ISO 80369 Test of Small-Bore Luer Connector for Liquids and Gases in Medical

Information on the most widely used ASTM standards within the materials testing industry

Descriptions of the most prominent lSO standards within the materials testing industry

Standards including EN, DIN, JlS, and more

Mechanical testing of polymer materials in the automotive industry is directly related to the safety of components and the reliability of the entire vehicle. UnitedTest can cover mechanical performance testing for automotive interior and exterior parts, as well as functional components, adapting to automaker standards and providing comprehensive testing solutions including tensile, impact, and fatigue tests.

Mechanical testing in the battery industry determines the tensile and puncture resistance of core components such as separators and electrodes, directly affecting battery safety and cycle life. UnitedTest can cover full-dimensional mechanical testing of battery materials, compatible with national and international standards, and provide customized testing solutions.

Mechanical testing in the consumer goods industry determines product durability and safety, such as impact resistance for toys and fatigue resistance for home appliances, making it core to compliance and quality. UnitedTest can cover mechanical tests for all categories of consumer goods, including tensile, impact, and hardness tests, compatible with national and international standards, and offers customized testing solutions.

In the field of medical and biomedical sciences, mechanical testing determines the safety and compatibility of implanted devices and biomaterials, making it a core part of regulatory approval. UnitedTest can cover a full range of tests including tensile, fatigue, and wear tests, compatible with national and international standards, and provides customized biomechanical testing solutions.

Material strength is a course that most engineering fields are required to study in university education. This interesting course is very practical and makes use of testing equipment in the materials laboratory.

Mechanical testing of industrial products and components is essential to ensure their load-bearing, fatigue resistance, and impact resistance, directly preventing production accidents and ensuring stable operation of equipment. UnitedTest can cover a full range of tests including tensile, hardness, and fatigue, complying with national and international standards, and provides customized industrial mechanical testing solutions.

Mechanical testing in the plastic pipe industry determines ring stiffness, impact resistance, and tensile performance, directly preventing pipe bursts and deformation risks. UnitedTest can cover full-dimensional mechanical testing of pipes, complies with ISO,ASTM,EN et.c, international standards, and provides customized testing solutions.

In the construction engineering and building materials industry, mechanical testing determines the compressive and tensile properties of materials such as concrete and steel, which is core to ensuring the safety and durability of buildings. UnitedTest can cover the full range of building material mechanical tests, complies with ISO, ASTM international standards, and provides customized testing solutions for compressive, tensile, and other properties.

Mechanical testing in the food and beverage industry involves the compressive and tensile performance of packaging and the safety of food texture, directly ensuring storage, transportation safety, and the eating experience. UnitedTest can cover all-dimensional mechanical testing for packaging and food texture, comply with national and international standards, and provide customized testing solutions.

Mechanical testing in the packaging industry determines the packaging's resistance to compression, impact, and tension, directly ensuring the safety of contents during storage and transportation. UnitedTest can cover comprehensive mechanical testing for packaging, complying with ISO, ASTM Standards, and provides customized testing solutions for compression, drop, tear, and more.

Mechanical testing in the transportation industry concerns the load-bearing and fatigue resistance performance of core components such as vehicles, tracks, and containers, directly ensuring transport safety and equipment durability. UnitedTest can cover mechanical testing for all types of transportation materials, complying with national and international standards, and provides customized testing solutions including tensile, fatigue, and impact tests.

Metallurgical testing examines the properties of metallic materials to determine if a particular metal is appropriate for its intended use.

Testing of polymer materials covers mechanical, thermal, and chemical properties, verifying strength, heat resistance, composition, and ensuring product quality and compliance.

UnitedTest offer world-class testing solution in testing for polymeric materials, including elastomers, thermoplastics, composites, coatings, and structural adhesives in a variety of industries.

Testing of rubber and elastomers is used to assess the various properties and performance of materials under different conditions. This is crucial for ensuring the safety, functionality, and quality of rubber and elastomer products used in industries such as automotive, construction, consumer goods, and aerospace.

