https://www.avient.com/sites/default/files/2022-03/Asia SEM Healthcare Product Selection Guide %281%29.pdf
PP OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Dynaflex™ G2706 28A USP Class VI, ISO 10993,
Food contact EtO Soft translucent grade,
grippy feel
Dynaflex™ G2711 43A USP Class VI, ISO 10993,
Food contact EtO Highly colorable solution,
grippy feel, low compression set
Versaflex™
CL2242 & CL2250 42A/ 50A USP Class VI, ISO 10993,
US Food contact EtO Clear boilable grades;
ABS, PC bondable
Versaflex™ G2705 N 60A USP Class VI, ISO 10993,
Food contact EtO/Steam High resilience,
low compression set
Versaflex™ HC3810 20A-90A USP Class VI, ISO 10993 EtO General purpose, unfilled
ABS, PC OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Versaflex™ OM1040 40A USP Class VI, ISO 10993 EtO Translucent
Versaflex™ OM3060 60A USP Class VI, ISO 10993 EtO Clear
VERSAFLEX™ CL AND DYNAFLEX™ TPEs
OVERMOLDING FOR
ERGONOMICS
• Adds good tactile surface with soft-touch feel
• Available in a variety of color effects and
textures
• Improves grip, cushion, and comfort
• Enhances functional performance like sealing
properties, vibration damping, oxygen
barrier, and scratch and abrasion resistance
• Reduces assembly costs, good processability
• Offers excellent adhesion to a wide range of
substrates
• Glucometers
• Medical tools overmolds
• Injector pens
• Analysis devices
VERSALLOY™ HC & VERSAFLEX™ HC TPEs
SEALING & RESEALING
• Rubbery feel and soft touch
• No coring, good puncture, and
resealability in static stoppers
• Meets low coefficient of friction
requirements in dynamic seals
• Low extractables
• Suitable to overmold onto polyolefins
• Sealing and resealing septum
• Seals and sanitary gaskets
• Syringe plungers and tips
MATERIAL DESCRIPTION HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Versalloy™
HC 9210-45N 45A USP Class VI EtO Good processability,
HC 9210-55N 55A USP Class VI EtO Good processability,
HC 9210-70N 70A USP Class VI EtO Good processability,
HC 9220-43N 43A USP Class VI,
ISO 10993-4/5 EtO Extrusion grade,
high temperature resistance
Versaflex™
HC 2110-35N 34A FDA, USP Class VI,
ISO 10993
Autoclave EtO
radiation Resealing, elevated comp set
Versaflex™
HC 2110-57B 57A FDA, USP Class VI,
ISO 10993
Autoclave EtO
radiation Low stiction
VERSAFLEX™ CL AND DYNAFLEX™ TPEs
HIGH CLARITY
GRADES WITHOUT
PLASTICIZERS
• Water clear grades formulated without
phthalate plasticizers
• Meets medical regulatory USP Class VI and
ISO 10993-4,5
• Food contact and FDA compliant
• Autoclave and radiation stable
• Low extractable
• High clarity (Haze 50 4.1, 100 4.5, 100 4, 70 6, 70
Tensile Modulus (MPa) 2200 2700 2600 2350 1820 1820
Flexural Strength (MPa) 80 90 104 86 68 68
Flexural Modulus (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 Rating @ 3.0 mm 5VA V-0 5VA V-0 HB V-0
UL-94 Rating @ 1.5 mm V-0 V-0 5VB V-0 HB V-0
UL-94 Rating @ 0.75 mm V-1 V-2 V-0 None None V-2
COMPETITIVE MATERIAL COMPARISON
ENGINEERED POLYMER FORMULATIONS
FOR HEALTHCARE
TRILLIANT™ HC THERMOPLASTICS
The family of Trilliant™ HC high-performance thermoplastics is formulated to meet the growing challenges
of medical devices and equipment.
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/2022-07/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/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/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/2023-03/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/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/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
https://www.avient.com/resource-center?document_subtype=0&document_type=59&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=28
MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield