Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopoeia, and ICH Q3D protocols for differentiation and patient adherence support Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce product carbon footprint

They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need   Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring

Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard Solutions compliant with USP Class VI and ISO-10993 regulations

HYPODERMIC NEEDLE MANUFACTURER N E E D L E H U B , C O V E R A N D S H I E L D • Compliance to ISO 6009 color coding for single use hypodermic needle • Biocompatibility of all component materials • Good mechanical and visual properties after sterilization (e.g. ETO / Gamma radiation) • Facilitated 510(k) submission with formulations registered under Device Master File MAF 1833 • Pre-tested raw materials to biocompatibility ISO10993, US and Eu Pharmacopeia, ICH-Q3D extractable metals • Enhanced stability with gamma stabilizing package • Minimized risk of change with change control beyond CAS number level • Ensured uninterrupted supply from multiple ISO 13485-2016 certified sites • MEVOPURTM ISO 6009 Standard / Customized Solutions KEY REQUIREMENTS WHY AVIENT?

Standard ISO 900 1:2O15 Scope of supply c II +t U t-r- '.F t- () (n rU '- c) l cu q) t_ l m Design, development, marketing & sales and related application support of UHMWPE, Ultra-High-Motecutar-Weight PolyEthytene fibers and UniDirecfionat sheets. Standard ISO 900 1:2015 Scope of suppty Version: 1 Revision date: 06 March 2024 Kerbusch - Director Certification Benelux Managing office: Bureau veritas lnspecLion and certification The Nethertan

Dedicated global technical centers and ISO 13485 certified manufacturing sites round out the service offer and provide consistent support for diagnostic devices.

Tested to ISO 10993

Raw materials tested to ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D

PCF values are calculated using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067