Conduct adhesive testing using various testing methods to determine their performance and characteristics in applications across multiple industries such as aerospace, automotive, construction, packaging, industrial, medical, and energy, thereby supporting application development and quality assurance.

UnitedTest supply machine and testing solution for tension, compression, fracture toughness, direct shear, triaxial and ultrasonic velocity are common concrete and rock testing applications.

UnitedTest has helped a number of companies involved in the wood, paper, cardboard, and corrugated industry with their testing needs. Our materials testing systems are capable of testing raw materials, components, and finished products.

UnitedTest testing system is trusted by leading medical device manufacturers, universities, and medical research laboratories worldwide. Whether testing tissues or bioresorbable materials, stents, or sutures, UnitedTest offers a variety of single-actuator and dual-actuator systems to meet your biomedical testing needs.

Mechanical testing in the textile fabric industry determines core properties such as fabric tensile strength, tear resistance, and wear resistance, directly affecting product durability and safety. UnitedTest can cover comprehensive mechanical tests for textiles, complying with national standards / ISO standards, and provides customized testing solutions including tensile, tear, and puncture tests.

The mechanical testing of industrial components directly determines the load-bearing, fatigue resistance, and wear resistance of the parts, helping to avoid equipment failure risks. UnitedTest can cover a full range of tests including tensile, hardness, and fatigue, is compatible with ISO/ASTM/GB standards, and provides customized mechanical testing solutions for industrial components.

Mechanical testing in the glass-ceramics industry determines core properties such as flexural strength, hardness, and fracture toughness, directly helping to avoid brittleness and failure risks. UnitedTest can cover comprehensive testing for flexural strength, hardness, and fracture toughness, compatible with national and ISO/ASTM standards, and provides customized testing solutions.

Tensile test evaluates material resistance to stretching, measuring strength/elongation critical for quality control. UnitedTest offers universal tensile testers (10-600KN) compliant with ASTM/ISO standards, providing tailored solutions for metals, polymers, medical & industrial materials.

Compression test assesses material resistance to compressive loads, measuring strength/deformation critical for quality validation. UnitedTest offers compression testing machines compliant with ASTM/ISO standards, providing tailored solutions for concrete, plastics, metals and industrial components.

Flexural & Bend tests evaluate material resistance to bending forces, measuring strength, stiffness and ductility for quality assurance. UnitedTest provides flexural testing machines (3-point/4-point bend) compliant with ASTM/ISO standards, offering tailored solutions for composites, plastics, metals and construction materials.

Torsion Test evaluates material resistance to rotational forces, measuring torsional strength/ductility critical for fasteners, insulators, shafts. UnitedTest offers torsion testers compliant with ASTM A938/ISO 16047, providing tailored solutions for automotive, aerospace, fastener industries.

Fatigue Test assesses material durability under cyclic loading, critical for predicting service life of industrial components. UnitedTest offers fatigue testing systems (axial/bending/torsion) compliant with ASTM E466/ISO 12106, providing tailored solutions for automotive, aerospace and manufacturing sectors.

Peel Test measures material adhesion strength by evaluating resistance to peeling forces, critical for adhesives, films, packaging. UnitedTest offers peel testers compliant with ASTM D903/ISO 8510, covering 90°/180° peel tests, and tailored solutions for packaging, automotive, textile industries.

Impact Test evaluates material resistance to sudden shock loads, critical for assessing toughness and fracture risk. UnitedTest offers impact testers (Charpy/Izod/fall weight) compliant with ASTM E23/ISO 148, providing tailored solutions for metals, plastics, glass and industrial components.

Tear & Shear Test evaluates material resistance to tearing and shearing forces, measuring critical strength parameters for quality control. Tear tests (Elmendorf/trouser/trapezoidal) assess resistance to crack propagation in films/fabrics, while shear tests measure resistance to parallel forces in joints/bolts. UnitedTest provides universal testing machines (10KN-600KN) with specialized fixtures for both tests, compliant with ASTM D624/D3164 and ISO standards, serving automotive, packaging and construction industries.

