https://www.avient.com/industries/healthcare/labware-diagnostics/ivd-devices
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
https://www.avient.com/industries/healthcare/remote-monitoring-wearables/home-care-monitors
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
https://www.avient.com/industries/healthcare/drug-delivery-systems/prefilled-syringes
Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard
Solutions compliant with USP Class VI and ISO-10993 regulations
https://www.avient.com/sites/default/files/2021-01/certificate-of-change-of-name-avient-canada-ulc.pdf
Number: BC1228188 CERTIFICATE OF CHANGE OF NAME BUSINESS CORPORATIONS ACT I Hereby Certify that POLYONE CANADA ULC changed its name to AVIENT CANADA ULC on January 15, 2021 at 12:13 PM Pacific Time.
Issued under my hand at Victoria, British Columbia On January 15, 2021 CAROL PREST Registrar of Companies Province of British Columbia Canada ELECTRONIC CERTIFICATE
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=4959
Geon(TM) DB5405 Neutral Iso Stable
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=3525
730C BROWN IN ISO 2510
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=2179
P1) ISO 6000
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=5092
Geon(TM) DB4842B ISO STABLE HI VISC
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=4228
ISO PURPLE TPU
Certificate of Analysis (COA) - labeled as "Material"