Always One Step Ahead – Medical Product Testing
As an accredited and recognised test laboratory for medical products, we support manufacturers, doctors and expert assessors in the field of certification testing, failure and damage analysis as well as research and development for medical products.
Our main focus is, among others, in strength, resistance and wear tests of joint endoprosthesis, osteosynthesis products, trauma products, surgical instruments and skin adhesive and patch products in accordance with the standard or special test procedures.
Mobility means quality of life as an essential, integral part of our everyday life, whether professional, family or leisure – medicine products serve as auxiliary aids in order to restore an effective quality of life following accidents or illnesses or at least improve it. The medical products industry is innovative and also fascinating at the same time.
Manufacturers can provide a comprehensive range of products worldwide, among others, joint endoprosthesis and fixing systems for partially or completely replacing damaged joints as well as bones or for stabilising them. They therefore provide holistic solutions which are coordinated with each other – starting with the surgical instruments up to implant systems as well as review products and appropriate additional training. Clinics and doctors want to provide their patients with solutions which guarantee a minimised invasive intervention, reduced healing phases and long-term reliability. Around 400,000 [1] endoprosthetic operations are executed on hip and knee joints (initial implantation) in Germany annually- against this background with regard to the economic importance and patient satisfaction, manufacturers and specialists doctors have been researching materials, design principles and treatment concepts to increase the life expectancy of artificial joints. For example, implants have now been developed whose design and spatial configuration is adjusted to the original anatomy and biomechanics. In addition, the anchoring of prostheses in the bone must be improved more and the wear and corrosion of the artificial joints can be significantly reduced.
[1] ERPD (Endoprothesenregister Deutschland, Annual Report 2015)Our portfolio
Simulation and Strength Assessments
As a holistic development partner, we provide reliable information about design and lifetime by determining component strengths and examining stress, strain, and stability already during construction and dimensioning process. By means of calculated assessments of strength, designs are optimized and designed to be reliable.
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Materialography
Whether for quality assurance, damage analysis or for research and development - in our accredited materialography laboratories we take a close look at both metallic and non-metallic materials of different composition with qualitative and quantitative characterization methods. This also includes the sample preparation procedures and the analysis, evaluation and documentation of the microscopic examination results.
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Damage analysis
Determining causes and effects experimentally - we assess damage cases and thus support the cause clarification. Our experienced engineers help you to investigate undesirable damage phenomena in detail - for example, by materialography, acoustic damage detection or non-destructive testing methods.
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Materials Testing Metals
Our material specialists accompany you in the implementation of your test programs as well as standardization, approval and certification of materials or manufacturing processes. We stand by your side during the entire test procedure, from the consultation, test planning and sample production, over the test itself up to the finished test report.
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Material Testing for Plastics and Composite Materials
From the base material through the manufacturing technology to the approval of the finished product - our material tests are DAkkS and NADCAP accredited. This includes static, cyclic and dynamic tests as well as static long-term tests, including sample production.
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Materials databases
The databases of our WIAM® product line provide material information and characteristic values that are used reliably for material selection, design, standardization, calculation and simulation. The data pool draws on material and fundamental experiments from the last five decades, and new materials are systematically integrated.
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Software and Software Solutions
We have solved the management of data and documents from processes in the areas of research and development, simulation and calculation, laboratory, quality management, process development and production planning - with the WIAM® database systems we offer suitable software solutions with flexible data structures, display options and evaluations.
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IMA Dresden implements comprehensive tests for materials and models – alongside knee and hip joint implants, the testing spectrum now extends to all joints such as feet, hands, shoulders and osteosynthesis products such as bone screws, plates and skin adhesives. Artificial ageing, particulate measurement, strength calculations and damage analysis enhance the range of services.
Furthermore, we will be pleased to advise you on the required test series for your product on the way to approval. And one thing is for sure, should there not be a standardised test standard yet, then we will support you with the development of test requirements and specifications, based on scientific studies and databases.
Flexible accreditation from DAkks (German Accreditation Body) and recognition from ZLG (Central Body of the States for Health Protection) enables us to test materials and components according to different standards, as well as developing new testing procedures. The appendix to our accreditation certificate includes a comprehensive overview of the scope of validity for our accreditation.
Hip joint implants
The technical documentation for hip joint implants requires the verification of varied, different product characteristics on the basis of standardised test procedures. Our laboratory facilities make it possible for us to implement the tests in accordance with the relevant directives and guidelines. In the case of polyethylene components, we recommend a particle analysis (shape, size and number of wear particles).
