Generated by Rank Math SEO, this is an llms.txt file designed to help LLMs better understand and index this website. # EndoLab: EndoLab® is one of the biggest and most established testing laboratories worldwide. We build our expertise on more than 28 years of experience in medical device testing. As a key partner of large and small device manufacturers, we are well-connected within the industry. We have led and contributed to numerous ASTM and ISO standards and believe this is key to staying up to date with the latest developments. Through that, we provide value to our clients and support them in their development processes. We are looking forward to hearing about your testing needs and to working with you. ## Sitemaps [XML Sitemap](https://endolab.org/sitemap_index.xml): Includes all crawlable and indexable pages. ## Posts - [How to apply at EndoLab](https://endolab.org/how-to-apply-at-endolab/): Just send us your CV, cover letter and relevant certificates. - [About EndoLab® – The implant testing company](https://endolab.org/endolab-implant-testing/): EndoLab is one of the biggest and most established testing laboratories worldwide with more than 25 years of experience. As a key partner of the industry, we are connected to authorities and private companies alike. By contributing to new testing standards, we shape the industry’s future and ensure we are always in tune with the latest developments. ## Pages - [Protected: Material information form – ISO 14243](https://endolab.org/surveys/material-information-form-iso-14243/): (takes approx. 25 min) - [Spinal Implant Test Plan Generator](https://endolab.org/surveys/spinal-implant-test-plan-generator/): (takes approx. 5 min) - [Knee implant test plan generator](https://endolab.org/surveys/knee-implant-test-plan-generator/): (takes approx. 3 min) - [Hip implant test plan generator](https://endolab.org/surveys/hip-implant-test-plan-generator/): (takes approx. 4 min) - [Feedback](https://endolab.org/surveys/feedback/): How can we improve? Feedback - How can we improve?How can we improve?Your name (optional)Your email address (optional)Submit Form - [Surveys](https://endolab.org/surveys/): Welcome to the EndoLab Survey Hub – find feedback forms, past results, and more, all in one place. - [Team](https://endolab.org/about-us/team/): We are constantly growing. Our 40+ experts are highly qualified and experienced and together, we have unrivalled experience in medical device testing. Our team is highly interdisciplinary, allowing us to ground our work on insights from mechanical and biomedical engineering, biochemistry and sports engineering. - [Failure analysis](https://endolab.org/research-test-development/failure-analysis/): EndoLab® specializes in failure and retrieval analysis of implants, providing critical insights into material degradation, fatigue, and corrosion effects. With decades of experience, we have developed a deep understanding of mechanical and electrochemical failure mechanisms, ensuring reliable evaluations. - [Downloads](https://endolab.org/downloads/): Our scope of accreditation, ISO 17025 certificate and other relevant documents are available to download below. - [Scope of certification](https://endolab.org/scope-of-certification/): View our Certificate and Scope - [Simulators](https://endolab.org/simulators/): The EndoLab Simulators - [Research projects](https://endolab.org/research-test-development/research-projects/): The safety of medical devices can only be guaranteed with the help of application-oriented test procedures. By using the latest technologies and simulation methods, we are working on continuous improvements in medical device testing.Within our team, a dedicated research group is working to answer current research questions of the field. Close contact with university institutions helps us to push the state of science forward together.In this context, we are also continuously looking for students to support us in research as part of internships or theses. - [Custom test procedures](https://endolab.org/research-test-development/custom-test-procedures/): EndoLab® has decades of experience with custom test procedures. We develop test protocols based on literature analysis, as well as on our own database. Test setups are realized by up to date 3D CAD software (CATIA), high precision measurement equipment and our own software development. Our accredited quality system according to ISO 17025 guarantees valid and reproducible test results for your benefit. - [Research & Test Development](https://endolab.org/research-test-development/): With its innovative solutions, Endolab strives to improve the testing of medical devices.Over the years, EndoLab has engaged in wide-ranging research both self-funded as well as in funded governmental projects. - [Why choose EndoLab](https://endolab.org/why-choose-endolab/): Global leaders in medical device testing - [Finite Element Analysis](https://endolab.org/finite-element-analysis/): We conduct Finite Element Analysis (FEA) studies following international standards or your custom protocols—and can even help develop them. Need support for design validation or structural analysis? We’ve got you covered. - [Consumables](https://endolab.org/implant-testing/consumables/): We provide testing services for a wide range of products, including medical devices and disposable items with both medical and non-medical applications. Our versatile static and dynamic machines can be easily customized to accommodate various testing requirements. If you don't find the specific test you're looking for, please feel free to reach out to us. We are committed to developing or identifying the ideal test method tailored to your product and needs. - [Exoprosthesis](https://endolab.org/implant-testing/exoprosthesis/): While our main focus lies on endoprosthesis devices, we have expanded our offerings in recent years to include a comprehensive range of exoprosthesis testing. We provide testing according to international standards, alongside our own self-developed, accredited test methods. Our services encompass a wide variety of lower limb devices, including transfemoral implants, ensuring the highest level of reliability and performance for your products. - [Wrist implants](https://endolab.org/implant-testing/wrist-implants/): Since there is a lack of standardization in wrist implants, we develop custom test methods specifically tailored to your novel implant design. Depending on the implant features, such as material composition, biomechanics, and intended function, we create specialized testing protocols that accurately evaluate its performance. Our approach ensures that all critical factors—such as fatigue resistance, wear, and mechanical strength—are thoroughly assessed. - [Elbow implants](https://endolab.org/implant-testing/elbow-implants/): There are only a few standardized test methods for elbow implants. ASTM F2887 covers all relevant testing to investigate stem fatigue, component disassembly, and wear of elbow devices. Additionally, we develop customized testing methods to address particular features of new devices based on our extensive experience with elbow joint replacements. - [Particle analysis](https://endolab.org/implant-testing/particle-analysis/): Analyzing the morphology of particles generated during various mechanical implant tests is crucial for assessing the long-term stability and performance of joint replacements. To address the needs of diverse material compositions, we provide a comprehensive suite of accredited methods for test fluid preparation and particle characterization. - [Dental implants](https://endolab.org/implant-testing/dental-implants/): Dental implants play a major role in modern dentistry. To ensure long-lasting patient satisfaction and safety they must endure high stresses and loads.  - [Vascular implants](https://endolab.org/implant-testing/vascular-implants/): We offer specialized testing for vascular devices, including stents, grafts, and catheters, with an accredited scope that covers fatigue and corrosion testing. Stent standards can be complex, and we help you navigate the requirements and terminology of the relevant international standards. Our goal is to support the safety, performance, and regulatory compliance of your vascular devices, providing guidance throughout the entire testing process. - [Ankle implants](https://endolab.org/implant-testing/ankle-implants/): Ankle implants have gained popularity in orthopedics, especially for patients with advanced arthritis or severe fractures. However, the ankle's unique range of motion and load-bearing requirements pose challenges in implant design and testing. - [Instruments](https://endolab.org/implant-testing/instruments/): At EndoLab, our instrument testing services cover a diverse range of devices and applications, including surgical needles, dental instruments, and pen injectors. We specialize in assessing the performance and durability of surgical instruments, with tests focused on fatigue resistance, autoclaving endurance, and corrosion protection. Surgical needles, for instance, are rigorously tested for penetration forces to ensure optimal performance. The field of instrument testing is vast, and our team is dedicated to helping you identify the most suitable test methods for your specific device. - [Osteosynthesis](https://endolab.org/implant-testing/osteosynthesis/): In general, non-active surgical implants are used for osteosynthesis and corrective surgery. As part of the preclinical evaluation under ISO 14630, static and dynamic load tests must be carried out following recognized test standards. These standards cover screws, plates, intramedullary devices, staples, cables, and many more. For new or special features of the implant, such as bioresorbable materials, we develop adaptations to the existing test procedures or completely new test methods. - [Finger implants](https://endolab.org/implant-testing/finger-implants/): The smallest joint group in the human body demands a high level of expertise in testing. As the only lab offering a custom finger wear simulator and self-developed wear protocol specifically for proximal interphalangeal (PIP) and metacarpophalangeal (MCP) artificial joint replacements, we are uniquely positioned to support your innovations. Bring us your new finger device, and let us provide the expert testing and support you need to ensure its success. - [Shoulder implants](https://endolab.org/implant-testing/shoulder-implants/): At EndoLab, we offer comprehensive shoulder testing services, specializing in both anatomic and reverse shoulder systems. As active members of the ASTM and ISO committees, we co-developed many of the standards used for shoulder testing. Our services include extensive fatigue and wear testing, designed to evaluate the long-term performance and durability of shoulder implants. Knowing the standards inside-out, we are happy to support you with your novel shoulder device. - [Spinal implants](https://endolab.org/implant-testing/spinal-implants/): Our spinal device testing services cover a wide range of components, including assemblies, cages, discs, and individual parts like screws and rods. We provide comprehensive testing for both static and dynamic fatigue properties, as well as wear testing, to ensure the durability and performance of your devices. As part of our commitment to innovation, we continually expand our accredited testing methods to keep pace with the latest advancements in spinal technology. - [Knee implants](https://endolab.org/implant-testing/knee-implants/): Next to hip implants, knee implants are one of the best-standardized implant groups. The testing required for knee joint devices is summarized in ISO 21536. We offer all relevant testing for TKR as well as individual knee components (tibial, femoral, and patella). Our accredited scope covers static and dynamic fatigue, wear, corrosion, and surface testing. Having tested thousands of knee devices we have accumulated extensive data that helps contextualizing the performance of your novel knee device. - [Hip implants](https://endolab.org/implant-testing/hip-implants/): Hip implants must endure high mechanical stress and long-term exposure in the human body, requiring rigorous testing for safety and durability. As one of the best-standardized implant groups, hip prostheses undergo comprehensive evaluations to meet strict regulations.  - [Implant testing](https://endolab.org/implant-testing/): With more than 25 years of experience in medical device testing, we specialize in a broad range of products, from large joints like hips and knees to small joints, osteosynthesis devices, as well as dental and vascular implants. Our services also extend to testing materials, consumables, exoprostheses, and instruments. We test according to 200+ international standards, self-developed tests, and custom protocols. Equipped with a large number of self-developed testing machinery, we ensure that your devices are tested quickly, thoroughly, and reliably. - [Material Testing](https://endolab.org/implant-testing/material-testing/): We do not only test final device prototypes but also offer comprehensive material testing services to ensure reliable performance of the materials used in your devices. Our expertise spans a wide range of materials, including metals, polymers, and ceramics, where we assess key properties such as strength, durability, and resistance to corrosion and fatigue. Additionally, we provide specialized services like particle analysis, accelerated aging, and coating evaluations, helping you optimize material performance and ensure long-lasting reliability for your products. - [Publications](https://endolab.org/research-test-development/publications/): Over the years the EndoLab team has published various articles on the topic of medical device testing and biomechanics. - [Hip Simulator](https://endolab.org/simulators/hip-simulator/): The EndoLab Hip Simulator - [About Us](https://endolab.org/about-us/): EndoLab® is one of the biggest and most established testing laboratories for medical devices worldwide. We build our expertise on more than 28 years of experience in medical device testing. As a key partner of large and small device manufacturers, we are well-connected within the industry. We have led and contributed to numerous ASTM and ISO standards and believe this is key to staying up to date with the latest developments. Through that, we provide value to our clients and support them in their development processes. - [Knee Simulator](https://endolab.org/simulators/knee-simulator/): The EndoLab Knee Simulator - [Career](https://endolab.org/career/): Your career with Endolab​ - [Endolab-Homepage](https://endolab.org/): We are one of the biggest and most renowned test labs for medical devices worldwide. Specializing in medical device testing, we offer fast, thorough, and reliable mechanical testing for all types of implants and medical devices. If you are looking for expert support in ensuring compliance and performance of your innovative device - you have come to the right place. - [Contact us …](https://endolab.org/contact/): We use Google reCaptcha technologies to prevent fake contact requests (spam). Please accept our cookie settings (Google reCaptcha) to send us a message. ## Ankle implants - [ASTM F2009](https://endolab.org/ankle-implants/astm-f2009/): The ASTM F2009 standard applies to all tapered connections of modular prostheses, such as total or partial hip or shoulder prostheses. The ISO 7206-10 standard is specific to hip femoral heads and describes the method to establish the tension load to disassemble modular head systems. - [ISO 21534](https://endolab.org/ankle-implants/iso-21534/): ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirementsISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parametersISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral componentsISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral componentsISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirementsISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testsISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurementISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementISO 14630: Non-active surgical implants - General requirementsISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays  - [PI-65](https://endolab.org/ankle-implants/pi-65/): PI-65: Determination of Total Ankle Replacement Contact Pressure - [ASTM F2665](https://endolab.org/ankle-implants/astm-f2665/): ASTM F2665: Standard Specification for Total Ankle Replacement Prosthesis - [ISO 22622](https://endolab.org/ankle-implants/iso-22622/): ISO 22622: Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test ## Consumables - [ISO 80369-20](https://endolab.org/consumables/iso-80369-20-2/): ISO 80369-20: Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods - [DIN EN 455-2](https://endolab.org/consumables/en-455-2-2/): DIN EN 455-2: Medical gloves for single use – Part 2: Requirements and testing for physical properties ## Custom test procedures - [Example 4:](https://endolab.org/custom-test-proce/example-4/): Static and fatigue testing of cages is performed according to ASTM F2077. For standard materials such as metal or PEEK, load blocks are manufactured by multipass milling with a small radius cutter. Due to the brittle behavior of ceramics, small geometrical deviations at the edges of the load block do generate high contact stresses. - [Example 3:](https://endolab.org/custom-test-proce/example-3/): Wear testing of total hip replacements, performed under the test conditions of ISO 14242-1, simulates level walking of a perfectly implanted device. In reality, there are a number of parameter such as aging, subluxation, high inclination angles, corrosion and third body contamination that might impact the wear behavior of a total hip replacement. EndoLab® has developed a battery of test protocols that focus on individual test conditions or combine multiple adverse conditions for worst case analysis. - [Example 2:](https://endolab.org/custom-test-proce/example-2/): Loading of peripheral vascular implants is known to be of multiaxial nature. While standard fatigue testing of stents simulates radial compression at high test frequencies, knee bending or motion of internal organs can cause mechanical stresses at a much lower frequency. EndoLab® has developed a test frame that allows for bending, tensile, rotational and radial stresses simultaneously. Of course the device is a multi-station test frame offering environmental control. - [Example 1:](https://endolab.org/custom-test-proce/example-1/): Mechanical loading of biological implants, intended for cartilage replacement, is an important research and pre-clinical testing tool. EndoLab® has developed a multi-station cartilage tester, based on studies performed by Wimmer et al., that fits into an incubator. Complex tribological test conditions are combined with biochemical analysis methods to gain insight into the behavior of living cells under simulated in-vivo conditions. ## Dental implants - [Temporomandibular joint wear test](https://endolab.org/dental-implants/temporomandibular-joint-wear-test/): EndoLab offers customized wear testing for temporomandibular joint (TMJ) implants using the proprietary EndoLab® A3R simulator. The test setup enables implant components to be evaluated under dynamic, chewing-like conditions and supports manufacturers in generating meaningful performance data for development, verification, and regulatory documentation. - [ISO 19023](https://endolab.org/dental-implants/iso-19023/): ISO 19023: Dentistry — Orthodontic anchor screws - [ISO 22683](https://endolab.org/dental-implants/iso-22683/): ISO 22683: Dentistry — Rotational adaptability test between implant body and implant abutment in dental implant systems - [ISO/TR 18130](https://endolab.org/dental-implants/iso-tr-18130/): ISO/TR 18130: Dentistry - Screw loosening test using cyclic torsional loading for implant body/implant-abutment connection of endosseous dental implants - [ISO 15912](https://endolab.org/dental-implants/iso-15912/): ISO 15192: Dentistry - Refractory investment and die material - [ISO/TS 13498](https://endolab.org/dental-implants/iso-ts-13498/): ISO/TS 13498: Dentistry - Torsion test of implant body/connecting part joints of endosseous dental implant systems - [ISO 14801](https://endolab.org/dental-implants/iso-14801/): ISO 14801: Dentistry - Fatigue test for endosseous dental implants. ## Elbow implants - [ASTM F2009](https://endolab.org/elbow-implants/astm-f2009/): ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses - [ISO 21534](https://endolab.org/elbow-implants/iso-21534/): ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirementsISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parametersISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral componentsISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral componentsISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirementsISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testsISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurementISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementISO 14630: Non-active surgical implants - General requirementsISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays  - [ASTM F2887](https://endolab.org/elbow-implants/astm-f2887/): ASTM F2887: Standard Specification for Total Elbow Prostheses ## Exoprosthesis - [PI-91](https://endolab.org/exoprosthesis/pi-91/): PI-91: Fatigue testing of transfemoral fixations - [ISO 10328](https://endolab.org/exoprosthesis/iso-10328/): ISO 10328: Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods   ## Finger implants - [Custom test for CMC wear](https://endolab.org/finger-implants/custom-test-for-cmc-wear/): In addition to gravimetric wear determination, further analyses are frequently performed upon request. These include characterization of wear particles and quantification of metal ions in the test fluid, providing valuable information on corrosion behaviour and biocompatibility. The assessment is complemented by high-resolution microscopy of the articulating surfaces and detailed photographic documentation of CMC wear patterns. - [ISO 21534](https://endolab.org/finger-implants/iso-21534/): ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirementsISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parametersISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral componentsISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral componentsISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirementsISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testsISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurementISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementISO 14630: Non-active surgical implants - General requirementsISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays  - [Custom test for finger wear](https://endolab.org/finger-implants/finger-joint-wear-test/): EndoLab® uses a custom made wear simulator for testing of proximal interphalangeal (PIP) and metacarpophalangeal (MCP) artificial joint replacements. The movement is reduced to one axis, whereby a constant axial force is applied. A typical wear test is performed up to five million cycles using three to six implants at 1.5 Hz test frequency. - [ASTM F1781](https://endolab.org/finger-implants/astm-f1781/): ASTM F1781: Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants. ## Finite Element Analysis - [ASTM F2514](https://endolab.org/finite-element-analy/astm-f2514/): ASTM F2514: Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading - [Validation support & Custom protocols](https://endolab.org/finite-element-analy/validation-support-custom-protocols/): At EndoLab, we are willing to do anything! - [ASTM F3161](https://endolab.org/finite-element-analy/astm-f3161/): ASTM F3161: Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions. - [ASTM F3334](https://endolab.org/finite-element-analy/astm-f3334/): ASTM F3334: Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components - [PI-87](https://endolab.org/finite-element-analy/pi-87/): Analogous to ASTM F2996, which simulates the physical testing of ISO 7206-4, EndoLab has developed a protocol to evaluate the static implant stresses and strains of non-modular metallic orthopaedic hip stem designs in the femoral neck region. The boundary conditions are setup according to ISO 7206-6. - [ASTM