Also available are OnColor HC Plus Colorants, certified to meet or exceed USP Class VI and ISO 10993 bio-compatibility requirements. KEY CHARACTERISTICS • Polymer colorants formulated specifically for healthcare product applications • Meets and exceeds various material performance requirements including FDA 21 CFR, ISO 10993 and USP Class VI • HC Plus colorants certified for bio-compatibility • Available as pre-color, concentrate, masterbatch or Smartbatch™ combined colorant/additive solution • Wide range of colors, striking special effects and custom color matching MARKETS AND APPLICATIONS OnColor™ HC and HC Plus Colorants are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.

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。

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。

Medical-grade thermoplastic elastomers that meet various regulatory requirements, such as ISO 10993 and USP Class VI

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

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.

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

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  

Biomerics manufactures its materials in ISO 13485 and FDA registered facilities in Salt Lake City, UT.