Products
Application

By Standard

By Industry

By Material

By Test Type

ASTM

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

ISO

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

Others

Standards including EN, DIN, JlS, and more

Automotive

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.

Batteries

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.

Consumer Products

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.

Biomedical

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.

University & Research

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.

Industrial Products

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.

Plastic Pipes

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.

Civil Engineering

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.

Food and Beverage

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.

Packaging

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.

Transportation Industry

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.

Metals

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

Composites

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

Plastics & Polymers

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

Rubber & Elastomers

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.

Adhesives

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.

Concrete & Rock

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

Wood & Paper

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.

Biomaterials and Tissue

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.

Textile

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.

Components

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.

Ceramic & Glass

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

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

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 Test

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

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

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

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

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

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

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 and Triaxial Test

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 Test

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

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

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

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.
Technical Support

Videos

Browse the video library to see theUnitedTest system in action

After-Sales

View our after-sales service

Download

Go to our download center to download

FAQ

Frequently Asked Questions
Company
News
Contact

English

Home >> Application >> By Standard >> ISO >> ISO 10000~19999 >> ISO 17137 Test Methods of cardiovascular absorbable implants

ISO 17137 Test Methods of cardiovascular absorbable implants

ISO/TS 17137:2021 Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

Based on the ISO/TS 17137 standard the evaluation of mechanical properties is a critical part of the design and safety validation process. Mechanical Evaluation like tension, radial force, Cyclic Fatigue Durability like constant pulsing. Because absorbable implants lose their structural integrity over time through degradation, their mechanical performance must be assessed not just at the time of implantation, but throughout their intended functional lifetime.

Core Mechanical Tests stipulated:

1, Mechanical Evaluation Test
Key test	Radial force (stents); Crush resistance; Tensile/bending performance; Structural integrity (no strut fracture, coating delamination, premature degradation)
Test Requirement	Test under physiologically relevant conditions: 37 °C, fully immersed in simulated body fluid; written justification is mandatory if tested under dry/room-temperature conditions. Follow device-specific standards: ISO 25539 series (endovascular devices) & ISO 5840 series (cardiac valve prostheses). Test time points cover the intermediate degradation stage (from post-deployment to undetectable mechanical attributes); advanced-stage testing is not performed (mechanical properties below detection limit). Characterize the temporary initial rise in mechanical properties (strength, rigidity) after implantation (caused by hydration, thermal equilibration for polymers/metals).
Test Equipment	Universal mechanical tester, Radial force tester, Three-point bending tester or Test fixtures (ASTM F2606)
Test Samples	Final sterilized finished devices (consistent with clinical specifications). Pre-conditioned to simulate clinical use: unpacking, preparation per IFU, simulated vascular tracking/deployment. Parallel samples tested at multiple degradation time points.
Importance	Verify initial mechanical function meets clinical requirements after deployment. Clarify mechanical property decay during degradation to ensure performance within the designed functional lifetime. Prevent early mechanical failure (stent collapse, fracture) leading to thrombosis/embolism.
Application for	Absorbable coronary/peripheral stents, vascular closure devices, heart valves, vena cava filters. Evaluate material selection, structural design, and manufacturing rationality.
2, Cyclic Fatigue Durability Test
Key Test	Radial Durability, Axial Durability, Bending Durability, Torsional loading Durability Test
Test requirement	Test duration covers the expected functional lifetime (limited to the intermediate stage). Conduct under physiological temperature/fluid environment; hyper-physiological loading can be used to analyze failure mechanisms. Accelerated testing: synchronize chemical degradation rate with accelerated loading rate (via temperature elevation, pH adjustment); justification required if not synchronized. Refer to ASTM F3211; for absorbable metals, in vitro tests can be supplemented/replaced by in vivo preclinical studies (tissue coverage provides mechanical support in vivo).
Test Equipment	Cyclic fatigue tester (pulsatile, axial, bending fatigue load). Vascular Stent Radial Pulsatile Fatigue Testing System Vascular Stent Uniaxial Tension Durability Testing Machine.
Test Samples	Sterilized finished products (clinical size/design). Pre-conditioned by simulated use. Multiple sample groups for different cycle numbers/degradation time points.
Importance	Evaluate long-term structural durability under cyclic loading to avoid fatigue fracture, particulate generation, or late adverse events. Confirm the matching of fatigue life and degradation cycle to ensure safety throughout the functional period.
Application	Implants under dynamic cyclic load (coronary stents, heart valve implants, vena cava filters).

