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BB 740.1.07.18
Intelligent Testing
1 The ZwickRoell Group
Contents Page
1.1 Passion and expertise 3
1.2 Trusted partner for the medical and pharmaceutical industries 4
2 Therapy Systems
2.1 Tests on injection systems 6
2.2 Tests on injection pens 8
2.3 Fully automated tests on injection systems 9
2.4 Tests on syringes 9
4 Biomechanics
4.1 Tests on hip implants 15
4.2 Tests on spinal column implants 16
4.3 Tests on knee implants, osteosynthesis implants and screws 20
5 Dental Industry
5.1 Tests on dental implants 18
5.2 Tests on dental ceramics 19
6 Latex, Rubber and Silicone Products
6.1 Tests on contact lenses 20
6.2 Tests on condoms 20
6.3 Tests on rubber gloves 20
2
1 The ZwickRoell Group
1.1 ZwickRoell—Passion
and expertise
Applications
The basis of a successful partnership: innovative employees, innovative products
Over 1000 people are employed at our headquarters Whether for static materials testing or the various forms
in Ulm, Germany. Many of them have been with us for of fatigue testing—we have the right solutions. We offer
years—decades even. Their knowledge, ability and products for hardness testing as well as instruments for
commitment are what lies behind the worldwide success impact testing and for melt index determination.
of the ZwickRoell Group.
And for that rare occasion when we don’t have a solution
We are present in over 50 countries around the world. that fits, our experts will find one—from the smallest cus-
tomization to a fully automated testing system or a test
bench for special purposes.
3
1.3 ZwickRoell—a trusted partner for the medical and pharmaceutical industries
4
The ZwickRoell Group
Intelligent testing solutions—the right product for every application
ZwickRoell's wide range of testing systems features modular design, enabling optimum adapta-
tion to testing requirements. We provide varied testing solutions, from standard-based tests to
materials testing machines for a variety of testing situations to complex, fully automated testing
systems. All ZwickRoell testing systems are synonymous with reliable test results, simple opera-
tion and a high level of availability.
Applications
research—testing solutions for all
segments
As well as testing systems for the fundamental
challenges associated with materials technolo-
gy we provide comprehensive testing solutions
for all relevant medical and pharmaceutical
segments: therapy systems, catheters/stents,
biomechanics, dentistry, latex/rubber, textile
medical products/instruments, packaging and
medical research.
5
2 Therapy Systems 2.1.1 Tests on autoinjectors the handling of autoinjectors. The
(ISO 11608-5) patient needs only to remove the
2.1 Tests on injection safety cap, position the injector
systems An autoinjector is a medical device and start the injection by pressing a
for administering liquid medications button.
Injection systems include items and is therefore subject to stringent
such as syringes, needles, autoin- quality checks. The subsequent injection process
jectors and injection pens with fixed is completely automated. How-
and variable dosing. ISO 11608-1 The correct injection at the right ever, this means that all relevant
describes the basic requirements dosage is critical in achieving a autoinjector functions must be
for injection systems. successful outcome to medication checked before production batch-
therapy, leading pharmaceuticals es are released on to the market.
manufacturers to strive for a high The checks are performed to ISO
level of automation in 11608-5.
6
Testing systems for this are available
from ZwickRoell, enabling automat-
ed testing as follows:
Applications
autoinjectors at the start and end of syringe systems used must be sub-
the injection can be recorded using jected to different spring loads. This
an optional microphone (audible can be done using force-controlled
feedback). simulation of a spring curve in a
ZwickRoell materials testing ma-
Other options include active track- chine. These tests can be used at
ing of the plunger and a retractable an early stage in the development of
needle; an HD camera can addition- an autoinjector and in prospective
ally be integrated to record fluid ex- aging tests. A single testing actuator
pulsion. These recordings can then with travel speeds of up to 0.5 m/s
be stored traceably with the test is generally used, along with the
results. The machine can also op- very fast testControl II electronics.
