Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

Geon(TM) DB5261 Neutral TT Iso Stable

White colorants for polyolefin containers and closures pre-tested to USP, EP, and ISO protocols

Global ISO Certificate Library

Global ISO Certificate Library

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

Mevopur Standard Colors Product Bulletin-CN3.26-1 MEVOPUR™ 着色剂 医疗应用的标准颜色 关键特性 • • • • • 监管支持 • • 预先测试的原材料库，包括： - ISO 10993 - USP , (class VI) - USP - ICHQ3D 可提取金属 - EuPh 向FDA提交的DMF / MAF文档适用于所有标 准颜色 医疗应用 • • • 医疗设备，例如导管，手术和牙科器械或药 物输送设备 药物包装，包括药瓶或瓶子 血液分析诊断或体外诊断（IVD） 产品公告 & 色卡 MEVOPUR 着色剂解决方案组合专为当今日益复 杂的医疗保健应用而设计。 ™ 在三个通过ISO 13485认证的医疗产线生产 全球统一的配方，提供全球一致性和供应链 保障 提供文件化的变更控制 原料指纹图谱和常规批次测试 多种标准颜色缩短产品开发时间 产品组合里符合标准的颜色用于： - 注射针头ISO 6009 - 眼科容器盖（美国眼科学院 / AAO - American Academy of Ophthalmology） 颜色 潘通色参照 PE 基料 PP 基料 透明PP 基料 PEBA 基料 PC 基料 ABS 基料* — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297 Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869 Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896 颜色可能与显示的实际颜色有所不同。

KEY CHARACTERISTICS • Available for polyethylene, polypropylene, ABS, polycarbonate and styrenics • Bio-content of resin carrier varies from 70% to 100% depending on polymer—calculated to ASTM D6866 standard • Manufactured at four ISO 13485 certified sites, providing global consistency and security of supply • Documented change control beyond CAS number, reducing risk of change • Drop-in solutions that can be processed like fossil-based grades on common injection molding and extrusion machines • Can be provided as ready-to-use pre-colored or additive formulation REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to US FDA and APPLICATION BULLETIN Sustainability Spotlight Bio-polymers Healthcare use limitations apply—see below.

REGULATORY SUPPORT • Drug delivery devices • Pharmaceutical packaging • Medical equipment KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing the risk of change • Allows crystallization in semi-crystalline polymers to begin faster and complete earlier REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.