Technical Data Sheet
Ecdel™ Elastomer 9967
- IV bags packaging
- Pharmaceutical packaging
- Chemical resistant with low extractables
- Excellent clarity
- Excellent toughness & flexibility without plasticizers
- Heat & sterilization stability
Meets ISO 10993 and/or USP Class VI biocompatibility requirement.
Ecdel™ elastomers are plasticizer free copolyester elastomers (COPE) that offer clarity, toughness, flexibility, and chemical resistance for flexible packaging including medical and pharmaceutical applications. Ecdel™ elastomer 9967 may be processed on standard injection molding, extrusion blow molding, profile extrusion, extrusion coating, or film extrusion equipment. Ecdel™ elastomers may be extrusion blow molded directly into bags or extruded into blown or cast film for later fabrication into bags. Ecdel™ elastomers are radiation, electron beam, ethylene oxide, and autoclave sterilization stable. 9967's high inherent viscosity may be helpful where good melt strength is required (blown film or profile extrusion).
This product has been CRADLE TO CRADLE CERTIFIEDTM Bronze, with Material Health Certificate, Platinum.
The CRADLE TO CRADLE CERTIFIED mark is a registered certification mark used under license through the Cradle to Cradle Products Innovation Institute, a nonprofit organization that administers the publicly available Cradle to Cradle CertifiedTM Product Standard which provides designers and manufacturers with criteria and requirements for continually improving product materials and manufacturing processes. The Cradle to Cradle CertifiedTM Product Standard guides designers and manufacturers through a continual improvement process that looks at a product through five quality categories—material health, material reutilization, renewable energy and carbon management, water stewardship, and social fairness. A product receives an achievement level in each category—Basic, Bronze, Silver, Gold, or Platinum—with the lowest achievement level representing the product’s overall mark.
The Material Health Certificate provides manufacturers with a trusted way to communicate their efforts to identify and replace chemicals of concern in their products. For more information about Cradle to Cradle certification and to obtain printable certificates for Eastman copolyesters, visit www.c2ccertified.org. Search for Eastman Chemical Company in Cradle to Cradle Certified Products Registry.
Eastman Medical Disclaimer
|Propertya||Test Methodb||Typical Value, Unitsc|
|Thickness of Film Tested|| ||0.13 mm (5 mils)|
|Refractive Index, nD||D 542||1.51 |
|Haze||D 1003||1 %||Gloss|| |
| @ 45°||D 2457||73 |
|Regular Transmittance||D 1003||91 %|
|Total Transmittance||D 1003||94 %||Tensile Stress @ Yield|| |
| T.D.||D 882||11.2 MPa (1600 psi)||Tensile Strength @ Break|| |
| M.D.||D 882||41.5 MPa (6000 psi)|
| T.D.||D 882||18.1 MPa (2600 psi)||Elongation @ Yield|| |
| M.D.||D 882||46 %|
| T.D.||D 882||20 %||Elongation @ Break|| |
| M.D.||D 882||330 %|
| T.D.||D 882||>550 %||Tensile Modulus, Tangent|| |
| M.D.||D 882||197 MPa (28600 psi)|
| T.D.||D 882||221 MPa (32000 psi)|
|Water Vapor Transmission Rateg||F 372||146 g/m2·24h (9.5 g/100in.2·24h)||Gas Permeability, O2|| |
| @ 30°C (86°F)||D 1434||940 cm3/m2*24h*atm (61 cm3/100in.2·24h·atm)|
|Coefficient of Friction||D 1894||>1 |
|Specific Gravity||D 792||1.13 ||Durometer Hardness|| |
| Shore A Scale||D 2240||95 |
| Shore D Scale||D 2240||55 |
|Tensile Stress @ Breakd||D 638||23 MPa (3300 psi)|
|Tensile Stress @ Yielde||D 638||13 MPa (1900 psi)|
|Elongation @ Yield||D 638||38 %|
|Elongation @ Break||D 638||400 %|
|Tensile Modulus||D 638||170 MPa (24650 psi)|
|Flexural Modulus||D 790||150 MPa (21750 psi)|
