https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
Lewiston, ME, 04240
United States of America
Scope
Avient CAI
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. 45484 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
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/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/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/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/resources/safety-data-sheets?page=2233
MB1614 MEDI-BALL RED
https://www.avient.com/resources/safety-data-sheets?page=4348
TR SC GREEN CAL V3
https://www.avient.com/resources/safety-data-sheets?page=6932
PE CAL BLUE
https://www.avient.com/resources/safety-data-sheets?page=2135
CAL CLASSIC LT ORANGE
https://www.avient.com/resources/safety-data-sheets?page=1650
MB2401 MEDI-BALL RED