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USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.

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Eastman Eastar™ 6763 Renew-25 Copolyester
Categories: Polymer; Thermoplastic; Polyester, TP

Material Notes: Eastar™ Renew copolyester 6763-25 meets ISO 10993 and/or USP Class VI biocompatibility requirement; Food Contact Status compliant. Eastar™ Renew 6763-25 is a clear, amorphous material that can be molded and extruded with ease. Its excellent performance properties include clarity, toughness, good melt strength, no dusting, no stress whitening, good heat sealability, easy cutting and thermoforming. Eastar™ Renew 6763-25 may be colored using color concentrates, dry colors, or liquid colorants. Eastar™ Renew 6763-25 can be safely sterilized with proper ethylene oxide, radiation, or electron beam methods without property loss or color shift. Eastar™ Renew 6763-25 provides:
  • Superior, long-term clarity provides easy identification of instruments
  • Excellent puncture resistance and impact toughness ensure package integrity
  • Excellent ability to be subjected to several methods of sterilization, providing flexibility and security to the device manufacturer
  • Excellent optical and physical property stability post sterilization
  • Good melt strength offers wide processing latitude and ease in thermoforming
The production and trimming of rigid medical trays made from sheet of Eastar™ Renew 6763-25 results in little or no dust or particulates. After the thermoformed trays are made, they are put in polybags. The polybags of trays are then placed in protective boxes for storage or shipment. As long as the polybags in the protective boxes are intact and no outside contamination is evident, the thermoformer or medical device manufacturer should not need to clean the tray prior to packaging a device and sealing the package. If contamination is found on the medical trays and cleaning is required, use a lint-free towel. Blowing the tray out with filtered, deionized, non-lubricated air is also acceptable, assuming this does not stir up dust from the surrounding area. Using alcohol, which could cause crazing, or water, which would not evaporate, is not recommended. Eastman Renew polymers have been certified by International Sustainability & Carbon Certification (ISCC), a global, independent agency for tracking sustainable content in a variety of industries. Renew polymers are produced with ISCC certified circular content by mass balance allocation.

Applications

  • Rigid medical packaging
Key Attributes
  • Easy primary & secondary operations
  • Excellent clarity
  • Excellent toughness
  • Gamma, ebeam, ETO sterilization stable

Information provided by Eastman.

Vendors: No vendors are listed for this material. Please click here if you are a supplier and would like information on how to add your listing to this material.
 
Physical PropertiesOriginal ValueComments
Density 1.27 g/ccASTM D1505
Water Absorption 0.130 %
@Time 86400 sec
immersion; ASTM D570
Water Vapor Transmission 7.00 g/m²/dayASTM F1249
Oxygen Transmission 10.0 cc-mm/m²-24hr-atmASTM D1434
Carbon Dioxide Transmission 49.0 cc-mm/m²-24hr-atmASTM D1434
Thickness 250 micronsASTM D374
 
