https://www.avient.com/resources/safety-data-sheets?page=4771
Geon(TM) DB5337 NEUTRAL ISO TT STAB FUNG
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resource-center?document_type=0&industry=0&product_family=84&product_subfamily=0&product_name=0&op=FILTER RESULTS&form_build_id=form-fNS88LG3BRw1MCsEhxqrGzoCcCISeOxlsDfIOUV4Mx0&form_id=resource_filter_form
Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.
https://www.avient.com/sites/default/files/resources/Polyolefins%2520Product%2520Selection%2520Guide.pdf
Offers a high level of stiffness and
heat resistance as well as excellent
impact resistance
Product Code - - - PP5410 B1 PP5420 B1 PP5430 B5 PP5440 B1
Reinforcement % - - - 10 20 30 40
Specific Gravity 73°F (23°C) - ASTM D792 0.96 1.05 1.14 1.23
Tensile Strength Yield psi ASTM D638 8000 10000 11500 13000
MPa ISO 527 55 69 79 90
Tensile Elongation Break % ASTM D638 8 2 2 2
Flexural Modulus 73°F (23°C) psi ASTM D790 525,000 795,000 850,000 1,000,000
MPa ISO 178 3600 5450 5800 7550
Notched Izod
73°F (23°C) ft-lb/in ASTM D256 1.10 1.30 1.50 1.60
kJ/m2 ISO 180 6.00 7.25 8.25 8.50
Heat Deflection 66 psi °F ASTM D648 280 305 310 315
°C ISO 75 138 152 154 157
264 psi °F ASTM D648 250 280 290 300
°C ISO 75 121 138 143 149
Linear Shrinkage
1/8 in wall % - 0.4–0.7 0.3–0.6 0.3–0.6 0.2–0.5
3.2 mm wall % - 0.4–0.7 0.3–0.6 0.3–0.6 0.2–0.5
Product Code - - - PP7410
A241
PP7420
B77
PP6430
A206-UV
PP6435
Reinforcement % - - - 10 20 30 35
Specific Gravity Yield - ASTM D792 0.98 1.05 1.14 1.17
Tensile Strength Yield psi ASTM D638 5300 9200 9000 13300
MPa ISO 527 37 64 62 92
Tensile Elongation Break % ASTM D638 8 4 4 4
Flexural Modulus 73°F (23°C) psi ASTM D790 240,000 420,000 695,000 810,000
MPa ISO 178 1650 2900 4800 5600
Notched Izod Impact 73°F (23°C) ft-lb/in ASTM D256 5.0 1.60 1.60 2.50
kJ/m2 ISO 180 27.5 9.00 9.00 14.00
Heat Deflection 66 psi °F ASTM D648 298 313 297 300
°C ISO 75 144 156 152 149
264 psi °F ASTM D648 210 272 265 288
°C ISO 75 92 133 128 142
Linear Shrinkage
1/8 in wall % - 0.4–0.7 0.3–0.6 0.3–0.6 0.2–0.5
3.2 mm wall % - 0.4–0.7 0.3–0.6 0.3–0.6 0.2–0.5
Maxxam™ Glass Fiber Reinforced
Homopolymer Polypropylene
Maxxam™ Glass Fiber
Reinforced Copolymer
71.866.POLYONE www.polyone.com
Product Code - - - PP5312
PP5320
A285
PP5330
A123
PP5340
B2
Reinforcement % - % - 12 20 30 40
Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.05 1.15 1.24
Tensile Strength Yield psi ASTM D638 4800 4400 3600 4900
MPa ISO 527 31 30 32 38
Tensile Elongation Yield % ASTM D638 5 4 4 3
Break % ASTM D638 20 15 20 10
Flexural Modulus 73°F (23°C) psi ASTM D790 285,000 380,000 355,000 460,000
MPa ISO 178 1950 2600 2450 3200
Notched Izod
73°F (23°C) ft-lb/in ASTM D256 0.6 0.55 1.5 0.60
kJ/m2 ISO 180 3.30 3.00 8.25 3.30
Heat Deflection 66 psi °F ASTM D648 235 255 230 280
°C ISO 75 113 124 110 138
264 psi °F ASTM D648 135 156 150 180
°C ISO 75 57 69 66 82
Linear Shrinkage
1/8 in wall % - 1.4–1.9 1.0–1.4 1.1–1.5 0.6–1.0
3.2 mm wall % - 1.4–1.9 1.0–1.4 1.1–1.5 0.6–1.0
Offers improved stiffness and heat
deflection as well as outstanding
dimensional stability.
