This formulation meets the requirements of the ISO 15759 standard for medical infusion equipment, and can be steam autoclaved using temperatures up to 121°C.

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.

Certificate Number: 255 ISO2P Date First Registered: 03/04/2023 Issued on: 11/04/2023 Valid until: 10/04/2026 Awarded to AVIENT PAKISTAN (PVT) LTD 1A/1, Sector#20, Korangi Industrial Area, Sector 20 Karachi, Pakistan In recognition of the Organization´s Food Safety Management System which complies with : ISO 22000:2018 Food Category : I For the scope of activities described below: Manufacturing & Processing of Polymer Resins & Master batch F-3/22/ A 100 Issue date : 06/2022 Version:03 It is mandatory to carry out the surveillance audit on its time.

Normative basis EN ISO 13485:2016 Medical devices – Quality Management System Page 1 of 3 Appendix of main certificate H61173 Central function Scope Norm / Revision Reg. no.

Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.

ISO 13485 certified manufacturing sites ISO 10993 and USP Class VI compliant solutions

Global ISO Certificate Library

OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified

They are available in certified USP Class VI and ISO 10993 compositions.

Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications.