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Complex Medical Material and Component Testing for the Medical Industry

August Nagel Strasse 11,
89079 Ulm Other,

Complex materials and component testing

Recent worldwide demands in the booming medical sector have resulted in the growth of more complex materials and component testing.

Increasing regulations regarding certification, traceability and auditing of data have introduced additional challenges to laboratory process management. As a result, more and more companies are turning to Zwick to provide a complete solution, due to its experience in the industry (which spans many decades).

Complex materials and component testing solutions

Zwick’s medical industry coordinator, Mr Erik Berndt, pays close attention to the market needs including the introduction of new products, applications and customer support. “Unlike many products in the market, complex mechanical tests, particularly those in orthopaedics, require a close co-operation between materials testing experts and medical specialists in order to match the test conditions as closely as possible to those found in the human body,” he explains.

Horizontal material-testing machine

“In addition, Zwick has recently worked with many global organisations that develop products for cardiovascular surgery. They need to measure the forces experienced when surgeons insert catheters into the human body to carry out investigations and surgery,” Mr Berndt continues.

“After we understood the test requirements, we realised that the normal materials testing machine, which sits on a laboratory bench, was not a good solution, so we developed a special horizontal version. To this point, we have sold more than ten of these systems worldwide.

“A key topic for many of our customers is the FDA certification, which is concerned with the traceability of data. This is often not included in typical materials testing software, but is managed by using third party add-on packages. Yet Zwick’s expanded traceability option, meeting FDA 21 CFR part 11, is fully integrated into its testXpert® II modular software and offers a complete audit trail on the data managed and produced by the software.”

Single-source data management

Mr Berndt also stated: “Part of this system is the user administration, enabling laboratory managers to have total flexibility in setting access rights. All activities are then logged, and customers benefit from a single source, easy-to-implement solution for their data management. In addition, all software version updates are automatically integrated, thereby saving expensive re-audit costs.”

DQ / IQ / OQ Support

Erik Berndt adds that “our customers often need DQ / IQ / OQ support. This ensures and documents that the testing system has been correctly installed and operates precisely according to the specification. As a consultancy option, Zwick’s installation engineers are trained to install, commission, and provide the DQ / IQ / OQ documentation for the complete testing system.”

About the Zwick Roell Group

Zwick Roell Group customers benefit from more than 150 years of experience in the manufacturing of high quality testing systems. Zwick is the global leader in static testing and is experiencing significant growth with its dynamic test systems. A financially strong and family-run business, its innovative product developments, diverse product range and global support provide tailored solutions targeted specifically at the needs of both research and development, and quality assurance customers.

Serving more than 20 industry sectors with 950 employees, via manufacturing facilities in Germany, regional headquarters in Atlanta, Georgia, USA and Singapore, as well as offices in 56 countries worldwide, the brand name Zwick is a guarantee of the highest quality and support. For more information see our website.

Testing Machines and Systems for the Medical Industry

This brochure provides an overview of instruments, machines, systems, and services available from Zwick Roell for testing products from the medical technology and pharmaceutical industries, as well as their use in research and development (R&D), production, quality assurance, and control. 

Testing of Spinal Implants

Pulsating compressive strength tests (R=0.1) are performed on six specimens with a test frequency of up to 5Hz. Result: Generation of a Wöhler curve with a number of cycles to crack up to 5 million.

Fatigue Tests on Hip Endoprotheses

The Zwick Amsler HC Compact servo-hydraulic testing machine is used to simulate dynamic loadings on a hip prosthesis stem in accordance with the relevant standards, ISO 7206-4, ISO 7206-6, ISO 7206-8 and ASTM F2068.

Fatigue Tests on Dental Implants to ISO 14801

Dental implants are used to replace teeth. The implant is embedded in the bone, acting as the root of the missing tooth. Zwick’s test fixtures meet the requirements specified in ISO 14801 and applies an oscillating pressure threshold load, which enables a comparison of dental implants of different constructions or sizes. 

Horizontal Testing of Catheter Systems

Catheters are used for many reasons, including for transporting micro-instruments integrated in a patient's body. They enable surgeons to make surgical procedures as minimally invasive as possible.

Autoinjector Testing with Zwick

An autoinjector is a medical device used to administer liquid medication that is subject to strict quality controls.

Zwick’s New PrecisionLine – A New Generation of Precision Testing Machines

Rapid technical advance combined with the need to use raw materials carefully has led to miniaturisation of mechanical, electromechanical and electronic components, causing a dramatic rise in demands placed on production accuracy as dimensional, form and positional tolerances become ever smaller.

