Certificate - ISO 9001 - Avient Corporation - 337726 - 23521672 (1).pdf

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?

HAZEL DOOR, ISO-FIX COVER

Geon(TM) DB5337 NEUTRAL ISO TT STAB FUNG

Geon(TM) DB5334 Neutral Iso-Stable

P1) ISO 2500

Geon(TM)DB5291 NEUTRAL ISO STABLE BETTER HS

P1) ISO 3000Y

Developed with the rigorous demands of the healthcare industry in mind, these innovative pre-colored compounds are formulated with materials that have been successfully tested for ISO 10993 biocompatibility, supporting compliance with the highest standards for medical applications.

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