https://www.avient.com/news/avient-launches-medical-tpe-grades-formulated-without-animal-derivatives
All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.
https://www.avient.com/sites/default/files/2021-05/certificate-section-28.pdf
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-premier-healthcare-colorants
Tested to ISO 10993
https://www.avient.com/news/avient-announces-industry-first-carbon-negative-and-carbon-neutral-thermoplastic-elastomers
Avient follows the ISO 14067:2018 standard to calculate PCF values and utilizes global formulation expertise, green manufacturing processes, and sourcing & logistics competence to achieve such low or negative values.
https://www.avient.com/news/avient-unveils-high-temperature-vibrant-colorants-healthcare-mdm-west-2022
They are tested to ISO 10993 standards, and can be customized with the addition of functional additives to enhance product performance.
https://www.avient.com/news/avient-expands-production-nymax-rec-recycled-nylon-formulations-istanbul
PCF values are calculated using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067
https://www.avient.com/news/avient-launches-two-new-sustainable-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2021
MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/knowledge-base/article/reduce-carbon-footprint-medical-plastics
Like all Mevopur products, Mevopur Healthcare Bio-based Polymer Solutions use raw materials pre-tested to ISO 10993-1, USP and , EP 3.1.3 / 3.1.5 (polyolefin packaging materials), USP (polyethylene) and ICH Q3D (elemental impurities).
https://www.avient.com/sites/default/files/2025-01/ISO 50001 Melle%2C Germany.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/resources/safety-data-sheets?page=2788
P1) ISO 2500
Certificate of Analysis (COA) - labeled as "Material"