https://www.avient.com/sites/default/files/2023-06/AVIENT_TPEs and LSR eBook.pdf
https://en.wikipedia.org/wiki/UV_degradation
Biocompatibility
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.
Some of the information arises from
laboratory work with small-scale equipment which may not provide a reliable indication of performance or
properties obtained or obtainable on larger-scale equipment.
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
China
has been assessed and certified as meeting the requirements of
麟 ISO 13485:2016
EN ISO 13485:2016
’骥鑫馨瓤) For the foiowing actratEes
Design and manufacture of medical grade thermoplastic elastomers
for non-active medical devices and active medical devices
遴;舞蒸;撇蒸 (non-implantable)
:护、::于b入沙黔娜;舞睡莎:器器舞蟒檬非拟拐称群亘爸竺舀‘。
https://www.avient.com/sites/default/files/2021-04/versaflex-tpe-contact-lens-case-case-study.pdf
The company tried several TPE grades, hoping to find
a material that would eliminate the adhesion problem
while providing comparable softness to silicone.
THE IMPACT
Avient’s formulation expertise produced a specialty
TPE solution that surpassed not only silicone but also
competitive TPEs to solve the gasket adhesion problem
for this medical manufacturer.
Adding to the value
of the solution, Avient provided a methodology to
quantify projected savings and calculate ROI, giving the
customer confidence to make a significant investment
in new tooling.
https://www.avient.com/sites/default/files/2025-03/ISO 13485 2025.pdf
3
Certificate
Certified sites according to appendix
Scope
concentrates and specialty compounds for the
Healthcare and Medical device market.
Normative basis
EN ISO 13485:2016 Medical devices – Quality Management System
Page 1 of 3
Appendix of main certificate H61173
Central function Scope Norm / Revision Reg. no.
https://www.avient.com/products/polymer-colorants/colorant-dispersions/stan-tone-rbx-rubber-dispersions
Enhanced and developed to meet specific requirements, Stan-Tone™ RBX dispersion technologies can be effectively used for a variety of applications, including industrial goods, automotive mats, rubber flooring, sponge rubber, wire and cable applications, and medical equipment.
https://www.avient.com/products/polymer-additives/surface-modifier-additives/cesa-low-retention-additives
Standard and custom color solutions for today’s complex medical applications
https://www.avient.com/products/engineered-polymer-formulations/general-engineered-formulations/custom-pre-colored-specialty-engineered-formulations
Antimicrobial corrosion and chemical resistant formulations to solve your medical application challenges
https://www.avient.com/products/polymer-additives/additive-dispersions/aquamix-additive-formulations
Portfolio of available dispersion colorants and additives for medical applications
https://www.avient.com/knowledge-base/article/selecting-and-molding-high-performance-thermoplastics
Recently, high-performance thermoplastics have been tapped for specialized 3D printed applications in aerospace and medical markets.
https://www.avient.com/sites/default/files/2020-07/phthalate-facts-brochure.pdf
Examples of
common applications include medical tubing, inflatables,
packaging film and sheets, garden hoses, toys and
automotive plastics.
PHTHALATES FACTS
PHTHALATES ARE KNOWN
TO BREAK DOWN IN THE
HUMAN BODY
Research has shown that after
entering the body, phthalate
are broken down into metabolites
within minutes and pass out
quickly in urine.2
PHTHALATE EXPOSURE
IS CONSIDERED LOW
Despite the fact that phthalates
are used in a wide range of
products, human exposure from
all sources is considered to be
extremely low.2
PHTHALATES ARE A USEFUL
CHOICE FOR HEALTHCARE
Flexible vinyl tubing does not
react with most medications,
allowing for reliable
administration of drugs, while
flexible vinyl bags prevent blood
contamination and extend shelf
life of the blood.3
PHTHALATES ARE
REGULATED
Based on earlier studies, a few
specific phthalates have been
banned for use in toys or other
items for sale to children
under twelve to reduce risk of
overexposure through hand-to-
mouth behaviors.
1 Source: chemicalsafetyfacts.org 2 Source: Centers for Disease Control and Prevention 3 Source: thisisplastics.com
www.avient.com
Copyright © 2020, Avient Corporation.
Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable
indication of performance or properties obtained or obtainable on larger-scale equipment.