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
Applications:
• 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
Applications:
• 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,
smooth surface aesthetics
Versalloy™
HC 9210-55N
55A USP Class VI EtO
Good processability,
smooth surface aesthetics
Versalloy™
HC 9210-70N
70A USP Class VI EtO
Good processability,
smooth surface aesthetics
Versalloy™
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/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
LB6000-
5024 RS HI
Natural
LB6000-
5021 RS S1
Black
LB6000-
5021 RS X2
Black
LB6000-
5019 X1
Black
LB6700-
5001 RS AF
Black
NN-
000/01M
Black SO
REC
LB6600-
5030 RS
Grey
LB3300-
5010 RS
Natural
LB3300-
5005 RS
Natural
REC
LB3220-
5001 RS C
Natural X1
LB8900-
5010 GP
Grey
LB8900-
5006 RS PE
Natural
LB8900-
5004 RS PE
Natural
LB4200-
5022 Black
LB4200-
5023
Natural
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/2022-10/Tossiat-IATF 16949-2016 POLYONE FRANCE SAS.pdf
and the applicable customer specific requirements
Revision:11
For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France
None
Bureau Veritas Certification Certificate N°: FR072877FR072877- IATF- IATF
IATF Certificate N°: 442787442787
Date Of Expiration: 01-February-202501-February-2025
Date Of Certification: 02-February-202202-February-2022
PRODUCT(S) DELIVEREDPRODUCT(S) DELIVERED
colour with additive concentrates for thermoplastic resins
and speciality compounds obtained by mixing and extrusion
PERMITTED EXCLUSION(S)PERMITTED EXCLUSION(S)
SCOPESCOPE
Design and manufacturing
Bureau Veritas Certification certify that the Quality Management System of the above organisation
has been audited and found to be in accordance with the requirements of
Route de la Vavrette, 01250, TOSSIAT FranceRoute de la Vavrette, 01250, TOSSIAT France
PolyOne France TossiatPolyOne France Tossiat
Awarded to
Certificate of ApprovalCertificate of Approval
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L
REMOTE SUPPORT FUNCTION(S)REMOTE SUPPORT FUNCTION(S)
(The official document is in English.
Revision:11
For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France
Bureau Veritas Certification Certificate N°: FR072877FR072877- IATF- IATF
IATF Certificate N°: 442787442787
Date Of Expiration: 01-February-202501-February-2025
Date Of Certification: 02-February-202202-February-2022
Route de la Vavrette, 01250, TOSSIAT FranceRoute de la Vavrette, 01250, TOSSIAT France
PolyOne France TossiatPolyOne France Tossiat
Awarded to
Appendix to the Certificate of ApprovalAppendix to the Certificate of Approval
Name Address Scope
AVIENT
LUXEMBOURG
ROUTE DE BASTOGNE, 19, 9836,
POMMERLOCH Luxembourg
Logistic, Supplier Management,
Purchasing
PolyOne Europe
Logistics
7 rue Blériot, 4460, GRACE HOLLOGNE
Belgium
Warehousing
Polyone Europe ul.
https://www.avient.com/sites/default/files/2023-06/ISO 45001 Suzhou - GLS.pdf
https://www.avient.com/sites/default/files/2023-11/ISO 14001_CN_Changzhou.pdf
https://www.avient.com/sites/default/files/2023-11/ISO 9001_CN_Changzhou.pdf
https://www.avient.com/sites/default/files/2021-11/suzhou-colormatrix-iso-900185.pdf
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/Ramos%2520IATF%252016949-2016%2520exp%25207-10-2021_0.pdf
For and on behalf of BSI:
Carlos Pitanga, Chief Operating Officer Assurance – Americas
Certification Date: 2018-07-11 Latest Issue: 2018-07-11 Expiry Date: 2021-07-10
BSI Certificate Number: 85585
IATF Number: 0315491
Page: 1 of 2
This certificate remains the property of BSI and shall be returned immediately upon request.
An electronic certificate can be authenticated online.
An electronic certificate can be authenticated online.
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.