Accredited Medical Device Testing Lab

INNOPROOF GmbH – Your independent, multiple award-winning laboratory for accredited preclinical testing of implants, surgical instruments, and packaging.

Akkreditiertes Prüflabor - mechanische Prüfungen an Medizinprodukten

State-of-the-art testing technology

Owner-operated & fast accessibility

Meaningful test reports with added value

Sustainable testing without hydraulic systems

Accreditations (click to open)

MRA-ILAC Vereinbarung
Deutsche Akkreditierungsstelle

Awards

Inspired Ideenwettbewerb in MV Sieger
Inno Award
Existenzgründerpreis
Prüflabor für medizinische Produkte und Implantate

Specialists in Medical Device Testing

If you are looking for preclinical testing in the fields of breast implants, joint replacement (hip, knee, shoulder endoprosthetics), osteosyntheses, spinal implants, or dental implants, contact us! We also specialize in testing bone cements, coatings, surgical instruments, and medical packaging.

Even if no standardized test methods exist yet for your product, we develop suitable methodologies with you to achieve a high level of safety already in the preclinical phase. We not only work according to standards but are also involved in the development and improvement of standards, e.g., in ISO and DIN committees as well as in ASTM committees and subcommittees.

INNOPROOF is located in the beautiful city of Rostock on the Baltic Sea coast. We look forward to welcoming you as a new customer of INNOPROOF GmbH.

Yours sincerely,
Carmen Zietz and Daniel Klüß

Contact us

Our Medical Device Testing Services

  • OZ Founder Award

  • INNOPROOF at MEDICA 2019

  • New service: Consulting on preclinical data

  • INNOPROOF celebrates its 7th anniversary

  • Partnership with SimQ

  • New accreditation certificate has arrived

  • New Accreditation Certificate 2025 arrived!

  • Präklinische Prüfung von Brustimplantaten

    Preclinical testing of breast implants

  • Mechanische Prüfung von Dentalimplantaten

    Mechanical testing of dental implants

  • Hip Implant testing from an accredited lab

    Mechanical hip implant testing

  • Knee implant testing from an accredited lab.

    Knee implant testing

  • Shoulder implant testing from an accredited lab.

    Shoulder implant testing

  • Mechanische Prüfung von Trauma- und Osteosyntheseimplantaten

    Mechanical testing of trauma and osteosynthesis implants

  • Mechanische Prüfung von Wirbelsäulenimplantaten

    Mechanical testing of spinal implants

  • Mechanische Prüfung von Knochenzementen nach ISO 5833

    Mechanical testing of bone cements

  • Mechanische Prüfung von Medizinverpackungen

    Mechanical testing of packaging for medical devices

  • Mechanische Prüfung von Gummihandschuhen

    Mechanical testing of medical gloves

  • Mechanische Prüfung von Implantat-Beschichtungen

    Mechanical testing of implant coatings

  • Mechanische Prüfung chirurgischer Instrumente ASTM F1089

    Mechanical and chemical testing of surgical instruments

  • Schadensanalyse Implantatbruch

    Failure analysis of implants and medical devices

  • Mechanische Prüfung von Sportschuhen

    Mechanical testing of sports shoes

  • New Website online

  • Prüfverfahren Brustimplantat ISO 14607:2024 Anhang B Prüfung der Hülle

    ISO 14607:2024 Annex B – Shell testing*

  • Ermüdungsprüfung Brustimplantate

    ISO 14607:2024 Annex C.1 – Fatigue testing*

  • Aufprallprüfung Brustimplantate

    ISO 14607:2024 Annex C.2 – Impact testing*

  • FDA Docket No. 2004D-0124 Dauerschwingversuch*

    ISO 14607:2024 Annex C.3 – Endurance load test / FDA Docket No. 2004D-0124

  • Mechanisches Prüfverfahren Brustimplantate nach ISO 14607:2024

    ISO 14607:2024 Annex D – Injection site*

  • Kohäsionsprüfung ISO 14607:2024 Brustimplantate

    ISO 14607:2024 Annex E – Cohesion testing*

  • Mechanisches Prüfverfahren Brustimplantate ISO 14607:2024 Anhang G Oberflächenmerkmale

