HAZEL ISO FIX DOOR V3 MAUVE DOOR, ISO FIX COVER V3

Avient currently has twenty-three facilities globally certified to the Corporation’s GMP program and two facilities certified to "ISO 13485, Medical Device - Quality Management Systems - Requirements for Regulatory Purposes." Global ISO Certificate Library

Avient's PCF Calculator adheres to the globally recognized ISO 14067:2018 standard for calculating Product Carbon Footprint and has obtained additional third-party certification through TÜV Rheinland for ISO 14067 compliance.  

They are also certified to meet biocompatibility requirements for ISO 10993 and USP Class VI standards. Avient's Suzhou facility operates under ISO 13485 quality management system certification, complying with the leading standards in medical device manufacturing.

Because Transcend is fully bio-compatible per ISO 10993 standards, we’re helping customers speed up development and market introduction. They are tested to ISO 10993 standards and can be customized with the addition of functional additives to enhance product performance.

This certification, in conjunction with the facility’s existing ISO 22000-certified Food Safety Management System and ISO 13485-certified Quality Management System for medical devices, also positions the Chin Bee site to meet stringent hygiene and regulatory requirements for products for mothers and children, food-contact packaging, and the medical and pharmaceutical industries.

Like other Mevopur products, the bio-based polymer solutions are formulated with raw materials pre-tested to ISO, USP, EP, and ICH Q3D protocols, supporting their compliance with safety and regulatory requirements for use in healthcare.   In Europe, Mevopur concentrates and ready-to-use formulations are manufactured in the ISO 13485-2016 certified site of Malmö, Sweden.

Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for identification and differentiation Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICHQ3D protocols to reduce product carbon footprint Flexible, durable, and colorable TPEs for improved grips and gaskets that comply with USP Class VI and ISO 10993

Mevopur™ Healthcare Colorants and Formulations: a range of medical grade concentrates and pre-colored formulations for a wide range of polymers used in applications such as remote patient monitoring, circulating blood contact, and invasive devices, with pre-tested biocompatibility according to ISO 10993, change control in place, production certified to ISO 13485-2016 and DMF/MAF files available Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: high-temperature solutions 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

Certificate Number: 255 ISO2P Date First Registered: 03/04/2023 Issued on: 11/04/2023 Valid until: 10/04/2026 Awarded to AVIENT PAKISTAN (PVT) LTD 1A/1, Sector#20, Korangi Industrial Area, Sector 20 Karachi, Pakistan In recognition of the Organization´s Food Safety Management System which complies with : ISO 22000:2018 Food Category : I For the scope of activities described below: Manufacturing & Processing of Polymer Resins & Master batch F-3/22/ A 100 Issue date : 06/2022 Version:03 It is mandatory to carry out the surveillance audit on its time.