Hardness test measures material's resistance to permanent indentation, critical for quality control. UnitedTest offers universal hardness testers (Rockwell/Brinell/Vickers) compliant with ASTM/ISO standards, plus tailored hardness testing solutions for diverse industrial needs.

Biaxial/triaxial tests evaluate material performance under multi-axis loads, critical for biomaterials, metals and composites. UnitedTest provides compliant testing machines (ASTM/ISO) for planar biaxial, static/fatigue triaxial tests, with tailored solutions for industrial & biomedical needs.

Friction and wear tests assess material resistance to friction, abrasion and wear, critical for industrial material performance validation. UnitedTest offers tribometers compliant with ASTM G99/ISO standards, covering pin-on-disk, four-ball tests, and tailored friction & wear testing solutions for diverse industries.

Pressure test evaluates material/component resistance to static/dynamic pressure, critical for sealing, strength and safety validation. UnitedTest offers pressure testing machines compliant with ASTM/ISO standards, covering burst, hold-pressure tests, and tailored solutions for industrial, automotive & medical sectors.

Fire test assesses material flammability, heat resistance and fire-retardant performance, critical for safety compliance across industries. UnitedTest offers fire testing equipment compliant with ASTM/ISO/UL standards, providing tailored fire test solutions for building materials, plastics and industrial components.

Non-destructive Test (NDT) evaluates material/component integrity without damage, critical for safety & quality across industries. UnitedTest offers ultrasonic/X-ray/magnetic particle NDT equipment compliant with ASTM/ISO standards, plus tailored NDT solutions for aerospace, automotive & manufacturing sectors.

ISO 80369 Small-bore connectors for liquids and gases in healthcare application.

ISO 80369 specifies the mechanical tests for verifying the safety and reliability of connectors under clinical conditions.The tests include:resistance to separation, axial pull-out force, air or liquid leakage resistance,stress cracking test etc.,

Main test stipulated in the ISO 80369:

1, Fluid Leakage Tests	Purpose: To ensure no fluid escapes the connection under pressure.
1.1 Leakage by Pressure Decay	The assembly is subjected to an air pressure between 300 kPa and 330 kPa for 15 to 20 seconds. The leakage rate must not exceed 0.005 Pa·m³/s. Use an pressure decay tester, Mate sample with reference connector; apply 300–330 kPa air pressure; hold 15–20 s; record leakage rate.
1.2 Positive Pressure Liquid Leakage	The assembly is subjected to water pressure between 300 kPa and 330 kPa for 30 to 35 seconds. There must be no visible droplet formation. Use Liquid pressure tester, Mate sample with reference connector; apply 300–330 kPa water pressure; hold 30–35 s; inspect for drips.
2, Sub-atmospheric Pressure Air Leakage Test	Purpose: To ensure air cannot be sucked into the line (preventing air embolisms) when a negative pressure is applied. A sub-atmospheric pressure between 80.0 kPa and 88.0 kPa is applied for 15 to 20 seconds. The leakage rate must not exceed 0.005 Pa·m³/s. Use Vacuum leak tester, apply specified sub-atmospheric pressure; hold 15–20 s; measure leakage.
3, Stress Cracking Test	Purpose: To ensure the connector material does not crack under environmental stress (e.g., exposure to chemicals or disinfectants). After being subjected to specific stresses defined in the reference test method, the connector must still pass the Fluid Leakage test. Use Stress testing apparatus ; Expose sample to standardized stress; conduct leakage test; confirm no failure.
4, Resistance to Separation from Axial Load Test	To ensure the connector does not pull apart accidentally. Luer Slip connectors: Must withstand an axial force of 23N to 25N for 10 to 15 seconds. Luer Lock connectors: Must withstand an axial force of 32N to 35N for 10 to 15 seconds. Use Tensile tester, Mate sample with reference; apply axial force; hold 10–15 s; check separation.
5, Resistance to Separation from Unscrewing Test	Purpose: To ensure the locking mechanism does not unscrew accidentally. Must withstand an unscrewing torque of 0.018 N·m to 0.020 N·m for 10 to 15 seconds without separating. Use torsion testing machine, Apply specified torque; hold; verify no separation.
6, Resistance to Overriding Test	Purpose: To ensure the threads/lugs do not strip or override each other when over-tightened. Must withstand an applied torque of 0.15 N·m to 0.17 N·m for 5 to 10 seconds without overriding. Use torsion testing machine, Apply torque; hold; inspect for thread/lug overriding.

