https://www.avient.com/sites/default/files/2024-08/Avient 2023 Sustainability Report_6.pdf
To find more details about our certifications, visit our ISO Certifications
14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and Responsible Care®.
Additionally, Avient’s self-assessments, based on ISO 9001/IATF 16949, are requested
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-and-additives-for-ivd-devices-application-bulletin-cn.pdf
主要特性 在三个通过ISO 13485认证的医疗生产线生 产全球统一的配方,提供全球一致性和供应 链保障 变更控制记录不限于CAS编号级别,降低变 更风险
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途: (a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“
植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械
https://www.avient.com/sites/default/files/2023-10/Value Added Services Brochure.pdf
issues Common compliance categories where we can assist: • UL • USP Class VI • ISO
10993 • ISO 1345 • REACH • RoHS • FDA • EU 10/2011 • China GB • MERCOSUR •
https://www.avient.com/sites/default/files/2023-10/Stat-Tech TPE Static Dissipative _ Electrically Conductive Thermoplastic Elastomers Product Overview_A4.pdf
Black Base Resin TPU TPU TPE TPE TPE TPE Physical Properties Hardness Shore ISO
48-4 85A 85A 50D 40A 60 A 60A Density ISO 1183 1.19 1.15 1 1.01 0.965 1.21
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives_Laser Welding Additives for Medical Devices Application Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing
formulations for different polymers REGULATORY SUPPORT • Raw materials tested to: - ISO
https://www.avient.com/sites/default/files/2022-07/REMAFIN EP White Masterbatches for Pharma Application Bulletin_CN.pdf
不含动物源性物质和邻苯二甲酸盐 适用于吹膜、注塑、吹塑和挤出 • • • 注册药品主文件(III型) 食品接触符合FDA/EU*要求 法规支持 原材料根据以下法规测试: - ISO
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途: (a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“
植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械
https://www.avient.com/sites/default/files/2021-07/mevopur-pharma-packaging-1-page-case-study.pdf
formulations available globally • Offered pre-tested raw materials and produced in an ISO
packaging requirements • Provided global formulations transferrable from our three ISO
https://www.avient.com/sites/default/files/2024-05/Mevopur-Surgical Gown-Case study snapshot_0520.pdf
TEXTILE MANUFACTURER S U R G I C A L D R A P E S & G O W N S • Pre-tested for ISO
raw materials for biocompatibility ISO10993 standard • Manufactured under ISO
https://www.avient.com/sites/default/files/2021-05/unterzertifikat-th.-bergmann.engl-.pdf
Gaggenau the introduction and application of a management system according to ISO
https://www.avient.com/resources/safety-data-sheets?page=4561
Geon(TM) DB5261 Neutral TT Iso Stable