F2996](https://endolab.org/finite-element-analy/astm-f2996/): ASTM F2996: Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems - [ASME V&V 40](https://endolab.org/finite-element-analy/asme-vv40/): Historically, regulatory bodies participating in the evaluation of orthopaedic implants (e.g. US FDA, TÜV, BSI) have been reluctant to accept the results of Computational Model and Simulation (CM&S) studies such Finite Element Analysis (FEA) in supporting product submissions. The primary concern has been regarding the accuracy, validity, and assessing the credibility of the results. ## Hip implants - [ASTM F2345](https://endolab.org/hip-implants/astm-f2345/): The test method according to ASTM F2345 describes the evaluation of the cyclic fatigue strength of ceramic modular femoral heads. For the test, test cones are used that are equivalent to the femoral stem of the total arthroplasty. Post-fatigue, a static burst test according to ISO 7206-10 is performed to determine the static strength of the femoral heads remaining after cyclic fatigue loading. Our internal test method PI-14 describes a similar test setup for cyclic testing of ceramic femoral heads. - [PI-99 (ASTM F2091)](https://endolab.org/hip-implants/pi-99/): PI 99: Standard Specification for Acetabular Prostheses - [ISO 7206-8](https://endolab.org/hip-implants/iso-7206-8/): PI-58 (ISO 7206-8): Implants for surgery – Partial and total hip joint prostheses – Part 8: Endurance performance of stemmed femoral components - [ISO 7206-6](https://endolab.org/hip-implants/iso-7206-6/): ISO 7206-4: Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components - [ISO 7206-1](https://endolab.org/hip-implants/iso-7206-1/): ISO 7206-1: Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions - [ASTM F3090](https://endolab.org/hip-implants/astm-f3090/): ASTM F3090: Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip Replacement - [ISO 21534](https://endolab.org/hip-implants/iso-21534/): ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirementsISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parametersISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral componentsISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral componentsISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirementsISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testsISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurementISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementISO 14630: Non-active surgical implants - General requirementsISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays  - [ISO 21535](https://endolab.org/hip-implants/iso-21535/): ISO 21535: Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint implants   - [ASTM F2979](https://endolab.org/hip-implants/astm-f2979/): ASTM F2979: Standard guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses   - [ASTM F2068 (PI-98)](https://endolab.org/hip-implants/astm-f2068/): ASTM F2068: Standard Specification for Femoral Prostheses - Metallic ImplantsISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral componentsISO 7206-6: Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral componentsASTM F1044: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsASTM F1147: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic CoatingsASTM F1978: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser - [ISO 11491](https://endolab.org/hip-implants/iso-11491/): ISO 11491: Implants for surgery – Determination of impact resistance of ceramic femoral heads for hip joint prostheses - [ASTM F3018](https://endolab.org/hip-implants/astm-f3018/): ASTM F3018: Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices - [ASTM F3446](https://endolab.org/hip-implants/astm-f3446/): ASTM F3446: Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Implants Using an Anatomical Motion Hip Simulator - [ISO 7206-12](https://endolab.org/hip-implants/iso-7206-12/): ISO 7206-12: Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method for acetabular shells - [ASTM F3047M](https://endolab.org/hip-implants/astm-f3047m/): Wear testing of hard-on-hard Total Hip Replacement (THR) systems is commonly conducted according to ISO 14242-1, with the components placed at the intended cup inclination and simulation of normal walking gait. The objective of ASTM F3047M is to demonstrate potential high-demand wear test features, including high cup inclination, edge loading, third-body wear, and microseparation. High-demand hip wear testing can be performed using the EndoLab® hip joint simulator. The image shows a cup positioned with a high cup inclination angle.   - [ASTM F3738](https://endolab.org/hip-implants/astm-f3738/): ASTM F3738: Standard Test Method for Hip Simulator Wear Testing of Metal-on-Polyethylene Articulations Under Adverse Conditions Using Third-Body Particles - [ISO 14242-4](https://endolab.org/hip-implants/pi-78-iso-14242-4/): ISO 14242-4: Implants for surgery - wear of total hip-joint prostheses - Part 4: Testing total hip joint prostheses under variations in surgical positioning - [PI-11](https://endolab.org/hip-implants/pi-11/): PI-11: Static/Dynamic Compressive Load Test – Hip Insert - [ASTM F2582](https://endolab.org/hip-implants/astm-f2582/): The EndoLab® hip joint simulator is used for this type of testing. According to ASTM F2582 all UHMWPE acetabular components have to be artificially aged prior to testing (see ASTM F2003). All three in-vivo angular displacements (flexion/extension, abduction/adduction and internal/external rotation) are simulated and a constant joint reaction force is applied. The specimens are inspected every 200,000 cycles up to 1.0 million cycles are reached or failure of the system. - [ASTM F2580](https://endolab.org/hip-implants/astm-f-2580/): ASTM F2580: Standard test method for evaluation of modular connection of proximally fixed femoral hip prosthesis - [ISO 21535](https://endolab.org/hip-implants/iso-21535-range-of-motion/): ISO 21535: Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants - [ASTM F1875](https://endolab.org/hip-implants/astm-f1875/): ASTM F1875: Standard Test Method for Long-Term Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Modular Head-Bore / Cone Taper Junctions - [ASTM F1820](https://endolab.org/hip-implants/astm-f1820/): ASTM F1820: Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices - [ISO 14242-1](https://endolab.org/hip-implants/iso-14242-1/): ISO 14242-1: Implants for surgery - wear of total hip prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for tests - [ISO 7206-2](https://endolab.org/hip-implants/iso-7206-2/): ISO 7206-2: Implants for surgery - Partial and total hip joint prostheses: Articulating surfaces made of metallic, ceramic and plastic materials - [PI-3](https://endolab.org/hip-implants/pi-3/): PI-3: Luxationsversuch ohne Schaft-Pfanne Kontakt (akkreditiertes Verfahren) - [ASTM F2009](https://endolab.org/hip-implants/astm-f-2009/): ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses - [ISO 7206-10](https://endolab.org/hip-implants/iso-7206-10-astm-f2345-pi-14/): ISO 7206-10: Implants for surgery – Partial and total hip-joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads - [ISO 7206-13](https://endolab.org/hip-implants/iso-7206-13/): ISO 7206-13: Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components   - [PI-58 (ISO 7206-8)](https://endolab.org/hip-implants/pi-58-iso-7206-8/): ISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components - [ISO 7206-4](https://endolab.org/hip-implants/iso-7206-4/): ISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components ## Instruments - [ISO 7864](https://endolab.org/instruments/testing-of-sterile-hypodermic-needles-for-single-use/): The international standard ISO 7864 specifies the requirements for sterile, single-use hypodermic needles intended primarily for the injection and withdrawal of fluids from the human body. - [Custom](https://endolab.org/instruments/surgical-instrument-impact-testing/): Overview - [ISO 16061](https://endolab.org/instruments/iso-16061/): ISO 16061: Instruments for use in association with non-active surgical implants — General requirements - [ISO 13402](https://endolab.org/instruments/iso-13402/): ISO 