|Tear Strength||D 1004||350 N (79 lbf)||Izod Impact Strength, Notched|| |
| @ -40°C (-40°F)||D 256||40 J/m (0.75 ft·lbf/in.)||Torsional Modulus Temperature|| |
| @ 240 MPa (35,000 psi)||D 1043||-28 °C (-18 °F)|
| @ 930 MPa (135,000 psi)||D 1043||<-70 °C (<-94 °F)|
|Water Absorption, 24 h immersion||D 570||0.4 %|
|Inherent Viscosity||EMN-A-AC-G-V-1||1.23 ||Flow Rate|| |
| (Condition 215°C/2.16 kg)||D 1238||8 g/10 min|
| (Condition 230°C/2.16 kg)||D 1238||12 g/10 min|
|Crystalline Peak Melting Point (Tm)||D 3418||205 °C (400 °F)|
|Crystallization Temperature on Cooling (Tcc)||DSC||140 °C (284 °F)|
|Glass Transition Temperature (Tg)||DSC||-40 °C (-40 °F)||Specific Heatf|| |
| @ 100°C (212°F) - solid||DSC||1.8 kJ/kg·K (0.43 Btu/lb·°F)|
| @ 150°C (302°F) - solid||DSC||2.0 kJ/kg·K (0.48 Btu/lb·°F)|
| @ 175°C (347°F) - solid||DSC||2.3 kJ/kg·K (0.55 Btu/lb·°F)|
| @ 200°C (392°F) - transition||DSC||3.1 kJ/kg·K (0.74 Btu/lb·°F)|
| @ 225°C (437°F) - melt||DSC||2.3 kJ/kg·K (0.55 Btu/lb·°F)|
| @ 25°C (77°F) - solid||DSC||1.6 kJ/kg·K (0.38 Btu/lb·°F)|
|Heat of Fusion||E 793||27 kJ/kg (11.6 Btu/lb)|
|Thermal Conductivity||C 177||0.19 W/m·K (1.3 Btu·in./h·ft2·°F)|
|Coefficient of Linear Thermal Expansion||D 696||15 x 10-5 /°C (mm/mm·°C) (8 x 10-5 /°F (in./in.·°F))|
|Brittleness Temperature||D 746||<-75 °C (<-103 °F)||Vicat Softening Temperature|| |
| @ 1 kg load||D 1525||170 °C (338 °F)|
It is the responsibility of the medical device manufacturer ("Manufacturer") to determine the suitability of all component parts and raw materials, including any Eastman product, used in its final product in order to ensure safety and compliance with requirements of the United States Food and Drug Administration (FDA) or other international regulatory agencies.
Eastman Chemical Company products have not been designed for nor are they promoted for end uses that would be categorized by either the United States FDA or by the International Standards Organization (ISO) as implant devices. Eastman products are not intended for use in the following applications: (1) in any bodily implant applications for greater than 30 days, based on FDA-Modified ISO-10993, Part 1 “Biological Evaluation of Medical Devices” tests (including any cosmetic, reconstructive or reproductive implant applications); (2) in any cardiac prosthetic device application, regardless of the length of time involved, including, without limitation, pacemaker leads and devices, artificial hearts, heart valves, intra-aortic balloons and control systems, and ventricular bypass assisted devices, or (3) as any critical component in any medical device that supports or sustains human life.
Eastman Chemical Company products offered for the medical market have met selected FDA-Modified ISO-10993, Part 1 “Biological Evaluation of Medical Devices” tests with human tissue contact time of 30 days or less. The tests include: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute), subchronic toxicity (sub-acute), implantation, hemocompatibility. The Manufacturer is responsible for the biological evaluation of the finished medical device.
The suitability of an Eastman Product in a given end-use environment is dependent upon various conditions including, without limitation, chemical compatibility, temperature, part design, sterilization method, residual stresses, and external loads. It is the responsibility of the Manufacturer to evaluate its final product under actual end-use requirements and to adequately advise and warn purchasers and users thereof.
Properties reported here are based on limited testing. Eastman makes no representation that the material in any particular shipment will conform exactly to the values given.
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