https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-colorants-and-formulations
Standard colors for use in needle hubs (ISO 6009)
ISO 6009 color range
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
USP Class VI and ISO 10993-4/5 compliant
ASTM ISO Shore A/D
ASTM/ISO %
https://www.avient.com/news/archives?page=27
Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials
Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).
https://www.avient.com/sites/default/files/resources/19.2540_C%2520Colorant%2520Chromatics%25209001-2015%2520Certificate%2520EXP%25202021%25209-24-2018.pdf
Certificate of Registration 9001:2015 MSP
9001:2015–MSP-ANAB-US (2.0)
Page 1 of 2
Certificate of Registration
of Quality Management System
to ISO 9001:2015
The National Standards Authority of Ireland certifies that:
Colorant Chromatics Ab
Kroklundsvagen 346
AX-22 320 Odkarby
Aland
Finland
has been assessed and deemed to comply with the
requirements of the above standard in respect of the scope of
operations given below:
The Design, Manufacture and Sales of
Fluoropolymer Color Concentrates and
Compounds
Additional sites covered under this multi-site certification are listed on the
Annex (File No. 19.2540/C)
Approved by:
Geraldine LarkinChief
Executive Officer
Approved by:
Lisa Greenleaf
Operations Manager
Registration Number: 19.2540/C
Certification Granted: May 15, 1997
Effective Date: Oct 20, 2018
Expiry Date: Oct 19, 2021
National Standards Authority of Ireland, 20 Trafalgar Square, Nashua, New Hampshire, NH 03063, USA T +1 603 882 4412
9001:2015–MSP-ANAB-US (2.0)
Page 2 of 2
Annex to Certificate Number: 19.2540/C
Scope of Registration:
The Design, Manufacture and Sales of Fluoropolymer Color
Concentrates and Compounds
Activity Location
Central Management Group,
Design, Manufacture
Colorant Chromatics
Kroklundsvagen 346
AX-22 320 Odkarby
Aland
Finland
File No.: 19.2540/C
Headquarters, Sales, Distribution Colorant Chromatics Europe B.V.
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/2020-07/PH -AVIENT LUXEMBOURG - 15608678 - ISO 14001.pdf
POLYONE FRANCE TOSSIAT
43, PLACE DE LA GARE
01250 TOSSIAT
FRANCE
Bureau Veritas Certification France certify that the Management System of the above
organization has been audited and found to be in accordance with the requirements of the
management system standard detailed below:
Standard
ISO 14001:2015
Scope of certification
THE DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES FOR
THERMOPLASTICS
Certification/Recertification Cycle Start Date: 03 May 2023
Subject to the continued satisfactory operation of the organization’s Management System,
this certificate expires on: 02 May 2026
Expiry date of previous cycle: NA
Certification/Recertification Audit date: 08 March 2023
Original Cycle Start Date: 15 July 2011
Certificate n°: FR081968-1
File n°:15608678 Revision date:24 April 2023
Laurent CROGUENNEC - President
Local Office: Bureau Veritas Certification France
Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense
Further clarifications regarding the scope of this certificate the applicability of the management system
requirements may be obtained by consulting the organization.
To check this certificate validity, please use the QR Code.
1/1
https://www.avient.com/sites/default/files/2024-03/QF-02 QMS Global Standard Response.PDF
Certain
facilities have also received
official certification to the ISO
14001 by third-party ISO
representatives.
page=19
7
Quality Management
3rd Party Certifications
All manufacturing facilities are certified to the ISO 9001 standard.
Some have additional certifications such as
ISO 13485, ISO 14000, ISO 22000 and other third-party certified standards such as Responsible Care® and
IATF.
https://www.avient.com/news/archives?page=51
PolyOne Specialty Coatings and Inks Kennesaw, GA Plant Achieves ISO 9001-2008 Certification
CLEVELAND – PolyOne today announced that its Specialty Coating and Inks plant in Kennesaw, GA recently achieved ISO 9001-2008 certification.
https://www.avient.com/news/archives?page=14
Avient Site in Glendale, Arizona Earns ISO 13485 Certification
The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutio
https://www.avient.com/sites/default/files/2022-06/ISO_9001_2015_Cert_PolyOne.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
F-27, MIDC, Ranjangaon, Shirur
Pune, Maharashtra 412 220
India
ISO 9001:2015
The Quality Management System is applicable to:
Certificate No: 51482
Certification Date: 08 April 2015
Effective Date: 03 March 2021
Expiration Date: 07 April 2024
Revision Date: 08 March 2021 Dominic Townsend, President
THE DESIGN AND MANUFACTURE OF COLOR, ADDITIVE CONCERTRATES AND SPECIALITY COMPOUNDS
This certificate may be found on the ABS QE Website (www.abs-qe.com).
For certificates issued in the People's Republic of China information may also
be verified on the CNCA website (www.cnca.gov.cn).