13402: Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure - [ISO 13926-1](https://endolab.org/instruments/iso-13926-1/): ISO 13926-1: Glass cylinders for pen-injectors for medical use - [ISO 11953](https://endolab.org/instruments/iso-11953/): ISO 11953: Clinical performance of hand torque instruments - [ANSI/AAMI NS28:1988/(R) 2006](https://endolab.org/instruments/intracranial-pressure-monitoring-devices/): ANSI/AAMI NS28:1988/(R) 2006 - Intracranial pressure monitoring devices   - [ASTM F3014 (PI-94)](https://endolab.org/instruments/astm-f3014/): ASTM F3014: Standard Test Method for penetration testing of needles used in surgical sutures - [ASTM F2528](https://endolab.org/instruments/astm-f2528/): ASTM F2528: Standard Test Methods for Enteral Feeding Devices with a Retention Balloon - [ISO 11608](https://endolab.org/instruments/iso-11608/): ISO 11608-1: Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods - [ASTM F1089](https://endolab.org/instruments/astm-f1089/): ASTM F1089: Standard Test Method for Corrosion of Surgical InstrumentsISO 13402: Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposureDIN EN ISO 13402: Chirurgische und zahnärztliche Handinstrumente - Bestimmung der Beständigkeit gegenüber Sterilisation, Korrosion und Wärmebehandlung ## Knee implants - [ASTM F2009](https://endolab.org/knee-implants/f2009/): The ASTM F2009 standard applies to all tapered connections of modular prostheses, such as total or partial hip or shoulder prostheses. The ISO 7206-10 standard is specific to hip femoral heads and describes the method to establish the tension load to disassemble modular head systems. - [ASTM F3495](https://endolab.org/knee-implants/astm-f3495/): ASTM F3495: Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components - [PI-96 (ASTM F2083)](https://endolab.org/knee-implants/astm-f2083/): ASTM F2083: Standard Specification for Knee Replacement Prosthesis - [ISO 21534](https://endolab.org/knee-implants/iso-21534/): ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirementsISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parametersISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral componentsISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral componentsISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirementsISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testsISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurementISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementISO 14630: Non-active surgical implants - General requirementsISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays  - [ASTM F1814](https://endolab.org/knee-implants/astm-f1814/): ASTM F1814: Standard Guide for Evaluating Modular Hip and Knee Joint Components - [ISO 21536](https://endolab.org/knee-implants/iso-21536/): ISO 21536: Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint implants - [PI-53](https://endolab.org/knee-implants/pi-53/): PI-53: Fatigue testing of stemmed femoral TKA components - [ISO 14243-5](https://endolab.org/knee-implants/iso-14243-5/): ISO 14243-5: Implants for surgery - Wear of total knee prostheses - Part5: Durability performance of the patellofemoral joint - Loading and displacement parameters for testing machines and corresponding environmental conditions for test - [ASTM F3210](https://endolab.org/knee-implants/astm-f3210/): ASTM F3210: Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions - [ASTM F3140](https://endolab.org/knee-implants/astm-f3140/): ASTM F3140: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements - [ASTM F3141](https://endolab.org/knee-implants/astm-f3141/): ASTM F3141: Standard Guide for Total Knee Replacement Loading Profiles - [ASTM F2722](https://endolab.org/knee-implants/astm-f2722/): ASTM F2722: Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops - [ASTM F2723](https://endolab.org/knee-implants/astm-f2723/): ASTM F2723: Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation - [ASTM F2777](https://endolab.org/knee-implants/astm-f2777/): ASTM F2777: Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion - [ISO 14243-1/3](https://endolab.org/knee-implants/iso-14243-1-3/): ISO 14243-1: Implants for surgery - Wear of total knee joint prosthesesPart 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for tests. - [ISO 7207-2](https://endolab.org/knee-implants/iso-7207-2/): ISO 7207-2: Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastic materials. Amendment 2 - [ASTM F1672 (PI-95)](https://endolab.org/knee-implants/astm-f1672/): ASTM F1672: Standard Specification for Resurfacing Patellar Prosthesis. - [ISO 14879-1 / ASTM F1800](https://endolab.org/knee-implants/iso-14879-1-astm-f1800/): ISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays - [PI-17](https://endolab.org/knee-implants/pi-17/): PI-17: Determination of Total Knee Implant Contact Pressure - [ASTM F2724](https://endolab.org/knee-implants/astm-f2724/): ASTM F2724: Standard Test Method for Evaluating Mobile Bearing Knee Dislocation - [ASTM F1223](https://endolab.org/knee-implants/astm-f1223/): ASTM F1223: Standard Test Method for Determination of Total Knee Replacement Constraint ## MT-Bone Cement analysis - [ASTM F3087](https://endolab.org/mt-bone-cement-analy/astm-f3087/): ASTM F3087: Standard Specification for Acrylic Molding Resins for Medical Implant Applications - [ASTM F451 and ISO 5833](https://endolab.org/mt-bone-cement-analy/astm-f451-and-iso-5833/): ASTM F451: Standard Specification for Acrylic Bone Cement - [ASTM F2118 / ISO 16402](https://endolab.org/mt-bone-cement-analy/astm-f2118-iso-16402/): ASTM F2118: Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials ## MT-Ceramic analysis - [ASTM C1499](https://endolab.org/mt-ceramic-analysis/astm-c1499/): ASTM C1499: Standard Test Method for Monotonic Equibiaxial Flexural Strength of Advanced Ceramics at Ambient Temperature - [ISO 13356 and ISO 6474-1/2](https://endolab.org/mt-ceramic-analysis/iso-13356-and-iso-6474-1-2/): ISO 13356: Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). - [PI-60 (ISO 6474)](https://endolab.org/mt-ceramic-analysis/pi-60-iso-6474/): PI-60: (ISO 6474; 1994) Implants for surgery - Ceramic materials based on high purity alumina - [DIN EN 843-2](https://endolab.org/mt-ceramic-analysis/din-en-843-2/): DIN EN 843-2: Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 2: Determination of Young's modulus, shear modulus and Poisson's ratio   - [DIN EN 843-4 / ISO 14705](https://endolab.org/mt-ceramic-analysis/din-en-843-4-iso-14705/): DIN EN 843-4: Advanced technical ceramics– Mechanical properties of monolithic ceramics at room temperature–Part 4: Vickers, Knoop and Rockwell superficial hardness ## MT-Coating analysis - [ASTM F1160](https://endolab.org/mt-coating-analysis/astm-f1160/): ASTM F1160: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/ Metallic Coatings. - [ASTM F1609](https://endolab.org/mt-coating-analysis/astm-f1609/): ASTM F1609: Standard Specification for Calcium Phosphate Coatings for Implantable Materials - [ISO 13175-3](https://endolab.org/mt-coating-analysis/iso-13175-3/): ISO 13175-3: Implants for surgery - Calcium phosphates - Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes - [ISO 13779-2](https://endolab.org/mt-coating-analysis/iso-13779-2/): ISO 13779-2: Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite - [ISO 13179](https://endolab.org/mt-coating-analysis/iso-13179/): ISO 13179: Implants for surgery - Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements - [ASTM F1926](https://endolab.org/mt-coating-analysis/astm-f1926/): ASTM F1926/F1926M: Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings - [ASTM F1978](https://endolab.org/mt-coating-analysis/astm-f1978/): ASTM F1978: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser. - [ASTM F1854](https://endolab.org/mt-coating-analysis/astm-f1854/): ASTM F1854: Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants. - [ASTM F1147 and ISO 13779-4](https://endolab.org/mt-coating-analysis/tensile-strength-of-coatings/): ASTM F1147: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings - [ASTM F1044](https://endolab.org/mt-coating-analysis/astm-f1044/): ASTM