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/Avient-2022-Sustainability-Report.pdf
To find more details about our certifications, visit our ISO
Certifications Librar y.
This methodology was developed
in accordance with ISO 14067:2018 for product carbon footprint and is aligned with ISO 14040/140440 for life cycle analysis.
ZERO
Major Non-Conformances
at ISO Sites
96%
Manufacturing Sites
Certified to an
International Standard
1,000+
Product Carbon
Footprint Calculations
Completed
HOME | Contents | Message from the CEO | About Us | People | Products | Planet | Per formance | Metrics | Index Sustainability Report | 2022 52Sustainability Report | 2022 52
https://responsiblecare.americanchemistry.com/
https://www.avient.com/company/policies-and-governance-0/global-iso-certificate-library
https://www.avient.com/company/policies-and-governance-0/global-iso-certificate-library
https://www.certipedia.com/certificates/C01-2023-03-21257059?
https://www.avient.com/sites/default/files/2021-12/certificate-of-registration-avient-s.a-r.l.-sweden-filial-nov-29-2021.pdf
e-Certificate of registration
Swedish Companies Registration Office
BRANCH
D1a- 6858922
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
516411-5031
2018-08-28
2021-11-30 17:11
2021-11-29
1 (3)
Pending matter(s)
The register indicates pending matter(s) regarding a change to
the registered information at the time this certificate was created.
e-Certificate of registration
Swedish Companies Registration Office
BRANCH
D1a- 6858922
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
516411-5031
2018-08-28
2021-11-30 17:11
2021-11-29
2 (3)
Registration number: 516411-5031
Business name: Avient S.à r.l., Sweden Filial
Address:
Drottninggatan 56
411 07 GÖTEBORG
County and municipality: Västra Götaland, Göteborg
Note:
MANAGING DIRECTOR
630516 Palm, Christoph, Gruss Strooss 35, L-9991 WEISWAMPACH,
LUXEMBURG
AUDITORS
556053-5873 Ernst & Young Aktiebolag, Box 7850, 103 99 STOCKHOLM
Represented by: 850807-5135
PRINCIPALLY RESPONSIBLE AUDITOR
850807-5135 Edman, Mikael Thomas Gunnar, c/o Ernst & Young AB,
401 82 GÖTEBORG
SIGNATORY POWER
Signatory power alone by
Palm, Christoph
FINANCIAL YEAR
Registered financial year: 0101 - 1231
DATE OF REGISTRATION OF CURRENT AND PREVIOUS BUSINESS NAMES
2021-11-29 Avient S.à r.l., Sweden Filial
2018-08-28 PolyOne S.à.r.l., Sweden Filial
INFORMATION ABOUT THE FOREIGN COMPANY
B226205
Avient S.á.r.l.
19, Route de Bastogne
L-9638 Pommerloch
LUXEMBURG
Registered office of the foreign company:
Pommerloch
Name of the register in which the foreign company is registered:
e-Certificate of registration
Swedish Companies Registration Office
BRANCH
D1a- 6858922
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
516411-5031
2018-08-28
2021-11-30 17:11
2021-11-29
3 (3)
RCS, Registre de Commerce,
Luxembourg Business Register
LUXEMBURG
Foreign company's financial year:
0101 - 1231
The above information is an extract from the Trade and Industry
Register Bolagsverket, the Swedish Companies Registration Office.
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/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/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.
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.
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/2023-03/Onflex-Cell Pack Cooling Tube-Application Snapshot.pdf
AVIENT SOLUTION
V E H I C L E B AT T E RY
M A N U FA C T U R E R
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/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/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。