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.

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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).

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.

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.

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.

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.

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

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.