https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.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?
https://www.avient.com/resources/safety-data-sheets?page=2179
P1) ISO 6000
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=4239
Geon(TM) DB4842A RED ISO STABLE LAM FR
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=6411
MAUVE DOOR, ISO-FIX COVER
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/news/avient-features-specialty-healthcare-material-solutions-services-mdm-west-2022
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.
Media contact
Scott Collins
scollins@collins-marcom.com
+1 216.382.884
https://www.avient.com/resources/safety-data-sheets?page=4959
Geon(TM) DB5405 Neutral Iso Stable
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=3525
730C BROWN IN ISO 2510
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/company/sustainability/sustainability-report/products/product-stewardship-and-product-safety
Risk Assessments – Avient is committed to conducting risk assessments on a prioritized list of hazardous materials greater than> 1 ton.
Global ISO Certificate Library
https://www.avient.com/sites/default/files/resources/CCG_ISO_9001_2015.pdf
https://www.avient.com/sites/default/files/2024-02/Suzhou (SEM) ISO 14001.pdf