https://www.avient.com/sites/default/files/2022-04/MEVOPUR LQ for Silicone Elastomers.pdf
Customized color solutions are available on request • Production under ISO 13485 / GMP quality system with change control management • Fingerprinting of raw materials and routine batch testing • Extractability evaluated in hexane, isopropanol, and water according to ISO 10993 part 18 REGULATORY SUPPORT • Raw materials are pre-tested to biologically- evaluated raw materials using ISO 10993-1 and USP chapters , Class VI • DMF/MAF documentation filed with the FDA for all standard colors APPLICATIONS MEVOPUR LQ formulations can be applied in demanding applications including: • Medical devices such as catheter tubing & connectors, syringe tips, and needleless connectors • Skin contact devices such as wearables or soft-touch surfaces of medical devices PRODUCT BULLETIN MEVOPUR™-LQ YELLOW (PMS1205C) Product Code FZ1M415005 MEVOPUR™-LQ TRANS YELLOW Product Code FZ1M415006 MEVOPUR™-LQ BLUE (PMS292C) Product Code FZ5M415008 MEVOPUR™-LQ TRANS BLUE Product Code FZ5M415009 MEVOPUR™-LQ RED (PMS198C) Product Code FZ3M415008 MEVOPUR™-LQ TRANS RED Product Code FZ3M415009 MEVOPUR™-LQ GREEN (PMS346C) Product Code FZ6M415008 MEVOPUR™-LQ TRANS GREEN Product Code FZ6M415009 MEVOPUR™-LQ VIOLET (PMS2655C) Product Code FZ4M415003 MEVOPUR™-LQ TRANS VIOLET Product Code FZ4M415004 CUSTOM-MADE Individual options Customized colors are also available to meet your needs, please contact us.
Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
https://www.avient.com/sites/default/files/resources/0514_02%2520PDI%2520ISO17025%2520Chemical_Extension%2520Cert2019.pdf
Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.
This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 30th day of March 2018. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to December 31, 2019 Revised October 08, 2019 0514-02.pdf SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Test Method or Standard: Test Description: 0514-02c.pdf
https://www.avient.com/sites/default/files/2020-07/tpes-for-healthcare-industry-bulletin.pdf
Versaflex™ & Versalloy™ Specialty Engineered Materials Thermoplastic Elastomers for Healthcare Applications Delivering specialized thermoplastic elastomer (TPE) solutions for demanding healthcare applications, Avient has performance-grade materials that are approved for USP VI, ISO 10993-4 and 10993-5.
VERSAFLEX™ HC MEDICAL TUBING SERIES • Improve extrusion rates, achieve high service temperature performance or increase clarity in medical tubing • Meet biopharmaceutical needs for weldability and minimize extractables during processing VERSALLOY™ HC SERIES • Obtain better flow in long, thin paths and lower shrink rates versus typical TPVs with our alloys, made with Santoprene™ TPV • Color easily and obtain a smooth tactile feel VERSAFLEX™ HC GASKETS & STOPPERS SERIES • Achieve no coring, good puncture and resealability in static stoppers • Meet low COF and low stiction requirements in dynamic seals VERSAFLEX™ CL E SERIES • Increase clarity and flexibility in bags, bottles and films • Mitigate risk with plasticizer-free formulations for film extrusion • Deliver excellent odor & O2 barrier performance for film extrusion INDUSTRY BULLETIN TPE HEALTHCARE PRODUCT SELECTOR GUIDE Versaflex™ HC MT Series Versaflex™ HC MT222 Clear 66A 0.88 14 - 334 2.30 629 4.34 898 6.19 430 220 36 ✔ ✔ High clarity, without