Overview of test procedures
| Standard | Title |
| ISO 7206-2 | Implants for surgery – Partial and total hip joint prostheses Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
| ISO 7206-4 | Implants for surgery – Partial and total hip joint prostheses Part 4: Determination of endurance properties of stemmed femoral components |
| ISO 7206-6 | Implants for surgery – Partial and total hip joint prostheses Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
| 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/DIS 7206-12 | Implants for surgery – Partial and total hip joint prostheses Part 12: Deformation test method for acetabular shells |
| ISO/DIS 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 |
| ASTM F 1820 | Standard Test method for Determining the Axial Disassambly Force of a Modular Acetabular Device |
| ASTM F 2009 | Standard Test method for Determining the Axial Disassambly Force of Taper connections of Modular Prostheses |
| ASTM F 2068 | Standard Specification for Femoral Prostheses -Metallic Implants |
| IMA-PV C/25 | Dynamic Strength Test for Hip Joint Implants – Ceramic Hip Joint Ball and –Socket |
| ASTM F 1875 | Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface (Method I) |
| ASTM F 2345 | Standard Test method for determination of static and Cyclic fatigue strength of ceramic Modular Femoral Heads |
| ISO 14 242-1 | Implants for surgery – Wear of total hip joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
| ISO 14 242-2 | Implants for surgery – Wear of total hip joint prostheses Part 2: Methods of measurement |
| ISO 14 242-3 | Implants for surgery – Wear of total hip joint prostheses Part 3: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
Knee Joint implants
The variety of types and design specifications in the area of knee endoprosthesis with regard to supply type, anchoring, articulation, system and the grade of coupling require defined test series for the approval procedure. Knee joint simulators are available for tribiological testing.
Overview of test procedures
| Standard | Title |
| ISO 7207-2 | Implants for surgery – Components for partial and total knee joint prostheses Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
| ISO 14 879-1 | Implants for surgery – Total knee prostheses Part 1: Determination of endurance properties of knee tibial trays |
| ASTM F 1800 | Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements |
| ASTM F 1223 | Standard Test Method for Determination of Total Knee Replacement Constraint |
| IMA-PV C/30 | Evaluating the contact area and the pressure distribution for articulating surfaces using pressure measuring films |
| IMA-PV C/31 | Knee joint implants Strength and resistance tests for investigating the fatigue behaviour of femoral components |
| IMA/PV C/38 | Knee joint implants Strength and resistance tests for investigating the fatigue behaviour of tibia plateaus with long shanks |
| ISO 14243-1 | Implants for surgery – Wear of total knee joint prostheses Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test |
| ISO 14 243-2 | Implants for surgery – Wear of total knee joint prostheses Part 2: Methods of measurement |
| ISO 14 243-3 | Implants for surgery – Wear of total knee joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test |
Shoulder Joint implants
There are currently only a few standardised test procedures for shoulder joints. We have created company-internal test instructions based on scientific publications or databases for meaningful testing. We can therefore cover anatomical and inverse designs. Edge loads are of particular interest for these endoprosthesis.
Overview of test procedures
| Standard | Title |
| IMA-PV C/32 | Shoulder joint endoprosthesis Dynamic strength testing – Shoulder shank |
| IMA-PV C/33.1 | Shoulder joint endoprosthesis Wear test – Anatomical shoulder |
| IMA-PV C/33.3 | Shoulder joint endoprosthesis Wear test – Shoulder with edge loading |
| IMA-PV C/33.4 | Shoulder joint endoprosthesis Wear test – Inverse shoulder |
Osteosynthesis implants / bone plates / bone screw / Intramedullary nails
Among other things, bone screws must resist defined torsional stress. The assessment of the flexural strength is of particular importance for bone plates. In there should be a case of failure, then a metallographic examination in our materialography laboratory is not only very instructive for this but also for all other implants.
Overview of test procedures
| Standard | Title |
| ISO 5836 | Implants for surgery; Metal bone plates; Holes corresponding to screws with asymmetrical thread and spherical under surface |
| ISO 5837-1 | Implants for surgery; Intramedullary nailing systems; Part 1: Intramedullary nails with cloverleaf of V-shaped cross-section |
| ISO 5838-1 | Implants for surgery; Skeletal pins and wires; Part 1: Material and mechanical requirements |
| ISO 5838-2 | Implants for surgery; Skeletal pins and wires; Part 2: Steinmann skeletal pins; Dimensions |
| ISO 5838-3 | Implants for surgery; Skeletal pins and wires; Part 3: Kirschner Skeletal wires |
| ISO 6475 | Surgical implants: bone screws made of metal with asymmetric thread and spherical head bottom; mechanical requirements and test methods |
| ASTM F 543 | Standard specification and Test Method for Metallic Bone Screws |
| ISO 9585 | Implants for surgery; Determination of bending strength and stiffness of bone plates |
| ASTM F 382 | Standard specification and Test method for Metallic Bone Plates |
| ASTM F 384 | Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices |
| ASTM F 1264 | Standard Specification and Test Methods for Intramedullary Fixation Devices |
Spinal implants
We provide examinations for vertebral fixation, connections of the individual components as well as examinations for the implant components. Insertion and expulsion tests are especially meaningful for the blocking implants in addition to the strength and resistance tests.