tionally be equipped with monitoring
systems to comply with the require-
ments of EN ISO 13849. Control 2.1.2.2 Tests on injection pens
and evaluation of these additional (ISO 11608-1)
functions and of the complete test
sequence is via ZwickRoell's testX- During insulin therapy the insulin
Products
7
Testing autoinjectors: over-
view
assurance tests on insulin pens and using an integrated high-resolution simplifies validation using measure-
cartridges is ISO 11608 Parts 1 and balance. Further automation of the ment system analysis (MSA Gauge
3. test can be achieved by using a R&R) studies. In addition to the
pattern-recognition camera for the automated test sequence, the ro-
A testing system with additional tor- dosing field setting. Manufacturers boTest R handling system provides
sion drive is required for these tests; can also test pens not filled with automatic specimen feed.
this allows the various pen functions medication. As well as forces/mo-
such as dose pre-setting, actua- ments, plunger rod advance is mea- 2.4 Tests on syringes
tion force, stroke and actual dose sured with high accuracy.
to be measured in a continuous Syringes have a wide range
sequence. Pen needles can also 2.3 Fully automated tests of application and come in cor-
be tested to ISO 11608-2 using a on injection systems respondingly numerous forms.
system of this type. As well as dose ZwickRoell has a large variety of
accuracy, needle unscrewing torque Reliable test results are a basic standardized test devices.
is measured. requirement when testing medical
products. Extensive automation
During testing of filled pens, dose improves test-result reproducibility,
accuracy is tested to ISO 11608-1 minimizes operator influence and
8
The ZwickRoell Group
Applications
Fig. 1. Testing system for injection pens Fig. 2. Fully automatic testing system for insulin pens
9
Test on finished syringes as per ISO 11040 Parts 4 and 8
10
2.4.5 Flexure test to EN ISO
9626
Applications
2.4.4 Luer/luer lock connec-
tions (ISO 80369 Parts 7 and 20)
11
3 Catheters and Stents The horizontal AllroundLine testing 3.1.3 Glidability tests on
machine features sufficient room catheters
3.1 Tests on catheters both above and below the main test
axis for multiple 3D models for dry The frictional behavior of cardio-
3.1.1 Testing cardiovascular testing or for tests in a tempera- vascular and urological catheters
and urological catheters ture-controlled medium bath. Tests must be tested when they are wet.
with or against the liquid flow are For this, the catheter is removed
Catheters are medical devices in the also possible. from a temperature-controlled water
highest risk category and are sub- bath and drawn through jaws which
ject to strict quality requirements. close with a defined gripping force.
Suitable testing systems are avail-
able from ZwickRoell.
12
These jaws can be opened and The grips are closed by means of Specimen clamping is in the vertical
closed automatically to enable re- a foot pedal, leaving both hands plane, with the bending angle (max.
peated cyclic testing. In addition, free for inserting the specimen. The 90°) generated via the kit's rotating
the jaws can be changed quickly to closing force is steplessly adjust- clamping unit.
provide different and/or undamaged able via a pneumatic control unit,
Applications
suitable for reproducible gripping of mm, with an accuracy of 0.1 mm.
the opposing end of the catheter.
Products
Fig. 1. Glidability test Fig. 2. Tensile test on catheter systems Fig. 3. Flexure test on catheters
13
3.2 Tests on stents Available from ZwickRoell is a test- 3.2.2 Non-contact strain mea-
ing solution featuring a zwickiLine surement on wires and stent
Stents are subject to heavy loads materials testing machine equipped struts
on insertion and while in place in with a 37 °C chamber to simulate
blood vessels or ureters. The stents tests at body temperature. To simulate stent systems, detailed
must be tested under these loads material characteristic values are
beforehand. Radial force is measured using required. Along with tests on the
Blockwise radial compression test entire system, components such
3.2.1 Radial compression test fixtures specifically designed for as single wires and stent struts are
on stents testing stents and available in var- often tested. This includes tensile
ious diameters and lengths. They strength and strain at break, as well
Together with obtaining accurate simulate the pressure exerted on as determination of minimum yield
material characteristic values, de- the stent by the artery, together with strength. This defines the force at
termination of radial compression the restoring force, by means of which a material under single-axis
strength is the most important test segmentally arranged wedge jaws tensile load demonstrates no per-
for stents. They must exert a radial which generate a uniform surface manent deformation. More efficient
force which is sufficient to ensure pressure. The stent is inserted, and above all more accurate is
that the stent remains fixed in the compressed radially to a minimum strain measurement using an exten-
previously narrowed location and target diameter, then unloaded. someter. The probability of error is
to prevent renewed constriction of much smaller since measurement
the blood vessels. ASTM F3067 takes place directly on the speci-
describes the radial compression men and therefore outside the force
testing of balloon-expandable and flow.
