https://www.avient.com/sites/default/files/2022-12/reSound Ultra Low Carbon Footprint TPE Product Bulletin_0.pdf
Calculated using the ISO 14067:2018 standard, the greenhouse gas (GHG) emissions are lowered by carbon sequestration and Avient’s green manufacturing practices.
This literature shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. * Calculated according to ISO 14067:2018
https://www.avient.com/sites/default/files/2021-11/avient-material-solutions-uk-cert-of-incorporation-name-change-nov-9-2021.pdf
https://www.avient.com/sites/default/files/2022-03/MEVOPUR Chemical Foaming Agents Application Bulletin_JP.pdf
主な特徴 • • • • • • ISO 13485の管理基準化で製造。
規制対応 • • • 評価試験*: - ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材料) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF（Type III）および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 軽量化 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。
a) 米国食品医薬品局（FDA）または国際標準化機構（ISO）により「インプラント」機器として分類される医療機器、または米国薬局方（USP）または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。
https://www.avient.com/resources/safety-data-sheets?page=4561
Geon(TM) DB5261 Neutral TT Iso Stable
https://www.avient.com/company/sustainability/sustainability-report/metrics/planet-data-and-metrics
⁴Certificates can be found at https://www.avient.com/company/policies-and-governance/global-iso-certificate-library
https://www.avient.com/company/policies-and-governance/it-systems-use-policy
Global ISO Certificate Library
https://www.avient.com/news/polyone-expands-healthcare-portfolio-biomerics’-specialty-medical-solutions
Biomerics manufactures its materials in ISO 13485 and FDA registered facilities in Salt Lake City, UT.
https://www.avient.com/news/avient-present-broad-array-innovative-and-sustainable-materials-solutions-chinaplas-2025
Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: based on polysulfone and PEEK resins with the capability of withstanding up to 1,000 autoclave cycles and high-heat sterilization at 150°C, these colorants are formulated with ingredient materials that have been successfully tested for ISO 10993 biocompatibility and are available in a line of bright and vivid transparent or opaque shades
https://www.avient.com/company/policies-and-governance
Global ISO Certificate Library
https://www.avient.com/news/plastics-and-rubber-thailand-2024-include-avients-showcase-specialty-and-sustainable-materials
Avient’s Product Carbon Footprint (PCF) Calculator: a tool that is third-party-certified by TÜV Rheinland, developed to evaluate the carbon footprint of Avient’s specialized and sustainable material solutions to help companies address the growing demand to create and meet sustainability commitments, understand the environmental impact of products, and navigate the complex landscape of reducing carbon emissions, particularly for upstream materials, and aligns with the ISO 14067:2018 standard for quantifying and reporting the carbon footprint of a product