USP Class VI and ISO 10993-4/5 compliant ASTM ISO Shore A/D ASTM/ISO %

Yes, as required by the standard(s) Does your company have documented procedures and controls in place for the selection, approval, and monitoring of external Yes, supplier selection conforms to IATF & ISO 13485 requirements. IATF and ISO 13485 managed within ETQ Reliance. ISO sites perform as needed; IATF 16949/ISO 13485 sites perform Gage R&R per standard requirements 10.4 Manufacturing, Production & Process Controls Are all manufacturing processes covered with formally written SOP's?

Pigments and eye-catching special effects • Prompt, precise and custom color matching • Biocompatible functional additives • FDA CFR 21, USP VI, ISO 10993-X, and/or USP 661-X • ISO 13485 facilities Avient Corporation 5 4. Requirements: Skin contact colorant certified for ISO 10993 biocompatibility OnColor™ HC Plus, MEVOPUR® 5.

Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally. Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS

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.

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 risk of change • Non-phthalate and formulated without animal-derived substances • Different tones of amber available on request —more or less red or yellow and/or lighter or darker • Also available in liquid form REGULATORY SUPPORT • Pre-tested raw materials: - ISO 10993-1 and USP parts (Class VI) - European Pharmacopeia, monograph 3.1.15, USP and elemental analysis as per ICH Q3D - USP criteria appearance of solution, color • Registered Drug Master File (Type III) by the FDA • Food contact compliance established with FDA/EU* • YBB00102002-2015 (oral liquid pharmaceutical PET bottles) compliance support APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.

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。

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。

KEY CHARACTERISTICS • Globally harmonized formulations are manufactured at four ISO 13485 certified medical sites, providing global consistency and increased security of supply • Documented change control available • A range of standard colors eliminates color matching to expedite development time • The portfolio includes compliant colors for use in: - Needle hub applications: ISO 6009 - Ophthalmic container closures (American Academy of Ophthalmology) REGULATORY SUPPORT • A library of pre-tested raw materials including: - 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* HEALTHCARE APPLICATIONS • Medical devices such as catheters, surgical and dental instruments, and drug delivery devices • Pharmaceutical packaging including vials and bottles • Diagnostics for blood analysis or In Vitro Diagnostics (IVD) PRODUCT BULLETIN & COLOR CARD * FDA/EU compliance information available upon request; exceptions may occur Color Pantone Reference PE Base PP Base Transparent PP Base PEBA Base PC Base Transparent PC Base* ABS Base* White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206 Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958 Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939 Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037 Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039 Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978 Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402 Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404 Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406 Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070 Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068 Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072 Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297 Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295 Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871 Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869 Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896 Colors may vary from actual color shown.