F1044: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings ## MT-Corrosion tests - [Ion concentration analysis](https://endolab.org/mt-corrosion-tests/ion-concentration-analysis/): Ion concentration analysis, similar to particle analysis, is a valuable addition to wear and fatigue testing, providing a more comprehensive understanding of an implant’s overall performance and biological activity. In fact, some standards like ASTM F1875, which describes fretting corrosion tests, as well as many notified bodies explicitly list ion concentration analysis as a (required) follow-up examination. - [ISO 16429](https://endolab.org/mt-corrosion-tests/iso-16429/): ISO 16429: Implants for surgery – Measurements of open-circuit potential to assess corrosion behavior of metallic implantable materials and medical devices over extended time periods   - [ASTM G102](https://endolab.org/mt-corrosion-tests/astm-g102/): ASTM G102: Standard Practice for Calculation of Corrosion Rates and Related Information from Electrochemical Measurements - [ASTM F1801](https://endolab.org/mt-corrosion-tests/astm-f1801/): ASTM F1801: Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials   - [ISO 13402](https://endolab.org/mt-corrosion-tests/iso-13402/): ISO 13402: Surgical and dental hand instruments – Determination of resistance against autoclaving, corrosion and thermal exposure - [ASTM F1089](https://endolab.org/mt-corrosion-tests/astm-f1089/): ASTM F1089: Standard Test Method for Corrosion of Surgical InstrumentsISO 13402: Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposureDIN EN ISO 13402: Chirurgische und zahnärztliche Handinstrumente - Bestimmung der Beständigkeit gegenüber Sterilisation, Korrosion und Wärmebehandlung - [ASTM F3044](https://endolab.org/mt-corrosion-tests/astm-f3044/): ASTM F3044: Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants - [ASTM F897](https://endolab.org/mt-corrosion-tests/astm-f897/): ASTM F897: Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws - [ASTM F1875](https://endolab.org/mt-corrosion-tests/astm-f1875/): ASTM F1875: Standard Test Method for Long-Term Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Modular Head-Bore / Cone Taper Junctions - [ASTM F2129](https://endolab.org/mt-corrosion-tests/astm-f2129/): ASTM F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices ## MT-Metal analysis - [ISO 16429](https://endolab.org/mt-metal-analysis/iso-16429/): ISO 16429: Implants for surgery – Measurements of open-circuit potential to assess corrosion behavior of metallic implantable materials and medical devices over extended time periods   - [ASTM F1801](https://endolab.org/mt-metal-analysis/astm-f1801/): ASTM F1801: Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials   - [ISO 7438](https://endolab.org/mt-metal-analysis/iso-7438/): ISO 7438: Metallic materials - Bend test - [ISO 5832-4](https://endolab.org/mt-metal-analysis/iso-5832-4/): ISO 5832-4: Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy - [ISO 5832-3](https://endolab.org/mt-metal-analysis/iso-5832-3/): ISO 5832-3: Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy - [ISO 6892-1](https://endolab.org/mt-metal-analysis/iso-6892-1/): ISO 6892-1: Metallic materials - Tensile testing - Part 1: Method of test at room temperature - [DIN 50134](https://endolab.org/mt-metal-analysis/din-50134/): DIN 50134: Testing of metallic materials - Compression test of metallic cellular materials - [ASTM F2516](https://endolab.org/mt-metal-analysis/astm-f2516/): ASTM F2516: Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials - [ISO 4967](https://endolab.org/mt-metal-analysis/iso-4967/): ISO 4967: Steel - Determination of content of nonmetallic inclusions - Micrographic method using standard diagrams - [ASTM F136](https://endolab.org/mt-metal-analysis/astm-f136/): ASTM F136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)   - [ISO 20160](https://endolab.org/mt-metal-analysis/iso-20160/): ISO 20160: Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta titanium alloy bars - [ASTM E112](https://endolab.org/mt-metal-analysis/astm-e112/): ASTM E112: Standard Test Methods for Determining Average Grain Size ## MT-Packaging - [ASTM F2824](https://endolab.org/mt-packaging/astm-f2824/): ASTM F2824: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids - [ISO 11607-1](https://endolab.org/mt-packaging/iso-11607-1/): ISO 11607-1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - [ASTM F1980](https://endolab.org/mt-packaging/f1980/): ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ## MT-Pins and wires - [ASTM F366](https://endolab.org/mt-pins-and-wires/astm-f366/): ASTM F366: Standard Specification for Fixation Pins and Wires - [ISO 5838-3](https://endolab.org/mt-pins-and-wires/iso-5838-3/): ISO 5838-3: Implants for surgery - Skeletal pins and wires - Part 3: Kirschner skeletal wires - [ISO 5838-2](https://endolab.org/mt-pins-and-wires/iso-5838-2/): ISO 5838-2: Implants for surgery - Skeletal pins and wires - Part 2: Steinmann skeletal pins - Dimensions - [ISO 5838-1](https://endolab.org/mt-pins-and-wires/iso-5838-1/): ISO 5838-1: Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements ## MT-Polymer analysis - [ASTM F732](https://endolab.org/mt-polymer-analysis/astm-f732/): ASTM F732: Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses - [ASTM F2381](https://endolab.org/mt-polymer-analysis/astm-f2381/): ASTM F2381: Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy - [ASTM F2102 / ISO 5834-4](https://endolab.org/mt-polymer-analysis/astm-f2102/): ASTM F2102: Standard Guide for evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants - [ASTM F2003 / ISO 5834-3](https://endolab.org/mt-polymer-analysis/astm-f2003-iso-5834-3-3/): ASTM F2003: Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air - [ASTM D732](https://endolab.org/mt-polymer-analysis/astm-d732/): ASTM D732: Standard Test Method for Shear Strength of Plastics by Punch Tool - [ASTM D882](https://endolab.org/mt-polymer-analysis/astm-d882/): ASTM D882: Standard Test Method for Tensile Properties of Thin Plastic Sheeting   - [ASTM D792](https://endolab.org/mt-polymer-analysis/astm-d792/): ASTM D792: Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement   - [ASTM D618](https://endolab.org/mt-polymer-analysis/astm-d618/): ASTM D618: Standard Practice for Conditioning Plastics for Testing   - [ASTM F1839](https://endolab.org/mt-polymer-analysis/astm-f1839/): ASTM F1839: Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments   - [ASTM F648](https://endolab.org/mt-polymer-analysis/astm-f648/): ASTM F648: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants - [ASTM F2183](https://endolab.org/mt-polymer-analysis/astm-f2183/): ASTM F2183: Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants - [ASTM D638](https://endolab.org/mt-polymer-analysis/astm-d638/): ASTM D638: Standard Test Method for Tensile Properties of Plastics ## MT-Scaffold - [ASTM F2952](https://endolab.org/mt-scaffold/astm-f2952/): Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold ASTM F2852   ## MT-Texture - [ASTM F2791](https://endolab.org/mt-texture/astm-f2791/): ASTM F2791: Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions ## Osteosynthesis - [PI-100 (ISO DIS 18967-1)](https://endolab.org/osteosynthesis/pi-100-iso-dis-18967-1/): PI-100: Implants for surgery - Bone anchoring systems - Part 1: Impact, expandable and threaded suture anchors requirements - [PI-82](https://endolab.org/osteosynthesis/pi-82/): PI-82: Determination of Screw Compression Force   - [ASTM F3437](https://endolab.org/osteosynthesis/pi-68/): ASTM F3437: Standard Test Method for Metallic Bone Plates Used in Small Bone Fracture Fixation - [ASTM F2502](https://endolab.org/osteosynthesis/astm-f2502/): ASTM F2502: Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants. - [ASTM F2180](https://endolab.org/osteosynthesis/astm-f2180/): ASTM F2180: Standard Specification for Metallic Implantable Strands and Cables. - [ASTM F564](https://endolab.org/osteosynthesis/astm-f564/): ASTM F564: Standard Specification and Test Methods for Metallic Bone Staples - [ASTM F1264 and ASTM F383](https://endolab.org/osteosynthesis/astm-f1264-and-astm-f383/): ASTM F383: Standard Practice for Static