self-expanding stents.
Fig. 1. Radial compression tests on stents Fig. 2. Tensile test on stent strut
14
The ZwickRoell Group
4 Biomechanics 4.1.2 Testing the anchoring of must withstand both compressive
a hip endoprosthesis and and torsion loadings. The optimum
4.1 Tests on hip implants other components materials and alloys are determined
by testing in a materials testing ma-
The hip joint is the articulation of the Hip endoprostheses can be an- chine with superimposed axial and
pelvis with the femur. Disease may chored in the femur with or with- torsional loadings.
necessitate replacement of part or out the use of bone cement. The
all of the hip joint with an implant. strength of the fastening in the bone 4.2 Tests on spinal implants
Applications
must be tested. For this an endo-
4.1.1 Fatigue tests on hip prosthesis is anchored in natural or 4.2.1 Tests on spinal implants
endoprotheses to ISO 7206 artificial bone Cyclic loading is used
and ASTM F2068 to enable measurement of forces ASTM F1717 describes static and
and of any micro-movements (via dynamic tests on spinal implant
The ZwickRoell HC Compact movement sensors) between pros- constructs in a vertebrectomy mod-
servo-hydraulic and LTM electro- thesis and bone. Artificial hip joints el. A spinal implant, generally con-
dynamic testing machines can be
used to simulate dynamic loadings
on a hip prosthesis stem in accor-
dance with the relevant standards:
ISO 7206-4, ISO 7206-6, ISO 7206-
8 and ASTM F2068. The mechani-
cal general requirements defined in
the standard, including the orien-
tation of the hip endoprosthesis to
the test load, the embedding height
and the load-application angle, can
be fulfilled exactly by means of the
Products
15
sisting of a rod and screw system, tical statistical evaluation of tests in ZwickRoell can design individual
is tested under static and dynamic the high-cycle fatigue and long-life blocks for customers on request, on
loading. The implants are mount- fatigue ranges. provision of the relevant data.
ed on a test block made of ultra
high molecular weight polyethylene 4.2.2 Tests on spinal implants All tests can also optionally be per-
(UHMWPE) material. The use of to ASTM F2077 formed under physiological (in-vivo)
simulated vertebral bodies improves conditions using the ZwickRoell
test reproducibility compared to ASTM F2077 describes a series of temperature-controlled bath at
those using human preparations. different quasi-static and oscillating 37 °C ± 2 °C.
tests to enable mechanical com-
In addition to purely axial tensile, parison of intervertebral body fusion 4.2.3 Torsion test on spinal
compression or flexure tests, a pure devices. These include shear, com- implants to ASTM F2077 and
or combined torsional load can be pression and torsion tests, which ASTM F1717
applied to spinal systems in ac- provide a simplified in-vivo simula-
cordance with standards including tion of the loads imposed on spinal As a result of comminuted fractures
ASTM F1717, ASTM F2706 and implants. of a vertebral body or tumors in the
ISO 12189. area of the spinal column it may
The spinal implant is loaded be- be necessary to replace a verte-
These tests can optionally be per- tween two plastic (oscillating test) bral body with an implant. These
formed under physiological (in vivo) or metal (quasi-static test) blocks. vertebral body implants are tested
conditions (e.g. temperature-con- These are matched to the external by carrying out quasi-static and
trolled saline solution) using the contour of the vertebral body. The oscillating torsion tests in accor-
ZwickRoell temperature-controlled fixtures required for testing to ASTM dance with ASTM F2077 and ASTM
bath. Also available from ZwickRoell F2077, together with the corre- F1717.
is the SAFD (Statistical Analysis of sponding interfaces, are available
Fatigue Data) program. This techni- from ZwickRoell as a basis for the
cal/scientific software enables prac- system.