Provides heat stabilization
• Excellent balance of properties
• Natural, black or custom colors
Product Code - - - PX5430 B1 PX5435 B1 PX5440 B1 PX5450 B1
Reinforcement Type - - - Glass Glass Glass Glass
Reinforcement % - % - 30 35 40 50
Specific Gravity 73°F (23°C) - ISO 1183 1.13 1.18 1.23 1.35
Tensile Strength Yield MPa ISO 527 102 105 113 130
Flexural Modulus 73°F (23°C) MPa ISO 178 6500 8000 9400 11,500
Notched Izod Impact 73°F (23°C) kJ/m2 ISO 180 9.4 9.3 11.0 12.0
Heat Deflection 264 psi °C ISO 75 152 152 153 154
Product Code - - - PP5120 B270-LO
MFR g/10 min ISO 1133 12
Tensile Modulus MPa ISO 527 3320
Tensile Stress Yield MPa ISO 527 32
Tensile Elongation Yield % ISO 527 4.6
Tensile Elongation Break % ISO 527 17
Flexural Modulus MPa ISO 178 3000
Charpy Impact 73°F (23°C) kJ/m2 ISO 179/1eU 38
Heat Aging 150°C h VW 44045 700 hr
VOC µg/g VDA 278 23.5
Fog µg/g VDA 278 30.5
Carbon Emissions µgC/g VDA 277 18
Odor Grade VDA 270 B3 3
10
Maxxam™ Filled
& Reinforced
A range of melt flows to process well in
sheet extrusion, thermoforming, profile
extrusion and blow molding operations
Product Code - - - PE4125
Reinforcement
- - - Talc
Reinforcement
- % - 25
Specific
73°F (23°C) - ASTM D792 1.15
Tensile
Yield psi ASTM D638 4050
MPa ISO 527 28
Tensile
Yield % ASTM D638 10
Break % ASTM D638 40
Flexural
73°F (23°C) psi ASTM D790 270,000
MPa ISO 178 1850
Notched
73°F (23°C) ft-lb/in ASTM D256 3.5
kJ/m2 ISO 180 20.0
Heat
66 psi °F ASTM D648 190
°C ISO 75 88
264 psi °F ASTM D648 115
°C ISO 75 46
12
www.polyone.com
Copyright © 2019, PolyOne Corporation.
https://www.avient.com/sites/default/files/2023-03/Onflex-Cell Pack Cooling Tube-Application Snapshot.pdf
AVIENT SOLUTION
VEHICLE BATTERY
MANUFACTURER
C E L L P A C K C O O L I N G T U B E
• Comply with ISO 3384-1:2011 for TPE compression set
• Comply with ISO 11359-2:1999 standard for linear thermal
expansion
• Good ethanediol resistance
• Good sealing performance
• Customized a Shore 60A hardness TPE
formulation with good physical property
retention
• Achieved good compression set and bonding
performance with PA12
• Qualified thermal expansion by customer
• Provided excellent ethanediol resistance under
both low and high temperature conditions
KEY REQUIREMENTS
CHEMICAL RESISTANCE + SEALING
LEARN MORE
OnFlex™ TPE Custom Formulation
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/resources/Lockport_IATF%252016949%25202016_EXP%25205-2021.pdf
For and on behalf of BSI:
Chief Operating Officer Assurance - Americas
Certification Date: 2018-05-10 Latest Issue: 2018-05-10 Expiry Date: 2021-05-09
BSI Certificate Number: 691920
IATF Number: 0303891
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/2021-01/avient-puerto-rico-llc-certificate-of-amendment.pdf
Roman, Secretary of State of the Government of Puerto Rico,
CERTIFY: That on July 13, 2020, at 08:50 AM, "POLYONE PUERTO RICO,
LLC", registry number 365432, performed the following transaction:
Name Change
Previous Actual
POLYONE PUERTO RICO, LLC AVIENT PUERTO RICO, LLC
CERTIFICATE OF AMENDMENT
Government of Puerto Rico
IN WITNESS WHEREOF, the undersigned by virtue
of the authority vested by law, hereby issues this
certificate and affixes the Great Seal of the
Government of Puerto Rico, in the City of San Juan,
Puerto Rico, today, July 13, 2020.
