https://www.avient.com/sites/default/files/2023-10/308659_en_46154.pdf
Ltd.
30, Hsing Pang Road
33068 Taoyuan Taiwan
Scope
Design and manufacture of colour and additive
concentrates and specialty compounds for the
Healthcare and Medical device market.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 46154 Validity 12.01.2022 – 11.01.2025
Issue 12.01.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
F.
https://www.avient.com/news/polyone-acquires-magenta-master-fibers
And consistent with the megatrend of improving health and wellness, additional textile growth opportunities include applications within the hygiene, healthcare and medical markets.
is a premier provider of specialized polymer materials, services and solutions.
You are advised to consult any further disclosures we make on related subjects in our reports on Form 10-Q, 8-K and 10-K that we provide to the Securities and Exchange Commission.
https://www.avient.com/sites/default/files/2020-07/comptek-catalog.pdf
We have helped
customers develop parts that are:
• Wear-resistant: End products such as
bearings and sleeves that do not
require lubrication
• Conductive: Electrical and/or thermal
conductivity, in molded and extruded parts
• X-Ray opaque: Used for medical and dental
devices.
Multi-use medical and dental products
• Aerospace parts
• Automotive systems
• Fuel and chemical handling equipment
• Sensors and pumps
• Home appliances
Let’s get started!
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/2020-07/versaflex-hc-syringe-plunger-english.pdf
Versaflex HC - Syringe Plunger - English
SYRINGE
MANUFACTURER
D I S P O S A B L E S Y R I N G E
P L U N G E R
• USP VI and ISO 10993-4,5 compliant
• Sterilize by gamma & EtO
• Long-term sealing performance
• Low coefficient of friction (COF)
• Consistent performance across barrel sizes
• Provided a formulated solution that met
rigorous medical application requirements
• Improved global supply continuity
• Increased process efficiency by replacing
previous thermoset material with TPE
Versaflex™ HC 2110-57B
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/trilliant-xr-ct-and-mri-scanners.pdf
Trilliant XR - CT and MRI Scanners
MEDICAL DEVICE
MANUFACTURER
M R I A N D C T S C A N N E R S
• Uniform shielding with no “hot spots”
• X-ray shielding up to 140 KeV
• Meet European Union’s Restriction of Hazardous
Substances (RoHS) future compliance requirements
• Provided a lead alternative solution that
delivered improved geometric flexibility for
more uniform radiation shielding
• Lowered shielding component costs 30-50%
by eliminating machining and assembly steps
Trilliant™ XR Lead Replacement
Thermoplastics
KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2023-07/CORE Medical Manikin Case Study Snapshot.pdf
LEADING MEDICAL
TRAINING COMPANY
M E D I C A L M A N I K I N S
• Ability to color code various body parts for more accurate
teaching and instruction
• Maintain durability and performance through repeated use
in a variety of training scenarios
• Meet customer’s regulatory requirements
• Provided specific colors and hardness for
easier identification of body parts
• Supplied a non-phthalate plastisol
formulation that maintained strength and
flexibility over an extended time
• Offered robust technical support and
regulatory assistance to meet all compliance
directives as required by customer
Core™ Non-Phthalate Plastisols
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-07/mevopur-needle-hub-1-page-case-study.pdf
NEEDLE HUB
MANUFACTURER
N E E D L E H U B C O L O R S
• RAL and Pantone® colors available in palette to align with
ISO 6009 color standard
• Opaque and transparent polypropylene selections
available in both masterbatch and ready-to-use precolors
• Raw materials pre-tested to ISO 10993 and USP Class VI
medical device guidelines
• Certified formulations available globally
• Provided RAL and Pantone colors as
required
• Developed custom polypropylene
formulations to meet specific opacities
• Offered pre-tested raw materials and
produced in an ISO 13485 certified site,
minimizing risk across the value chain
• Provided global formulations transferrable
from our three ISO 13485 certified facilities
Mevopur™ Healthcare Colors
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
240625-2017-AQ-RGC-NA-PS
Initial certification date:
14 September 2017
Valid:
08 February 2025 – 07 February 2028
This is to certify that the management system of
PolyOne-Shanghai, China
88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode:
91310000607342402D)
has been found to conform to the Quality Management System standard:
ISO 13485:2016
This certificate is valid for the following scope:
Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates
Used for the Plastic Parts of Medical Devices
http://www.dnv.com
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/additive-dispersions/aquamix-additive-formulations
Portfolio of available dispersion colorants and additives for medical applications