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.
Without limiting the generality of this statement, Avient products shall not be used in any medical device application intended for:
(1) exposure to human tissue or body fluids for 30 days or greater;
(2) “plastic” (cosmetic or reconstructive) surgery use;
(3) reproductive implants or any birth control device; or
(4) any critical component in a permanently (greater than 30 days) implanted medical device that supports or sustains human life.
https://www.avient.com/sites/default/files/2020-08/mesa-stain-colorants-1-pager-1.pdf
https://www.avient.com/sites/default/files/resources/Ramos_ISO_14001.pdf
Gamma 650
Parque Industrial Santa María
Ramos Arizpe, Coahuila 25900
México
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
ISO 14001:2015
The Environment Management System is applicable to:
COMPOUNDING OF THERMOPLASTIC PRODUCTS
This certificate may be found on the ABS QE Website (www.abs-qe.com).
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。
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/2023-01/ECCOH XL 8148 - Photovoltaic Cable - Application Snapshot.pdf
Name of topic
CABLE
PRODUCER
P H O T O V O L T A I C C A B L E
• Simplified supply chain and inventory by providing one
solution for both insulation and jacket coating
• Provided a material that gave cable a good surface finish
and improved cable life time value (passed Arrhenius life
time prediction as per IEC 60216-1 in internal lab test)
• Reduced catalyst dosage resulting in lower material cost
• Improved customer processing speeds
• Enabled flame retardant performance to EN 50618 and
IEC 60332-1 standards on complete cable
ECCOH™ XL 8148 + ECCOH XL CAT 005
Formulations
KEY REQUIREMENTS
WHY AVIENT?
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/content/name-change-details
Sucursal en España
https://www.avient.com/resources/safety-data-sheets?page=5240
PC (ISO) WHITE CC
DOWNY BLUE 1
DOWNY BLUE 1.B
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.