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/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/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
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/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/2021-12/PREPERM _ Edgetek Low-loss Dielectric Thermoplastics Technical Bulletin.pdf
KEY PROPERTIES AND PERFORMANCE
FR GRADES H GRADES PEEK GRADES LCP GRADES FLEX GRADES
PROPERTIES CONDITION ISO UNIT PPE400FR PPE700FR PPE950FR PPE1200FR H1500HF H2300HF PEEK700 PEEK900 PEEK1000 PEEK1200 LCP650 LCP800 LCP950 FLX400 FLX700 FLX1100
Dielectric Constant (Dk) 2.4 GHz 4.0 7.0 9.5 12.0 15.0 23.0 7.0 9.0 10.0 12.0 6.5 8.0 9.5 4.0 7.0 11.0
Loss Tangent (Df) 2.4 GHz 0.0030 0.0039 0.0042 0.0045 0.0010 0.0037 0.0024 0.0025 0.0024 0.0027 0.0043 0.0045 0.0047 0.0010 0.0009 0.0012
Density 1183 g/cm3 1.44 1.97 2.20 2.50 2.60 3.40 1.94 2.20 2.30 2.40 2.00 2.15 2.30 1.52 1.93 2.50
Melt Flow Index (MFI) 5 kg, 300 °C
(unless noted) 1113 g/10 min 17 12 13 5 5 8 15 @ 380 °C 13 @ 380 °C 10 @ 380 °C 6 - - - 11 @ 230 °C 2 @ 230 °C 0.3 @ 230 °C
Tensile Strength at Break 23 °C/73 °F 527 MPa 47 52 44 45 23 40 64 62 65 67 75 80 75 11 17 25
Flexural Modulus 23 °C/73 °F 178 MPa 3100 4500 - 9300 2100 5000 6200 7600 9200 11000 8000 8500 8500 1400 1600 2900
Unnotched Izod 23 °C/73 °F 180 kJ/m2 NB 42 20 9 17 10 28 25 18 15 31 20 12 NB NB NB
-20 °C/-4 °F 180 kJ/m2 - - - - 17 10 - - - - - - - - -
Notched Izod 23 °C/73 °F 180 kJ/m2 14 6 4 3 5 4 6 4 4 4 10 6 4 59 23 13
-20 °C/-4 °F 180 kJ/m2 - - - - 5 4 - - - - - - - - - -
STANDARD GRADES RADOME GRADES
PROPERTIES CONDITION ISO UNIT PPE260 PPE300 PPE320 PPE350 PPE400 PPE440 PPE500 PPE650 PPE800 PPE950 PPE1200 RS260 RB260 RS265FR
Dielectric Constant (Dk) 2.4 GHz 2.6 3.0 3.2 3.5 4.0 4.4 5.0 6.5 8.0 9.5 12.0 2.6 2.6 2.7
Loss Tangent (Df) 2.4 GHz 0.0009 0.0009 0.0010 0.0009 0.0009 0.0009 0.0009 0.0009 0.0009 0.0009 0.0010 0.0009 0.0012 0.0032
Density 1183 g/cm3 1.07 1.18 1.21 1.27 1.43 1.50 1.62 1.86 2.10 2.20 2.40 1.06 1.08 1.09
Melt Flow Index (MFI) 5 kg, 300 °C 1113 g/10 min 15 15 16 14 14 14 15 11 10 4 2 21 16 25
Tensile Strength at Break 23 °C/73 °F 527 MPa 40 45 47 50 50 48 45 43 37 37 36 50 42 52
Flexural Modulus 23 °C/73 °F 178 MPa 2700 2400 2000 2600 2800 2700 2600 2600 2300 2600 2600 2200 2200 2600
Unnotched Izod 23 °C/73 °F 180 kJ/m2 NB NB NB NB NB NB NB NB 50 28 24 NB NB NB
-20 °C/-4 °F 180 kJ/m2 NB NB NB NB NB NB NB 50 47 27 25 NB NB NB
Notched Izod 23 °C/73 °F 180 kJ/m2 8 55 69 35 22 20 15 9 8 5 4 19 14 11
-20 °C/-4 °F 180 kJ/m2 8 15 20 14 12 10 9 8 8 5 4 10 12 10
PREPERM™ SERIES
PROPERTIES CONDITION ISO UNIT 8027 8025 8037 8019 8028 8026 8044 8029 8041 8045 8048 8036 8056 8031
Dielectric Constant (Dk) 1 GHz, 23 °C 3.0 3.1 3.4 3.6 3.8 4.4 4.8 5.3 5.4 5.9 6.0 7.0 7.3 9.0
Loss Tangent (Df) 1 GHz, 23 °C 0.0012 0.0012 0.0008 0.0010 0.0010 0.0010 0.0004 0.0008 0.0006 0.0002 0.0006 0.0007 0.0002 0.0007
Density 1183 g/cm3 1.25 1.26 1.35 1.39 1.45 1.59 1.72 1.75 1.79 1.89 1.88 2.06 2.086 2.25
Melt Flow Index (MFI) 5 kg, 300 °C 1113 g/10 min 16 19 10 11 15 13 10 10 15 15 19 10 18 4.7
Tensile Strength at Break 23 °C/73 °F 527 MPa 59 54 54 62 59 54 52 58 52 45 49 45 37 38
Flexural Modulus 23 °C/73 °F 178 MPa 2780 2560 2850 3060 3350 3700 3157 4300 4320 3137 4150 3370 2560 4200
Notched Izod 23 °C/73 °F 180 kJ/m2 15.3 14 14.8 14 12.6 10.4 9.9 8.6 7.4 7.9 6.6 7.1 6.2 6.8
EDGETEK™ 7600 SERIES
Copyright © 2021, Avient Corporation.
https://www.avient.com/sites/default/files/2020-10/auto-injector-application-study.pdf
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.
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
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.