https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-dynaflex-medical-face-mask.pdf
EUROPEAN MEDICAL
DEVICE MANUFACTURER
F A C E M A S K V E N T I L A T I O N
V A L V E
• ISO 9001 and USP VI compliant
• Compatible with overmolding onto PP
• Translucent and highly colorable
• Soft touch
• Provided valuable regulatory support and
documentation, enabling faster internal trials and
material qualification for this customer
• Worked together with customer to select the best
material from a broad portfolio of medical TPE
grades
• Trusted as a polymer supplier for multiple
healthcare applications
Dynaflex™ G2711 Thermoplastic Elastomer
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
BIOCOMPATIBILITY + SOFT TOUCH
LEARN MORE
© 2020, All Right Reserved
Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012
https://www.avient.com/products/thermoplastic-elastomers/dynaflex-thermoplastic-elastomers
European medical device manufacturer
https://www.avient.com/news/archives?page=51
– At MD&M West 2017 this week, PolyOne is highlighting the UltraMIST® Ultrasound Healing Therapy system, an innovative device f
ANAHEIM, Calif. – At Medical Design and Manufacturing (MD&M) West 2017 this week, PolyOne is demonstrating commercial medical products designed
https://www.avient.com/sites/default/files/2022-04/MEVOPUR LQ for Silicone Elastomers.pdf
Avient products have not been designed for nor are they promoted or intended for use in:
(a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under
US Pharmacopoeia (USP) or ISO standards; or
(b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or
(c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for:
(1) exposure to human tissue or body fluids for 30 days or greater;
(2) “plastic” (cosmetic or reconstructive) surgery use;
(3) reproductive implants or any birth control device; or
(4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device, including the suitability of all raw materials and
components used for its manufacture, and with all applicable laws and regulations.
1.844.4AVIENT
www.avient.com
https://www.avient.com/resource-center?document_type=221&all=1
Medical Grade Colorants and Additives for Wearable Medical Devices
Discover more about Avient medical grade colorant and additives for wearable medical devices.
Explore the power of polymer solutions for hygiene & medical nonwovens
https://www.avient.com/news/avient-add-further-capacity-medical-grade-mevopur-materials-asia-pacific
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Avient To Add Further Capacity For Medical-Grade Mevopur™ Materials in Asia Pacific
SINGAPORE – December 16, 2020 – Avient Corporation, a premier provider of specialized and sustainable material solutions and services, announced that it will equip an existing facility in Singapore with a new production line to meet the growing demand for specialty pre-colored ‘medical grade’ Mevopur™ polymers in the region.
Demand from local and regional customers for pre-colored Mevopur materials stems from an increase in the Asia Pacific market for medical and diagnostic devices and pharmaceutical packaging.
https://www.avient.com/sites/default/files/resources/PDI_Healthcare_Brochure_2011_0.pdf
HC_Industry bulletin_PDI_final.indd
www.polymerdiagnostics.com
Industr y Bul let in
Comprehensive consulting and testing
expertise for medical materials and
device companies
Committed to Growing with the Medical Industry
Since 2009, PDI has invested over $2 million to improve and extend our capabilities to serve our medical
materials and device clients.
PDI) is a complete solutions provider of plastics testing and polymer
consulting within the medical materials and device industries.
PDI) is a complete solutions provider of plastics testing and polymer
consulting within the medical materials and device industries.
https://www.avient.com/idea/medical-stoppers-improved
Stoppers and septums for medical infusion therapy systems must reseal after multiple penetrations.
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.
https://www.avient.com/sites/default/files/resources/Application%2520Bulletin%2520Resilience%2520HC.pdf
APPLICATION BULLETIN
Resilience™ HC for Medical Device Housings
Offering Improved Resistance to Hospital Disinfectants
EFFECT ON POLYMER HOUSINGS
FOR MEDICAL DEVICES
Unfortunately, the increased disinfection
practices among healthcare providers have
another effect.
Rigid polymers typically used
to make housings for medical devices are
failing to resist these chemicals.
The consequences to the medical
device manufacturer could include increases in:
• Service calls to repair damaged devices
• Warranty claims on damaged devices
• Product returns of damaged devices
TYPICAL APPLICATIONS
Below are just a few examples of the many
types of medical devices protected by rigid
polymer housings and frequently cleaned
with harsh disinfectants to fight HAI’s.
https://www.avient.com/knowledge-base/article/beginner-s-guide-tpe?rtype[]=1164
What are medical grade TPEs?
Not surprisingly, the healthcare market has additional regulatory requirements for those creating medical products and devices.
Additionally, automotive parts and devices made from TPE make vehicles lighter and more fuel efficient.
https://www.avient.com/idea/andwin-scientific-innovation-improves-dosing-accuracy
Once the syringe is removed, the adapter reseals and the cap can be put back on the bottle while the device remains in place.
The two teams reviewed a range of possible materials for the dosing adapter, which consists of the self-sealing membrane and a cylindrical shell with flexible fins that lock the device in place.
With the dosing adapter in place, medication bottles also have an additional layer of child-resistance.