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https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
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ASTM ISO Shore A/D
ASTM/ISO %
https://www.avient.com/sites/default/files/2025-07/ColorMatrix Amosorb Oxyloop-1 Product Bulletin.pdf
ColorMatrix™ Amosorb™ Oxyloop-1 O2 Scavenging Additive to Enhance Recycling Part of the ColorMatrix™ Amosorb™ range, ColorMatrix Amosorb Oxyloop-1 is a recycling enhancer oxygen scavenging additive formulated to achieve leading results in terms of bottle-to-bottle recyclability.
KEY BENEFITS • EPBP bottle-to-bottle recyclability accredited • Non-nylon based product • Compatible with rPET (recommended for >up to 100% rPET content) • No scavenging delay or deactivation • Excellent bottle clarity • Fit to use in monolayer as well as multi-layer bottle structures * European Platform for Bottle Packaging 1 https://eur-lex.europa.eu/legal-content/EN/ LSU/?
REGULATORY ColorMatrix Amosorb Oxyloop-1 meets direct food contact regulatory requirements in major markets.
https://www.avient.com/company/sustainability/planet/environmental-stewardship
ISO 14001 certifications follow intensive environmental audits of organizations, conducted by third-party ISO representatives.
At present, multiple Avient facilities hold ISO 14001 Certification.
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-spanish.pdf
Versaflex HC - Syringe Plunger - Spanish
FABRICANTE DE
JERINGAS
É M B O L O D E J E R I N G A
D E S E C H A B L E
• Cumplir con las normas USP VI e ISO 10993-4,5
• Esterilización con gamma y EtO
• Rendimiento de sellado a largo plazo
• Bajo coeficiente de fricción (COF)
• Rendimiento uniforme en jeringas de diferentes diámetros
• Ofreció una solución formulada que cumple
con los requerimientos rigurosos de una
aplicación médica
• Mejoró la continuidad del suministro global
• Aumentó la eficiencia del proceso al
sustituir el material termoestable anterior
con un TPE
Versaflex™ HC 2110-57B
REQUERIMIENTOS CLAVE
¿POR QUÉ AVIENT?
https://www.avient.com/sites/default/files/2024-06/Avient Melle - 2024.pdf
Bergmann GmbH
Adolf-Dambach-Str. 2-4
76571 Gaggenau
die Einführung und Anwendung eines Managementsystems gemäß
DIN EN ISO 50001:2018
für den Geltungsbereich:
Entwicklung und Produktion von technischen Thermoplasten; an den Standorten
gemäß Anlage.
https://www.avient.com/news/avient-highlight-bio-based-polymer-solutions-pharmapack-2024
Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.
Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally.
Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS
https://www.avient.com/news/new-european-fire-safety-standards-met-polyone’s-eccoh-formulations-wire-and-cable
In addition, these proven materials comply with the newly harmonized EN 13501 EU standard for reaction to fire.
Michelle Maniscalco
Marketing Communications Manager, North America
PolyOne Corporation
+1 440-930-1988
michelle.maniscalco@avient.com
https://www.avient.com/news/medtec-china-2024-avient-announces-healthcare-tpu-manufacturing-expansion
Additionally, Avient’s ISO 13485 manufacturing site in Singapore for its Mevopur™ formulations recently achieved ISO/IEC 17025 accreditation for Biological Evaluation of Medical Devices–Part 5: Tests for In-Vitro Cytotoxicity.
Mevopur™ Healthcare Colorants and Functional Additives: formulations pre-tested to support compliance with regulatory requirements, such as USP Class VI, ISO 10993, EP3.1, USP661.1, and ICH Q3D and manufactured across a global network of ISO 13485-certified facilities or under GMP certifications.
PCF values are available for these products and are based upon a TUV-certified ISO-14067: 2018 process.
https://www.avient.com/sites/default/files/2020-09/oncolor-hc-product-bulletin-1.pdf
Also available are OnColor HC Plus Colorants,
certified to meet or exceed USP Class VI and ISO
10993 bio-compatibility requirements.
KEY CHARACTERISTICS
• Polymer colorants formulated specifically for
healthcare product applications
• Meets and exceeds various material
performance requirements including
FDA 21 CFR, ISO 10993 and USP Class VI
• HC Plus colorants certified for bio-compatibility
• Available as pre-color, concentrate,
masterbatch or Smartbatch™ combined
colorant/additive solution
• Wide range of colors, striking special effects
and custom color matching
MARKETS AND APPLICATIONS
OnColor™ HC and HC Plus Colorants are an
excellent choice for medical devices and parts,
pharmaceutical or cosmetic packaging, and many
other healthcare related polymer applications.