Fig. 1. Fatigue test on spinal implant Fig. 2. Torsion test on vertebral body implant
16
4.3 Tests on knee implants, strength of bone plates are tested
osteosynthesis implants in 3-point and 4-point flexure tests;
and screws the flexure test kit consists of two
anvils in parallel alignment, with
4.3.1. Fatigue tests on tibial fixed mountings. It is also possible
Applications
via a defined compression die. ZwickRoell also offers the associat-
ed embedding devices.
4.3.2 Flexure test on bone
plates to ASTM F382 and
ISO 9585
Fig. 1. Fatigue test on tibial tray Fig. 2. Flexure test on bone plates
17
5 Dental Industry dynamic testing machine. The tests nical-scientific program SAFD (Sta-
can optionally be performed under tistical Analysis of Fatigue Data).
5.1 Tests on dental implants physiological (in vivo) conditions
using the ZwickRoell tempera- 5.1.2 Test on dental products
5.1.1 Fatigue test on dental ture-controlled bath. For practical under physiological conditions
implants to ISO 14801 statistical evaluations of fatigue
tests in the finite life range (high For tests on teeth, dentures, and
Dental implants are used to replace cycle fatigue) and in the transitional filling materials, ZwickRoell offers
teeth. The implant is embedded in range to fatigue strength (long life a test stand based on the HCT 10
the bone, acting as the root of the fatigue), ZwickRoell offers the tech- servo-hydraulic testing machine,
missing tooth. The test device for
dental implants (chewing simula-
tor) applies an oscillating/pulsating
compressive load as specified in
ISO 14801.
18
which enables a dynamic load with The linear guide contained in the However the instrumented indenta-
axial force up to 10 kN and a torque guide frame ensures exact align- tion test, based on measurement of
of up to 100 Nm. ment between the flexure table indentation depth, has proved very
and the die. This simplifies remov- effective.
In this test up to five specimens are ing and re-installing the device by
Applications
6872 is available from ZwickRoell. for example be verified by means of
The basis of the device is a guide hardness testing. Due to limited re-
frame in which the flexure tables flectivity, optical hardness testing as
and dies required for the flexure test per Vickers can only be employed
are installed. to a limited extent.
Products
Fig. 1. Chewing simulator Fig. 2. 4-point flexure test on dental ceramics Fig. 3. Hardness test on dental ceramics
19
6 Latex, Rubber and Sili- ZwickRoell offers a tempera- 6.2 Tensile test on condoms
cone Products ture-controlled bath with special
submersible pneumatic grips for zwickiLine table-top testing ma-
6.1 Tests on contact lenses testing contact lenses. The values chines are ideal for determining
determined are Young's modu- the tear strength and strain at tear
Manufacturers of hydrogels and lus, strain up to break, and tensile of condoms. The pulleys are ar-
finished contact lenses must test strength. ranged horizontally and mounted
certain elastic characteristics of the at one end only. One of the pulleys
material. To simulate the repeated Since the forces measured here is driven via a toothed belt propor-
application and removal of lenses, are very small, the buoyancy com- tionally to the crosshead movement,
the break resistance of the dry and ponents of the specimen grips allowing the condom specimen to
moist material, as well as the struc- suspended in the bath must be be loaded uniformly over its entire
ture of the material at deflection, compensated for in the testing soft- circumference.
must be tested. ware.
6.3. Tensile test on rubber
gloves to ISO 11193-1/2,
ISO 37
20
The ZwickRoell Group
7 Textile Medical employed in this area call for a wide The sequence is controlled by a
Products and Instruments range of materials tests and func- specially adapted program from
tion tests. ZwickRoell’s testXpert III testing
7.1 Testing textile medical software. This test fixture can also
products 7.1.1 Unrolling test for gauze be used for pull-off tests on plaster
bandages (band-aid) strips.
