https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below. Avient makes no representations, guarantees, or warranties of any kind with respect to the information contained in this document about its accuracy, suitability for particular applications, or the results obtained or obtainable using the information. Avient makes no warranties or guarantees respecting suitability of either Avient’s products or the information for your process or end-use application.
https://www.avient.com/sites/default/files/2021-08/avient-cdp-climate-change-questionnaire-2021.pdf
In addition, Avient has externally certified EHS&S management systems, including ISO 9001 worldwide. ISO 14001, Responsible Care 14001, ISO 45001, ISO 50001, and OHSAS 18001, certification at 74% of facilities. In addition, Avient has ISO 9001 worldwide and ISO 14001 and ISO 50001 certification at many facilities.
https://www.avient.com/sites/default/files/2023-03/Silcosperse Flame Retardant Additives Product Bulletin %281%29.pdf
Manufacturers have the ability to design and validate to meet UL criteria, including: • UL 94 V-0 • UL 94 V-1 • UL 94 V-2 NON-HALOGENATED CHOICES Silcosperse flame retardants are also available as non-halogenated formulations. Avient makes no representations, guarantees, or warranties of any kind with respect to the information contained in this document about its accuracy, suitability for particular applications, or the results obtained or obtainable using the information. Avient makes no warranties or guarantees respecting suitability of either Avient’s products or the information for your process or end-use application.
https://www.avient.com/news/avient-feature-specialty-technologies-and-services-healthcare-mdm-west-2023
Manufactured across a global network of ISO 13485 facilities, they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, and ICH Q3D. Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines. They are offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.
https://www.avient.com/company/policies-and-governance/cpsia-information
What is the Consumer Product Safety Improvement Act (CPSIA)? The Consumer Products Safety Commission (CPSC) Global ISO Certificate Library
https://www.avient.com/sites/default/files/2023-10/LubriOne Product Selection Guide.pdf
Avient makes no representations, guarantees, or warranties of any kind with respect to the information contained in this document about its accuracy, suitability for particular applications, or the results obtained or obtainable using the information. Avient makes no warranties or guarantees respecting suitability of either Avient’s products or the information for your process or end-use application. AVIENT MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, either with respect to the information or products reflected by the information.
https://www.avient.com/news/cosmetic-packaging-reimagined-versaflex-pkg-thermoplastic-elastomers-polyone
Achieve regulatory compliance with REACH SVHC, FDA 21 CFR Avient Announces First Quarter 2025 Results... Avient To Hold First Quarter 2025 Conference Call...
https://www.avient.com/products/polymer-additives/healthcare-additives/mevopur-healthcare-functional-additives
Safety Data Sheets Technical Data Sheets Browse our library of product data sheets containing technical descriptions and details.
https://www.avient.com/sites/default/files/2024-07/Ballistic Resistant Composite Panels Product Selection _ Install Guide.pdf
Be sure to wear appropriate safety equipment including safety glasses and dust masks when fabricating. 3. Property GlasArmor Panel ThermoBallistic Panel Test Method Glass Content 55 wt% 73 wt% Density 0.066 lb/in3 1.83 g/cm3 0.062 lb/in3 1.72 g/cm3 ASTM D-792 Flex Mod 2.1–2.7 msi 14.5 - 18.6 GPa 2.5 msi 17.2 GPa ASTM D-790 Flex Strength 65 ksi 448 MPa 14 ksi 96.5 MPa ASTM D-790 Barcol Hardness 50–60 n/a ASTM D-2583 Fire Rating 1 hour1 n/a ASTM E-119-09c Flame Spread Rating 452 n/a ASTM E-84-08a Smoke Developed Rating 1652 n/a ASTM E-84-08a MATERIAL DATA (TYPICAL VALUES) 1 UL Level 3 panel was fire tested as part of a wall system with steel studs and drywall face sheet 2 NFPA & IBC Class B rating achieved www.avient.com Copyright © 2023, Avient Corporation. Avient makes no representations, guarantees, or warranties of any kind with respect to the information contained in this document about its accuracy, suitability for particular applications, or the results obtained or obtainable using the information.
https://www.avient.com/sites/default/files/2020-12/maxxam-fr-case-study.pdf
THE SOLUTION The manufacturer worked with Avient to identify alternatives to FEP insulation that would meet requirements in their data cable. After Avient delivered test data for pair combinations and the manufacturer’s team completed material trials, they were able to replace FEP with Maxxam FR material in four out of four insulation pairs. Upon achieving full-scale production, the manufacturer was also able to reach line speeds of over 1,000 fpm at thicknesses of 10 mil or below, while reducing material costs by 33%.