https://www.avient.com/knowledge-base/article/whats-difference-tpes-vs-silicones?rtype[]=1164
In Handbook of Polymer Applications in Medicine and Medical Devices,¹ Laurence W.
LSR has a long-standing track record of use in the medical industry.
Medical-grade TPEs can rival LSR in biocompatibility performance, depending on their chemistry.
https://www.avient.com/industries/packaging/cosmetics-packaging/skin-care
Medical Tubing
Medical Packaging
Medical Packaging
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/sites/default/files/2020-10/auto-injector-application-study.pdf
Requirements:
Excellent clarity, scratch resistance
and exceptional toughness for
visualization of medicant
levels
Avient Distribution HC Portfolio:
Acrylic, copolyester, PC
2.
Requirements:
Thermal conductivity for warming
of medicants
Trilliant™ Therma-Tech™
Thermally Conductive
Formulations
Heating system
13
Heat Exchanger
14
Technology Enabled
Design
Connected medical devices are
transforming the way care is
delivered by making it simpler, easier,
more collaborative, and more data
driven.
Smart health devices improve patient
medication adherence and monitoring
https://www.avient.com/news/new-details-specialty-sustainable-technologies-and-services-avient-featured-k-2022
Customer success story with a medical device company using Avient’s Colorant Chromatics™ Transcend™ Bio-compatible Premier Healthcare Colorants: Intended specifically for medical applications, the pre-colored solutions that are fully bio-compatible per ISO 10993 standards helped provide a customer that manufactures medical devices with ultra-high-heat resistance and performance for its orthopedic instruments without compromising safety.
https://www.avient.com/resource-center?document_type=59&page=18
Mevopur™ Bio-Based Polymer Solutions for Medical Devices and Pharmaceutical Packaging (Chinese)
Learn more about the benefits of using Mevopur™ bio-based polymer solutions in medical devices and pharmaceutical packaging (Chinese language version)
Liquid color & additive concentrates designed for use in medical devices and pharmaceutical packaging (Chinese language version)
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=10
Medical Mannikins
Compartment Cover for Medical Device
Auto-Injector Housing - Medical Delivery Device
https://www.avient.com/resource-center?document_type=59&page=10
Medical Mannikins
Compartment Cover for Medical Device
Auto-Injector Housing - Medical Delivery Device
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=10
Medical Mannikins
Compartment Cover for Medical Device
Auto-Injector Housing - Medical Delivery Device
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
These antistatic concentrates can be used to increase
the visual appeal of a medical device by avoiding
charge-related dust accumulation.
APPLICATIONS
• Medical devices
• Drug delivery devices
• Labware
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing risk of change
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP
biological evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
* FDA/EU compliance information available upon request
Copyright © 2023, Avient Corporation.
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 with all applicable laws and regulations, including
the suitability of all raw materials and components used for its manufacture.