https://www.avient.com/sites/default/files/2025-03/65537-Certificate-05MAR2025.pdf
Page 1 of 5 https://abs.zertic.com https://abs.zertic.com ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Avient Corporation Avon Lake Corporate Responsible Care Corporate Support Activities in Sr.
Toluca 2000 Toluca Estado de México 50200 Mexico ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
Unit 3 Dodworth Business Park, Dodworth Barnsley South Yorkshire S75 3SP United Kingdom ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-dynaflex-medical-face-mask.pdf
EUROPEAN MEDICAL DEVICE MANUFACTURER F A C E M A S K V E N T I L A T I O N V A L V E • ISO 9001 and USP VI compliant • Compatible with overmolding onto PP • Translucent and highly colorable • Soft touch • Provided valuable regulatory support and documentation, enabling faster internal trials and material qualification for this customer • Worked together with customer to select the best material from a broad portfolio of medical TPE grades • Trusted as a polymer supplier for multiple healthcare applications Dynaflex™ G2711 Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2025-03/ISO 13485 2025.pdf
Normative basis EN ISO 13485:2016 Medical devices – Quality Management System Reg. no.
EN ISO 13485:2016 H61173 01.03. 2025 29.02. 2028 Locations Scope Norm / Revision Reg. no.
EN ISO 13485:2016 H61173 01.03. 2025 29.02. 2028 Avient Colorants USA LLC 17 Foss Rd.
https://www.avient.com/sites/default/files/2022-12/reSound Ultra Low Carbon Footprint TPE Product Bulletin_0.pdf
Calculated using the ISO 14067:2018 standard, the greenhouse gas (GHG) emissions are lowered by carbon sequestration and Avient’s green manufacturing practices.
PRODUCT BULLETIN reSound RS0200-9001 80 reSound RS0200-9001 60 Manufacturing Plant Location Gaggenau McHenry Suzhou Gaggenau McHenry Suzhou Cradle-to-Gate PCF* -0.46 -0.40 -0.40 -0.09 -0.03 -0.02 Hardness, Shore A 80 60 Overmold Substrate PP, PE PP, PE TECHNICAL PROPERTIES COMPARISON TO ALTERNATIVES Greenhouse gas (GHG) emissions from cradle-to-gate production 1.844.4AVIENT www.avient.com Copyright © 2022, Avient Corporation.
This literature shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. * Calculated according to ISO 14067:2018
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/2023-01/45324-Certificate-13JAN2023.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 45324 Certification Date: 24 February 2014 Effective Date: 13 January 2023 Expiration Date: 23 January 2026 Revision Date: 13 January 2023 Dominic Townsend, President DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE MEDICAL DEVICE INDUSTRY This certificate may be found on the ABS QE Website (www.abs-qe.com).
WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations Avient Corporation ISO 13485:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2025-09/54139-Certificate-28AUG2025.pdf
Certificate NEU Specialty Engineered Materials Certificate Of Conformance This is to certify that the Quality Management System of: NEU Specialty Engineered Materials 15 Corporate Drive North Haven CT 06473 United States has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 13485:2016 The Quality Management System is applicable to: Compounding, Prototype Services and Supply of Thermoplastics for the Medical Device Industry.
Rev1 This certificate’s validity is subject to the organization maintaining their system in accordance with ABS Quality Evaluations, Inc. 1701 City Plaza Dr Spring, TX 77389 USA requirements for management system certification.
For certificates issued in the People’s Republic of China information may also be verified on the Certification and Accreditation Administration of the People’s Republic of China’s website (www.cnca.gov.cn).
https://www.avient.com/resource-center/knowledge-base/article/deep-black-shades-polyester-textiles?pname%5B0%5D=20342
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/resource-center/knowledge-base/article/deep-black-shades-polyester-textiles?ind%5B0%5D=6601
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/sites/default/files/2024-09/24 EN 47.pdf
CERTIFICATE Signed for the certification body: Eric Louys Chairman Certification Committee CERTIFICATE EN ISO 50001 : 2018 Energy Management System VINÇOTTE nv Jan Olieslagerslaan 35, 1800 Vilvoorde, Belgium This is to certify that Avient Located at Rue Melville Wilson 2 5330 Assesse Belgium has established and maintains an energy management system according the requirements of EN ISO 50001 : 2018 “Energy Management System” for: Design and manufacture of colour and additive concentrates, thermoplastic resins and speciality compounds This certificate is based on the result of an energy audit documented in the audit report 61231731.
Certificate number: 24 EN 47 Valid from 1 February 2024 to 31 January 2027 Further clarifications regarding the scope of this certificate and the applicability of EN ISO 50001 : 2018 requirements may be obtained by consulting the organization.
This certificate is granted during the Certification Commission of 1 February 2024 and is subject to the General Regulations of VINÇOTTE nv.