https://www.avient.com/sites/default/files/2025-01/Tossiat-IATF 16949-2016 POLYONE FRANCE SAS Certificate FR094003.pdf
Date Of Certification: 11 December 2024
Date Of Expiration: 10 December 2027
IATF Certificate N°: 0558656
Bureau Veritas Certification Certificate No: FR094003 - IATF Revision: 1
For Bureau Veritas Certification Holding, Tour ALTO, 4 place des saisons, 92400 COURBEVOIE – France
(The official document is in English.
Any translations of this document shall be used for reference only.)
1/2
Certificate of Approval
AWARDED TO
PolyOne France Tossiat
Route de la vavrette, 01250, Tossiat - France
IATF USI: LWZS4P
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
IATF 16949 - FIRST EDITION
and the applicable customer specific requirements
SCOPE
Design and manufacturing
PERMITTED EXCLUSION(S)
None
PRODUCT(S) DELIVERED
colour with additive concentrates for thermoplastic resins and speciality compounds
obtained by mixing and extrusion
https://e-cer.bureauveritas.com/68LJQE0ZV0CO6I7YW0YSXOUMV9WWROQPHPI2AOHRRLFFVRAVTFVZGXKWIE3TOWLTTKEWCPQB9UNAPXHH6T0HXOMUEDVYPRPJLEXBBTKQYPBRICYOKY143TECQ5UMHGA3JX
Date Of Certification: 11 December 2024
Date Of Expiration: 10 December 2027
IATF Certificate N°: 0558656
Bureau Veritas Certification Certificate No: FR094003 - IATF Revision: 1
For Bureau Veritas Certification Holding, Tour ALTO, 4 place des saisons, 92400 COURBEVOIE – France
(The official document is in English.
Any translations of this document shall be used for reference only.)
2/2
Appendix to the Certificate of Approval
AWARDED TO
PolyOne France Tossiat
Route de la vavrette, 01250, Tossiat - France
IATF USI: LWZS4P
REMOTE SUPPORT FUNCTION(S)
NAME ADDRESS SCOPE
AVIENT LUXEMBOURG
19, Route de bastogne,
9638, Pommerloch -
Luxembourg
IATF USI: GAZS9A
Purchasing, Logistics, Supplier
Management
PolyOne Europe Logistics
7 Rue bleriot, 4460,
Grace-Hollogne - Belgium
IATF USI: P4WA4Y
Warehousing
Polyone Poland
Ul. wschdnia 6, 99-300,
Kutno - Poland
IATF USI: C4W5ZL
Logistics
https://e-cer.bureauveritas.com/68LJQE0ZV0CO6I7YW0YSXOUMV9WWROQPHPI2AOHRRLFFVRAVTFVZGXKWIE3TOWLTTKEWCPQB9UNAPXHH6T0HXOMUEDVYPRPJLEXBBTKQYPBRICYOKY143TECQ5UMHGA3JX
2024-12-13T10:07:11+0100
Authenticity and Integrity
https://www.avient.com/sites/default/files/2022-08/IATF 16949 North Baltimore.doc.pdf
Microsoft Word - IATF 16949 North Baltimore[80].doc
ABS Quality Evaluations
Certificate Of Conformance
This is to certify that the Quality Management System of:
Avient Corporation Engineered Materials Division
Avient Corporation
733 E.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Page 1 of 2
ABS Quality Evaluations
IATF 16949:2016
Certificate Of Conformance
ANNEX
Certificate No:
IATF No:
38972
0422162
Avient Corporation Engineered Materials Division
At Below Facilities:
Facility: Corporate
33587 Walker Road
Avon Lake, OH 44012
U.S.A.
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
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/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。