https://www.avient.com/sites/default/files/resources/US_Norwalk_IATF16949_2020Exp.pdf
ECert.pdf Page 1 of 2 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.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 39913 Effective Date: 30 November 2017 Expiration Date: 29 November 2020 Issue Date: 30 November 2017 IATF No: 0280241 Alex Weisselberg, President DESIGN AND MANUFACTURE OF COLOR CONCENTRATES (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations PolyOne Corporation IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/resources/Dyersburg%2520IATF%252016949-2016%2520exp%25208-13-2021.pdf
ECert.QECertificate Page 1 of 2 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.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 39032 Effective Date: 14 August 2018 Expiration Date: 13 August 2021 Issue Date: 17 August 2018 IATF No: 0322936 Alex Weisselberg, President MANUFACTURE, DESIGN AND SUPPLY OF PROPRIETARY THERMOPLASTIC COMPOUNDS, INCLUDING THE SUPPLY OF TOLL COMPOUNDING SERVICES (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations PolyOne Corporation IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2022-05/MEVOPUR LQ for Silicone Elastomers_CN.pdf
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。
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-for-needle-hubs-bulletin-cn.pdf
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。
https://www.avient.com/sites/default/files/2023-07/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 GRADES • Improve extrusion rates, achieve high service temperature performance or increase clarity in medical tubing • Traditional and bio- based formulations specifically for biopharmaceutical tubing to meet the 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 • 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 Medical Tubing Grades 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 Versalfex™ HC BIO BT218 Natural 70A 0.88 18 58 416 2.87 668 4.60 1190 8.20 630 - - ✔ ✔ Weldable, kink resistant, contains 40% bio-derived content (Gen 1 biomass) 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 ✔ ✔ Versaflex™ OM 8940X-1 Clear 42A 0.91 - - 233 - 311 - 1573 - 1059 - - - - PK, COPE overmold Versaflex™ OM 4052 Natural 56A 1.01 27 - 271 - 557 - 1680 - 670 - - ✔ - Excellent chemical resistance; PK, PC, ABS, PC/ABS overmoldVersaflex™ OM 4063 Natural 54A 1.12 30 - 365 - 580 - 1640 - 670 - - ✔ - 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/resources/US_Norwalk_RC14001_2020Exp.pdf
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:
https://www.avient.com/sites/default/files/2023-10/LubriOne Product Selection Guide.pdf
Steel – Static 0.25 0.46 0.18 0.15 0.12 0.19 0.11 0.14 0.13 0.24 0.17 0.17
Impact
Notched Izod Impact (23°C,
3.18 mm, Injection Molded) J/m ASTM D256A 41 64(6) 110 107 107 70 80 37 37 75 – 69
Thermal Properties
Heat Deflection Temperature ASTM D648
0.45 MPa °C 215(6) – 250 215 216 184 152 151(6) 153(6) 218(6) – –
1.8 MPa °C 65(6) 239(7) 244(6) 210 210 75 94 81.1(6) 88 197(6) – 135(5)
Electrical Properties
Surface Resistivity ohms/sq ASTM D254 – – – 1.30x1012 1.9x1012 5.2x1012 – – – – – 1.0x109
Dielectric Strength (Short Time) kV/mm – – 8.5 – – – – – – – – –
Flammability
Flame Rating Class UL 94 HB – – HB HB HB – HB – – – –
LubriOne™ Internally Lubricated Formulations
NOTES (1) Type I, 5.1mm/min
(2) Type I, 21.3 mm/min
(3) Type I, 50 mm/min
(4) Type I, 5.1mm/min, Break
(5) 3.2 mm thick, Unannealed
(6) 6.35 mm thick, Unannealed
(7) 3.2 mm thick, Annealed
PRODUCT DESCRIPTION UNITS TEST
METHOD
5024 RS HI
5021 RS S1
5021 RS X2
5019 X1
LB6700-
5001 RS AF
Black
NN-
000/01M
Black SO
REC
LB6600-
5030 RS
Grey
LB3300-
5010 RS
LB3300-
5005 RS
REC
LB3220-
5001 RS C
Natural X1
5010 GP
Grey
5006 RS PE
5004 RS PE
LB4200-
5022 Black
LB4200-
5023
Base Polymer PA 6 PA6/PA66 PA66 PBT PC PKE POM
Lubricant UHMWPE1 UHMWPE UHMWPE UHMWPE UHMWPE MoS22 Graphite UHMWPE UHMWPE UHMWPE Graphite UHMWPE UHMWPE MoS2 UHMWPE
Filler type GF10 GF30 GF30 GF50 GF50 Unfilled GF33 GF20 MI20 GF10 Unfilled GF20 GF30 Unfilled Unfilled
General Properties
Specific Gravity g/cm3 ISO 1183 1.18 1.35 1.39 1.55 1.58 1.14 1.44 1.42 1.46 1.23 1.26 1.34 1.43 1.4 1.35
Mechanical Properties
Tensile Modulus (23°C) MPa ISO 527-1 4250 9500 9000 15500 16600 3500 10600 6300 3330 4000 1630 5300 9250 2470 2150
Tensile Strength (Yield, 23°C) MPa ISO-527-2 97 150 160 205 200 85 164 102 55 60 60 108 99.1 55 50
Tensile Elongation (Break, 23°C) % ISO-527-2 12 2.5 3 2.7 2.4 3.4 2.0 4.2 8 2.5 46 3.7 1.5 11 11
Flexural Strength (23°C) MPa ISO 178 103 – – 285 265 108 215 127 78 85 38 155 117 73 68
Flexural Modulus (23°C) MPa ISO 178 3250 – – 12400 11100 2690 9000 4700 3000 3100 1380 4600 5450 2210 2070
Impact
Charpy Notched Impact Strength
(23°C, Injection Molded) kJ/m^2 ISO 179 14 12 10 15 10 3 6 7.7 4.3 12 15 10 7.6 8 5
Charpy Unnotched Impact
Strength (23°C, Injection Molded) kJ/m^2 ISO 179 82 55 61 75 60 65 50 47 69 - NB 63 36 NB NB
Thermal Properties
Deflection Temperature Under Load
1.8 Mpa, Unannealed °C ISO 75-2/A 107 – – 204 – 73 235 – – – 90 210 204 86 80
Cofficient of Friction (CoF) & Wear Rate
CoF vs.
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/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/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。