https://www.avient.com/sites/default/files/2021-07/neu-quality-commitment-2021.pdf
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Only the electronic version of this document in ETQ is the controlled version of the document.
In the event that
the NEU determines that it is the root cause of the Customer complaint, a corrective
action will be issued, and preventive actions will be developed to address the root
cause.
10.0 MANAGEMENT OF SUPPLIERS
10.1 NEU will maintain and ensure oversight and monitoring of applicable suppliers in
accordance with the requirements of ISO 13485 Quality Management System.
11.0 TRACABILITY, RECORDS & RETENTION
11.1 NEU is responsible for establishing and maintaining controlled documentation of
product and raw material component traceability during all stages of production and
shipment.
11.2 An electronic record of the manufacturing conditions and raw materials (vendor ID and
lot number) used to manufacture each batch is retained and preserved for a period of at
least 7 years from the manufacture date or as specified by applicable Regulatory
Requirements.
11.3 An electronic record of the Customer purchase order and NEU sales order confirmation
will be retained and for a period of at least 7 years from order acceptance date.
11.4 A representative sample of the product manufactured will be retained for a period of at
least 1 year from manufacture date.
12.0 EXPIRATION
12.1 NEU’s obligations contained in this Quality Commitment will automatically expire if the
Customer does not purchase product from NEU for a period of one year.
https://www.avient.com/sites/default/files/2024-09/Maxxam FR Polyolefin Formulations - Product Overview.pdf
Temp (HDT 0,45 MPa) °C 60–100 80–145 80–160 40–80 60–120 60–110 60–100 80–145 80–145 40–80 60–120 60–110
Flammability, UL94 Step V2-V0/5VA V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0
Glow Wire
Flammability Index °C 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960
CTI V 450–00 450–600 450–600 450–600 450–600 450–600 350–600 350–600 350–600 350–600 350–600 350–600
Oil Resistance – + + + + + + + + + + + +
Drying Required – Y Y Y Y Y Y Y Y Y Y Y Y
Process (IM, EX, BM)1 – (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX)
Other Modifications2 – Impact, HS,
GB, T, HS,
UV, LM GF, HS, UV, LM Impact, HS,
GB, T, HS,
UV, LM GF, HS, UV, LM Impact, HS,
UV, LM GF, HS, UV, LM Impact, HS,
GB, T, HS,
UV, LM GF, HS, UV, LM
Descriptions
Lower density
with moderate
strength.
Good
chemical
1 IM: Injection Molding, EX: Extrusion, BM: Blow Molding
2 HS: Heat Stabilized, UV: UV Stablized, LM: Lasermarking.
https://www.avient.com/sites/default/files/2023-11/ISO 9001 2015_Hickory NC.pdf
1616267 Certification Effective Date: April 1, 2021
Issue Date: March 30, 2021 Certificate Expiry Date: March 31, 2024
________________________________________________________________________________
ISO 9001
Registered by:
QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.
https://www.avient.com/sites/default/files/2021-04/trilliant-hc8900-medical-device-housing-case-study.pdf
DEVICE
MANUFACTURER
M E D I C A L D E V I C E H O U S I N G
• Improved chemical resistance compared to PC/ABS,
PC/PET & COPE
• Flame retardant (FR) rating of V-1 at 0.75 mm
• Zero BPA & non-halogenated FR material
• Available in standard hospital grade pre-colors
• Provided a cost-effective material with superior
chemical resistance to traditional materials
• Formulated a medical-grade, semi-crystalline
blend to support regulatory testing and
approvals
• Demonstrated superior property retention and
crack resistance after exposure to hospital-
grade disinfectants, including Virex® Tb,
helping to extend the device life
Trilliant™ HC8900 Thermoplastics
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2020-09/case-study-one-pager-hybrid-5g-cable.pdf
OFC
MANUFACTURER
5 G H Y B R I D C A B L E
J A C K E T I N G & I N S U L A T I O N
• Fire performance: reduce smoke and fume production,
high flame and char resistance
• Reduce development time
• Meet required standards: UL 1581 (Class XL) mechanical
properties , UL 1685 (flame test/smoke parameters), FT2
& FV2 (VW1)
• Accelerated speed to market, reducing
development time to three months
• Instilled confidence and proved material
expertise as solutions passed extensive
testing ahead of competition
• Optimized cable manufacture process and
line speed following trials at customers
facility
ECCOH 5549/1 LDD & Syncure™ S100FH
KEY REQUIREMENTS
WHY AVIENT?
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?