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Testing in the Medical and Pharmaceutical Industry

From specification (URS) to validation – we're here for you! Regardless of whether it is a question of standards or the development of a suitable testing solution, or whether support from the in-house qualification department is required. With over 50 years of experience in the medical and pharmaceutical sector, we enjoy the trust of international manufacturers, research institutes and certification bodies. We offer tried-and-tested testing solutions and set new standards, for example in autoinjector testing.

Applications Standards Pharmacopeia Services / Industry-specific products Interesting customer projectsDownloads Contact us

Overview of applications in the medical and pharmaceutical industry

Therapy Systems
to Therapy Systems
Catheters and stents
to Catheters and stents
Biomaterials and clinical research
to Biomaterials and clinical research
Dental Industry
to Dental Industry
Biomechanics and Orthopedics
to Biomechanics and Orthopedics
Latex, Rubber, Silicone
to Latex, Rubber, Silicone
Medical textile products
to Medical textile products
Surgical instruments
to Surgical instruments
Medical packaging
to Medical packaging

Services and industry-specific products

DQ IQ OQ Qualification Service
ZwickRoell offers comprehensive solutions and individually tailored documentation for the qualification of your testing system.
to DQ IQ OQ Qualification Service
Traceability
Traceable test results in accordance with FDA 21 CFR Part 11 using testXpert.
to Traceability
Medical | Cleanrooms
ISO 14644-1, ISO 14644-14, VDI 2083 Page 9.1
Cleanroom-compatible materials testing machines to ISO and VDI standards including certificate.
to Medical | Cleanrooms
Medical | Automated tests
Automation in the medical industry ✓ Autoinjector ✓ Insulin pens & pen injectors ✓ Syringes ✓ Luer lock connections
to Medical | Automated tests
Medium Container for Medical Testing Applications
The temperature-controlled medium bath for tests in liquid media.
to Medium Container for Medical Testing Applications
37°C Temperature Chamber
The efficient solutions for tests at room temperature up to 37 °C.
to 37°C Temperature Chamber

Important standards in the medical and pharmaceutical industry

Short description Standards
Medical | Cleanrooms ISO 14644-1, ISO 14644-14, VDI 2083 Page 9.1
Medical Industry | Autoinjectors ISO 11608-5
Medical | Testing of face masks ISO 16900, ASTM D5035
Medical | Luer/Luer lock connection - replaced by ISO 80369 ISO 594-1, ISO 594-2
Medical | Hip implants | Fatigue testing femoral shaft / finite life fatigue ISO 7206-4, ISO 7206-6
Medical | Hip implants | Compression/tensile test modular femoral heads ISO 7206-10
Medical | Hip implants | Deformation test method acetabular shell ISO 7206-12
Medical | Hip implants | Forces for disassembly of acetabular shell / liner ASTM F1820
Medical | Hip implants | Resistance to torque on femoral head - femoral shaft ISO 7206-13
Medical | Hip implants | Force for disassembly taper connection ASTM F2009
Medical | Hip implants | Fatigue strength of ceramic femoral heads ASTM F2345
Medical | Hip implants | Fatigue test metallic femoral stems ASTM F2580
Medical | Knee implants | Fatigue test tibial tray ISO 14879-1, ASTM F1800
Medical | Spinal implants | Static & dynamic test / vertebrectomy model ISO 12189, ASTM F1717, ASTM F2706
Medical | Dental implants | Fatigue test ISO 14801
Medical | Packaging | Residual seal force (RSF) vial USP 1207
Medical | Insulin pens and pen injectors | Quality assurance test ISO 11608-1, ISO 11608-2, ISO 11608-3, USP 1383, USP 382
Medical | Dental industry | Flexural strength ceramics ISO 6872, EN 843-1
Medical | Catheter | Tensile test ISO 10555
Medical | Medical examination gloves | Tensile test ISO 11193-1, ISO 11193-2
Medical | Syringes, prefilled | Test method for assessing integrity and functionality ISO 11040, ISO 11040-4, ISO 11040-6, ISO 11040-8, USP 1383, USP 382
Medical | Spinal implants | Tests on intervertebral body fusion devices ASTM F2077, ASTM F2267
Medical | Stents | Radial compression test ASTM F3067
Medical | Syringes | Plunger glide force ISO 7886-1, USP 1383, USP 382
Medical | Luer/Luer lock connection ISO 80369-7, ISO 80369-20
Medical | Bone plates | Flexural strength ISO 9585, ASTM F382
Medical | Bone screws | Mechanical properties ISO 6475, ASTM F543
Medical | Cannulas & needles | Break resistance ISO 9626
Name Type Size Download
  • Industry Brochure: medical industry PDF 6 MB
  • Product Information: Traceable and Reliable Test Results in Accordance with FDA 21 CFR Part 11 PDF 1 MB
  • Industry Brochure: Biomechanics PDF 8 MB

If you are looking for the optimal solution for each of your requirements, please contact our industry experts.

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Interesting customer projects

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