MEVOPUR Colors for Needle Hubs Bulletin_CN * 可根据要求提供FDA/EU合规信息 应用公告 MEVOPUR™用于针头和导管座的 标准颜色 为了帮助我们的客户满足医疗行业标准要求，埃 万特开发了一系列符合ISO 6009标准颜色编码的 针座、导管座和翼梁的标准颜色。 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 不含动物源性物质和邻苯二甲酸盐 可将颜色与添加剂相结合，以增强产品性能 和防护性能 法规支持 经过预测试的原材料： - 美国药典（USP）23，第87和88章（VI类） 萃取和生物学评价 - ISO 10993，第4、5、10、11和18部分， 萃取和生物学评价 - 美国药典和欧洲药典中针对USP 、 ICH Q3D可萃取金属和EP3.1聚烯烃的测试的 其他监管支持信息 FDA器械主文件 食品接触符合FDA/EU*要求 针头的标称外径 （mm） 颜色说明 RAL 潘通色号 透明产品代码 不透明产品代码 0.4 中灰色 7035 423 C PP7M665125 PP7M665127 0.45 褐色 8017 7588 C PP8M665294 PP8M665296 0.5 橘黄色 2003 173 C PP2M665298 PP2M665300 0.55 中紫色 4005 7676 C PP4M665290 PP4M665292 0.6 深蓝色 5010 288 C PP5M665894 PP5M665896 0.7 黑色 9005 黑色 C PP9M664950 PP9M664952 0.8 深绿色 6001 7483 C PP6M665687 PP6M665689 0.9 黄色 1021 115 C PP1M665211 PP1M665213 1.1 乳白色 1015 7401 C PP0M665290 PP0M665292 1.2 粉色 3015 502 C PE3M665725 PP3M665727 适用医疗保健使用限制—见下文。 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；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

可根据要求提供多种定制化 颜色解决方案 根据ISO 13485/GMP质量体系生产，并拥有变 更控制管理 原材料红外光谱分析和常规批次检测 根据ISO 10993第18部分对正己烷、异丙醇及 水中的可萃取性进行评估 法规支持 原材料根据ISO 10993-1和USP第、 章（VI类）对原材料进行生物评估的预测试 向FDA提交所有标准颜色的DMF/MAF文件 应用 医疗器械，如导管和连接器、注射器针头及无 针连接器 与皮肤接触设备，如可穿戴设备或医疗器械的 柔软触感表面 MEVOPUR LQ 配方可用于要求严苛的应用，包 括： MEVOPUR™-LQ 不透明红（PMS198C） 产品编号：FZ3M415008 MEVOPUR™-LQ 透明红 产品编号：FZ3M415009 MEVOPUR™-LQ 不透明蓝（PMS292C） 产品编号：FZ5M415008 MEVOPUR™-LQ 透明蓝 产品编号：FZ5M415009 MEVOPUR™-LQ 不透明黄（PMS1205C） 产品编号：FZ1M415005 MEVOPUR™-LQ 透明黄 产品编号：FZ1M415006 MEVOPUR™-LQ 不透明绿（PMS346C） 产品编号：FZ6M415008 MEVOPUR™-LQ 透明绿 产品编号：FZ6M415009 MEVOPUR™-LQ 不透明紫（PMS2655C） 产品编号：FZ4M415003 MEVOPUR™-LQ 透明紫 产品编号：FZ4M415004 定制化选择 也可以根据您的需求 定制颜色， 请联系我们。 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；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof. RC14001®:2015 Certificate No: 55334 Effective Date: 30 October 2017 Expiration Date: 29 October 2020 Issue Date: 30 October 2017 Alex Weisselberg, President DESIGN AND MANUFACTURE OF COLOR CONCENTRATES Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:

