https://www.avient.com/sites/default/files/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.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/sites/default/files/2024-07/TPE Whitepaper_0.pdf
Ergonomic Enhancements
TPE soft grips can also optimize medical practitioners’ control of surgical instruments during procedures
and protect expensive handheld diagnostic devices.
In addition, when used to produce easy-open
pill bottles in various colors that can be clearly identified, TPEs aid arthritic patients while they self-
administer medications at home.
4.
In addition, the formulation
meets ISO 15759 requirements for medical infusion equipment and is
manufactured in an ISO 13485 facility.
https://www.avient.com/sites/default/files/2021-05/avnt-tpe-beginner-guide-fin.pdf
What are medical
grade TPEs?
What are medical grade
TPEs?
Medical tubing made from
TPE is likewise formulated from a medical grade that withstands various
fluids without degrading.
https://www.avient.com/resource-center?document_type=59&document_subtype=117&page=0
Disinfectant Resistance for Medical Device Housings - Case Study
Manufacturer boosts disinfectant resistance for medical device housings using Trilliant HC High Performance Formulations
https://www.avient.com/resource-center?document_type=59&document_subtype=127&industry=0&product_family=81&product_subfamily=0&product_name=0&op=FILTER RESULTS&form_build_id=form-Ojq3VtEkRrXIsgZSyKvAgO_Z3JHuKtjJLR7xfOXoAI8&form_id=resource_filter_form&page=2
Disposable Medical Tray
Medical Device Housing
https://www.avient.com/resource-center?document_type=0&industry=0&product_family=84&product_subfamily=0&product_name=0&op=FILTER RESULTS&form_build_id=form-fNS88LG3BRw1MCsEhxqrGzoCcCISeOxlsDfIOUV4Mx0&form_id=resource_filter_form&page=1
Explore the power of polymer solutions for hygiene & medical nonwovens
Discover how Avient's polymer colorants and additives can help increase the performance and appeal of nonwovens used in hygiene and medical applications
https://www.avient.com/products/polymer-additives/repellant-antimicrobial-additives/cesa-withstand-antimicrobial-additives
Antimicrobial Additives for Medical Gowns
Customized Cesa™ WithStand Antimicrobial Additives were used for medical gowns to support compliance and performance.
https://www.avient.com/resource-center?document_type=59&page=26
The lower extractable profile of Versaflex™ HC BT218 thermoplastic elastomer provided a drop-in material replacement with excellent clarity and performance for a medical tubing extruder
Medical Device Housing
https://www.avient.com/resource-center?document_subtype=0&document_type=59&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=31
Disinfectant Resistance for Medical Device Housings - Case Study
Manufacturer boosts disinfectant resistance for medical device housings using Trilliant HC High Performance Formulations
https://www.avient.com/resource-center?document_type=59&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=6
Explore the power of polymer solutions for hygiene & medical nonwovens
Discover how Avient's polymer colorants and additives can help increase the performance and appeal of nonwovens used in hygiene and medical applications