    ISO 14607:2024 Annex G – Surface characteristics*

  • FDA Docket No. 2004D-0124 Dauerschwingversuch*

    ISO 14607:2007 – Static rupture strength

  • Präklinische Prüfung von Brustimplantaten nach Verfahren ASTM F703 Gel Bleeding

    ASTM F703 Gel Bleeding*

  • Properties of the gel filling with the BTC 2000

    Properties of the gel filling

  • Gel Bruchtest

    Gel compression fracture test

  • Gel Peeling test Breast Implantat

    Peel test between filling and shell

  • Formstabilität Test für Brustimplantate

    Shape stability

  • Biegeprüfung ASTM F832 4

    ASTM F382 bending test for bone plates*

  • ASTM F384 Biegeversuch an Nagelplatten*

    ASTM F384 bending test on nail plates*

  • ASTM F543 Kortikale Knochenschrauben*

    ASTM F543 cortical bone screws*

  • ASTM F564 bone staples*

  • ASTM-F-1264-Intramedullary-nails

    ASTM F1264 intramedullary nails*

  • IP-05-05 Fatigue testing of sliding nails

  • ASTM F 1044 Scherfestigkeit*

    ASTM F1044 shear strength*

  • ASTM F 1147 Zugfestigkeit*

    ASTM F1147 tensile strength*

  • ASTM F 1044 Scherfestigkeit*

    ISO 13179-1 and ASTM F1160 coatings*

  • ASTM F 1978 Abriebbeständigkeit von Beschichtungen*

    ASTM F1978 abrasion resistance of coatings*

  • ISO/TS 13498 Torsionsprüfung enossale Implantate*

    ISO/TS 13498 – Torsion testing of endosseous implants*

  • ISO-14801-Dental-implant-fatigue

    ISO 14801 – Fatigue testing of endosseous implants*

  • ISO/TR 18130 – Torsion testing between implant and abutment*

  • ISO 22683 – Rotation fit testing between implant and abutment*

  • IP-06-02 – Fatigue testing of bridge constructions

  • ISO 11953 – Torque wrench*

  • Tooth preservation ISO 3630* and ISO 6876*

  • ASTM F1717 Korpektomie Modell*

    ASTM F1717 corpectomy model*

  • ASTM F2077 Fusionsimplantate*

    ASTM F2077 fusion implants*

  • Mechanische und chemische Prüfung von chirurgischen Instrumenten

    ASTM F1089 corrosion of surgical instruments*

  • ISO 3630-1 root canal instruments*

  • ISO 11953 torque wrenches*

  • ISO 7206-4 und -6 Dauerschwingprüfung

    ISO 7206-4 and ISO 7206-6 – Fatigue testing*

  • ISO 7206-10 – Static burst test

  • ISO 7206-13 – Ball torsion test*

  • ISO 21535 Bewegungsumfang*

    ISO 21535 – Range of motion*

  • ASTM F1820 Insert-Ausdrückprüfung*

    ASTM F1820 – Insert push-out test*

  • ASTM F1875 – Corrosion testing of the taper connection

  • ASTM F2009 – Ball pull-off test*

  • ISO 5833 Knochenzement*

    ISO 5833 bone cement*

  • ISO 14879-1 Dauerschwingprüfung Tibiaplateau*

    ISO 14879-1 – Fatigue testing of tibial plateau components*

  • ASTM F3210 Ermüdung Femurkomponente*

    ASTM F3210 – Fatigue testing of femoral components*

  • ASTM D642 Kompressionsprüfung

    ASTM D642 compression test*

  • ASTM F88 Siegelnahtprüfung

    ASTM F88 seal strength test*

  • ASTM F1140/F1140M Packaging Burst Test

  • ASTM F1886 visual inspection*

  • ASTM F1929 Dichtheitsprüfung mittels Dye Penetration Test

    ASTM F1929 dye penetration seal integrity test*

  • ASTM F2096 Bubble Emission Test*

    ASTM F2096 bubble emission test*

  • ASTM F2203 linear dimensions*

  • ASTM F2028 Glenoid-Lockerungsprüfung*

    ASTM F2028 – Glenoid loosening test*

  • DIN EN 455-4 Haltbarkeit von Handschuhen*

    DIN EN 455-1 glove watertightness*

  • DIN EN 455-2 Physikalische Eigenschaften von Handschuhen*

    DIN EN 455-2 physical properties of gloves*

