Date Of Certification: 11 December 2024 Date Of Expiration: 10 December 2027 IATF Certificate N°: 0558656 Bureau Veritas Certification Certificate No: FR094003 - IATF Revision: 1 For Bureau Veritas Certification Holding, Tour ALTO, 4 place des saisons, 92400 COURBEVOIE – France (The official document is in English. Any translations of this document shall be used for reference only.) 1/2 Certificate of Approval AWARDED TO PolyOne France Tossiat Route de la vavrette, 01250, Tossiat - France IATF USI: LWZS4P Bureau Veritas Certification certify that the Quality Management System of the above organisation has been audited and found to be in accordance with the requirements of IATF 16949 - FIRST EDITION and the applicable customer specific requirements SCOPE Design and manufacturing PERMITTED EXCLUSION(S) None PRODUCT(S) DELIVERED colour with additive concentrates for thermoplastic resins and speciality compounds obtained by mixing and extrusion https://e-cer.bureauveritas.com/68LJQE0ZV0CO6I7YW0YSXOUMV9WWROQPHPI2AOHRRLFFVRAVTFVZGXKWIE3TOWLTTKEWCPQB9UNAPXHH6T0HXOMUEDVYPRPJLEXBBTKQYPBRICYOKY143TECQ5UMHGA3JX Date Of Certification: 11 December 2024 Date Of Expiration: 10 December 2027 IATF Certificate N°: 0558656 Bureau Veritas Certification Certificate No: FR094003 - IATF Revision: 1 For Bureau Veritas Certification Holding, Tour ALTO, 4 place des saisons, 92400 COURBEVOIE – France (The official document is in English. Any translations of this document shall be used for reference only.) 2/2 Appendix to the Certificate of Approval AWARDED TO PolyOne France Tossiat Route de la vavrette, 01250, Tossiat - France IATF USI: LWZS4P REMOTE SUPPORT FUNCTION(S) NAME ADDRESS SCOPE AVIENT LUXEMBOURG 19, Route de bastogne, 9638, Pommerloch - Luxembourg IATF USI: GAZS9A Purchasing, Logistics, Supplier Management PolyOne Europe Logistics 7 Rue bleriot, 4460, Grace-Hollogne - Belgium IATF USI: P4WA4Y Warehousing Polyone Poland Ul. wschdnia 6, 99-300, Kutno - Poland IATF USI: C4W5ZL Logistics https://e-cer.bureauveritas.com/68LJQE0ZV0CO6I7YW0YSXOUMV9WWROQPHPI2AOHRRLFFVRAVTFVZGXKWIE3TOWLTTKEWCPQB9UNAPXHH6T0HXOMUEDVYPRPJLEXBBTKQYPBRICYOKY143TECQ5UMHGA3JX 2024-12-13T10:07:11+0100 Authenticity and Integrity

Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau die Einführung und Anwendung eines Managementsystems gemäß DIN EN ISO 50001:2018 für den Geltungsbereich: Entwicklung und Produktion von technischen Thermoplasten; an den Standorten gemäß Anlage.

Additionally, Avient’s self-assessments, based on ISO 9001/IATF 16949, are requested of suppliers in order to provide insight into the core components of their Quality Management Systems (QMS) and subsequently used as approval criteria for Avient’s most sensitive end applications.

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.

The materials are produced under a third-party certified ISO 13485:2016 quality management system and backed by comprehensive change control of raw materials, formulation, and manufacturing standards to enable consistent batch-to-batch quality.”

Customer success story with a medical device company using Avient’s Colorant Chromatics™ Transcend™ Bio-compatible Premier Healthcare Colorants: Intended specifically for medical applications, the pre-colored solutions that are fully bio-compatible per ISO 10993 standards helped provide a customer that manufactures medical devices with ultra-high-heat resistance and performance for its orthopedic instruments without compromising safety. 

¹PCF values are calculated with Avient’s TÜV certified PCF-Calculator according to ISO 14067.  

In addition, Avient can provide product carbon footprint (PCF) values for these and other products using our PCF calculator, which was developed in accordance with ISO 14067:2018 Standard and third-party certified by TÜV Rhineland. 

Avient PCF values are determined using its PCF Calculator, which is certified by TÜV Rheinland and meets the ISO 14067:2018 standard.  

Mevopur™ Colorants represent a broad range of color concentrates and formulations, developed specifically for use in today’s complex healthcare applications, which meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661 and ICH Q3D.