Bend and Torsion Testing of Intramedullary Rods - [PI-19](https://endolab.org/osteosynthesis/pi-19/): PI-19: Gliding nail fatigue test - [ASTM F382](https://endolab.org/osteosynthesis/astm-f382/): ASTM F382: Standard Specification and Test Method for Metallic Bone Plates - [ASTM F897](https://endolab.org/osteosynthesis/astm-f897/): ASTM F897: Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws - [ASTM F1541](https://endolab.org/osteosynthesis/astm-f1541/): ASTM F1541: Standard Specification and Test Methods for External Skeletal Fixation Devices - [ASTM F543](https://endolab.org/osteosynthesis/astm-f543/): ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws. - [ASTM F384](https://endolab.org/osteosynthesis/astm-f384/): ASTM F384: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices ## Particle analysis - [Ion concentration analysis](https://endolab.org/particle-analysis/ion-concentration-analysis/): Ion concentration analysis, similar to particle analysis, is a valuable addition to wear and fatigue testing, providing a more comprehensive understanding of an implant’s overall performance and biological activity. In fact, some standards like ASTM F1875, which describes fretting corrosion tests, as well as many notified bodies explicitly list ion concentration analysis as a (required) follow-up examination. - [ISO 17853](https://endolab.org/particle-analysis/iso-17853/): ISO 17853: Wear of implant materials – Polymer and metal wear particles – Isolation, characterization and quantification - [ASTM F1877](https://endolab.org/particle-analysis/test/): ISO 17853: Wear of implant materials – Polymer and metal wear particles – Isolation, characterization and quantification - [ASTM F3306](https://endolab.org/particle-analysis/astm-f3306/): ASTM F3306: Standard Test Method for Ion Release Evaluation of Medical Implants - [ASTM F561](https://endolab.org/particle-analysis/particle-analysis/): ISO 17853: Wear of implant materials - Polymer and metal wear particles - Isolation, characterization and quantification ## Research projects - [Implant system testing](https://endolab.org/research-project/implant-system-testing/): In this project a test procedure for the numerical and mechanical testing of implant systems is being developed. Physiologically realistic load collectives are determined by means of a complex algorithm for the classification of implants using suitable measurable implant parameters, transferred to simulations of the mechanical load capacity as well as necessary geometrical and material dimensions of the implants and verified by means of test setups for the physiological testing of implant systems in static and dynamic loading cases with combined bending and torsional loading. - [InDx](https://endolab.org/research-project/indx/): The thumb base joint is fundamental for human dexterity and functional activity but is prone to debilitating arthritis. Approximately 5% of the world population suffers from this condition with over 25 million Europeans affected. Simple tasks become impossible such as getting dressed, opening a jar, using a key to open a door. This is certainly a relevant socioeconomic and humanitarian concern, which causes a substantial cost burden on healthcare systems, yet the effective treatment for end-stage thumb base arthritis lags far behind other joints, given challenges of the small, complex anatomy. The InDx project aims to enable the commercialization of the InDx implant, the world’s first implant designed to accommodate the complex biomechanics of the thumb base joint and restore the natural movement of the thumb. The consortium is led by Loci Orthopaedics, a technology-driven SME spin-out company from the National University of Ireland, Galway. - [ASIMOV](https://endolab.org/research-project/asimov/): A gradient-free load application to avoid stress peaks or micromovements between a metallic implant and its anchorage in the native bone and the associated risks, e.g. implant loosening, is a desired property that has not been consistently implemented in any available endoprosthetic treatment to date. Especially mechanically critical anchorage cases, such as on the acetabulum (hip socket) after tumor resections, can be designed with the help of new manufacturing processes in such a way that stress peaks in the transition between bone and implant are significantly reduced. In addition, gradient-free load application can be used for classic anchorage cases in the femur, humerus or tibia. Physiological knowledge, software-based modelling and optimization algorithms as well as additive manufacturing in combination represent a new, previously unavailable methodology for designing, producing, testing and marketing deformation-adapted implants in the future.In this project, EndoLab has a special focus on particle release and structural safety. ## Shoulder implants - [ASTM F2009](https://endolab.org/shoulder-implants/astm-f2009/): ASTM F2009: Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses - [PI-90](https://endolab.org/shoulder-implants/pi-90/): PI-90 (ISO/CD 24085-2): Implants for Surgery - Partial and total shoulder joint prosthesis - Part 2: Determination of resistance to torque off head fixation of modular humeral prostheses - [PI-89](https://endolab.org/shoulder-implants/pi-89/): PI-89 (ISO/CD 24085-1): Implants for Surgery - Partial and total shoulder joint prosthesis - Part 1: Determination of resistance to static load of ceramic humeral heads and glenospheres - [ISO 21534](https://endolab.org/shoulder-implants/iso-21534/): ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirementsISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parametersISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral componentsISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral componentsISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirementsISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testsISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurementISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementISO 14630: Non-active surgical implants - General requirementsISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays  - [PI-62](https://endolab.org/shoulder-implants/pi-62/): PI-62: Anatomic Shoulder System Wear Test - [PI-61](https://endolab.org/shoulder-implants/pi-61/): PI-61: Reverse Shoulder System Wear Test - [ASTM F2028](https://endolab.org/shoulder-implants/astm-f2028/): ASTM F2028: Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation - [ASTM F1829](https://endolab.org/shoulder-implants/astm-f1829/): ASTM F1829: Standard Standard Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear. - [ASTM F1378](https://endolab.org/shoulder-implants/astm-f1378/): ASTM F1378: Standard Specification for Shoulder Prostheses. ## Spinal implants - [ASTM F3574](https://endolab.org/spinal-implants/astm-f3574/): ASTM F3574: Standard Test Methods for Sacroiliac Joint Fusion Devices - [ASTM F3631](https://endolab.org/spinal-implants/astm-f3631/): ASTM F3631: Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices - [ISO 23089-2](https://endolab.org/spinal-implants/iso-23089-2/): ISO 23089-2: Implants for surgery — Pre-clinical mechanical assessment of spinal implants and particular requirements —Part 2: Spinal intervertebral body fusion devices - [ASTM F2346](https://endolab.org/spinal-implants/astm-f2346/): ASTM F2346: Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs - [ASTM F3295](https://endolab.org/spinal-implants/astm-f3295/): ASTM F3295: Standard Guide for Impingement Testing of Total Disc Prostheses - [ISO 21534](https://endolab.org/spinal-implants/iso-21534/): ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirementsISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parametersISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral componentsISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral componentsISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirementsISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testsISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurementISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementISO 14630: Non-active