PP OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Dynaflex™ G2706 28A USP Class VI, ISO 10993, Food contact EtO Soft translucent grade, grippy feel Dynaflex™ G2711 43A USP Class VI, ISO 10993, Food contact EtO Highly colorable solution, grippy feel, low compression set Versaflex™ CL2242 & CL2250 42A/ 50A USP Class VI, ISO 10993, US Food contact EtO Clear boilable grades; ABS, PC bondable Versaflex™ G2705 N 60A USP Class VI, ISO 10993, Food contact EtO/Steam High resilience, low compression set Versaflex™ HC3810 20A-90A USP Class VI, ISO 10993 EtO General purpose, unfilled ABS, PC OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Versaflex™ OM1040 40A USP Class VI, ISO 10993 EtO Translucent Versaflex™ OM3060 60A USP Class VI, ISO 10993 EtO Clear VERSAFLEX™ CL AND DYNAFLEX™ TPEs OVERMOLDING FOR ERGONOMICS • Adds good tactile surface with soft-touch feel • Available in a variety of color effects and textures • Improves grip, cushion, and comfort • Enhances functional performance like sealing properties, vibration damping, oxygen barrier, and scratch and abrasion resistance • Reduces assembly costs, good processability • Offers excellent adhesion to a wide range of substrates • Glucometers • Medical tools overmolds • Injector pens • Analysis devices VERSALLOY™ HC & VERSAFLEX™ HC TPEs SEALING & RESEALING • Rubbery feel and soft touch • No coring, good puncture, and resealability in static stoppers • Meets low coefficient of friction requirements in dynamic seals • Low extractables • Suitable to overmold onto polyolefins • Sealing and resealing septum • Seals and sanitary gaskets • Syringe plungers and tips MATERIAL DESCRIPTION HARDNESS REGULATORY STERILIZATION CHARACTERISTICS Versalloy™ HC 9210-45N 45A USP Class VI EtO Good processability, HC 9210-55N 55A USP Class VI EtO Good processability, HC 9210-70N 70A USP Class VI EtO Good processability, HC 9220-43N 43A USP Class VI, ISO 10993-4/5 EtO Extrusion grade, high temperature resistance Versaflex™ HC 2110-35N 34A FDA, USP Class VI, ISO 10993 Autoclave EtO radiation Resealing, elevated comp set Versaflex™ HC 2110-57B 57A FDA, USP Class VI, ISO 10993 Autoclave EtO radiation Low stiction VERSAFLEX™ CL AND DYNAFLEX™ TPEs HIGH CLARITY GRADES WITHOUT PLASTICIZERS • Water clear grades formulated without phthalate plasticizers • Meets medical regulatory USP Class VI and ISO 10993-4,5 • Food contact and FDA compliant • Autoclave and radiation stable • Low extractable • High clarity (Haze 50 4.1, 100 4.5, 100 4, 70 6, 70 Tensile Modulus (MPa) 2200 2700 2600 2350 1820 1820 Flexural Strength (MPa) 80 90 104 86 68 68 Flexural Modulus (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 Rating @ 3.0 mm 5VA V-0 5VA V-0 HB V-0 UL-94 Rating @ 1.5 mm V-0 V-0 5VB V-0 HB V-0 UL-94 Rating @ 0.75 mm V-1 V-2 V-0 None None V-2 COMPETITIVE MATERIAL COMPARISON ENGINEERED POLYMER FORMULATIONS FOR HEALTHCARE TRILLIANT™ HC THERMOPLASTICS The family of Trilliant™ HC high-performance thermoplastics is formulated to meet the growing challenges of medical devices and equipment.

Custom color masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to boost visual appeal

NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.

NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.

Product Carbon Footprint values are calculated with Avient’s third-party certified PCF Calculator by TÜV Rheinland according to ISO 14067.  

They provide comparable performance to 100% virgin equivalents and can help reduce product carbon footprint (PCF), which can be quantified on request using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067.   

Developed with the rigorous demands of the healthcare industry in mind, these innovative pre-colored compounds are formulated with materials that have been successfully tested for ISO 10993 biocompatibility, supporting compliance with the highest standards for medical applications.