Series-level principles, application categories and non-interconnectability framework.
Current edition: 2025Medical Connector Verification
ISO 80369 Testing Equipment for Small-Bore Connector Compliance
Reference connectors, Luer gauges, leakage test systems, force/torque fixtures and ISO 80369-20 test equipment for small-bore medical connector verification in enteral, respiratory, limb-cuff, neuraxial, intravascular and hypodermic applications.
Technical Overview
What Is ISO 80369 Testing Equipment?
ISO 80369 Testing Equipment verifies small-bore medical connectors for dimensional fit, leakage, separation force, unscrewing torque, overriding resistance, stress cracking and application-specific non-interconnectability.
The correct configuration depends on the connector application, standard part, edition year, Annex method and required reference interface. A reference connector is a defined mating interface used during performance testing.
It is not automatically the same as a simple go/no-go dimensional gauge. Complete ISO 80369 verification may require reference connectors, gauges, pressure/vacuum circuits, force testers, torque systems, environmental conditioning and controlled fixtures.
<8.5 mmSmall-bore definition
Part 20Common test methods
6% taperISO 80369-7 Luer
Application-specificReference interfaces
Which ISO 80369 Part Applies?
Selecting ISO 80369 Testing Equipment starts with the intended clinical application—not with visual similarity to a Luer fitting. The series reduces the risk of accidental cross-connections between medical delivery systems. Editions and publication status change, so confirm the applicable edition in the official ISO standards catalogue and record it in the regulatory submission or design-control plan.
Current Standard Version Note: ISO 80369 standards are updated over time. Before selecting gauges, reference connectors or ISO 80369-20 test systems, confirm the exact part, edition year, Annex, figure and acceptance criteria required by your regulatory submission, laboratory method or customer specification.
Connectors for breathing systems and driving gases, with application-specific reference interfaces.
2024 edition / confirm corrigendumConnectors for enteral feeding tubes, syringes and giving sets.
Application partThe earlier work item was postponed; do not assume a published Part 4 requirement without verification.
Verify statusConnectors for blood-pressure cuffs, tourniquets and related pneumatic applications.
IEC publicationCurrent requirements for neural connections; replaces the withdrawn 2016 edition.
Current edition6% Luer taper connectors for intravascular or hypodermic applications.
Current editionEdition 2 common performance test methods; replaces withdrawn ISO 80369-20:2015.
Current editionReference Connectors, Gauges and Functional Test Systems
Where ISO 80369 Testing Equipment Is Used
The correct test configuration depends on the clinical application, connector design and verification stage. These are the most common scenarios for reference connectors, gauges and functional test systems.
01ISO 80369-7
Luer Connector Verification
Verification of 6% Luer taper connectors used in intravascular and hypodermic devices, including lock and slip configurations.
- Syringes, needles and IV components
- Leakage, separation and torque tests
- Figure C.1–C.6 reference selection
02ISO 80369-3
Enteral Feeding Connections
Testing small-bore connectors used for enteral nutrition systems while controlling application-specific mating interfaces.
- Feeding tubes and administration sets
- Male/female reference connector tests
- Leakage and connection integrity
03ISO 80369-6
Neural Device Connections
Verification of connectors for neuraxial and other neural applications using the applicable 2025 edition requirements.
- Neuraxial delivery components
- Application-specific references
- Performance and non-interconnectability
04Parts 2 & 5
Gas and Limb-Cuff Systems
Connector evaluation for breathing-system or driving-gas applications and pneumatic limb-cuff inflation equipment.
- Respiratory tubing interfaces
- Blood-pressure cuff connections
- Pressure, leakage and separation tests
05R&D / V&V
Medical Device Design Verification
Engineering teams use reference interfaces and functional systems to qualify connector geometry before design transfer.
- Prototype comparison and tolerance review
- Design verification evidence
- Failure analysis and corrective action
06QA / Laboratory
Incoming, Type and Production Testing
Manufacturers and independent laboratories use controlled fixtures and calibrated instruments for repeatable acceptance testing.
- Incoming connector inspection
- Type-test and regulatory programs
- Batch release and supplier qualification
Application Testing in the Laboratory
How to Select ISO 80369 Testing Equipment
No single instrument performs every requirement. ISO 80369 Testing Equipment must be selected according to the connector application, standard edition, mating reference and required method. A defensible system combines the correct reference connector with calibrated pressure, force, torque and environmental equipment.
Reference Connectors
Application-specific male or female mating interfaces defined by the relevant part and figure. Material, geometry, surface condition and traceability must be controlled.
