® PEBAX6333 SA 01 MED Polyether block amide Pebax® 6333 SA 01 MED is a thermoplastic elastomer made of flexible polyether and rigid polyamide. This grade offers the highest quality and it is specially designed to meet the stringent requirements of the medical applications such as minimally invasive devices. Pebax® 6333 SA 01 MED also offers an excellent combination of properties such as: kink resistance, low friction coefficient and superior dynamic response. Upon request, letters regarding USP Class VI compliance can be provided. MAIN CHARACTERISTICS Property Density Water Absorption at Equilibrium At 20°C and 50 % R.H. Water Absorption At 23°C and 24 h in water Melting Point Vicat Point Under 1 daN Shrinkage (after 24 h, 4 mm, mold at 40°C) // ⊥ Hardness (*) Instantaneous After 15 s Tensile Test (*) Stress at Break Strain at Break Flexural Modulus (*) Charpy Impact (*) Unnotched 23°C Unnotched -30°C V-notched 23°C V-notched -30°C (*) Samples conditioned 15 days at 23°C - 50 % R.H. (c) = Complete Break Typical Value 1.01 0.7 1.1 169 157 1.2 1.4 64 58 53 >350 285 No break No break No break 20 (c) Unit g/cm3 % % °C °C % % Shore D Shore D MPa % MPa kJ/m² kJ/m² kJ/m² kJ/m² Test Method ISO 1183 ISO 62 ISO 11357 ISO 306 Internal method ISO 868 ISO 527 ISO 178 ISO 179 PEBAX® 6333 SA 01 MED MAIN APPLICATIONS • • Tubings like angiography and angioplasty catheters. Flexible injected parts. PROCESSING CONDITIONS Extrusion Melt Temperature (Min / Recommended / Max) Injection Melt Temperature (Min / Recommended / Max) Mold Temperature Drying (only necessary for bags opened for more than two hours) Time Temperature 4 - 6 hours 65 - 75°C 210°C / 225°C / 240°C 230°C / 260°C / 290°C 25 – 60°C PACKAGING This grade is delivered dried in sealed packaging (20 kg bags) ready to be processed. TDS / 59906 / Janvier 2013 - ARKEMA Société anonyme au capital de 614 937 940 euros - 445 074 685 RCS Nanterre - SHELF LIFE Two years from the date of delivery. For any use above this limit, please refer to our technical services. Arkema strictly prohibits the use of any polymers, including medical grades, in applications that are implanted in the body or in contact with bodily fluids or tissues for greater than 30 days. Unless Arkema otherwise expressly agrees by written contract, the Arkema trademarks and the Arkema name shall not be used in conjunction with customers’ medical devices, including without limitation, permanent or temporary implantable devices, and customers shall not represent to anyone else, that Arkema allows, endorses or permits the use of Arkema products in such medical devices. Further, all implantable medical devices, whether permanent or temporary, carry a risk of adverse consequences. With regard to implantable medical devices, you should not rely upon the judgment of Arkema. Any decision regarding the appropriateness of a particular medical device in a particular medical application or for a specific clinical use should be based upon the judgment of your physician, medical device supplier and the United States Food & Drug Administration and/or the European process of Medical Device notification. Unless otherwise specifically stated by Arkema in writing, Arkema does not perform clinical medical studies on implantable medical devices. Arkema cannot weigh the benefits against the risks of a device and does not offer a medical judgement on the safety or efficacy of use of any Arkema product in a medical device. The statements, technical information and recommendations contained herein are believed to be accurate as of the date hereof. Since the conditions and methods of use of the product and of the information referred to herein are beyond our control, ARKEMA expressly disclaims any and all liability as to any results obtained or arising from any use of the product or reliance on such information; NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE GOODS DESCRIBED OR THE INFORMATION PROVIDED HEREIN. The information provided herein relates only to the specific product designated and may not be applicable when such product is used in combination with other materials or in any process. The user should thoroughly test any application before commercialization. Nothing contained herein constitutes a license to practice under any patent and it should not be construed as an inducement to infringe any patent and the user is advised to take appropriate steps to be sure that any proposed use of the product will not result in patent infringement. See Safety Data Sheet for Health & Safety Considerations. Arkema Specialty Polyamides 420, rue d’Estienne d’Orves 92705 Colombes Cedex - France arkema.com - pebax.com
