https://www.avient.com/news/avient-highlight-bio-based-polymer-solutions-pharmapack-2024
Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.
Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally.
Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS
https://www.avient.com/sites/default/files/resources/PolyOne%2520Standard%2520Quality%2520Response_2016_6_9.pdf
Avon Lake, OH 44012
P: +1 (440) 930-3000
I: +1 (866) 737-2066
F: +1 (440) 930-3064
Dear Valued Customer:
Thank you for your inquiry regarding the quality system at PolyOne.
ISO certificates can be found at
www.polyone.com under Quick Links > ISO
List.
Yes.
5.2 Supplier Management
1.
https://www.avient.com/sites/default/files/2024-12/67599-Certificate-06DEC2024.pdf
Certificate Avient Corporation
Certificate Of Conformance
This is to certify that the Quality Management System of:
Avient Corporation
33587 Walker Road
Avon Lake OH
44012
has been assessed by ABS Quality Evaluations, Inc. and found to be in
conformance with the requirements set forth by:
ISO 9001:2015
The Quality Management System is applicable to:
Design and manufacture of colour and additive concentrates, thermoplastic resins and
specialty compounds
Certificate No: 65799
Certification Date: 01 OCT 2020
Effective Date: 25 SEP 2023
Expiration Date 30 SEP 2026
Revision Date: 06 DEC 2024
Dominic Townsend, President
Page 1 of 4
ISO 9001:2015
Certificate Of Conformance
ANNEX
Certificate No.: 65799
Avient Corporation
At the below facilities
Avient Corporation -
Avon Lake, OH
Management of QMS, Design and manufacture of colour and additive concentrates,
thermoplastic resins and specialty compounds
33587 Walker Road Avon Lake OH
44012 United States
Avient (Argentina) SA Administration, Site management, Manufacture, Laboratory (QC and Colormatching),
Procurement, Maintenance, Infrastructure, Warehouse and Transport, Sales
Av.
Administration, Site management, Manufacture, Laboratory, Maintenance,
Infrastructure, Warehouse and Transport, Sales
Autopista Medellín KM 2.5 – COTA
Colombia
France S.A.S.
1995 route de la Vallée du Giffre
Saint-Jeoire en Faucigny 74490
France
Germany GmbH
Kornkamp 50 Ahrensburg Thuringia
22926 Germany
Germany GmbH
Administration, Site management, Manufacture, Laboratory, Maintenance,
Infrastructure, Warehouse and Transport
Hohenrhein 1 Lahnstein Thuringia
56112 Germany
Avient Guatemala S.A.
Kalisabi No.
1, Kec.
https://www.avient.com/resources/safety-data-sheets?page=209
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=2221
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=4598
STAN-TONE HCC-103250 PH G (BS)
STAN-TONE HCC-103249 Q RED (BS)
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=5566
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/sites/default/files/2024-10/ECCOH_ LSFOH 5983 Formulation - Power Cable Jacket - Application Snapshot.pdf
CABLE
MANUFACTURER
J A C K E T F O R P O W E R C A B L E
• High tear resistance > 11 N/mm
• High environmental stress cracking resistance (ESCR)
• Cost efficient solution
• Hot pressure resistance above 80°C
• Provided a jacket solution that complies with
LTS1 requirements as per the BS 7655-6.1
standard
• Enabled use in over-armored cables operating
at a maximum conductor temperature of 90°C
• Supported our customer in optimizing the
processing of the new material
ECCOH LSFOH 5983 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/news/specialty-and-sustainable-healthcare-material-solutions-avient-medtec-china-2023
June 1, 2023
Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines.
Versaflex™ HC 2110-57B TPEs comply with ISO 10993-4, ISO 10993-5, and USP Class VI and are suitable for Ethylene Oxide (EtO) sterilization without residue or allergens.
https://www.avient.com/company/policies-and-governance-0/avients-position-biodiversity
Global ISO Certificate Library