Dimensional Gauges
Go/no-go or profile inspection tools where explicitly defined. A dimensional gauge alone cannot demonstrate leakage, separation or torque performance.
Pressure and Vacuum Circuits
Regulated pressure/vacuum sources, transducers, timers, sealed circuits and fixtures for pressure-decay, liquid leakage and subatmospheric leakage tests.
Force Test Equipment
Calibrated axial loading with appropriate alignment and fixtures for resistance-to-separation testing.
Torque Test Equipment
Controlled connection, unscrewing, overriding and disconnection torque with suitable sensors and application-specific holding fixtures.
Conditioning and Data
Environmental conditioning, test media, acquisition and traceable calibration records appropriate to the required method and uncertainty.
Match the Test Requirement to the Correct ISO 80369 Equipment
Use this matrix to separate dimensional gauge selection from functional ISO 80369-20 testing. It helps engineers and procurement teams confirm whether they need a single reference connector, a Luer gauge set, a fixture package or a complete leakage / force / torque test system.
| Customer Need | Required Equipment | Typical KingPo Solution | Selection Notes |
|---|---|---|---|
| Dimensional verification of Luer connectors | ISO 80369-7 male plug gauge, female ring gauge or Figure C.1–C.6 reference connector set. | ISO 80369-7 Luer Gauge Set and Reference Connectors. | Choose by connector sex, lock/slip configuration and required figure. |
| Leakage by pressure decay or liquid leakage | Application-specific reference connector, sealed fixture, regulated pressure source, pressure transducer, timer and data system. | ISO 80369-20 leakage test fixture or integrated leakage test system. | Confirm test medium, pressure level, stabilization time and dead volume. |
| Subatmospheric air leakage | Vacuum source, reference connector, bubble observation / measurement setup and sealed fixture. | ISO 80369-20 subatmospheric air leakage tester. | Used when the method requires vacuum leakage evaluation instead of positive pressure. |
| Axial separation force | Force tester, calibrated load cell, axial alignment fixture and application-specific reference connector. | Axial load test fixture for ISO 80369 connector separation testing. | Alignment is critical; fixture error can dominate the result. |
| Unscrewing / disconnection torque | Torque tester, torque sensor, coaxial holding fixture and mating reference connector. | ISO 80369 torque test system or torque fixture package. | Confirm rotation direction, speed, axial load influence and peak capture method. |
| Overriding resistance | Combined torque / axial load setup with a rigid connector holding fixture. | Overriding torque fixture for application-specific connectors. | Do not substitute a simple handheld torque wrench for controlled verification. |
| Stress cracking evaluation | Conditioning environment, stressed mating fixture, reference connector and follow-up leakage test system. | Stress cracking setup plus leakage verification equipment. | Requires controlled sequence: conditioning, stress exposure, then functional check. |
ISO 80369 Testing Equipment for Common Test Methods
| Test Area | What It Evaluates | Typical Equipment | Critical Control |
|---|---|---|---|
| Leakage | Positive-pressure air or liquid leakage and subatmospheric air ingress. | Reference connector, regulated pressure/vacuum, transducer, timer, liquid circuit or observation setup. | Seal integrity, test pressure, stabilization, media and fixture dead volume. |
| Axial Separation | Resistance to connector separation under an axial load. | Force tester, calibrated load cell, aligned gripping and reference connector fixture. | Axis alignment, loading profile, dwell time and connector preconditioning. |
| Unscrewing / Disconnection | Resistance to unintended unscrewing and controlled disconnection behavior. | Torque system, torque transducer, coaxial fixtures and reference connector. | Connection procedure, rotation rate, axial influence and peak torque capture. |
| Overriding | Resistance to over-torquing or thread/lock override. | Combined torque/axial test configuration and application-specific mating reference. | Applied axial force, torque direction, fixture rigidity and endpoint definition. |
| Stress Cracking | Material performance after defined stress and environmental exposure. | Conditioning environment, mating reference/fixture and subsequent functional leak test equipment. | Conditioning time, temperature, humidity, stress state and test sequence. |
Edition warning: ISO 80369-20:2015 has been withdrawn. New projects should review ISO 80369-20:2024 and the applicable application-specific part. Do not reuse an old Annex method, load or acceptance value without an edition review.
Recommended ISO 80369 Verification Workflow
Classify
Identify the connector's intended healthcare application and applicable part.
Freeze Edition
Record the exact standard edition and regulatory or customer requirements.
Select References
Match connector sex, lock/slip style and required figure reference.
Build Method
Configure pressure, force, torque and conditioning equipment for each test.
Document
Record calibration, uncertainty, conditioning, samples, raw data and results.
ISO 80369-7 Luer Gauges and Reference Connectors
Start with the guide if the required figure is not yet known. Select the complete set for laboratories handling multiple male/female and lock/slip configurations, or open an individual product page when the standard figure and test object have already been confirmed.
ISO 80369-7 Luer Gauges & Reference Connectors GuideUnderstand connector types, Figure C.1–C.6 selection, test applications and the difference between reference connectors and dimensional gauges.→
Complete SetISO 80369-7 Luer Gauge Set and Reference ConnectorsFigure C.1–C.6 plus plug and ring gauge options.
Dimensional GaugeMale Plug Gauge for Female Luer ConnectorsBasic dimensional and fit verification for female Luer interfaces.
Dimensional GaugeFemale Ring Gauge for Male Luer ConnectorsBasic dimensional and fit verification for male Luer interfaces.
Figure C.1Female Reference Luer Lock ConnectorReference mating configurations for male Luer connector testing.
Figure C.2Male Reference Luer Slip ConnectorReference mating configurations for female Luer connector testing.
Figure C.3Female Reference ConnectorFemale mating reference used for defined male Luer lock tests.
Figure C.4Male Reference Luer Lock ConnectorMale mating reference for defined female Luer test configurations.
Figure C.5Female Reference Luer Slip ConnectorFemale slip reference for defined male Luer connector tests.
Figure C.6Male Reference ConnectorReference for female Luer lock separation and overriding test setups.
Browse all KINGPO Medical Test Equipment →
Build the ISO 80369 Topic Cluster
Use these resources to compare ISO 80369 products, review related standard guides and check KingPo medical testing evidence before selecting a connector test configuration.
ISO 80369-7 Luer Gauges GuideSelection guidance for Figure C.1–C.6 reference connectors, plug gauges and ring gauges.
ISO 80369-7 Luer Gauge SetComplete product page for Luer gauge and reference connector selection.
Medical Test Equipment CategoryBrowse related medical connector, leakage, force, torque and safety testing equipment.
Medical Testing Successful CasesReview KingPo delivery evidence for medical device laboratories and inspection centers.
Request Configuration ReviewSend drawings, test methods and standard editions for equipment matching.
Email Technical TeamAttach connector drawings or sample photos for quotation support.
Traceability and Procurement Evidence
Information KINGPO Needs
- Standard part, edition, clause, Annex and figure
- Connector application, sex and lock/slip configuration
- Drawing, tolerances and available samples
- Required dimensional and functional tests
- Target laboratory workflow and reporting format
- Calibration or ISO/IEC 17025 certificate expectations
Evidence to Request Before Acceptance
Request a drawing-linked equipment list, material and hardness specification where applicable, dimensional inspection record, serial-number identification, calibration scope for force/torque/pressure instruments, sample method demonstration and factory acceptance criteria. A certificate for one instrument does not automatically establish traceability for every reference connector and fixture in the system.
Frequently Asked Questions
Is a reference connector the same as a go/no-go gauge?
No. A reference connector is a defined mating interface used for functional tests. A go/no-go gauge checks a specified dimensional condition. Some products may be informally called gauges, but the required function and figure must be confirmed before ordering.
Which standard contains the common performance test methods?
ISO 80369-20:2024, Edition 2, specifies common test methods used to evaluate performance requirements in the ISO and IEC 80369 series and ISO 18250 series. It replaces ISO 80369-20:2015.
Does ISO 80369-7 replace ISO 594?
ISO 80369-7 is the current framework for 6% Luer taper connectors used in intravascular or hypodermic applications. Legacy files may still reference ISO 594, so the required regulatory edition and transition strategy must be confirmed.
Can one Luer gauge test enteral and neuraxial connectors?
No. The purpose of the series is application differentiation and reduced misconnection risk. Enteral, neural and intravascular/hypodermic connectors use application-specific geometries and reference interfaces.
Do I need both male and female reference connectors?
That depends on the connector under test and required methods. Testing male DUT connectors generally requires the appropriate female reference, and vice versa. Lock and slip configurations may require different references.
What changed for ISO 80369-6?
ISO 80369-6:2016 is withdrawn and a 2025 edition is available. New projects should review ISO 80369-6:2025 rather than assuming that a 2016 test plan remains current.
Can a gauge set alone prove full ISO 80369 compliance?
No. Full verification can include design, dimensional, non-interconnectability and functional performance requirements. Leakage, separation, torque and environmental tests require additional calibrated systems and controlled procedures.
What should I send for an accurate quotation?
Send the ISO or IEC 80369 part and edition, Annex/figure numbers, connector drawing, male/female and lock/slip configuration, required test list, sample availability and certificate requirements.