Textiles are used for numerous
medical applications, including To avoid the problem of individual 7.1.2 Measuring the peel
Applications
dressing and treating wounds, a fibers of gauze bandages "catching" adhesion force of wound
wide variety of suture materials, tex- on the winding below and prevent- dressings
tile-based implant structures (e.g. ing reliable unrolling, it is necessary
hernia net implants) and surgical to determine the force required to EN 1939 describes the method for
drapes and clothing. Materials used unwind the bandages from a roll. measuring the adhesive force of
include natural and synthetic fibers, For this, a ZwickRoell materials test- self-adhesive tapes. To measure the
together with breathable films and ing machine with a nominal force adhesive force of wound dressings
material combinations. The many 10 kN is used, together with a mo- or other self-adhesive medical prod-
different products and materials tor-driven unrolling unit. ucts the specimen is pulled off a
metal plate during the test. This can
be performed at various angles.
21
7.1.3 Tests on surgical suture Products for use in this area are The measured value determined is
materials and needle/thread subject to certification and in-pro- the maximum tensile force, includ-
combinations duction quality checks before being ing the average value per direction
released on to the market. A central of removal.
Methods used for characterization component of EN 13795 is the test
of surgical suture materials include methods for measuring product 7.2 Testing surgical
tensile tests. During the test the characteristics such as the tear instruments
monofilament, multifilament and strength of surgical textiles in both
braided yarn structures used must dry and wet states. Tensile tests Surgical instruments may be divided
be securely clamped. A wide range applying transverse and longitu- into holding, grasping, and cutting
of ZwickRoell specimen grips are dinal strain to individual materials instruments, as well as into suture
available for this. It is also neces- or seams are used to simulate the instruments, optics, and combined
sary to verify by means of additional loadings and strains imposed on instruments. ZwickRoell’s wide
tensile tests that the thread is held textiles in use. product range, with its modular
securely in the needle. design concept, allows for the con-
7.1.5 Testing medical struction of many different test ar-
7.4.1 Testing surgical textiles non-wovens rangements for use on components
for prevention of infection and finished goods, for example de-
The tests performed on medical termining characteristics of a cutting
Reusable or single-use textiles for non-wovens are as varied as their edge or measuring wear resistance.
surgical masks and gowns and range of use. One important test is
drapes are intended to ensure in- the tensile test on strip specimens
fection prevention for doctors and (EN 29073-3 / ISO 9073-3 / ASTM
patients in both inpatient and out- D5035).
patient contexts.
Fig. 1. Tensile test on medical textiles Fig. 2. Penetration test for a bone drill Fig. 3. Compression test on sagittal saw
blade
22
The ZwickRoell Group
8 Medical and Pharma- and the plastic blisters is measured. 8.1.2 Testing seamed seal
ceutical Packaging A variable gripping unit is used to strength
retain the blister packaging. During
8.1 Tests on blister packs the test, up to 90 % of the lid is A tensile test is performed on
peeled off. 15mm-wide strips at a peel angle of
8.1.1 Peel tests on peel and 90°. The seal must display a defined
blister packs The screw clamp has a maximum strength, depending on the purpose
opening width of 2 mm and is suit- for which the packing material is
This device is suitable for testing the able for gripping forces up to 300 N. used. The strips can be cut using
Applications
seam seal of peel-off packaging by foil-cutters, parallel blades or scis-
peeling off the lid or sealing-mate- sors.
rial of dimensionally stable or rigid
packaging. The tensile strength of
the adhesive bond between the film
Products
23
8.1.3 Push-out test on blister 8.2 Other tests
packs
8.2.1 Determination of the re-
This device is suitable for testing the sidual seal force (RSF) of vials
push-out force of blister contents
such as pills and other medical The residual seal force (RSF) is the
products. Pushed-out remains fall force with which the rubber stopper
out of the pack via the ejection between the flanged cap and the
chute in the compression platen. neck of the vial is braced. This force
Specimen alignment is facilitated measurement provides an indirect
by a laser pointer which focuses on indication of the present security
the die position above the specimen of the vial closure. However, these
before the push-out test. measurements must be correlated
The rustproof compression die is with established tests that examine
designed for a maximum force of the seal integrity of the stopper.
30 N.
For testing the residual seal force
8.1.4 Compression test on of flanged caps, ZwickRoell recom-
pills and tablets mends a device with inserts and
compression dies of various sizes.
The test kit includes identical up- Measuring the preload force of the
per and lower specimen grips. The rubber stopper on an aluminum
tablet is placed on the test surface flanged cap indicates the seal in-
Fig. 1. Compression test on pill/tablet
and held by the lateral, compression tegrity of the vial closure. Modular
spring-loaded clamping sheet. The design allows the various inserts to
compression test kit is available in be changed quickly and easily.
various versions.
Fig. 2. Push-out test on blister packs Fig. 3. Determination of residual seal force
(RSF)
24
8.2.2 Push and turn test on 8.2.3 Determination of the 8.2.4 Compression tests on
screw caps breakaway torque of syringe cardboard packaging
tip caps
This test determines the superim- The procedure used for the box
posed compression/torsional forces Torque is applied to tip caps on crush test (BCT) varies according
Applications
The integrated torsion transducer
records the torque for the complete
rotation.
Products
Fig. 1. Push and turn test on screw cap Fig. 2. Determination of tip cap breakaway Fig. 3. Box crush test on medication
force packaging
25
9 Biomaterials and research into this area calls for a 9.1.2 Triaxial test on biomate-
Clinical Research testing machine capable of applying rials and tissues
multi-axial loads to the tissue spec-
9.1 Tests on biomaterials imen. The biaxial testing machine To enable determination of the
incorporates four linear drives which shear properties of soft biological
are controlled independently of each (orthotropic) tissue a testing system
9.1.1 Biaxial test on biomate- other via position, force or strain. for triaxial applications has been de-
rials Force measurement is via (water- veloped. The testing machine con-
proof) load cells, two of each in the sists of two main components: an
To enable adequate modeling the X and Y directions. There are also upper platform designed to move
biomechanical behavior of soft bi- four electronic measurement and vertically (in the z-direction) and a
ological tissues and its underlying control units plus a fluid-bath for lower platform designed to move
structure must first be accurately optimum temperature conditioning in the horizontal plane in two direc-
determined. As biological tissues of the sample. tions perpendicular to each other (x
found in the body are continuous- and y-directions).
ly exposed to multi-axial loads,
During the test the tissue specimen
is attached to the upper and lower
platforms using a thin coating of
super glue and immersed in a tem-
perature-conditioned physiological
solution. The lower platform moves
relative to the horizontally fixed up-
per platform, causing the specimen
to shear
26
9.1.3. Triaxial test on tissue 9.2 Tests on bones 9.2.2 Flexure test on sheep
using torsion bones
Load test on human femur
The testing machine for cardiovas- with strain gauges applied A 3-point flexure test on sheep
cular tissues allows an axial force bones is designed to determine
Applications
Products
Fig. 1. Triaxial test on tissue using torsion Fig. 2. Load test on human femur Fig. 3. Flexure test on sheep bones
27
10 Products and Services AllroundLine Torsion drives
AllroundLine is suitable for applica- Torsion drives from 2 Nm to 2,000
10.1 Testing machines for tions in all fields. A proven operating Nm are available for torsion tests on
quasi-static applications concept combined with flexible, materials or components. ZwickRo-
modular load-frame design guar- ell supplies a variety of testing ma-
zwickiLine antees an optimum solution for chines to cater for different require-
Included in our testing machines demanding testing applications. It ments, including varied installation
rated up to 5 kN is the single-col- is equally ideal for quality-control options.
