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/2022-04/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/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/2022-07/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/2023-11/Responsible Care_14001 Global Cert_Avient.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
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 10
ABS Quality Evaluations
Avient Corporation
RC14001®:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Design and Manufacture of Colorants and Additives for Plastics
Page 6 of 10
ABS Quality Evaluations
Avient Corporation
RC14001®:2015
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/2021-05/avient-colorants-singapore-name-change-certificate-may-17-2021.pdf
CERTIFICATE CONFIRMING INCORPORATION OF COMPANY
AVIENT COLORANTS SINGAPORE PTE.