  • DIN EN 455-4 shelf life of gloves*

  • ASTM F1829 – Glenoid shear test

  • ASTM D5276: Drop Test of Loaded Containers by Free Fall

  • ASTM D6344: Concentrated Impacts to Transport Packages

  • ASTM F1980 accelerated aging

    ASTM F1980: Accelerated aging of sterile barrier systems and medical devices

  • DIN EN 868-5:2019 Peel Test of Flexible Packaging

Medical Device Testing Lab - Who we are

Carmen Zietz Geschäftsführerin vom Prueflabor für mechanische Prüfungen an Medizinprodukten

Dr. rer. hum. Dipl.-Ing. Carmen Zietz

Managing Director and Owner

Daniel Kluess, Inhaber vom Prüflabor für mechanische Prüfungen an Medizinprodukten

Priv.-Doz. Dr.-Ing. habil. Daniel Klüß

Managing Director and Owner

Our Equipment for Medical Device Testing

Testing Machines by Instron

Our sixteen testing machines from the manufacturer Instron operate with forces up to +/- 3.0 kN and +/- 10 kN. Eight of these machines are additionally equipped with a torsion unit, allowing combined load and motion profiles to be applied. The torsion units can apply torque up to 25 Nm. Read our user report here on the Instron company website.
Instrons mechanische Prüfung

Testing Machines by Electroforce

Thanks to their electromagnetic drives, the testing machines operate with almost no wear, allowing us to achieve high forces at high frequencies. Our eight testing machines from TA Instruments / Electroforce operate with forces up to +/- 7.5 kN and frequencies up to 100 Hz. For lower force ranges, additional electrodynamic testing machines from the manufacturer Instron have been acquired.

Electroforce Pruefmaschinen

Testing Machine for Dental Implants

With the Dyna5dent, we can test up to five dental implants simultaneously according to ISO 14801. Each station is individually controlled, allowing different load levels to be applied under load control. Whether using an S-N curve or staircase method, testing dry at room temperature or in saline solution at 37°C, load and temperature values are continuously recorded during the tests.

Dynamess Prüfmaschinen für Dentalimplantate

Testing Machines by Zwick

Our equipment includes two electromechanical testing machines from Zwick. These machines allow for compression and tensile tests, one in the range up to 5 kN and the other up to 50 kN. For our standardized test methods, these machines are used, for example, in rupture tests of breast implants, tensile strength and shear strength tests of coatings, and pull-off tests of conical connections.

Prüfmaschine für Brustimplantat der Firma Zwick.

Test Stands for Breast Implants

At INNOPROOF, breast implants are tested according to ISO 14607:2024 Annex C.1 on four test stands, each equipped with 12 stations. Under a static load of 50 N, shear stresses are applied to the implants using an electrically driven moving plate over more than 6,500,000 cycles. The test stands operate in accordance with the standard at a frequency of 3.3 Hz.

Prüfmaschine für Brustimplantate.

Digital Microscopy by Keyence

With our digital microscope from Keyence, we can generate depth-of-field sharp images of samples, for example, before and after testing. Depending on the chosen objective lens, magnifications of up to 200x or up to 5000x are possible. The 3D depth of field allows consistently sharp imaging of curved samples or samples viewed at an angle.

Digitalmikroskop Keyence

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