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/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/sites/default/files/2025-01/Stethoscope Dispersions Case Study Snapshot.pdf
MEDICAL DEVICE
MANUFACTURER
S T E T H O S C O P E S
• Provide a silicone paste colorant dispersion for liquid silicone
rubber (LSR) to use in stethoscope ear tips
• Create a custom-colored vinyl plastisol formulation for
stethoscope tubing
• Harmonize color across materials to meet specific process
and performance requirements
• Deliver effective communication and cross-functional
collaboration
• Offered dependable silicone paste colorants
that allowed for comfort and easy sterilization
• Provided a colored vinyl plastisol to reduce
tackiness and support product longevity
• Collaborated internally to align all materials and
provide color consistency across components
• Supported fast color changes and met quality
specifications through constant communication
and technical expertise
Silcopas Silicone Paste Colorants and
CORE Vinyl Plastisols for Healthcare
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/vinyl-formulations/vinyl-plastisols-organosols/core-vinyl-plastisols-healthcare
https://www.avient.com/products/polymer-colorants/colorant-dispersions/colorants-liquid-silicone-rubber
Slide 1: Medical device manufacturer
https://www.avient.com/news/avient-unveils-high-temperature-vibrant-colorants-healthcare-mdm-west-2022
CLEVELAND – March 30, 2022 – Avient today announced that it will launch new biocompatible colorants at the upcoming Medical Device & Manufacturing West exhibition in Anaheim, California.
Colorant Chromatics™ Transcend™ Premier Healthcare Colorants are formulated to offer ultra-high heat resistance and performance specifically for medical applications, and are available in a range of vivid colors.
https://www.avient.com/resource-center?document_type=59&document_subtype=117
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/products/vivo-formulations-healthcare
We have the material and formulation expertise to manufacture the right solution for your medical application.
Antimicrobial corrosion and chemical resistant formulations to solve your medical application challenges
Designed to help you overcome challenges for healthcare devices and applications
https://www.avient.com/resource-center?document_subtype=127&document_type=59&form_build_id=form-Ojq3VtEkRrXIsgZSyKvAgO_Z3JHuKtjJLR7xfOXoAI8&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=81&product_name=0&product_subfamily=0&page=2
Disposable Medical Tray
Healthcare device OEM benefitted from single source supplier for pre-colored solutions, Trilliant™ HC thermoplastics, and regulatory support
Medical Device Housing
https://www.avient.com/sites/default/files/2020-09/oncolor-hc-product-bulletin-1.pdf
These customizable color solutions enhance
brand value and promote product differentiation
for medical device, cosmetic, or pharmaceutical
polymer applications.
OnColor
HC Plus Colorants have been tested across a
wide range of medical polymers to provide
added confidence in meeting these critical bio-
compatibility standards.
KEY CHARACTERISTICS
• Polymer colorants formulated specifically for
healthcare product applications
• Meets and exceeds various material
performance requirements including
FDA 21 CFR, ISO 10993 and USP Class VI
• HC Plus colorants certified for bio-compatibility
• Available as pre-color, concentrate,
masterbatch or Smartbatch™ combined
colorant/additive solution
• Wide range of colors, striking special effects
and custom color matching
MARKETS AND APPLICATIONS
OnColor™ HC and HC Plus Colorants are an
excellent choice for medical devices and parts,
pharmaceutical or cosmetic packaging, and many
other healthcare related polymer applications.
https://www.avient.com/sites/default/files/2020-08/trilliant-case-study-1.pdf
MANUFACTURER BOOSTS
DISINFECTANT RESISTANCE
FOR MEDICAL DEVICE
HOUSINGS
HIGH PERFORMANCE MEDICAL FORMULATIONS
© 2020, All Rights Reserved
Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012
To learn more about Trilliant HC, contact Avient
at +1.844.4AVIENT (1.844.428.4368).
Here’s a case in point: A leading manufacturer of
medical devices in North America had established
a great brand with excellent quality, but wanted
to improve the resistance of its PC/ABS equipment
housings to this new disinfection protocol.
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‘。