Overview of test procedures
| Standard | Title |
| ASTM F 1717 | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| ASTM F 1798 | Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| ASTM F 2193 | Standard Specifications and Test Methods for Components used in the surgical fixation of Spinal Skeletal System |
| ASTM F 2077 | Test Methods for Intervertebral Body Fusion Devices |
| ASTM F 2267 | Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression |
| IMA/PV C/40 | Vertebral implant expulsion test |
TISSUE ADHESIVE TESTING
Wound or tissue adhesives provide a painless alternative to wound closure using surgical sutures. The mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. Prior to clinical use, these adhesive properties must be determined and the wound closure strength must be demonstrated. For the required tests we are accredited as laboratory according to guideline 93/42/ EWG and DIN EN ISO/IEC 17025.
materials and material combinations
In addition to the design, the utilisation of the suitable material and/or the suitable material combination is the basis for the long-term success after implantation. Material selection tests and analysis on material samples as well as finished implants ensure increased reliability for the patient application. Age is an ever increasing influence on the functional capability of the implants and is therefore of particular interest. We can provide you with artificial ageing in accordance with international standards. Our engineers will be pleased to provide you with more detailed information.
Overview of test procedures
Materials – Metals
| Standard | Title |
| DIN ISO 5832-1 | Surgical Implants – Metallic Materials Part 1: Stainless steel |
| DIN ISO 5832-2 | Surgical Implants – Metallic Materials Part 2: Unalloyed titanium |
| DIN EN ISO 5832-3 | Surgical Implants – Metallic Materials Part 3: Titanium-Aluminium 6-Vanadium-4-Wrought Alloy |
| DIN ISO 5832-4 | Surgical Implants – Metallic Materials Part 4: Cobalt-Chrome-Molybdenum-Cast Alloy |
| DIN ISO 5832-5 | Surgical Implants – Metallic Materials Part 5: CoCrWNi-Forged Alloy |
| DIN ISO 5832-6 | Surgical Implants – Metallic Materials Part 6: CoNiCrMo-Forged Alloy |
| DIN ISO 5832-7 | Surgical Implants – Metallic Materials Part 7: CoCrNiMoFe-Alloy |
| DIN ISO 5832-8 | Surgical Implants – Metallic Materials Part 8: CoNiCrMoWFe-Forged Alloy |
| DIN ISO 5832-9 | Surgical Implants – Metallic Materials Part 9: FeCrNiMnMoNbN Forged highly-stitched rust-free steel |
| DIN ISO 5832-11 | Surgical Implants – Metallic Materials Part 11: TiAlNb-Wrought Alloy |
| DIN ISO 5832-12 | Surgical Implants – Metallic Materials Part 12: CoCrMo Forged Alloy |
| DIN ISO 5832-14 | Surgical Implants – Metallic Materials Part 14: Titanium Molybdenum-15 Zirconium-5 Aluminium-3 Wrought Alloy |
Materials – Plastics
High-performance plastics have established themselves as an important standard material in the manufacture of implants. There are however still ongoing optimisation processes and new scientific findings for these materials, which must be evaluated in mechanical tests.
IMA Dresden provides a specialised, plastic department for this in house. Your orders are therefore always dealt with expertly.
| Standard | Title |
| DIN ISO 5834-1 | Surgical Implants – Ultra-high Molecular Polythene Part 1: Moulding compounds |
| ASTM F 2003 | Standard Practice for Accelarate Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
Materials – Ceramic
Ceramic materials are gaining ever-increasing popularity in the field of implant technology.
In particular, their optimal biological compatibility as well as the very durable material properties in the area of wear behaviour now make this material very interesting for applications in medical products.
| Standard | Title |
| ISO 6474-1 | Surgical Implants – Ceramic Materials Part 1: Ceramic materials based on pure aluminium oxide |
| ISO 6474-2 | Surgical Implants – Ceramic Materials Part 2: Composite materials on the basis of high-purity aluminium oxides strengthened with zirconium oxide |
| ISO 13 356 | Surgical Implants – Ceramic materials made from yttrium-stabilised tetragon zirconium oxide |
Additional testing procedures
| Standard | Title |
| ASTM F 1877 | Standard Practice for Characterization of Particles |
| IMA-PV A/14 | Special information in the test instruction for the fluorescent penetration testing of hip joint implants |
| IMA-PV C/29 | Tribological pairing ball/plate Wear testing with oscillating loads |
| IMA-PV C/35 | Methods for fatigue tests to confirm a required durability strength |
| IMA-PV C/36 | Cylinder-Plate-Trial– cylinder-plate-trial to examine the wear behaviour of materials for knee joint endoprosthesis |
| ASTM F 1147 | Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
SIMULATION AND STRENGTH CALCULATION
In the economic demands for shorter production development times and innovative and high-quality designs with better material efficiency and weight-optimized structures for optimal power flow.
We support you with the versatile simulation tasks, which are pending in the product development up to the virtual test bench. This challenge includes, for example, the simulation of contact situations, interference fit assembly, hyperelastic materials, plastics, and lifetime estimation of the structure. In addition, we identify worst case geometry variants (e.g. according to ASTM F2996, ASTM F3161-16) that lead to shortening of test times and cost reduction in the experimental evidence.
Our goal is the structural and cost optimization of your medical product already in the development stage.
