medical device testing

IMA MATERIALFORSCHUNG UND ANWENDUNGSTECHNIK GMBH
MEDICAL PRODUCT TESTING
JOINT IMPLANTS
IMPLANTS FOR OSTEOSYNTHESIS
IMPLANT MATERIALS
Strength and wear testing of all joint implants
Wear testing of hip and shoulder implants
Four station knee joint
The IMA Materialforschung und Anwendungstechnik GmbH laboratory for
medical product testing supports you with standardized test services regarding
international regulations.
ACCEPTED AND ACCREDITED
LABORATORY FOR MEDICAL
PRODUCT TESTING
Our long-term professional expertise
developed from our unique position in
between industry and academia research. We
accompany you throughout the part of
technical documentation.
Determining your product related strength,
fatigue and tribological properties is our main
business.
We meet the high level technical demands of
medical product approval to provide you best
test services according to national and
international standards. Our excellent trained
engineers benefit from long-term knowledge
by facing new challenges. Since 1995 we have
successfully performed medical device test
services on implant products.
We will be pleased to furnish you with detailed
information regarding technical test series for
medical product approval in accordance to
current normative references and guidelines.
CUSTOMIZED TESTING
Beyond present standards customized tests
based on current scientific publications are in
increasing demand. Our medical device testing
engineers support you with special test
methods.
HIP JOINT IMPLANTS
A wide range of normative test series are
required to cover technical documentation.
Our test equipment enables all relevant
fatigue, strength and wear tests. In the case of
polyethylene wear we recommend an
additional analysis of wear particles (size and
morphology).
KNEE JOINT IMPLANTS
In accordance to the wide range of knee
implant designs (e.g. mobile, fixed bearing, bior uni-condylar systems) we perform necessary
fatigue, strength and wear tests. For
tribological test we provide a four station knee
joint simulator (Stanmore KS4) related to
international standards.
SHOULDER JOINT IMPLANTS
Shoulder joint implants having less test
standards so far. For a meaningful technical
documentation we developed internal test
methods based to recognized scientific
publications and international guidelines.
Those methods cover anatomical and inverse
shoulder implant systems. Especially worst case
conditions like edge loading are of particular
interest.
NEW STANDARDS
Tissue adhesives
ASTM F2255 (Tissue Adhesive Lap Shear Properties)
ASTM F2256 (Tissue Adhesive Peel Properties)
ASTM F2258 (Tissue Adhesive Tension Properties)
ASTM F2458 (Tissue Adhesive Wound Closure Strength)
simulator
Fractured surface of a hip stem neck section
Push-out experimental set-up for a hip implant
Failure analysis - based on long-term experience and comprehensive expertise we
expose failure analysis, for example, of revised implants.
IMPLANTS FOR OSTEOSYNTHESIS
TYPICAL STANDARDS
Exemplary bone screws torsion load or bone
plates bending strength is in special interest
for technical documentations.
In the case of implant failure, metallographic
analysis are recommended and could be
handled at IMA Materialforschung und
Anwendungstechnik GmbH as well.
SPINE IMPLANTS
Medical product approval, for example,
requires static and fatigue tests for
interconnection mechanism and tests for
components of spinal skeletal fixation systems.
Blocking devices are commonly tested for load
induced subsidence and expulsion
characteristics.
MATERIALS AND MATERIAL
BEARINGS
Apart from design, the implant material and
its suitable bearing are essential properties for
long term survivorship after implantation.
Screening tests and analysis on material
samples, final implant products or material
bearings lead to an increased in vivo reliability.
Aging influence is highly discussed as key issue
for implant material functionality. We offer
the recommended accelerated aging according to international standards.
Hip joint implants
ISO 7206-2 (Articulating surface)
ISO 7206-4, -6 (Endurance of stems)
ISO 7206-10, -12 (Head and socket)
ASTM F1875 (Fretting corrosion)
ISO 14242 (Wear test)
Knee joint implants
ISO 7207-2 (Articulating surface)
ISO 14879-1 (Endurance of tibial trays)
ISO 14243 (Wear test)
ASTM F1223 (Replacement constraint)
IMA-PV C/31 (Fatigue femoral component)
Shoulder joint implants
IMA-PV C/32 (Strenght of shoulder stems)
IMA-PV C/33.1 (Wear test of anatomic shoulder implants)
IMA-PV C/33.3 (Edge loading)
IMA-PV C/33.4 (Wear test of inverse shoulder implants)
Implants for ostheosynthesis
ASTM F382 (Metal bone plates)
ASTM F384 (Metal angled fixation devices)
ASTM F543 (Metal bone screws)
ASTM F1264 (Intramedullary fixation devices)
Spine implants
ASTM F1717 (Spinal implant constructs)
ASTM F1798 (Interconnecting mechanisms)
ASTM F2193 (Components)
ASTM F2077 (Cages)
ASTM F2267 (Subsidence test)
IMA-PV C/40 (Expulsion test)
Materials/-bearings
ISO 5832-1 to -9, -11/-12, -14 (Metals)
ISO 6474-1, -2 (Ceramics)
ISO 5834-1 (Polyethylene)
ISO 17853 (Particle analysis, polymere and metal)
ASTM F1877 (Particle analysis)
ASTM F2003 (Artificial aging)
ASTM F1978 (Taber Abraser)
IMA-PV C/36 (Cylinder on plate test)
IMA-PV C/29 (Ball on plate test)
IMA MATERIALFORSCHUNG UND ANWENDUNGSTECHNIK GMBH
QUALITY MANAGEMENT
Our laboratory for medical device testing is DAkkS (German Accreditation Body) accredited
according to DIN EN ISO/IEC 17025 and recognized by ZLG (Central Authority of the Laender for
Health Protection with regard to Medicinal Products and Medical Devices) by registration
number ZLG-AP-235.10.68.
CONTACT
Dr. rer. nat. Uta Kremling
Head of Medical Product Testing
P: +49 (0)351 8837-2259
F: +49 (0)351 8837-530
E: [email protected]
Dipl.-Ing. Marcel Langner
Laboratory Manager Medical Product Testing
T: +49 (0)351 8837-2273
F: +49 (0)351 8837-530
E: [email protected]
IMA Materialforschung und Anwendungstechnik GmbH
Wilhelmine-Reichard-Ring 4, D-01109 Dresden
P: +49 (0)351 8837-0 I F: +49 (0)351 8837-6312 I E: [email protected]
www.ima-dresden.de