plasticizersVersaflex™ HC MT224 Clear 75A 0.89 19 - 468 3.23 773 5.33 1360 9.40 530 321 56 ✔ ✔ Versaflex™ HC MT226 Clear 84A 0.88 20 - 606 4.17 885 6.10 1600 11.00 600 433 76 ✔ ✔ Versaflex™ HC MT317 Clear 68A 0.89 17 69 450 3.10 660 4.55 870 6.00 470 221 39 ✔ ✔ Very high service temperature Versaflex™ HC BT218 Natural 67A 0.89 19 69 381 2.60 683 4.70 1186 8.20 608 - - ✔ ✔ Weldable, kink resistant Versaflex™ HC Gaskets & Stoppers Series Versaflex™ HC 2110-35N Natural 34A 0.90 19 47 145 1.00 261 1.80 400 2.76 620 97 17 ✔ ✔ Good resealing Versaflex™ HC 2110-43N Natural 43A 0.98 12 46 134 0.92 368 2.54 723 4.98 710 - - ✔ ✔ Good compression set Versaflex™ HC 2110-57B Black 59A 1.01 20 37 369 2.54 558 3.85 537 3.70 350 147 26 ✔ ✔ Low stiction Versaflex™ CL E Series Versaflex™ CL E85 Clear 84A 0.90 20 72 752 5.18 1160 8.00 1550 10.70 450 433 76 ✔ ✔ High clarity, without plasticizers; E95 also offers excellent odor & O2 barrier Versaflex™ CL E90 Clear 90A 0.90 27 73 1000 6.89 1230 8.50 1830 12.60 57 - - ✔ ✔ Versaflex™ CL E95 Clear 95A 0.90 38 71 1680 11.60 1730 11.90 2500 17.20 580 720 126 ✔ ✔ Versaflex™ HC 3810 Series Versaflex™ HC 3810-20N Natural 20A 0.88 16 54 123 0.80 185 1.30 342 2.40 650 - - ✔ - Formulated without animal derivatives, excellent colorability, translucent Versaflex™ HC 3810-30N Natural 30A 0.89 18 58 170 1.20 245 1.70 459 3.20 680 - - ✔ - Versaflex™ HC 3810-40N Natural 40A 0.88 19 59 191 1.30 275 1.90 506 3.50 670 - - ✔ - Versaflex™ HC 3810-50N Natural 50A 0.89 21 61 264 1.80 366 2.50 699 4.80 690 - - ✔ - Versaflex™ HC 3810-60N Natural 60A 0.88 24 65 459 3.20 594 4.10 790 5.40 510 - - ✔ - Versaflex™ HC 3810-70N Natural 70A 0.88 28 67 535 3.70 684 4.70 1000 6.90 570 - - ✔ - Versaflex™ HC 3810-80N Natural 80A 0.88 30 67 689 4.80 869 6.00 1390 9.60 620 - - ✔ - Versaflex™ HC 3810-90N Natural 90A 0.88 27 89 1087 7.50 1350 9.30 1890 13.00 570 - - ✔ - Versalloy™ HC 9210 Series Versalloy™ HC 9210-45N Natural 45A 0.89 19 39 160 1.10 320 2.20 484 3.33 480 100 18 - ✔ Smooth surface aestheticsVersalloy™ HC 9210-55N Natural 53A 0.89 20 44 208 1.44 335 2.31 580 4.00 610 120 21 - ✔ Versalloy™ HC 9210-70N Natural 70A 0.89 23 53 356 2.45 510 3.52 780 5.38 590 180 32 - ✔ Versalloy™ HC 9220 Series Versalloy™ HC 9220-70 Natural 70A 0.95 17 51 453 3.12 - - 643 4.43 265 208 36 ✔ ✔ ExtrudableVersalloy™ HC 9220-80 Natural 80A 0.94 18 59 553 3.67 777 5.36 945 6.52 415 208 36 ✔ ✔ Versalloy™ HC 9220-90 Natural 90A 0.94 25 55 1030 8.13 1350 9.33 1945 13.45 620 400 70 ✔ ✔ Standard Healthcare Grades Versaflex™ G2705N Natural 60A 0.88 - - - - 528 3.64 670 4.62 470 - - ✔ ✔ Natural, high strength Versaflex™ CL 2242 Clear 43A 0.89 23 - 152 1.05 294 2.02 731 5.00 780 124 22 ✔ ✔ High clarity, boilable Versaflex™ CL 2250 Clear 50A 0.89 20 - 220 1.52 337 2.32 827 5.70 770 140 25 ✔ ✔ Versaflex™ OM Series Versaflex™ OM 1040X Natural 42A 0.92 22 - 180 1.24 301 2.08 504 3.47 580 100 18 ✔ ✔ ABS/PC overmoldVersaflex™ OM 3060 Clear 59A 0.90 33 - 420 2.90 360 2.48 500 3.45 480 180 32 ✔ ✔ Color Hardness Specific Gravity Compression Set @ 23°C Compression Set @ 100°C 100% Modulus 300% Modulus Tensile Strength Elongation Tear Strength ISO 10993 USP VI Special Characteristics ASTM Shore A ASTM/ISO ASTM % ASTM % ASTM psi Mpa ASTM psi Mpa ASTM psi ISO Mpa ASTM % ASTM pll ISO kN/m GENERAL PROPERTIES TENSILE PROPERTIES OTHER For further information on specific grades, review technical data sheets.