Mechanical PropertiesOriginal ValueComments
Hardness, Rockwell R 106ASTM D785
 109ISO 2039-2
Tensile Strength at Break 28.0 MPaASTM D638
 28.0 MPaISO 527
Film Tensile Strength at Yield, MD 59.0 MPaASTM D882
Film Tensile Strength at Yield, TD 55.0 MPaASTM D882
Tensile Strength, Yield 50.0 MPaASTM D638
 50.0 MPaISO 527
Film Elongation at Break, MD 400 %ASTM D882
Film Elongation at Break, TD 400 %ASTM D882
Film Elongation at Yield, MD 4.00 %ASTM D882
Film Elongation at Yield, TD 4.00 %ASTM D882
Elongation at Break 100 %ISO 527
 130 %ASTM D638
Tensile Modulus 2100 MPaASTM D638
 2100 MPaISO 527
Flexural Yield Strength 68.0 MPaISO 178
 70.0 MPaASTM D790
Flexural Modulus 2000 MPaISO 178
 2100 MPaASTM D790
Izod Impact, Notched 37.0 J/m
@Temperature -40.0 °C
ASTM D256
 101 J/m
@Temperature 23.0 °C
ASTM D256
Izod Impact, Unnotched NB
@Temperature -20.0 °C
ASTM D4812
 NB
@Temperature 23.0 °C
ASTM D4812
 NB
@Temperature -30.0 °C
ASTM D4812
 NB
@Temperature -40.0 °C
ASTM D4812
Izod Impact, Notched (ISO) 4.20 kJ/m²
@Temperature -40.0 °C
Type 1 Specimen, Type A Notch; ISO 180
 6.20 kJ/m²
@Temperature 23.0 °C
Type 1 Specimen, Type A Notch; ISO 180
Izod Impact, Unnotched (ISO) NB
@Temperature -20.0 °C
Type 1 Specimen; ISO 180
 NB
@Temperature 23.0 °C
Type 1 Specimen; ISO 180
 NB
@Temperature -30.0 °C
Type 1 Specimen; ISO 180
 NB
@Temperature -40.0 °C
Type 1 Specimen; ISO 180
Puncture Energy 28.0 J
@Temperature 23.0 °C
Energy @ Max. Load, 2.5 mm (0.100 in.) Thick Plaques; ASTM D3763
 33.0 J
@Temperature 23.0 °C
Energy @ Max. Load, 3.2 mm (0.125 in.) Thick Plaques; ASTM D3763
 35.0 J
@Temperature -40.0 °C
Energy @ Max. Load, 2.5 mm (0.100 in.) Thick Plaques; ISO 6603-2
 36.0 J
@Temperature -40.0 °C
Energy @ Max. Load, 3.2 mm (0.125 in.) Thick Plaques; ISO 6603-2
 40.0 J
@Temperature 23.0 °C
Energy @ Max. Load, 2.5 mm (0.100 in.) Thick Plaques; ISO 6603-2
 41.0 J
@Temperature -40.0 °C
Energy @ Max. Load, 2.5 mm (0.100 in.) Thick Plaques; ASTM D3763
 44.0 J
@Temperature 23.0 °C
Energy @ Max. Load, 3.2 mm (0.125 in.) Thick Plaques; ISO 6603-2
 50.0 J
@Temperature -40.0 °C
Energy @ Max. Load, 3.2 mm (0.125 in.) Thick Plaques; ASTM D3763
Tear Strength, Total 93.0 NMD, PPT Tear Resistance; ASTM D2582
 93.0 NTD, PPT Tear Resistance; ASTM D2582
Tear Strength 36.0 kN/mMD, Tear Propagation Resistance, Split Tear Method @ 254 mm/min (10 in./min); ASTM D1938
 36.0 kN/mTD, Tear Propagation Resistance, Split Tear Method @ 254 mm/min (10 in./min); ASTM D1938
 36.0 kN/mMD, Trouser @ 200 mm/min; ISO 6383-1
 36.0 kN/mTD, Trouser @ 200 mm/min; ISO 6383-1
Elmendorf Tear Strength MD 1400 gASTM D1922
Elmendorf Tear Strength TD 1700 gASTM D1922
Dart Drop Test 400 g
@Temperature 23.0 °C
ASTM D1709A Modified
 500 g
@Temperature -18.0 °C
ASTM D1709A Modified
Film Tensile Strength at Break, MD 52.0 MPaASTM D882
Film Tensile Strength at Break, TD 52.0 MPaASTM D882
 
Electrical PropertiesOriginal ValueComments
Volume Resistivity 1.00e+15 ohm-cmASTM D257
Surface Resistivity per Square 1.00e+16 ohmASTM D257
Dielectric Constant 2.40
@Frequency 1.00e+6 Hz
ASTM D150
 2.60
@Frequency 1000 Hz
ASTM D150
Dielectric Strength 16.0 kV/mmShort Time, 500 V/sec rate-of-rise; ASTM D149
Dissipation Factor 0.00500
@Frequency 1000 Hz
ASTM D150
 0.0200
@Frequency 1.00e+6 Hz
ASTM D150
Arc Resistance 158 sec
 
Thermal PropertiesOriginal ValueComments
CTE, linear 51.0 µm/m-°CASTM D696
Specific Heat Capacity 1.30 J/g-°C
@Temperature 60.0 °C
DSC
 1.76 J/g-°C
@Temperature 100 °C
DSC
 1.88 J/g-°C
@Temperature 150 °C
DSC
 1.97 J/g-°C
@Temperature 200 °C
DSC
 2.05 J/g-°C
@Temperature 250 °C
DSC
Thermal Conductivity 0.210 W/m-KASTM C177
Deflection Temperature at 0.46 MPa (66 psi) 70.0 °CASTM D648
Deflection Temperature at 1.8 MPa (264 psi) 64.0 °CASTM D648
Vicat Softening Point 85.0 °CASTM D1525
Glass Transition Temp, Tg 80.0 °CDSC
 
Optical PropertiesOriginal ValueComments
Haze 0.800 %ASTM D1003
Gloss 108 %45°; ASTM D2457
Transmission, Visible 85.0 %Transparency; ASTM D1003
 89.0 %Regular; ASTM D1003
 91.0 %Total; ASTM D1003
 
Processing PropertiesOriginal ValueComments
Melt Temperature 249 - 271 °C
Mold Temperature 16.0 - 38.0 °C
Drying Temperature 65.0 °C
Dry Time 4.00 - 6.00 hour
 
Compliance PropertiesOriginal ValueComments
USP Class VI YesSee notes for details

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PEATM4116 / 323739

USP Class VI adhesives

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