It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

gate location, fill/pack/warp/cool) & material solution • Evaluates component design viability with preferred Avient material solution • Fiber analysis determines fiber orientation and length • Predicts part quality and manufacturability (shrink, warp, weld line location) FILLING PART QUALITYFIBER ORIENTATION Finite Element Analysis (FEA) • Virtually simulates how an application will perform in real-world conditions with a high level of precision • Able to represent a variety of problems, test methods, models and outputs to evaluate the design, process and material combination for validation or optimization • Dynamic - Acceleration - Impact - Break/no break - Transmitted force - Energy absorption • Thermal Mechanical - Temperature Computational Fluid Dynamics (CFD) - Heat path - Dominant heat transfer - Temperature mapping - Coupling with mechanical simulations FEA Simulation Capabilities • Static - Displacement/rotations - Stress and strains - Contact pressure - Reaction forces/moments - Factors of safety • Vibration - Eigen frequencies - Harmonic response ○ Harmonic displacement, acceleration and stress Software Used • Autodesk Moldflow • Digimat • Simulia/Abaqus • MSC Cradle • CAD/CAE - MSC Apex - SolidWorks Failure Mode Effect Analysis (FMEA) Support By leveraging mold filling simulation, multiphysics simulation, and the understanding of the link between design, process and material, we can help inform your decision-making process for product development.

FOUR MAIN PLASTIC VARIABLES Flow Rate Plastics are a non-Newtonian fluid, therefore, with a higher shear rate, the viscosity of the material is reduced. This will FIGURE 43 - Non-Newtonian Fluid Flow Low Level of Orientation Frozen Layer Highly Oriented Laminates Gate Transducer A Transducer B Hydraulic x 10 Filling Hold Start of mold shrinkage Time Pack P ss A B FIGURE 45 - Non-Newtonian fluid flow Relative Viscosity = Transfer Position * Fill Time Shear Rate = 1 Fill time FIGURE 46 - Pressure vs. Reduce the clamp tonnage until flash is seen around the parting line, then increase the clamp tonnage by 5-10% Minimize Cycle Time • Mold Open/Close – Should be as fast as possible, without slamming, and still produce a nice fluid motion • Ejector Speed – As fast as possible, without influencing part quality • Ejector Stroke – Only stroke the ejectors as many times as needed to separate the part from the core - i.e.

Learn how one manufacturer used compliant Cesa™ Fiber Additives in nonwoven medical face masks Explore the power of polymer solutions for hygiene & medical nonwovens Discover how Avient's polymer colorants and additives can help increase the performance and appeal of nonwovens used in hygiene and medical applications

KEY CHARACTERISTICS • Ease of conversion from liquid plastisol to fused thermoplastic solid • Available in a range of hardness and colors • Used in molding, casting and dip coating, including hot and cold dipping • Customizable formulations for automotive, healthcare, industrial and other specialty applications to comply with regulatory requirements including FDA, RoHS, REACH, Prop-65, CPSIA and CONEG • Non-phthalate formulations available for healthcare, playground equipment, outdoor furniture and other high-touch applications MARKET AND APPLICATIONS CORE™ Vinyl Plastisols are available for a wide variety of uses, including: • Automotive air filters • Tool handles, grips • Outdoor furniture and playground equipment • Fencing, wire grates • Industrial textiles • Healthcare masks, molds, medical tape, manikins and stethoscopes • Medical cannula • Sound barriers • Seals/barriers for food packaging • Construction coatings • Electrical insulators • Protective caps • Antistatic flooring and mats www.avient.com Copyright © 2020, Avient Corporation.

Delivering on critical application demands, it provides weldability, kink resistance, and tensile strength performance comparable to leading medical tubing materials, including silicone and TPE. Offering reliable performance, optical clarity and expanded design freedom, these medical- grade TPEs may be customized to meet specific regulatory demands or application needs.

MEDICAL ORANGE PE MEDICAL GREEN PE

Disinfectant Resistance for Medical Device Housings - Case Study Manufacturer boosts disinfectant resistance for medical device housings using Trilliant HC High Performance Formulations

POST MEDICAL TEAL POST MEDICAL TEAL

With these solutions, manufacturers can reduce potential risks and loss of revenue from counterfeits in consumer goods, medical devices, packaging, and consumer electronics markets. This material portfolio also delivers excellent flame, chemical, and UV light resistance, making it a cost-effective replacement for various engineered polymers and metal in applications such as laundry consoles, circuit board housings, medical equipment, and LED lighting.