Arkema 2013 Pebax 3533 SA 01 MED

Polyether block amide Pebax ® 3533 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. Upon request, letters regarding USP Class VI compliance can be provided.

MAIN CHARACTERISTICS

Property

Typical Value

Unit

Test Method

Density

1.00 g/cm 3 ISO 1183

Water Absorption at Equilibrium At 20°C and 50 % R.H. Water Absorption

At 23°C and 24 h in water 0.4 1.2 % % ISO 62

Melting Point 144 °C ISO 11357 Vicat Point Under 1 daN

77 °C ISO 306 Shrinkage (after 24 h, 4 mm, mold at 40°C) // ⊥

0.5 0.8 % %

Internal method

Hardness (*) Instantaneous After 15 s 82 / 33 80 / 25

Shore A / Shore D Shore A / Shore D

ISO 868

Tensile Test (*) Stress at Break Strain at Break 39 >600 MPa % ISO 527 Flexural Modulus (*) 21 MPa ISO 178

Charpy Impact (*) Unnotched 23°C Unnotched -30°C V-notched 23°C V-notched -30°C

No break No break No break No break

kJ/m² kJ/m² kJ/m² kJ/m²

ISO 179

(*) Samples conditioned 15 days at 23°C - 50 % R.H.

PEBAX ® 3533 SA 01 MED

T D S / 58837 / J a n v i e r 2013 - A R K E M A S o c i ét é a n o n y m e a u c a p i t a l d e 614 937 940 e u r o s - 445 074 685 R C S N a n t e r r e -

Arkema Specialty Polyamides 420, rue d’Estienne d’Orves

92705 Colombes Cedex - France arkema.com - pebax.com

MAIN APPLICATIONS

• Arterial catheters. • Flexible injected parts.

PROCESSING CONDITIONS

Extrusion

Melt Temperature (Min / Recommended / Max)

190°C / 205°C / 220°C Injection

Melt Temperature (Min / Recommended / Max)

180°C / 210°C / 240°C

Mold

Temperature

10 – 30°C

Drying (only necessary for bags opened for more than two hours) Time

Temperature

4 - 8 hours 5

5 - 65°C

PACKAGING

This grade is delivered dried in sealed packaging (25 kg bags) ready to be processed.

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.