https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Medical Devices Application Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number reducing risk of change • Non-phthalate and formulated without animal- derived substances • Available for use in a wide range of polymers including polyolefins, styrenics, polycarbonate and alloys, polyester, POM • Functionality can be combined with colorants into convenient combination concentrates and ready-to-use formulations 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 FUNCTIONALITY TARGET APPLICATIONS DRUG DELIVERY DEVICES SYRINGES & NEEDLES DIAGNOSTICS CATHETERS Clarifying PP Sorbitol-free for transparent applications with reduced migration and improved thermal stability Lubricant— permanent/ non-migrating Fast acting reduction in friction for wide variety of polymers such as PP, ABS, POM, PC Protection from UV in transparent applications for PP, PE, PETG, COP UV blocking in 290-450nm with no impact on clarity; can be combined with colors (e.g., amber) Antistatic ready-to- use solution for PP, ABS, PC/ABS Permanent/non-migrating; fast decay time independent of % relative humidity Gamma/e-beam sterilization protection of the polymer Preserving the properties of PP and COC/COP; reduction in yellowing using Color Compensation Technology (CCT) Reduced material consumption/cycle time—nucleation Fast acting new generation nucleant for PE and PP; improved thermal and mechanical properties allows wall thinning; reduction of tolerance/dimensional problems between different colors Laser marking replacing ink printing/labels Solvent-free, high-speed identification for Nd/YAG laser for PE,PP, ABS, PC, POM Antioxidants for PE, PP, TPE Thermal protection during converting/downstream sterilization Brand protection/ anticounterfeit Covert and non-covert systems Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-01/Disinfectant Resistant Trilliant and Versaflex HC Materials Program Bulletin_0.pdf
Trilliant™ HC high performance formulations were developed for specific healthcare enclosure needs, including: • Chemical resistance to common disinfectants • UL 94 ratings of 5VA at 3.0, V-0 at 1.5 mm & V-1 at 0.75 mm • Retained color aesthetics after chemical exposure • Ability to utilize existing PC/PET & COPE tooling Tested using an adaptation from ASTM D543 for environmental stress cracking resistance (ESCR), 15 bars of each material were placed into jigs at 1% and 2% strain.
Virex® Tb Vesphene™ IIse CaviCide™ Trilliant™ HC 8910 +++ +++ +++ Trilliant™ HC 8920 (FR) – +++ +++ FR PC/PET – + ++ FR COPE (copolyester) + ++ +++ Tensile Strength Property Retention After 72-hour Continuous Exposure +++ Best (>90% retention), ++ Better (50-90% retention), + Good (
Designed for two- shot injection molding and formulated for the appropriate substrate, these medical-grade TPEs are compatible with rigid PVC, copolyesters, all PC alloys, ABS, TPUs and PEI substrates.
https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
Concentrates and pre-colored formulations are available for a wide range of polymers, including PE, PP, PEBA, PC, ABS, and others.
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.
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-and-additives-for-ivd-devices-application-bulletin-cn.pdf
功能 目标应用 血液采集 试剂容器/ 试剂盒 移液器/ 器具 设备/配件 即用型配方避免对分析测试的干扰; 可萃取金属数据 聚合物对激光能量的激活可提供高 对比度、无溶剂的 高速鉴别 定制母粒和即用型配方可提供 透明和不透明颜色,同时允许激光 传输/吸收 PE和PP的新一代快速成核剂;提 高尺寸稳定性,热性能和机械性能 降低湿蒸汽透过率(MVTR) HDPE即用型配方 吸湿母粒 减少 BCT(血液收集管)中因氧传 输造成的真空损失,并保护试剂免 受氧化降解 在290-450nm波长范围内阻挡紫 外线,对透明度没有影响;保护光 敏试剂 自检/即时检验 (POCT) 用于实验室自动化/ 鉴别编码的着色剂 颜色—低迁移/减 低干扰 颜色—生物相容 性评估 透明PP PP、ABS、 PC/ABS的抗静电 性能 激光焊接可 快速、可靠地组装 一系列聚合物 半结晶聚合物 的成核剂,例如 HDPE、PP、POM 防止氧气进入的 PET吸氧剂 透明容器(PP、 PE、PETG、COP) 中的紫外光防护 防潮以改善屏障 激光打标的UDI替 代油墨印刷/贴标 PP、ABS、PC和 高温聚合物的颜 色,符合UL认证 为各种聚合物提供多种颜色,能够 为您的工艺提供适用的即用型配方 或母粒 降低不符合现行和拟定法规(如 IVDR)的风险 即用型解决方案/母粒支持针对电器 外壳的UL要求 永久性/非迁移性即用型配方;不受 相对湿度(%)影响的快速静电衰 减时间 不含山梨醇,最大限度地减少潜在 迁移 1.844.4AVIENT www.avient.com 版权所有© 2021埃万特公司。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用: (1) 接触人体组织或体液长达30天或更长时间; (2)“整形”(整容或重建)手术; (3) 生殖植入物或任何节育器械;或者 (4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2022-08/Environmental Stress Cracking Resistance _ESCR_ Design Guide %281%29.pdf
Figure 4 shows a top and side view of a corner with constant wall thickness where coring has been applied.
Wall Thickness (mm) C o o li n g T im e ( S e c ) 40 35 30 25 20 15 10 5 0 0 1 2 3 4 ABS PC Nylon 6/6 FIGURE 1 - Wall thickness vs. cooling time of various plastics FIGURE 2 - Designing for wall thickness changes FIGURE 3 - Internal and external radius guidelines FIGURE 4 - Coring for tight radius design ESCR Design Guide 2 CONTOUR Where possible, contouring the products’ exterior form, as shown in Figure 5, can help to eliminate pooling of fluids.
The heat will melt the plastic around FIGURE 9 - Proper boss design FIGURE 10 - Boss design guidelines ESCR Design Guide 4 it, allowing the plastic to relax, reflow, and solidify.
https://www.avient.com/resources/safety-data-sheets?page=3045
STOCK BROWN PC-#4
https://www.avient.com/resources/safety-data-sheets?page=3916
TRANS NICKEL GREY PC
Geon(TM) DB1587A Orange 60-4
https://www.avient.com/resources/safety-data-sheets?page=6440
297264-4-EXPLC501FM NAT
PC HYLEX YELLOW
https://www.avient.com/resources/safety-data-sheets?page=6393
MP-73397PC WHITE PC
PBT SURF 4 V2
https://www.avient.com/resources/safety-data-sheets?page=1941
71057PC EPIC EQUALIZER PC VIOLET
UV Black Umber V.4