ISO 80369 developed to eliminate misconnections between medical connectors used in different clinical scenarios—one of the leading causes of patient harm in healthcare. Each part targets a unique medical application with dedicated dimensions, geometry, and performance rules, so connectors from different parts are dimensionally non-interconnectable.

Part Number	Official Title	Core Application	Key Purpose & Content
ISO 80369‑1	General requirements	All healthcare small‑bore connectors	Content: defines the fundamental terms, general requirements, and the framework for testing the "non-interconnectable" characteristics of small-bore connectors. Purpose: ensures that a connector made for one specific medical application cannot physically fit into a port meant for a completely different application.
ISO 80369‑2	Connectors for breathing systems and driving gases applications	Respiratory, anesthesia, driving gas circuits	To standardize connectors for airway management and gas delivery, ensuring they cannot be mistakenly connected to non-respiratory devices like IV lines.
ISO 80369‑3	Connectors for enteral applications	Enteral feeding, gastric suction	Enteral connectors (often referred to as ENFit connectors) are designed so they physically cannot connect to IV ports, Luer locks, or respiratory tubing. This prevents liquid nutrition or medication from being accidentally delivered into a vein or an airway.
ISO 80369‑4	Connectors for urethral and urinary applications	Urethral catheters, urinary drainage	To create a dedicated, secure, and mismatch-proof connection standard for urological devices.
ISO 80369‑5	Connectors for limb cuff inflation applications	Blood pressure cuffs, tourniquet cuffs	These connectors are designed specifically for inflating and deflating cuffs. The standard ensures that the inflation bulbs and valves are incompatible with other medical connectors to prevent accidental cross-use.
ISO 80369‑6	Connectors for neuraxial applications	Epidural, intrathecal, spinal anesthesia	Neuraxial procedures are extremely sensitive and high-risk. This standard dictates the dimensions and performance requirements for connectors used in these applications to ensure they are completely distinct from all other connector types.
ISO 80369‑7	Connectors with 6% (Luer) taper for intravascular or hypodermic applications	IV therapy, hypodermic syringes, needles, cannulas	This part governs the traditional Luer taper connectors (both slip and lock varieties). Because IV access is critical and ubiquitous, this standard tightly controls the dimensions, material rigidity, pressure tolerances of Luer connectors to ensure they only fit other Luer-compatible devices.
ISO 80369‑20	Common test methods	All parts of ISO 80369	Content: Testing protocols used to evaluate the performance, leakage, stress cracking, and axial strength of the connectors defined in Parts 2 through 7 . Purpose: It ensures specific medical application a connector is tested under the exact same rigorous conditions to prove its safety and reliability.

Related test standard:

ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements

ISO 594-2 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings

Notice: ISO 594-1 & ISO 594-2 was withdrawn and replaced by ISO 80369-7.

A single column tensile tester is a sophisticated material testing instrument designed for measuring mechanical properties of various materials under tension, compression, bending, shear, and other loading conditions. As the name suggests, it features a single vertical column supporting a moving crosshead that applies force to test specimens.

Medical Luer Connector Multifunctional Testing Machine can detect the leakage, air leakage, separation force, unscrewing torque, silky resistance, overload resistance, stress cracking, pressure attenuation leakage, positive pressure air leakage, negative pressure air leakage of Luer joint.

Medical Device Flow Volume Tester is a specialized equipment designed to detect the flow of medical devices. Suitable for infusion sets, blood transfusion sets, infusion needles, catheters, anesthesia filters, etc.,

Manual torsion tester is mainly used to execute torsion test for various kinds materials, manual loading, high accuracy torsion transducer to measure torque, photoelectric encoder to measure torsion angle, digital display test result.

We offer customization to meet your specific needs. Our expert team will collaborate with you to develop the perfect product for you