DQ / IQ / OQ: Support with Validation of Zwick Testing Systems

Very high demands are placed on the quality and reliability of products used in medical engineering. Quality assurance is therefore an essential item in national and international laws and directives. Examples of these include the German Medicine Act (AMG) relating to the manufacture o

Zwicki-Line Receives Certification of Clean-Room Capability

A large percentage of medical or pharmaceutical items are produced in clean rooms in which the concentration of airborne particles is maintained at the required low level. EN ISO 14644 describes the requirements for clean rooms and associated clean-room areas. Different classifications are alloca

Zwick Holds Seminar on Testing Medical Technology

Materials testing in the metals and plastics industries has become an increasingly significant part of Zwick's activities. The same is true of medical engineering technology, the number of orders received from this field having doubled in the last four years alone. 22 July 2009 saw around 50 spe

Medical Technology: Information from Zwick Roell on New Testing Technologies

When future technologies are mentioned, the booming field of medicine ranks among the leaders. As a market leading supplier of materials and components testing systems, Zwick is experiencing an increasing demand for complex material and component testing equipment. The number of orders from the m

New Biaxial Testing Machine for Biomechanics

Biaxial tests are used to characterize the anisotropic properties of elastic tissues. The new biaxial testing machine was developed specially for mechanical testing of natural and artificial elastic tissues. Planar mechanical tests can also be performed and uniaxial, equibiaxial, non-uniform load

Zwick testXpert® II Has Integrated FDA 21 CFR Part 11 Traceability

Zwick’s testing software testXpert® II has been developed with a fully integrated option to meet the requirements of FDA 21 CFR Part 11. These guidelines, set by the US Food and Drug Administration, are intended to make sure that each record can be traced back to its source. The time and dat

testXpo 2009 – Asian Forum for Materials Testing

Zwick invites you to the 6th Asian Forum for Materials Testing, which will take place from 24 to 25 June in Singapore. Lectures and presentations by prominent industry leaders and Zwick Roell industry experts complement the exhibition, giving visitors a well-rounded perspective of materials testi

New Test Fixture in Accordance with EN ISO 7886-1

Zwick has introduced a new test fixture for use in medical applications. It determines the force required to move the plunger of sterile single use hypodermic syringes and is in accordance with EN ISO 7886-1. The 20N capacity fixture consists of an adjustable upper and lower fixture to

Soft Robot Mimics Caterpillar Movement

The Zwick testing machine enables researchers to characterize and model silicone materials for complex soft-bodied robots. Researchers at Tufts University in the US are using a Zwick biaxial testing machine to test biological and engineered biocompatible materials for the development of

New Products for Testing Plastics

Zwick is concentrating its activities in the plastics field through its own competence center. The “Plastics Testing Initiative” has been underway for two years. The range of products for testing plastics is being systematically expanded within the framework of this initiative. Helmut F

Medical Engineering: Quality and Safety at Aesculap

The Aesculap division of B. Braun Meisungen AG is the largest manufacturer of surgical instruments in the world. For safety and materials testing, Aesculap relies on Zwick know-how, using Zwick machines for materials and function testing in widely differing areas. In addition, Zwick provides advi

17th International Forum for Materials Testing

Whether you are in research and development or in quality control, the forum for materials testing in Ulm / Germany promises to be a must-attend event for everyone who conducts mechanical testing and is interested in gaining the latest knowledge in this field. In the past this event has

New Products for Testing Products

Zwick is concentrating its activities in the plastics field through its own competence center. The “Plastics Testing Initiative” has been underway for two years, and the range of products for testing plastics is being systematically expanded within the framework of this initiative. Helmut Fahrenh

The New Touch PC – Materials Testing in Comfort

Zwick's newly-developed Touch PC is designed to make materials-testing machines even easier and more efficient to operate. The Touch PC combines a user-friendly touch-screen with a powerful, integrated embedded industrial computer. Space is saved by mounting the system directly on the m

Zwick to Attend 5th Asian Forum for Materials Testing

The growing demand for advanced materials testing systems in the Asia-Pacific region is a positive trend that prepares organisations in the region to enter the global arena. The Zwick Roell Group aims to promote and enhance this growth by showcasing testing systems ranging from universal testing

testXpo 2008 – 5th Asian Forum for Materials Testing

The growing demand for advanced materials testing systems in the Asia-Pacific region is a positive trend that prepares organisations in the region to enter the global arena. The Zwick Roell Group aims to promote and enhance this growth by showcasing testing systems ranging from universal testing

Hips Put to Test

The human hip has to carry about 2.5 times the body weight of most full-grown humans for many decades. The hip joint has been optimized by nature for such a permanent stress with about 160 million cycles of alternating load. These forces and strains consist of the body weight and the stabilizing

A Record Attendance for Zwick’s International Forum for Materials Testing

Zwick's 16th International Forum for Testing Technologies in Ulm, Germany from October 22nd to 25th drew international acclaim. A record number of almost 2,000 visitors witnessed the latest developments from the company and its 30 co-exhibitors. The visitors came from 37 countries including Franc

testXpo – 16th International Forum for Materials Testing

The 2007 International Forum for Materials Testing will take place from the 22nd to the 25th of October. Over the past 16 years this event has acquired an excellent international reputation, and at this year's event there will be both a full range of innovative and successful solutions for destru

Zwick GmbH & Co KG

August Nagel Strasse 11

89079 Ulm