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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

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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

StandardTitle
ISO 7206-2Implants for surgery – Partial and total hip joint prostheses
Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
ISO 7206-4Implants for surgery – Partial and total hip joint prostheses
Part 4: Determination of endurance properties of stemmed femoral components
ISO 7206-6Implants for surgery – Partial and total hip joint prostheses
Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
ISO 7206-10Implants for surgery – Partial and total hip joint prostheses
Part 10: Determination of resistance to static load of modular femoral heads
ISO/DIS 7206-12Implants for surgery – Partial and total hip joint prostheses
Part 12: Deformation test method for acetabular shells
ISO/DIS 7206-13Implants for surgery – Partial and total hip joint prostheses
Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
ASTM F 1820Standard Test method for Determining the Axial Disassambly Force of a Modular Acetabular Device
ASTM F 2009Standard Test method for Determining the Axial Disassambly Force of Taper connections of Modular Prostheses
ASTM F 2068Standard Specification for Femoral Prostheses -Metallic Implants
IMA-PV C/25Dynamic Strength Test for Hip Joint Implants – Ceramic Hip Joint Ball and –Socket
ASTM F 1875Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface (Method I)
ASTM F 2345Standard Test method for determination of static and Cyclic fatigue strength of ceramic Modular Femoral Heads
ISO 14 242-1Implants 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 14 242-2Implants for surgery – Wear of total hip joint prostheses
Part 2: Methods of measurement
ISO 14 242-3Implants 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

StandardTitle
ISO 7207-2Implants for surgery – Components for partial and total knee joint prostheses
Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
ISO 14 879-1Implants for surgery – Total knee prostheses
Part 1: Determination of endurance properties of knee tibial trays
ASTM F 1800Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
ASTM F 1223Standard Test Method for Determination of Total Knee Replacement Constraint
IMA-PV C/30Evaluating the contact area and the pressure distribution for articulating surfaces using pressure measuring films
IMA-PV C/31Knee joint implants
Strength and resistance tests for investigating the fatigue behaviour of femoral components
IMA/PV C/38Knee joint implants
Strength and resistance tests for investigating the fatigue behaviour of tibia plateaus with long shanks
ISO 14243-1Implants 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 14 243-2Implants for surgery – Wear of total knee joint prostheses
Part 2: Methods of measurement
ISO 14 243-3Implants 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

StandardTitle
IMA-PV C/32Shoulder joint endoprosthesis
Dynamic strength testing – Shoulder shank
IMA-PV C/33.1Shoulder joint endoprosthesis
Wear test – Anatomical shoulder
IMA-PV C/33.3Shoulder joint endoprosthesis
Wear test – Shoulder with edge loading
IMA-PV C/33.4Shoulder 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

StandardTitle
ISO 5836Implants for surgery; Metal bone plates; Holes corresponding to screws with asymmetrical thread and spherical under surface
ISO 5837-1Implants for surgery; Intramedullary nailing systems;
Part 1: Intramedullary nails with cloverleaf of V-shaped cross-section
ISO 5838-1Implants for surgery; Skeletal pins and wires;
Part 1: Material and mechanical requirements
ISO 5838-2Implants for surgery; Skeletal pins and wires;
Part 2: Steinmann skeletal pins; Dimensions
ISO 5838-3Implants for surgery; Skeletal pins and wires;
Part 3: Kirschner Skeletal wires
ISO 6475Surgical implants: bone screws made of metal with asymmetric thread and spherical head bottom; mechanical requirements and test methods
ASTM F 543Standard specification and Test Method for Metallic Bone Screws
ISO 9585Implants for surgery; Determination of bending strength and stiffness of bone plates
ASTM F 382Standard specification and Test method for Metallic Bone Plates
ASTM F 384Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
ASTM F 1264Standard 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

StandardTitle
ASTM F 1717Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F 1798Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F 2193Standard Specifications and Test Methods for Components used in the surgical fixation of Spinal Skeletal System
ASTM F 2077Test Methods for Intervertebral Body Fusion Devices
ASTM F 2267Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
IMA/PV C/40Vertebral implant expulsion test

 

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

StandardTitle
DIN ISO 5832-1Surgical Implants – Metallic Materials
Part 1: Stainless steel
DIN ISO 5832-2Surgical Implants – Metallic Materials
Part 2: Unalloyed titanium
DIN EN ISO 5832-3Surgical Implants – Metallic Materials
Part 3: Titanium-Aluminium 6-Vanadium-4-Wrought Alloy
DIN ISO 5832-4Surgical Implants – Metallic Materials
Part 4: Cobalt-Chrome-Molybdenum-Cast Alloy
DIN ISO 5832-5Surgical Implants – Metallic Materials
Part 5: CoCrWNi-Forged Alloy
DIN ISO 5832-6Surgical Implants – Metallic Materials
Part 6: CoNiCrMo-Forged Alloy
DIN ISO 5832-7Surgical Implants – Metallic Materials
Part 7: CoCrNiMoFe-Alloy
DIN ISO 5832-8Surgical Implants – Metallic Materials
Part 8: CoNiCrMoWFe-Forged Alloy
DIN ISO 5832-9Surgical Implants – Metallic Materials
Part 9: FeCrNiMnMoNbN Forged highly-stitched rust-free steel
DIN ISO 5832-11Surgical Implants – Metallic Materials
Part 11: TiAlNb-Wrought Alloy
DIN ISO 5832-12Surgical Implants – Metallic Materials
Part 12: CoCrMo Forged Alloy
DIN ISO 5832-14Surgical 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.

StandardTitle
DIN ISO 5834-1Surgical Implants – Ultra-high Molecular Polythene
Part 1: Moulding compounds
ASTM F 2003Standard 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.

StandardTitle
ISO 6474-1Surgical Implants – Ceramic Materials
Part 1: Ceramic materials based on pure aluminium oxide
ISO 6474-2Surgical Implants – Ceramic Materials
Part 2: Composite materials on the basis of high-purity aluminium oxides strengthened with zirconium oxide
ISO 13 356Surgical Implants – Ceramic materials made from yttrium-stabilised tetragon zirconium oxide

 

Additional testing procedures

StandardTitle
ASTM F 1877Standard Practice for Characterization of Particles
IMA-PV A/14Special information in the test instruction for the fluorescent penetration testing of hip joint implants
IMA-PV C/29Tribological pairing ball/plate
Wear testing with oscillating loads
IMA-PV C/35Methods for fatigue tests to confirm a required durability strength
IMA-PV C/36Cylinder-Plate-Trial– cylinder-plate-trial to examine the wear behaviour of materials for knee joint endoprosthesis
ASTM F 1147Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings