Invibio PEEK-OPTIMA® Reinforced Mechanical Properties,

Physical Properties and Biocompatibility

PEEK-OPTIMA Reinforced has enhanced mechanical and physical properties compared with the base
polymer, rendering the material useful for more demanding, load bearing applications, currently beyond
theMechanical Properties,
capability of PEEK-OPTIMA Natural.Physical Properties and Biocompatibility
Benefits of PEEK-OPTIMA Reinforced:
 FDA master file access
 Biocompatibility
 Proven applications
 FDA cleared devices
 MRI, CT and X-ray compatibility
 Surface modification options possible
 Bone-like modulus
 Excellent strength and creep resistance
 Low wear
 Excellent fatigue resistance
 Can be sterilised by steam, EtO and gamma

Enhanced Performance
The results in Table 1 indicate the typical mechanical properties of injection moulded tensile, flexural and
Izod impact test parts according to relevant indicated international test methods.

Table 1
Typical Mechanical Properties of Injection Moulded Tensile Bars and Plaques made from
PEEK-OPTIMA Reinforced (LT1DA30)
Injection Moulded Bars Method Units Value
Tensile Strength at Yield ISO 527 MPa (ksi) 225 (32.6)
Tensile Elongation at Break ISO527 % 1.80
Flexural Modulus ISO 178 GPa (ksi) 21 (3,045)
Flexural Strength ISO 178 MPa (ksi) 337 (48.8)
Impact Strength Notched Izod ISO 180 kJ/m² 10.40
Impact Strength Un-Notched Izod ISO 180 kJ/m² 46.16
 Injection Moulded Plaques Method Units Value
Tensile Strength at Yield║┴ ISO-527 MPa (ksi) 182-140
Tensile Modulus ║┴ ISO 527 GPa (ksi) (26-20)
15.0-9.9
Tensile Elongation (Break)║┴ ISO 527 % (2176-1436)
1.7-1.9
Compression Strength ISO 604 MPa (ksi) 210-191
Compression Modulus ║┴ ISO 604 GPa (ksi) (30.5-27.7)
11.1-9.7
Shear Modulus║┴ ISO15310 GPa (ksi) (1610-1407)
3.6
Poisson’s Ratio ISO 527 - (525) 0.35

║Parallel to filling direction ┴Perpendicular to filling direction

Short fibres are randomly dispersed or flow oriented; this being affected by mould geometry and moulding
conditions. Consistent with commercial non-implantable fibre filled polymer materials, the mechanical
properties of moulded parts with this material will depend on these and other factors and should be taken
into account in the design procedure.

Compared with PEEK-OPTIMA® Natural, PEEK-OPTIMA Reinforced offers enhanced strength and
stiffness at biomechanically useful levels of performance. Table 2 compares PEEK-OPTIMA Natural (LT1)
with PEEK-OPTIMA Reinforced (LT1DA30). These are batch examples and not specification values.

Table 2
PEEK-PEEK-OPTIMA® Natural LT1 Vs PEEK-OPTIMA Reinforced LT1DA30
PEEK-OPTIMA
PEEK-OPTIMA
Property Method Units Reinforced
Natural (LT1)
(LT1DA30)
2
Melt Viscosity TM-VX-12 kNs/m 0.43 0.88
Melt Stability TM-VX-12 % 0.0 2.4
Colour TM-VX-19 - B Black
Black Speck (Sized Film) TM-VX-17 Sq mm 0.14 N/A
Black Speck (Granule) Average TM-VX-11 Count/1 0 N/A
MFI TM-VX-33 00g
g/10 min 3.3 N/A
Tensile Strength (at yield) ISO 527 MPa 100 225
Tensile Elongation at Break ISO 527 % 30 1.8
2
Impact Strength (Notched Izod) ISO 180 kJ/m 7.3 10.4
2
Impact Strength (Unnotched Izod) ISO 180 kJ/m No Break 46
Flexural Modulus ISO 178 GPa 4.0 21
Flexural Strength ISO 178 MPa 162 337
Specific Gravity ISO 1183 g/cc 1.3 1.4
Moisture Content TM-VX-38 % 0.11 <0.50
Carbon fibre content ASTM D-3171 % - 30
Extraneous Contamination - Pass Pass
Granule cut TM-VX-11 - Pass Pass
Glass Transition Temperature TM-VX-25 C 149 145
Melting Point TM-VX-25 C 345 340
Re-crystallisation Temperature TM-VX-25 C 288 284
Mechanical Stiffness Compared with Cortical Bone
The stiffness of injection moulded tensile bars made from PEEK-OPTIMA® Reinforced is similar to that of
cortical bone. Figure 1 illustrates the relative stiffness of ceramics, orthopaedic metallic alloys and PEEK-
OPTIMA Reinforced, in comparison with cortical bone. Metallic alloys are 5-10 times as stiff, while
ceramics are up to 16 times as stiff as bone.

This might be important in orthopaedic applications for which a modulus mismatch between implant and
the surrounding bone might lead to clinical complications in the long-term, for example, partial bone
resorption, implant loosening and bone fracture.

Figure 1.
Relative Material Stiffness Compared with Cortical Bone
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Sterilisation
PEEK-OPTIMA Reinforced is resistant to steam, gamma radiation and exposure to ethylene oxide.

Samples injection moulded under standard Invibio® moulding conditions and subjected to Gamma
Sterilisation (75kGy), ETO sterilisation (3 Cycles) and 1000 hour Steam (134°C at 2 Bar) were tested
according to standard test methods in order to evaluate the effects of these conditions on a range of
mechanical, chemical and physical properties, including cytotoxicity. The results of these tests are shown
in Table 3.

These results indicate that PEEK-OPTIMA polymer with carbon fibres is remarkably resistant to the
sterilisation methods commonly used within the healthcare industry.
 Table 3.
Effect of Gamma, EtO and Steam Sterilization on the
Mechanical and Physical Properties of PEEK-OPTIMA® Reinforced

Gamma ETO (3 Steam (1000 hours

Test Units Control
(75kGy) Cycles) 134°C 2 Bar)
Tensile Strength at Yield (ISO 527) MPa 225 225 223 214
Tensile Elongation at Break (ISO527) % 1.8 1.6 1.6 1.2
Flexural Modulus (ISO 178) GPa 21 21 21 22
Flexural Strength (ISO 178) MPa 337 339 336 300
Impact Strength Notched Izod (ISO 180) kJ/m² 10.4 10.0 10.0 8.7
Impact Strength Un-Notched Izod (ISO 180) kJ/m² 46.2 45.5 45.8 41.0
Specific Gravity (ISO 1183) g/cc 1.40 1.40 1.40 1.40
Glass Transition Temperature (onset) (TM-VX-25) °C 145 144 144 143
Melting Point (TM-VX-25) °C 340 340 340 343
Re-Crystallisation Temperature (TM-VX-25) °C 284 284 285 283
Cytotoxicity (ISO 10993-5) - Pass Pass Pass Pass

Creep
The long-term application of load produces time related strain in polymers and compounds. This
phenomenon is termed ‘creep’. The creep resistance of a material can be measured by recording the
percentage strain as a function of time at different stress levels at a selected temperature. Creep resistant
materials display relatively flat creep curves in which the creep strain increases at a low rate even at
significant stress levels. Injection moulded tensile bars made from PEEK-OPTIMA Reinforced (LT1DA30)
display excellent creep resistance as shown in Figure 2.

Figure 2
Creep Strain Vs Time PEEK-OPTIMA Reinforced @20°C
1

0.9
150MPa
0.8

0.7
Elongation [%]

0.6 120MPa

100MPa
0.5

0.4 80MPa

0.3 60MPa

0.2 40MPa

0.1 20MPa

0
0.001 0.01 0.1 1 10 100 1000 10000
log time [h]
The creep modulus for PEEK-OPTIMA® Reinforced injection moulded tensile bars is shown in Figure 3.

Figure 3
Tensile Creep Modulus for Injection Moulded Tensile Bars at 20°C

50

45

40

Creep Modulus (GPa) . 35

30

25
40MPa
20
120MPa
15

10

0
0.01 0.10 1.00 10.00 100.00 1000.00 10000.00
Time (hrs)

Fatigue
The fatigue strength of a material is a measure of its ability to sustain cyclic loading. Injection moulded
tensile bars (ISO 527 type 1B) subjected to sine wave load cycling at 5Hz and 20Hz show a high degree
of fatigue resistance (resisting high loads for many cycles) as shown in Figure 4.

Figure 4
Fatigue Data for LT1DA30 Injection Moulded ISO Tensile Bars at 0.5Hz and 10Hz

250

200
Stress [MPa]

150

100

50

0
10 100 1000 10000 100000 1000000 10000000
Cycles [ ]
0.5 Hz 10 Hz 0.5 Hz (no break) 10 Hz (no break) smoothing function (0.5 Hz) smoothing function (10 Hz)
Wear
Evaluation by simulator studies of PEEK-OPTIMA® Reinforced as a bearing material in medical devices
has shown excellent wear resistance.

Biocompatibility
PEEK-OPTIMA® Reinforced has been tested according to EN ISO 10993-1 ‘Biological Evaluation of
Medical Devices’ referring to toxicologically relevant effects of potentially leachable chemical substances
and residues. Additionally, a worst case scenario PEEK-OPTIMA® Reinforced compound containing a
higher carbon fibre loading (35%) has been tested according to the requirements of United States
Pharmacopoeia plastics class VI, ISO 10993-10 (sensitization), ISO10993-6 (implantation), and ISO
10993-3 (genotoxicity). Cytotoxicity studies have been performed in the unsterilised, steam sterilised,
ethylene oxide sterilised and gamma sterilised conditions.

The results of these tests confirm that PEEK-OPTIMA® Reinforced compounds demonstrate no evidence
of cytotoxicity, systemic toxicity, irritation or any macroscopic reaction response. The insolubility of PEEK-
OPTIMA® Reinforced is in compliance with the requirements of ISO 10993-1. There is no evidence that
any harmful leachable ingredients and/or residues are contained and/or released.
Europe and Asia Pacific Americas
Invibio Ltd. Invibio Inc.
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INV-MP-PR-0131-A (3/2014)