https://www.avient.com/news/polyone-expands-lineup-pre-certified-biocompatible-healthcare-colorants-and-additives
These colorants and additives are pre-certified to meet USP Class VI or ISO 10993 biocompatibility testing for global healthcare applications, such as medical devices, pharmaceutical, and health & wellness products.
We can now offer expanded resin families that incorporate biocompatible functional additives, in both masterbatch and compounded forms, that meet or exceed industry standards for USP Class VI or ISO 10993 biocompatibility testing.”
https://www.avient.com/news/specialty-polymer-solutions-avient-improved-durability-and-sustainability-healthcare-products-pharmapack-2023
All materials in this range are formulated to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS.
All the materials are manufactured in ISO 13485-2016 certified sites and supported by testing to ISO 10993-1, USP, EP, and ICH Q3D protocols.
https://www.avient.com/products/polymer-additives/healthcare-additives/mevopur-healthcare-functional-additives
Global network of ISO 13485 certified manufacturing sites
ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission
MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield
https://www.avient.com/company/policies-and-governance-0/avients-human-rights-policy
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/avients-position-water-stewardship
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/cpsia-information
PDI is accredited under ISO 17025 by A2LA (the American Association for Laboratory Accreditation) to perform testing as an independent laboratory body.
Global ISO Certificate Library
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-biocompatible-peek-pre-colored-compounds
Biocompatibility: Our PEEK solutions have passed ISO 10993 biocompatibility testing, ensuring safety and reliability for medical applications.
Passed ISO 10993 biocompatibility testing, suitable for medical use
https://www.avient.com/news/avient-launches-new-bio-based-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2022
Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/news/avient-attains-acc-responsible-care-14001-global-certification-environmental-health-safety-and-security-excellence
Obtaining the RC14001® certification is unique as it encompasses security, product safety, and transportation elements, setting itself apart from the individual ISO 14001 and ISO 45001 certifications.”
https://www.avient.com/news/polyone-specialty-tpe-material-enables-oems-meet-skin-sensitivity-testing-requirements
– June 24, 2014 – PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer (TPE) solutions, today announced that its Versaflex™ CE 3620 material meets all ISO 10993-10:2010 testing requirements with no signs of irritation.
Several Versaflex CE materials have been used in wearable electronics applications without irritation for a number of years, and the recent ISO testing results underscore this track record.
