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。
https://www.avient.com/sites/default/files/2022-05/MEVOPUR LQ for Silicone Elastomers_CN.pdf
可根据要求提供多种定制化
颜色解决方案
根据ISO 13485/GMP质量体系生产,并拥有变
更控制管理
原材料红外光谱分析和常规批次检测
根据ISO 10993第18部分对正己烷、异丙醇及
水中的可萃取性进行评估
法规支持
原材料根据ISO 10993-1和USP第、
章(VI类)对原材料进行生物评估的预测试
向FDA提交所有标准颜色的DMF/MAF文件
应用
医疗器械,如导管和连接器、注射器针头及无
针连接器
与皮肤接触设备,如可穿戴设备或医疗器械的
柔软触感表面
MEVOPUR LQ 配方可用于要求严苛的应用,包
括:
MEVOPUR™-LQ 不透明红(PMS198C)
产品编号:FZ3M415008
MEVOPUR™-LQ 透明红
产品编号:FZ3M415009
MEVOPUR™-LQ 不透明蓝(PMS292C)
产品编号:FZ5M415008
MEVOPUR™-LQ 透明蓝
产品编号:FZ5M415009
MEVOPUR™-LQ 不透明黄(PMS1205C)
产品编号:FZ1M415005
MEVOPUR™-LQ 透明黄
产品编号:FZ1M415006
MEVOPUR™-LQ 不透明绿(PMS346C)
产品编号:FZ6M415008
MEVOPUR™-LQ 透明绿
产品编号:FZ6M415009
MEVOPUR™-LQ 不透明紫(PMS2655C)
产品编号:FZ4M415003
MEVOPUR™-LQ 透明紫
产品编号:FZ4M415004
定制化选择
也可以根据您的需求
定制颜色,
请联系我们。
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/US_N%2520Baltimore_IATF%252016949_Exp%25209-2021.pdf
ECert.QECertificate
Page 1 of 2
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.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016
The Quality Management System is applicable to:
Certificate No: 38972
Effective Date: 04 September 2018
Expiration Date: 03 September 2021
Issue Date: 31 December 2018
IATF No: 0328156 Alex Weisselberg, President
DESIGN AND MANUFACTURE OF CUSTOM PVC PLASTISOL AND PVC SLUSH MOLD POWDER
(WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
Page 2 of 2
ABS Quality Evaluations
PolyOne Corporation
IATF 16949:2016
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2021-04/iatf-16949-58976-lockport-17nov2020.pdf
ECert - 2020-11-17T151438.723.pdf
Page 1 of 2
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.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016
The Quality Management System is applicable to:
Certificate No: 58976
Effective Date: 08 February 2019
Expiration Date: 09 August 2022
Revision Date: 17 November 2020
IATF No: 0349837 Dominic Townsend, President
DESIGN AND MANUFACTURE OF THERMOPLASTIC COMPOUNDS
(WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
Page 2 of 2
ABS Quality Evaluations
Avient Corporation
IATF 16949:2016
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/resources/US_Norwalk_IATF16949_2020Exp.pdf
ECert.pdf
Page 1 of 2
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.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
IATF 16949:2016
The Quality Management System is applicable to:
Certificate No: 39913
Effective Date: 30 November 2017
Expiration Date: 29 November 2020
Issue Date: 30 November 2017
IATF No: 0280241 Alex Weisselberg, President
DESIGN AND MANUFACTURE OF COLOR CONCENTRATES
(WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
Page 2 of 2
ABS Quality Evaluations
PolyOne Corporation
IATF 16949:2016
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/resources/Dyersburg%2520IATF%252016949-2016%2520exp%25208-13-2021.pdf
ECert.QECertificate
Page 1 of 2
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.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
ABS Quality Evaluations
This is to certify that the Quality Management System of:
PolyOne Corporation
Plastics Compounds and Colorants Group
107 Jackson Street
Dyersburg, TN 38024
IATF 16949:2016
The Quality Management System is applicable to:
Certificate No: 39032
Effective Date: 14 August 2018
Expiration Date: 13 August 2021
Issue Date: 17 August 2018
IATF No: 0322936 Alex Weisselberg, President
MANUFACTURE, DESIGN AND SUPPLY OF PROPRIETARY THERMOPLASTIC COMPOUNDS, INCLUDING THE
SUPPLY OF TOLL COMPOUNDING SERVICES
(WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
Page 2 of 2
ABS Quality Evaluations
PolyOne Corporation
IATF 16949:2016
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.