https://www.avient.com/sites/default/files/2022-04/Asia SEM Healthcare Product Selection Guide_CN.pdf
Versaflex™ OM3060 PP包覆成型 硬度 法规 灭菌 特性 28A 环氧乙烷 柔软的半透明材料,粘性好 43A 环氧乙烷 高度可着色的解决方案, 粘性好,不易压缩变形 42A/ 50A 环氧乙烷 透明的耐高温级材料; ABS、PC可粘合 60A 环氧乙烷/蒸汽 弹性高,不易压缩变形 20A-90A 环氧乙烷 用途广泛,无填充 ABS,PC包覆成型 硬度 法规 灭菌 特性 40A USP VI级,ISO 10993 环氧乙烷 半透明 60A USP VI级,ISO 10993 环氧乙烷 透明 应用: VERSAFLEX™ CL与DYNAFLEX™ 热塑性弹性体 包覆成型,符合人体 工程学设计 • • • • • • 触感柔软,有利于形成良好的表面 有多种颜色效果和纹理可供选择 提高抓握力、缓冲力和舒适度 提高性能表现,如密封性能、减震、隔氧、 耐刮擦和耐磨性能 降低装配成本,加工性能良好 可牢固包覆于各种基材上 • • • • 血糖仪 医用工具包覆成型 注射笔 分析仪器 Dynaflex™ G2706 Dynaflex™ G2711 Versaflex™ CL2242 & CL2250 Versaflex™ G2705 N Versaflex™ HC3810 Versaflex™ OM1040 USP VI级,ISO 10993, 食品接触 USP VI级,ISO 10993, US食品接触 USP VI级,ISO 10993, 食品接触 USP VI级,ISO 10993 USP VI级,ISO 10993, 食品接触 材料描述 硬度 法规 灭菌 特性 45A USP VI级 55A USP VI级 70A USP VI级 43A 环氧乙烷 34A USP VI级, ISO 10993-4/5 FDA,USP VI级, ISO 10993 57A 挤出级,耐高温 再密封,压缩变形性能提高 摩擦低 Versalloy™ HC 9210-55N Versalloy™ HC 9210-70N Versalloy™ HC 9220-43N Versaflex™ HC 2110-35N Versaflex™ HC 2110-57B FDA,USP VI级, ISO 10993 环氧乙烷 加工性能良好,表面光洁、美观 环氧乙烷 环氧乙烷 加工性能良好,表面光洁、美观 加工性能良好,表面光洁、美观 高压灭菌、环氧乙烷、 辐射灭菌 高压灭菌、环氧乙烷、 辐射灭菌 应用: VERSALLOY™ HC与VERSAFLEX™ HC 热塑性弹性体 密封和再密封 • • • • • 柔软的橡胶质感 无抽芯,静态推塞被刺穿后再密封性良好 满足动态密封的低摩擦系数要求 可萃取物含量低 适合在聚烯烃上包覆成型 • • • 密封和密封隔膜 密封件和卫生垫圈 注射器推塞和塞头 Versalloy™ HC 9210-45N 材料描述 硬度 法规 灭菌 特性 65A/ 75A/ 84A 54A 67A 辐射灭菌 高压灭菌器 透明度高,不含增塑剂,无油 工作温度高,可高温灭菌 环氧乙烷、辐射灭菌 Versaflex™ HC MT555 Versaflex™ HC BT218 应用: VERSAFLEX™ CL与DYNAFLEX™ 热塑性弹性体 高透明度级,不含增塑剂 • • • • • • • 无色透明级,配方不含邻苯二甲酸酯增塑剂 符合医疗法规USP VI级和ISO 10993-4、5的 要求 食品接触用并符合FDA标准 可高压灭菌和辐射灭菌 可萃取物含量低 透明度高(雾度50 4.1, 100 4.5, 100 4, 70 6, 70 拉伸模量(MPa) 2200 2700 2600 2350 1820 1820 挠曲强度(MPa) 80 90 104 86 68 68 挠曲模量(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等级,3.0mm 5VA V-0 5VA V-0 HB V-0 UL-94等级,1.5mm V-0 V-0 5VB V-0 HB V-0 UL-94等级,0.75mm V-1 V-2 V-0 无 无 V-2 竞争材料对比 医疗保健特种工程聚合物配方 TRILLIANT™ HC热塑性塑料 Trilliant™ HC高性能热塑性弹性体系列配方是专为应对日趋严苛的医疗器械和设备而开发的。
https://www.avient.com/sites/default/files/2022-07/MEVOPUR Chemical Foaming Agents Application Bulletin_CN.pdf