umn zwickiLine, which offers a testing or as part of research proj-
powerful, flexible testing solution ects. Development and manufac- These torsion drives were devel-
for a wide range of materials and ture of AllroundLine, including all oped as a modular system, making
components. This materials testing mechanical, electronic and software them suitable for retrofitting also.
machine is equally ideal for research components, together with the A Master Test Program for multiple
and development and for routine comprehensive range of accesso- test axes plus a graphical sequence
quality assurance testing. The wide ries, takes place at ZwickRoell's editor for four test axes are available
range of equipment options allows production facility in Germany, in the testXpert III testing software.
zwickiLine to be used for testing enabling optimum matching of all For pure torsion tests there are the
both materials and a variety of com- items. These materials testing ma- TorsionLine testing machines with
ponents. chines are available in a force range horizontal testing axis and optional
from 5 kN to 250 kN. weight loading unit.
Testing machines: zwickiLine and zwickiLine with torsion drive AllroundLine testing machine
28
10.2 Testing machines for LTM electrodynamic testing HC Compact servo-hydraulic
dynamic applications machine testing machine
Electrodynamic testing machines The HC Compact servo-hydraulic
Electromechanical testing are used to determine material and testing machine comprises a hy-
actuator component fatigue-strength in the draulic power-pack, test frame and
Applications
Products
Electromechanical testing actuator LTM electrodynamic testing machine HC Compact servo-hydraulic testing machine
29
10.3 Automation • The machine can be used
during idle times (lunch breaks
Various forms of test automation for and night shifts), increasing
the medical engineering and phar- utilization and enabling
maceutical industries are available “faster” results.
from ZwickRoell. Key advantages
and features are listed below. • The testing system reduces
the testing costs per specimen
• The elimination of operator and pays for itself very quickly.
influence (hand temperature/ • The system enables
moisture, off-center or angled secure, reliable documentation
specimen insertion etc.) and statistical long-term
results in high test-result monitoring
reproducibility.
• Qualified laboratory staff are The levels of automation range from
relieved of routine activities, multiple tests within a single testing
leaving them available machine to full automation with ro-
for more complex tasks. botic specimen feeding system.
Fig. 1. Multiple tests on autoinjectors Fig. 2. Testing system with fully automated specimen feed
30
10.4 Testing in biophysical • Container (Duran glass) can be Testing at temperature
environment moved axially to enable clamping
of the specimen outside the liquid ZwickRoell's 37 °C temperature
Testing in liquid media medium. chambers enable testing at con-
• Various test fixtures or specimen trolled temperatures (e.g. up to
Applications
• Suitable for static and servo-hy- struments (flexible endoscopes)
draulic testing machines. • Testing catheter insertability in 3D
• For applications in media such models
as saline solutions, ethyl alcohol, • Performing horizontal tests in-
blood etc. cluding in temperature-controlled
medium Fig. 3. Temperature chamber installed in a
materials testing machine
Products
Fig. 1. Fluid bath with temperature control Fig. 2. Horizontal testing machine with fluid bath
unit
31
Fig. 1. Workflow based on working processes: administrator's view, with full functionality - www.testXpert.de
10.5 testXpert III testing A workflow based on your lab Intelligent user management allows
software processes you to define user roles or import
The software guides you through user roles direct from Windows
Intuitive and workflow-based the various stages of a test, from accounts via LDAP. The user can
from the very start! preparing and running the test to focus on the task at hand right from
testXpert III is the result of close analyzing results. the start and avoid input errors.
collaboration with users in materials • Set up testing system—configure testXpert III is workflow-based
testing and the experience gained all machine-related settings for your throughout, keeping training time to
from over 30,000 successful testX- testing application. a minimum and enabling efficient,
pert installations. With its intuitive, • Configure test—set all test-relat- reliable testing.
structured operation, testXpert III ed parameters, such as selecting
is easy to use right from the start. results with the intelligent wizard. System Configuration Builder
Informative icons and clear visual • Run test—experience fast and — a unique software concept
linking of related items assist the easy navigation through the entire System Configuration Builder allows
user, while reducing mouse move- test sequence. you to preset and save all relevant
ment and clicks. View results—verify all test data, testing system and safety settings
also in secure mode. such as crosshead position, fixture
separation or sensor configuration
Fig. 2. View optimized for the tester (left); intelligent wizard for test configuration (right)
32
in a freely definable system configu-
ration. The saved system configura-
tion checks the connected sensors.
