https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
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/2020-08/willowwood-prosthetics-case-study.pdf
After extensive testing, including mechanical testing to
ISO 10328 standards and a six-month participant clinical
trial, WillowWood introduced DuraWalk™, their most
advanced low-activity foot.
https://www.avient.com/sites/default/files/2022-12/Cesa Fiber Additives Antimicrobials Product Bulletin.pdf
PRODUCT BULLETIN
KEY BENEFITS
Avient’s antimicrobial concentrates for fiber
applications provide the following benefits:
• High active-ingredient loading which translates
to excellent efficacy at low let-down ratios
• Easily withstand 50 washings in ISO 20743
standard tests
• Also applicable for bi-component technology
• Low levels of abrasiveness means higher
process performance—reducing cost in the
spinning phase
• Can be combined with colors and with other
additives (e.g., flame retardants) into a single
combination concentrate for convenience
• Product guidance and technical assistance from
our experts
Copyright © 2022, Avient Corporation.
https://www.avient.com/sites/default/files/2023-12/Cesa Light Additives for Injection Molding Product Bulletin.pdf
The white ABS
plastic samples, produced with and without Cesa
Light Additives, were exposed to simulated sunlight
conditions using the weathering test ISO 4892-
2:2013.
https://www.avient.com/sites/default/files/2025-01/NEUSoft Product Selection Guide.pdf
Whether your application demands can be supported
by the NEUSoft Express color palette or require
customization, all our NEUSoft TPUs are designed with
patient safety and regulatory specifications in mind,
complying with ISO 10993 and USP Class VI standards.
https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%252014001_2015_EXP%25202021_0.pdf
Industrial Valle del Cinca
s/n Apartado 18
22300 Barbastro, Huesca
Spain
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
ISO 14001:2015
The Environment Management System is applicable to:
DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.
https://www.avient.com/sites/default/files/2024-05/Avient Zertifikat deutsch - 2024.pdf
Bergmann GmbH
Adolf-Dambach-Str. 2-4
76571 Gaggenau
die Einführung und Anwendung eines Managementsystems gemäß
DIN EN ISO 50001:2018
für den Geltungsbereich:
Entwicklung und Produktion von technischen Thermoplasten; an den Standorten
gemäß Anlage.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-3810-covid-19-containment-tube-screw-caps-case-study.pdf
DIAGNOSTICS
MANUFACTURER
C O V I D - 1 9 C O N T A I N M E N T
T U B E S C R E W C A P S
• Wide range of durometers with consistent raw materials
• Processing consistencies across the durometer ranges for
an easy transition between materials
• Materials formulated without animal derivatives at a
competitive cost
• Offered a comprehensive range of solutions
to accommodate specific application
demands such as barrier, flexibility, and
sealing performance
• Provided materials manufactured in an ISO
13485 certified facility
• Delivered a series of medical-grade TPEs
that could be extruded and injection molded
Versaflex™ HC 3810 Thermoplastic
Elastomers
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING
EXTRUDER
B I O P H A R M A C E U T I C A L
T U B I N G
• Low leachables & extractables
• Great tensile performance and kink resistance
• Good thermal weldability
• Excellent clarity and medical blue tint
• ISO 10993-4 & 5, USP Class VI & Animal Derivative Free
(ADF)
• Supplied drop-in material replacement to
overcome supply constraints of incumbent TPE
• Offered a lower extractable profile than
comparable materials in the market
• Enabled easy material transition without changes
in tooling or thermal welding machine settings
• Formulated solution with proprietary additives to
provide clarity and prevent yellowing after
sterilization
Versaflex™ HC BT218 Thermoplastic
Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2024-02/Santa Clara_ISO22000.pdf
Plasticos 28
Santa Clara Coatitla
55540 Ecatepec de Morelos, Estado de México
Mexico
Scope
Category I
Production of customer specific Masterbatches
for Food packaging materials on the dedicated
extrusion lines
Normative base
ISO 22000:2018 Food Safety Management Systems
Requirements for any organization in the food chain
Reg. no. 46389 Validity 25. 02. 2021 – 24. 02. 2024
Issue 30. 06. 2021
Swiss Made
sqs.ch
F.