主要特性 根据ISO 13485规定的程序生产 变更控制记录的级别高于CAS编号级别,降低 变更风险 可用于常规注塑机和挤出设备—由技术支持团 队提供设置支持 可用于聚烯烃、苯乙烯和共聚物 可与着色剂联用 • • • • • 注册药品管理档案(III类)和/或医疗器械主 文件 食品接触声明符合美国FDA和EU规范 法规支持 原材料根据以下法规测试: - ISO 10993-1 - USP第、章(包含VI级) - 欧洲药典,各论3.1.3/3.1.5章节(聚烯烃包 装材料) - 美国药典(聚乙烯) - 杂质元素符合ICH Q3D要求 • • • 轻量化 1.844.4AVIENT www.avient.com 版权所有© 2022埃万特公司。
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。
https://www.avient.com/sites/default/files/2025-03/65537-Certificate-05MAR2025.pdf
Page 1 of 5 https://abs.zertic.com https://abs.zertic.com ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Avient Corporation Avon Lake Corporate Responsible Care Corporate Support Activities in Sr.
Toluca 2000 Toluca Estado de México 50200 Mexico ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
Unit 3 Dodworth Business Park, Dodworth Barnsley South Yorkshire S75 3SP United Kingdom ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
China has been assessed and certified as meeting the requirements of 麟 ISO 13485:2016 EN ISO 13485:2016 ’骥鑫馨瓤) For the foiowing actratEes Design and manufacture of medical grade thermoplastic elastomers for non-active medical devices and active medical devices 遴;舞蒸;撇蒸 (non-implantable) :护、::于b入沙黔娜;舞睡莎:器器舞蟒檬非拟拐称群亘爸竺舀‘。
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS • Medical devices • Drug delivery devices • Labware 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 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* * FDA/EU compliance information available upon request Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants 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 USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2021-04/colormatrix-optica-specialty-toners-for-pc-product-bulletin.pdf
MARKETS AND APPLICATIONS ColorMatrix Optica is formulated for PC resins used in the production of: • Automotive interiors • Appliance housings • Consumer goods • Food packaging • Finished materials such as PC sheet • Electrical & Electronics REGULATORY • No heavy metals or restricted ingredients • In-house chemical testing and verification system compliant with ISO ISO/IEC 17025:2005 • Dedicated product stewardship team globally and locally