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/sites/default/files/2024-12/ISO9001_English_Suzhou ColorMatrix.pdf
CNSUZ3-SUH9-20240123104552 QUALITY MANAGEMENT SYSTEM\,, CERTIFICATE Certificate No. 00124Q30506R5S/3200 We hereby certify that Color Matrix Plastic Colorants (Suzhou) Co., Ltd Business Registration Number: 91320505799067336K Registered I Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China by reason of its Quality Management System has been awarded this certificate for compliance with the standard ISO 9001:2015 The Quality Management System Applies in the following area: Production Activities of Plastic Colorant & Additive (UV Blockers, Anti-Oxidation, Anti-Aging) Certified since: January 8, 2009 Valid from: January 16, 2024 Valid until: January 4, 2027 the expiry date of last certification cycle: January 4, 2024 the date of recertification audit: December 21, 2023 to December 22, 2023 After a surveillance cycle, the certificate is valid only when used together with an Acceptance Notice of Surveillance Audit issued by CQC.
Please access www.cqc.com.cn for checking validity of the certificate.
This certificate and its relevant information can query in the website of Certification and Accreditation Administration of the People's Republic of China ( www.cnca.gov.cn). � 'Pf.ili>..P]' GNAs:::� � MANAGEMENT SYSTEM ...,,._.....
https://www.avient.com/sites/default/files/2024-12/ISO14001_English_Suzhou ColorMatrix.pdf
� ENVIRONMENTAL MANAGEMENT,_, ' J� - � Certificate No. 00124E30295R4S/3200 We hereby certify that Color Matrix Plastic Colorants (Suzhou) Co., Ltd Business Registration Number: 91320505799067336K Registered/ Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China by reason of its Environmental Management System has been awarded this certificate for compliance with the standard ISO 14001:2015 The Environmental Management System Applies in the following area: Production and Related Management Activities of Plastic Colorant & Additive (UV Blockers, Anti-Aging,Anti-Oxidation) Certified since: June 6, 2012 Valid from: January 17, 2024 Valid until: January 7, 2027 the expiry date of last certification cycle: January 7, 2024 the date ofrecertification audit: December 21, 2023 to December 22, 2023 After a surveillance cycle, the certificate is valid only when used together with an Acceptance Notice of Surveillance Audit issued by CQC.
Please access www.cqc.com.cn for checking validity of the certificate.
This certificate and its relevant information can query in the website of Certification and Accreditation Administration of the People's Republic of China ( www.cnca.gov.cn). � 'PliiAPT ih �� � GNAS :::; 1�� ':t '"�� � =�� SYSTEM -si;�-;;db;:·x�-Zh��x� MEMBER OF ••••• ......... .· .•.. •·····--·· . . � IQNET CHINA QUALITY CERTIFICATION CENTRE Section 9, No.188, Nansihuan(the South Fourth Ring Road) Xilu(West Road), Beijing 100070, China http://www.cqc.com.cn A 0082431 20221:f=�&
https://www.avient.com/resource-center/knowledge-base/article/regulatory-issues
These include ISO pre-certified colorants; FDA-compliant materials from engineering thermoplastics and elastomers to vinyl, styrenics and olefins; RoHS and REACH compliant materials; and much more.
https://www.avient.com/sites/default/files/2024-03/Global Supplier Quality Manual_2024.pdf
Minimum requirements are adopted from the ISO 9001 standard.
Avient requires a Certification of Analysis (COA) and supplier specification documents for every shipment of raw material.
Avient categorization for a “supplier” FDA Food & Drug Administration IATF International Automotive Task Force Interested Party Term referenced in ISO 9001.
https://www.avient.com/industries/healthcare/labware-diagnostics/laboratory-equipment
Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for identification and differentiation
Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICHQ3D protocols to reduce product carbon footprint
Flexible, durable, and colorable TPEs for improved grips and gaskets that comply with USP Class VI and ISO 10993
https://www.avient.com/news/advanced-technologies-and-sustainable-material-innovations-avient-debut-chinaplas-2024
Mevopur™ Healthcare Colorants and Formulations: a range of medical grade concentrates and pre-colored formulations for a wide range of polymers used in applications such as remote patient monitoring, circulating blood contact, and invasive devices, with pre-tested biocompatibility according to ISO 10993, change control in place, production certified to ISO 13485-2016 and DMF/MAF files available
Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: high-temperature solutions 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/email-fraud-information
Global ISO Certificate Library
https://www.avient.com/resource-center/services/product-carbon-footprint-pcf-calculator
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 confirms our tool meets defined criteria and safety-relevant aspects.
https://www.avient.com/sites/default/files/2024-01/308699_en_46089.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. 70 01 _1 /A pr il 20 22 /V er si on 2 .0 Certificate Avient Colorants Germany GmbH Hohenrhein 1 56112 Lahnstein Germany Scope Production of Color Concentrates and Compounds Normative base ISO 50001:2018 Energy Management System Reg. no. 46089 Page 1 of 1 Validity 17. 12. 2023 – 16. 12. 2026 Issue 17. 12. 2023 A.Grisard, President SQS F.