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/sites/default/files/2024-12/ISO 22000-2024. Avient Sta. Clara 308865_en_46389 %2811%29.pdf
View PDF
The SQS herewith attests that the organisation named below has a management system that meets the requirements of
the normative base mentioned.
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Certificate
Avient Colorants MX S.A. de C.V.
Normative base
ISO 22000:2018 Food Safety Management Systems - Requirements
for any organization in the food chain
Reg. no. 46389
Page 1 of 1
Validity 25. 02. 2024 – 24. 02. 2027
Issue 20. 12. 2023
A.Grisard, President SQS F.
https://www.avient.com/company/sustainability/performance/report-archive
2023 CDP Certification
Global ISO Certificate Library
https://www.avient.com/company/sustainability/planet/responsible-care
In order to receive certification, an ACC member or Partner company must demonstrate conformance to the Responsible Care Management System’s comprehensive set of EHS&S requirements, which are validated through an independent, third-party audit process.
Global ISO Certificate Library
https://www.avient.com/company/sustainability/planet/environmental-stewardship/agency-support
CSA International is an independent product safety certification organization that helps achieve compliance with US and Canadian standards.
Avient currently has twenty-three facilities globally certified to the Corporation’s GMP program and two facilities certified to "ISO 13485, Medical Device - Quality Management Systems - Requirements for Regulatory Purposes."
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2024-08/PCF One-pager.pdf
CERTIFIED FOR ACCURACY AND
RELIABILITY
Our PCF Calculator is
third-party certified
by TÜV Rheinland and
aligns with the ISO
14067:2018 standard for quantifying and reporting
the carbon footprint of a product.
This certification
ensures that our tool meets rigorous criteria and
addresses relevant safety aspects, providing you
with reliable and accurate data.
https://www.avient.com/resource-center?document_subtype=0&document_type=59&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=1
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
Edgetek™ Engineered Polymer Formulations achieved a UL 94 V-0 flammability rating certification for server cabinets
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/resource-center?document_type=59&page=1
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
Edgetek™ Engineered Polymer Formulations achieved a UL 94 V-0 flammability rating certification for server cabinets
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/resource-center?document_type=59&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=1
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
Edgetek™ Engineered Polymer Formulations achieved a UL 94 V-0 flammability rating certification for server cabinets
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
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.”