https://www.avient.com/sites/default/files/2022-04/Asia SEM Healthcare Product Selection Guide_CN.pdf
Versaflex™ OM3060 PP包覆成型 硬度 法规 灭菌 特性 28A 环氧乙烷 柔软的半透明材料,粘性好 43A 环氧乙烷 高度可着色的解决方案, 粘性好,不易压缩变形 42A/ 50A 环氧乙烷 透明的耐高温级材料; ABS、PC可粘合 60A 环氧乙烷/蒸汽 弹性高,不易压缩变形 20A-90A 环氧乙烷 用途广泛,无填充 ABS,PC包覆成型 硬度 法规 灭菌 特性 40A USP VI级,ISO 10993 环氧乙烷 半透明 60A USP VI级,ISO 10993 环氧乙烷 透明 应用: VERSAFLEX™ CL与DYNAFLEX™ 热塑性弹性体 包覆成型,符合人体 工程学设计 • • • • • • 触感柔软,有利于形成良好的表面 有多种颜色效果和纹理可供选择 提高抓握力、缓冲力和舒适度 提高性能表现,如密封性能、减震、隔氧、 耐刮擦和耐磨性能 降低装配成本,加工性能良好 可牢固包覆于各种基材上 • • • • 血糖仪 医用工具包覆成型 注射笔 分析仪器 Dynaflex™ G2706 Dynaflex™ G2711 Versaflex™ CL2242 & CL2250 Versaflex™ G2705 N Versaflex™ HC3810 Versaflex™ OM1040 USP VI级,ISO 10993, 食品接触 USP VI级,ISO 10993, US食品接触 USP VI级,ISO 10993, 食品接触 USP VI级,ISO 10993 USP VI级,ISO 10993, 食品接触 材料描述 硬度 法规 灭菌 特性 45A USP VI级 55A USP VI级 70A USP VI级 43A 环氧乙烷 34A USP VI级, ISO 10993-4/5 FDA,USP VI级, ISO 10993 57A 挤出级,耐高温 再密封,压缩变形性能提高 摩擦低 Versalloy™ HC 9210-55N Versalloy™ HC 9210-70N Versalloy™ HC 9220-43N Versaflex™ HC 2110-35N Versaflex™ HC 2110-57B FDA,USP VI级, ISO 10993 环氧乙烷 加工性能良好,表面光洁、美观 环氧乙烷 环氧乙烷 加工性能良好,表面光洁、美观 加工性能良好,表面光洁、美观 高压灭菌、环氧乙烷、 辐射灭菌 高压灭菌、环氧乙烷、 辐射灭菌 应用: VERSALLOY™ HC与VERSAFLEX™ HC 热塑性弹性体 密封和再密封 • • • • • 柔软的橡胶质感 无抽芯,静态推塞被刺穿后再密封性良好 满足动态密封的低摩擦系数要求 可萃取物含量低 适合在聚烯烃上包覆成型 • • • 密封和密封隔膜 密封件和卫生垫圈 注射器推塞和塞头 Versalloy™ HC 9210-45N 材料描述 硬度 法规 灭菌 特性 65A/ 75A/ 84A 54A 67A 辐射灭菌 高压灭菌器 透明度高,不含增塑剂,无油 工作温度高,可高温灭菌 环氧乙烷、辐射灭菌 Versaflex™ HC MT555 Versaflex™ HC BT218 应用: VERSAFLEX™ CL与DYNAFLEX™ 热塑性弹性体 高透明度级,不含增塑剂 • • • • • • • 无色透明级,配方不含邻苯二甲酸酯增塑剂 符合医疗法规USP VI级和ISO 10993-4、5的 要求 食品接触用并符合FDA标准 可高压灭菌和辐射灭菌 可萃取物含量低 透明度高(雾度50 4.1, 100 4.5, 100 4, 70 6, 70 拉伸模量(MPa) 2200 2700 2600 2350 1820 1820 挠曲强度(MPa) 80 90 104 86 68 68 挠曲模量(MPa) 2500 2700 2500 2300 1980 1590 HDT:0.45、1.8(MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70 UL-94等级,3.0mm 5VA V-0 5VA V-0 HB V-0 UL-94等级,1.5mm V-0 V-0 5VB V-0 HB V-0 UL-94等级,0.75mm V-1 V-2 V-0 无 无 V-2 竞争材料对比 医疗保健特种工程聚合物配方 TRILLIANT™ HC热塑性塑料 Trilliant™ HC高性能热塑性弹性体系列配方是专为应对日趋严苛的医疗器械和设备而开发的。
https://www.avient.com/industries/healthcare/remote-monitoring-wearables/continuous-glucose-monitors-cgm
Color and functional additive masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased appeal and performance
https://www.avient.com/industries/healthcare/catheter-materials-medical-tubing/catheters
Standard colors for needle hubs, cannula hubs, and wings matching ISO 6009 color coding
https://www.avient.com/products/advanced-composites/continuous-fiber-composite-panels/hammerhead-marine-composite-panels
ISO 845
https://www.avient.com/news/where-sustainability-matters-avient-highlight-its-latest-solutions-support-circular-economy-chinaplas-2023
They 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/2024-05/Mevopur-Surgical Gown-Case study snapshot_0520.pdf
Medical textile manufacturer LEARN MORE MEDICAL 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 10993 biocompatibility standard • Available in standard blue or other customized colors • Compatible with ETO sterilization • Suitable for use in non-woven SMS spunbond layer • Offered standard blue and custom colors such as green • Pre-tested raw materials for biocompatibility ISO10993 standard • Manufactured under ISO 13485 certified medical sites with change control in place MevopurTM Healthcare Colorants and Formulations KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2021-07/mevopur-pharma-packaging-1-page-case-study.pdf
PHARMACEUTICAL PACKAGING OEM V I A L S , B O T T L E S & C O N T A I N E R S • Raw materials pre-tested to USP 661.1 and ICHQ3D guidelines • Stabilization during molding and sterilization processes for both opaque and transparent polymer materials • Certified formulations available globally • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the pharmaceutical value chain • Delivered specialized formulated solutions to meet stringent pharmaceutical packaging requirements • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Concentrates KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/resources/safety-data-sheets?page=4561
Geon(TM) DB5261 Neutral TT Iso Stable
https://www.avient.com/company/policies-and-governance/it-systems-use-policy
Global ISO Certificate Library
https://www.avient.com/industries/healthcare/catheter-materials-medical-tubing/medical-tubing
Medical-grade thermoplastic elastomers that meet various regulatory requirements, such as ISO 10993 and USP Class VI