https://www.avient.com/news/polyone-features-more-materials-approach-medical-devices-mdm-west-2020
OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified
https://www.avient.com/news/polyone-develops-new-silicone-alternative-tpe-medical-tubing
Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications.
https://www.avient.com/news/polyone-launches-neu-view-technology-radiopaque-translucent-catheters
They are available in certified USP Class VI and ISO 10993 compositions.
https://www.avient.com/idea/changing-regulations-ivdr
Dedicated global technical centers and ISO 13485 certified manufacturing sites round out the service offer and provide consistent support for diagnostic devices.
https://www.avient.com/idea/medical-stoppers-improved
This formulation meets the requirements of the ISO 15759 standard for medical infusion equipment, and can be steam autoclaved using temperatures up to 121°C.
https://www.avient.com/sites/default/files/resources/Ramos_ISO_14001.pdf
Gamma 650
Parque Industrial Santa María
Ramos Arizpe, Coahuila 25900
México
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
ISO 14001:2015
The Environment Management System is applicable to:
COMPOUNDING OF THERMOPLASTIC PRODUCTS
This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/industries/healthcare/labware-diagnostics/ivd-devices
Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopoeia, and ICH Q3D protocols for differentiation and patient adherence support
Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce product carbon footprint
https://www.avient.com/industries/healthcare/drug-delivery-systems/prefilled-syringes
Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard
Solutions compliant with USP Class VI and ISO-10993 regulations
https://www.avient.com/industries/healthcare/remote-monitoring-wearables/home-care-monitors
They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need
Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring
https://www.avient.com/sites/default/files/2024-02/ISO 14001吉力士-中英文%5B21%5D.pdf