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Ideal for “can’t fail” medical applications

Stevens Urethane film, sheet and tubing is already specified in many sophisticated medical products and equipment, due to its unique combination of critical performance characteristics. Usually, when two or more of these properties are required, urethane will cost-effectively outperform any other material. TPU’s durability, purity, fabricability, and ease of disposal make it particularly attractive for medical product design and manufacture. Application Examples.

No Problems With Plasticizers

Urethane is inherently flexible, so it doesn’t require plasticizers like vinyl does. Those plasticizers cause vinyl to become brittle and stiff over time, perhaps even cracking. This is particularly a problem where the product has a long shelf life or is exposed to temperature extremes, such as in an ambulance or at a remote first aid station. Additionally, there is the long-standing industry problem of vinyl plasticizers and other chemicals leaching out of PVC formulations, often leading to degradation or the material, and possible application contamination problems. Not so with TPU — no plasticizers, no problems.

TPU Outperforms Other Thermoplastics

Stevens polyurethane film, sheet and tubing combine the best properties of rubber and plastic, and urethane consistently outperforms other commonly used plastics in many medical applications. At equal thicknesses and durometers, urethane is substantially stronger than vinyl, for example. It is extremely resistant to deterioration from skin oils, which makes it better for skin-contact products, and it provides a comfortable, non-plastic feel, even at low temperatures.

Stevens Urethane is also more environmentally friendly than vinyl and other films. Many manufacturers of disposable products have changed to urethane because of environmental problems resulting from the toxic by-products generated when incinerating disposable products fabricated from PVC.

In comparison to other materials, urethane’s properties and characteristics offer many advantages for medical applications.

Agency Approvals

Some grades of Stevens Urethane are manufactured with resins listed by the National Sanitation Foundation (NSF) as meeting the requirements of Standard 61. Other grades are made with ingredients that conform to the requirements of sections of the Food and Drug Administration (FDA) 21 CFR code for certain food contact applications also applicable to medical use. Others include candidate materials for USP Class VI classification, and lot traceable versions. Stevens will also help you with FDA 510K filings.

Size

Stevens Urethane film and sheet are available in thicknesses from .001" to .125", in widths from 5" and up, and in a variety of colors, opacities and surface textures. Stevens Urethane tubing is available in ID sizes from 1/16" to 1", OD sizes from 1/8" to 1-1/4" with wall thicknesses ranging from 1/32" to 1/8", and is available in a variety of colors and opacities. Stevens Plurotubing™ consists of two or more tubes, of variable sizes and colors, bonded into a single multiple unit, and is designed for coding purposes, or tracking fluids between components.

Selecting the proper grade. Most medical applications use one of three grades of Stevens Urethane:

ST-1880 A general purpose 87 Shore A polyurethane used for many broad applications.

ST-1882 A softer, more pliable polyether urethane grade that easily conforms to shapes and contours.

ST-2592 Designed for more severe applications, this high-performance polyether urethane grade offers greater temperature and puncture resistance than the softer grades.

Some design criteria may require flame resistant and/or breathable materials. We can help you define performance parameters, verify material selection, and implement your design. For the specific grade best suited for your application, please contact Stevens for applications assistance.

Email Technical Support or Tell us about your application.

Performance Characteristics/Properties.

bullet art Durometer (Hardness) Urethane film and sheet can be produced in a range of durometers (Shore A 75 - Shore D 55) from relatively stiff to a thin film having an extremely soft, non-plastic feel that is ideal for products that come in contact with the skin.

bullet art Low temperature flexibility Urethanes feature superior flexibility over a wide durometer range, even at temperatures as low as -60°F (-50°C).

bullet art Tensile strength Tensile strength ranges from 4,000 to 10,000 psi, assuring reliability and durability over the life span of the end product. Because urethanes are tough, they can be used in thinner gauges when compared to vinyl.

bullet art Elongation TPU film and sheet can elongate as much as 800% and return to its original dimension without significant loss of “memory.” This, along with its flex fatigue resistance, makes it ideal for bladders and other components subjected to a range of physical and temperature stresses.

bullet art Abrasion resistance Polyurethane provides excellent abrasion resistance, for reliability and long life in applications where it is fabricated with materials such as wovens, or in the case of tubing, used to connect movable components in medical devices. Urethanes also excel as a tough outer protective “skin” for laminates, or as a thick, strong seat cushion film.

bullet art Chemical and environmental resistance Polyether and polyester urethanes each have specific chemical resistance characteristics, such as resistance to hydrocarbons, chemicals, ozone, bacteria, fungus, and moisture, as well as skin oils. Urethane may be sterilized with ethylene oxide without yellowing, and with gamma sterilization in cases where a limited amount of yellowing is acceptable.

bullet art Sterilization Depending on the formulation selected, urethanes can offer excellent resistance to a wide range of hydrocarbons, chemicals, ozone, fungus, moisture, and sterilant gases such as ethylene oxide.

bullet art Kink Resistance Urethane tubing exhibits excellent flexibility and kink resistance.

bullet art Fabrication versatility Urethane is easy to work with. It can be fabricated in many ways with many different substrates, enhancing design versatility. Sheet can be fabricated with urethane tubing to provide the benefits of urethane to an entire product system, such as in linked bladder applications. Stevens Urethane can be:

bullet art Cut
bullet art Sewn
bullet art Adhesive bonded
bullet art Laminated
bullet art Vacuum formed
bullet art Radio frequency (RF) sealed
bullet art Thermally bonded to itself or other materials
bullet art Printed or silk-screened


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