https://www.avient.com/resources/safety-data-sheets?page=1806
MAX ORGANIC LOADED HXMMA/BS
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/news/avient-feature-specialty-technologies-and-services-healthcare-mdm-west-2023
Manufactured across a global network of ISO 13485 facilities, they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, and ICH Q3D.
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.
They are offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.
https://www.avient.com/sites/default/files/2024-12/Certificate ISO 22000_Tangerang.pdf
Kalisabi No. 1,
Kec.
Cibodas
15138 Kecamatan Cibodas, Tangerang
Indonesia
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. 46391
Page 1 of 1
Validity 25. 02. 2024 – 24. 02. 2027
Issue 25. 02. 2024
A.Grisard, President SQS F.
https://www.avient.com/resources/safety-data-sheets?page=2192
WHITE CC 1% LDR
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=1299
1% UV BROWN
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/news/archives?page=52
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=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/products/polymer-additives/laser-marking-additives/colorant-chromatics-uv-laser-marking-technology
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Permanent marking with outstanding contrast of 60-80% to meet aerospace industry standards SAE AS4373F and EN-3475-706
https://www.avient.com/knowledge-base/article/securing-supplies-medical-plastic-solutions?ind[]=6598
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.
https://www.avient.com/knowledge-base/article/securing-supplies-medical-plastic-solutions?pname[]=17815
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.