The test can only be started if the
parameters match the preset re-
Standard-compliant testing
testXpert III offers over 600 pre- Fig. 1. Saved test configurations can be recreated following a change of test arrangement,
pared Standard Test Programs, allowing tests to be performed using identical settings.
preconfigured to test standard
requirements and with integrated
results tables and statistics. You can
begin standard-compliant testing
Applications
immediately. testXpert III will take
care of the rest!
33
Traceable, tamper-proof test
results in accordance with
FDA 21 CFR Part 11
34
Windows standard programs. In
addition testXpert III performs CRC
checks to ensure the system is tam-
per-proof. Output can be generated
in "readable" form (HTML / PDF) in
Electronic Signature
The Electronic Signature function
also provides a reliable safeguard
against unwanted changes to the
test program/test series, while
enabling documented assumption
of responsibility combined with a
change to paperless documenta-
tion.
Applications
The signature on the test log can be
replaced by a digital signature for
the test program/test series by en-
tering user name and password in
the testing software. It is also possi-
ble to specify how many signatures
are required and who is authorized
to sign. Once in signed status the
test program and test series are Fig.
Bild 1. Configuration
1: Detaillierte of user management
Konfiguration guidelines
der Benutzerverwaltungsrichtlinien
safeguarded against unauthorized
changes.
Products
35
10.6 Support for validation
of ZwickRoell testing
systems
36
Modular qualification solutions Wide-ranging benefits Experience
of the ZwickRoell The content of the documents is
In addition to the basic pack- Qualification Service based on years of experience in the
age, ZwickRoell can also provide qualification of testing machines.
semi-individual/individual and pe- Cost and time savings The documents are continually up-
Applications
cians. Qualification of a ZwickRoell testing accredited and can provide calibra-
system which has already been in- tion of testing systems in addition to
stalled is also possible. qualification on a "one-stop" basis.
Products
37
10.7 Daily Check device 10.8 Retrofitting for testing • Extensometers—maximum
machines measuring precision, measure-
The Daily Check device is used for ment in compliance with ISO
regular checks on load cells up to Every year over 3,500 customers 9513
500 N by means of comparison upgrade their testing machines us- • Safety for operator and ma-
values which have been measured ing proven ZwickRoell products: chine, with retrofitting of safety
following recalibration / adjustment. technology (e.g. safety doors)
• Load cells—sensitive and robust to existing testing systems
Advantages and features with the highest accuracy class • testXpert III—stay up to date at
• Use with any required number • Specimen grips and test fixtures all times; testing software up-
of machines–easy to install and Modular design enables easy dates and upgrades ensure you
remove and flexible retrofittin always have the latest functions
• Detection of systematic errors in • Temperature chambers and
compression and tensile direc- medium containers
tions in load cell (Xforce load
cells feature symmetrical design)
• Performing checks between pe-
riodic calibrations ensures that
the load cell is free of systematic
errors.
• The results of the daily check
are recorded in a testXpert
report.
Fig. 3. Various specimen grips and test fixtures for biomechanics tests
38
10.9 Overview of 10.9.1 Training courses in
ZwickRoell services the ZwickRoell Academy
Applications
ready to provide expert assistance. We can also assist in the event of
capacity bottlenecks
With the latest technology and test- or perform cross-validation tests.
ing machines, we guarantee fast,
standard-compliant testing. Natu-
Fig. 1. ZwickRoell provides continuous support throughout the entire life-cycle of materials testing systems.
39
ZwickRoell GmbH Co. KG
August-Nagel-Str. 11
D-89079 Ulm
Phone +49 7305 10 - 0
Fax +49 7305 10 - 11200
info@zwickroell.com
www.zwickroell.com