Core purpose of ISO 17137

To establish full-lifecycle requirements for absorbable cardiovascular implants, covering design, fabrication, packaging, sterilization, shelf-life, risk management, and in vitro / preclinical / clinical evaluation. It targets the unique hazards of absorbable materials (premature degradation, particulate generation, fracture, late adverse events) to ensure clinical safety and performance.

Related products and device

ISO 17137 Tensile testing machine

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.

ISO 17137 Fatigue Testing Machine / Cyclic Testing Machine

UnitedTest Fatigue Testing Machine mainly used at a variety of material and components, parts for both dynamic and static mechanical property testing, include tension, compression, low cycling test, match with high-low temperature chamber can execute the temperature test.

ISO 17137 cardiovascular absorbable implants Radial Pulsatile Fatigue Testing System

Radial Pulsatile Accelerated Durability Tester is designed to perform accelerated pulsatile durability testing on vascular implants such as stents or valve frames, in accordance with relevant requirements of ISO 25539 and ASTM F2477.

ISO 17137 cardiovascular absorbable implants Uniaxial Tension Durability Testing Machine

Vascular Stent Uniaxial Tension Durability Testing Machine is designed to perform accelerated axial fatigue and durability testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic axial loading.

ISO 17137 cardiovascular absorbable implants Bending Durability Tester

Vascular Stent Bending Durability Tester is designed to perform accelerated bending fatigue testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic bending loading.

ISO 17137 cardiovascular absorbable implants Torsion Durability Tester

UTCA-VST6 Vascular Stent Torsion Durability Tester is designed to perform accelerated torsional fatigue testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic torsional loading.

Related Standard

ISO 7198 Mechanical Tests and Other Evaluations for Vascular Implants –

ISO 7198 specifies test and performance requirements for tubular vascular grafts and vascular patches (surgical vascular prostheses). It defines mechanical tests (with full method/equipment/sample details) and other physicochemical, biological, dimensional, preclinical/clinical tests.

ISO 12417-1 Test Methods for Cardiovascular implants and extracorporeal systems –

ISO 12417-1 specifies requirements for Vascular Device-Drug Combination Products (VDDCPs) (drug-eluting stents, drug-coated balloons, drug-bearing vascular grafts, etc.). It mandates mechanical tests for the device part (DP) (to verify structural/functional integrity) and a suite of drug-related, physicochemical, biological, and clinical tests. Mechanical performance must comply with device-specific standards (ISO 25539-2, ISO 10555-4, ISO 7198) and remain unaffected by the drug-containing part (DCP).

ASTM F3067 Radial Loading Test of Vascular Stents –

ASTM F3067 establishes in vitro test frameworks to characterize the radial mechanical performance of balloon-expandable vascular stents and self-expanding vascular stents. It quantifies three key indicators: radial strength and collapse pressure for balloon-expandable stents, and chronic outward force (COF) for self-expanding stents.

ASTM F3036 Testing of Absorbable Stents –

ASTM F2942 specifies in vitro test methodologies to evaluate the cyclic durability of vascular stents under non-radial mechanical deformations (axial, bending, and torsion) that occur in vivo due to musculoskeletal motion, breathing, or cardiac activity. include Axial, bending, torsional, Pulsatile Durability, Radial Loading etc., test.

ASTM F2606 Three-Point Bending Test for Balloon-Expandable Vascular Stents and Stent Systems –

ASTM F2606 defines quantitative three-point bending procedures to characterize the bending flexibility and stiffness of balloon-expandable vascular stents and stent systems (pre-deployment and deployed states). It is a critical testing protocol in the biomedical engineering field. Since vascular anatomies are naturally curved and tortuous, a stent must be flexible enough to navigate through the delivery pathway (trackability) and conform to the vessel's curvature once deployed without causing vascular trauma . This standard provides the guidelines to measure these mechanical properties accurately.

ASTM F2942 Vascular Implants Axial, bending, torsional and compression durability testing –

ASTM F2477 Test for in-vitro Pulsatile Durability Testing of Vascular Stents –

ASTM F2477 designed to evaluate the long-term fatigue durability and radial cyclic deformation resistance of vascular implants under simulated physiological pulsatile loading conditions. It is crucial for simulating the cyclical stresses these medical devices endure inside human blood vessels.

< Previous: ISO 16402 Acrylic resin cement Flexural fatigue testing

> Next: ISO 18164 rolling resistance test of passenger car, truck, bus and motorcycle tyres