surgical implants - General requirementsISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays  - [ISO 18192-3](https://endolab.org/spinal-implants/iso-18192-3/): ISO 18192-3: Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar and cervical prostheses - [ASTM F2789](https://endolab.org/spinal-implants/astm-f2789/): ASTM F2789: Standard guide for Mechanical and Functional Characterization of Nucleus Devices   - [PI-76](https://endolab.org/spinal-implants/pi-76/): PI-76: (WK45142) Standard Practice for Mechanical Characterization of Spinous Process Plates - [ASTM F2706](https://endolab.org/spinal-implants/astm-f2706v/): ASTM F2706: Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model - [ASTM F2694 / F2790](https://endolab.org/spinal-implants/astm-f2694-f2790/): ASTM F2694: Standard Test Method for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses - [ASTM F2624](https://endolab.org/spinal-implants/astm-f2624/): ASTM F2624: Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants - [ISO 12189](https://endolab.org/spinal-implants/iso-12189/): ISO 12189: Implants for surgery - Mechanical testing of implantable spinal devices - Fatigue test method for spinal implant assemblies using an anterior support - [PI-52](https://endolab.org/spinal-implants/pi-52/): PI-52 (accredited procedure): Expulsion test - spinal implants - [ISO 18192-2](https://endolab.org/spinal-implants/iso-18192-2/): ISO 18192-2: Implants for surgery - Wear of total spinal intervertebral disc prostheses - Part 2: Nucleus replacements   - [ASTM F2267](https://endolab.org/spinal-implants/astm-f2267/): ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression - [ISO 18192-1](https://endolab.org/spinal-implants/iso-18192-1/): ISO 18192-1: Test Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test - [ASTM F2077](https://endolab.org/spinal-implants/astm-f2077/): ASTM F2077: Test Methods For Intervertebral Body Fusion Devices - [ASTM F1717](https://endolab.org/spinal-implants/astm-f1717/): ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. - [ASTM F1798](https://endolab.org/spinal-implants/astm-f1798/): ASTM F1798: Evaluation of the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants. - [ASTM F2193](https://endolab.org/spinal-implants/astm-f2193/): ASTM F2193: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System. ## Vi-Catheters - [ISO 10555-1](https://endolab.org/vi-catheters/iso-10555-1-3/): ISO 10555-1: Intravascular catheters – Sterile and single-use catheters - Part 1: General requirements - [ISO 80369-20](https://endolab.org/vi-catheters/iso-80369-20/): ISO 80369-20: Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods - [ISO 10555-5](https://endolab.org/vi-catheters/iso-10555-5/): ISO 10555-5: Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters - [ISO 10555-4](https://endolab.org/vi-catheters/iso-10555-4/): ISO 10555-4: Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilation catheters - [ISO 10555-3](https://endolab.org/vi-catheters/iso-10555-3/): ISO 10555-3: Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters ## Vi-Other Vascular Devices - [ISO 11070](https://endolab.org/vi-other-vascular-de/iso-11070/): ISO 11070: Sterile single-use intravascular introducers, dilators and guidewires - [ISO 7198](https://endolab.org/vi-other-vascular-de/iso-7198/): ISO 7198: Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubularvascular grafts and vascular patches ## Vi-Stent Delivery Systems - [ASTM F2606](https://endolab.org/stent-delivery-sys/astm-f2606/): ASTM F2606: Standard guide for three point bending of balloon expandable vascular stents and stent systems. - [ISO 25539 / ASTM F2079](https://endolab.org/stent-delivery-sys/iso-25539-astm-f2079/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539 / ASTM F2081](https://endolab.org/stent-delivery-sys/iso-25539-astm-f2081-2/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-10/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-9/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-8/): ISO 25539-1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses. - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-7/): ISO 25539-1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-6/): ISO 25539‐2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stents. - [ASTM F2743](https://endolab.org/stent-delivery-sys/astm-f2743/): ASTM F2743: Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent. - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-5/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539 / ASTM F2394](https://endolab.org/stent-delivery-sys/iso-25539-astm-f2394/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539 / ASTM F2081](https://endolab.org/stent-delivery-sys/iso-25539-astm-f2081/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-4/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-3/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses. - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539-2/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses. - [ISO 25539](https://endolab.org/stent-delivery-sys/iso-25539/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses. ## Vi-Stents and Endovascular Prostheses - [ASTM F3044](https://endolab.org/vi-stents-and-endova/astm-f3044/): ASTM F3044: Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants - [ASTM F2129](https://endolab.org/vi-stents-and-endova/astm-f2129/): ASTM F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices - [ASTM F2606](https://endolab.org/vi-stents-and-endova/astm-f2606/): ASTM F2606: Standard guide for three point bending of balloon expandable vascular stents and stent systems - [ISO 25539](https://endolab.org/vi-stents-and-endova/iso-25539-2/): ISO 25539-1:2003: Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses - [ISO 25539 / ASTM F2081](https://endolab.org/vi-stents-and-endova/iso-25539-astm-f2081-2/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prosthesesISO 25539‐2: Cardiovascular implants - Endovascular devices - Part 2: Vascular stentsASTM F2081: Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents - [ISO 25539 / ASTM F2081](https://endolab.org/vi-stents-and-endova/iso-25539-astm-f2081/): ISO 25539-1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539 / ASTM F3505](https://endolab.org/vi-stents-and-endova/iso-25539-astm-f3505/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539 / ASTM F3067](https://endolab.org/vi-stents-and-endova/iso-25539-astm-f3067/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ISO 25539](https://endolab.org/vi-stents-and-endova/iso-25539/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses - [ASTM F2942](https://endolab.org/vi-stents-and-endova/astm-f2942/): ASTM F2942: Standard Guide for in vitro Axial, Bending, Torsional, and Compression Durability Testing of Vascular Stents and Vascular Stent-Grafts - [ISO 25539 / ASTM F2477](https://endolab.org/vi-stents-and-endova/iso-25539-astm-f2477/): ISO 25539‐1: Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses ## Wrist implants - [ISO 21534](https://endolab.org/wrist-implants/iso-21534/): ISO 21534: Non-active surgical implants - Joint replacement implants - Particular requirementsISO 4287: Geometrical Product Specifications (GPS) - Surface texture: Profile method - Terms, definitions and surface texture parametersISO 7206-4: Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties of stemmed femoral componentsISO 7206-8: Implants for surgery - Partial and total hip joint prostheses - Part 8: Methods of determining endurance performance of stemmed femoral componentsISO 14155-1: Clinical investigation of medical devices for human subjects - Part 1: General requirementsISO 14242-1: Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for testsISO 14242-2: Implants for surgery - Wear of total hip joint prostheses - Part 2: Methods of measurementISO 14243-2: Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurementISO 14630: Non-active surgical implants - General requirementsISO 14879-1: Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays  - [ASTM F1357](https://endolab.org/wrist-implants/astm-f1357/): ASTM F1357: Standard Specification for Articulating Total Wrist Implants