functional performance of small-bore connectors intended for use as connections on enteral medical devices and accessories. Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices, including access ports.

This standard does not specify dimensions and requirements for medical devices or accessories that use these connectors. Such requirements are specifically provided in international standards for specific medical devices or accessories. This standard does not specify requirements for small-diameter connectors used for:

• Gastric suction medical devices only.
• Only oral medical devices, for example a syringe with an oral tip that is not designed to be connected to another medical device, are intended for direct administration into 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 medication or liquid, and other rectal access medical devices.
• Gastrointestinal endoscopy equipment.
• Skin level gastrostomy medical devices.

Manufacturers are encouraged to incorporate the small-diameter connectors specified in this standard into enteral medical devices or accessories, even if they are not currently required by the relevant specific medical device standards. It is anticipated that the requirements for small-diameter connectors specified in ISO 80369 will also be added when the relevant specific medical device standards are revised.

• The standard "EN ISO 80369-5 Part 5: Connectors for limb cuff inflation applications" describes the dimensions and requirements for the design and functional performance of small-bore connectors intended for use as connections for limb cuff inflation applications of medical devices and accessories. Limb cuff inflation applications include connections between a sphygmomanometer and its cuff. This standard does not specify requirements for medical devices or accessories that use these connections. Such requirements are specifically provided in international standards for specific medical devices or accessories. This standard does not specify requirements for pressurization and depressurization of the retention mechanism (e.g., balloon) used to hold invasive medical devices in place.

Manufacturers are encouraged to incorporate the small-bore connectors specified in this standard into medical devices, medical systems, or accessories, even if they are not currently required by the specific relevant medical device standards. It is anticipated that the requirements for the small-bore connectors specified in this standard will be incorporated when the specific relevant medical device standards are revised. Requirements for small-bore connectors intended for use in neonatal patients to connect a cuff to a sphygmomanometer are intended to be added to this standard through an amendment or new edition.

• The standard "EN ISO 80369-6 Part 6: Connectors for neuraxial applications" specifies requirements for small-bore connectors intended for use in neuraxial applications. Neuraxial applications include the use of medical devices designed for drug delivery to neuraxial regions, wound infiltration anesthesia, and other regional anesthesia procedures, or for monitoring or removal of cerebrospinal fluid for therapeutic or diagnostic purposes.

Neuraxial delivery sites include the spine, intrathecal or subarachnoid space, and the ventricles of the brain. Neuraxial delivery anesthetics can be administered regionally, affecting a large portion of the body, such as a limb, and include plexus blocks such as branchial plexus blocks or single-nerve blocks. Neuraxial delivery procedures involve continuous infusion of local anesthetic agents into wounds.

For the purposes of this standard, hypodermically injected local anesthesia is not considered a neuraxial application. This standard specifies the dimensions and requirements for the design and functional performance of these small-diameter connectors designed for use with medical devices. This standard does not specify requirements for medical devices or accessories that use these connectors. Such requirements are specifically provided in international standards for specific medical devices or accessories. Manufacturers are encouraged to incorporate the small-diameter connectors specified in this standard into medical devices, medical systems, or accessories, even if they are not currently required by the relevant specific medical device standards. It is anticipated that the requirements for the small-diameter connectors specified in ISO 80369 will also be added when the relevant specific medical device standards are revised.

• The standard “EN ISO 80369-7 Part 7: Connectors for intravascular or hypodermic applications” describes the dimensions and requirements for the design and functional performance of small-bore connectors intended for connections of medical devices and accessories in intravascular applications or hypodermic connections in hypodermic applications.

The Luer connector was originally designed for use at pressures up to 300 kPa. This standard does not specify requirements for medical devices or accessories that use these connectors. Such requirements are provided in specific documents for specific medical devices or accessories. This standard does not specify requirements for the following small-bore connectors specified in other documents:

• Hemodialysis device, hemodiafilter and hemofilter blood compartment ports (ISO 8637 standard and the relevant part of ISO 8638 standard referring to blood compartment ports)
• Connectors for hemodialysis, hemodiafiltration and hemofiltration equipment (ISO 8637 standard)
• Infusion system closure piercing connectors (ISO 8536-4 standard)

Manufacturers are encouraged to incorporate the small-diameter connectors specified in this standard into medical devices or accessories, even if they are not currently required by the specific relevant medical device documentation. It is expected that the requirements for the small-diameter connectors specified in this standard will be incorporated when the specific relevant medical device documentation is revised.

• The standard "EN ISO 80369-20 Part 20: Common test methods" describes test methods for assessing the performance requirements for small-diameter connectors specified in the ISO 80369 series of standards. These methods are:
  • Leakage by pressure reduction testing: This test method is a new test method that is not part of the older ISO 594 series. However, it is based on the informative liquid leakage testing method described in ISO 594-1.
  • Drop drop positive pressure liquid leak test method (previous liquid leak test): This test method is performed in the same manner as in the ISO 594 series of standards.
  • Sub-atmospheric pressure air leak test method (formerly air leak test): This test method is a new test method that is not part of the former ISO 594 series of standards. The ISO 594 series test method for sub-atmospheric pressure establishes an unspecified sub-atmospheric test pressure and instructs the observer to continuously look for the formation of bubbles of an unspecified size.
  • Stress crack test method: This test method is performed in the same manner as in the ISO 594 series. The acceptance criteria have been modified to require a functional leak test to be performed after the stress crack test method is performed.
  • Test method for resistance to separation from axial load (formerly separation force test): This test method is performed in the same manner as in the ISO 594 series of standards. The title and principle are explained in detail to explain the purpose of the test.
  • Test method for resistance to separation by unscrewing: This test method is performed in the same manner as the ISO 594 series of standards. The title and principle are explained in detail to explain the purpose of the test.
  • Resistance to invalidation test method: This test method is performed in the same manner as the ISO 594 series of standards.
  • Screw removal separation test method: This test method replaces the test method described in the ISO 594 series of standards to account for locking, non-locking (slip-on), and swivel collar connectors. It is intended to ensure that connectors that are plugged and unplugged multiple times a day can be successfully removed by the user.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, has a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services in accordance with the EN ISO 80369 standard for "Small-diameter connectors for liquids and gases in healthcare applications."