https://www.avient.com/sites/default/files/2021-11/0514-02-dec2021.pdf
Avon Lake, OH
for technical competence in the field of
Chemical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories.
This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 28th day of February 2020.
_______________________
Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 0514.02
Valid to December 31, 2021
Revised September 21, 2021
0514-02s
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
Test Method or Standard:
Test Description:
0514-02c
https://www.avient.com/sites/default/files/2023-11/ISO14001 Global Cert_Avient.pdf
Activity: Design and Manufacture of Colorants and Additives for Plastics
Page 6 of 10
ABS Quality Evaluations
Avient Corporation
ISO 14001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Compound, Supply, and Prototyping Services of Thermoplastics Activity: Design and Manufacture of Colorants and Additives for Plastics
Page 8 of 10
ABS Quality Evaluations
Avient Corporation
ISO 14001:2015
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 Plastics Compounding Material and
Thermoplastic Elastomers
Page 10 of 10
ABS Quality Evaluations
Avient Corporation
ISO 14001:2015
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/2024-05/ISO14001 Global Cert_Avient_2024.pdf
Activity: Design and Manufacture of Colorants and Additives for Plastics
Page 6 of 10
ABS Quality Evaluations
Avient Corporation
ISO 14001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Compound, Supply, and Prototyping Services of Thermoplastics Activity: Design and Manufacture of Colorants and Additives for Plastics
Page 8 of 10
ABS Quality Evaluations
Avient Corporation
ISO 14001:2015
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 Plastics Compounding Material and
Thermoplastic Elastomers
Page 10 of 10
ABS Quality Evaluations
Avient Corporation
ISO 14001:2015
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/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/2021-11/suzhou-colormatrix-iso-900185.pdf
https://www.avient.com/sites/default/files/2024-09/24 EN 47.pdf
CERTIFICATE
Signed for the certification body:
Eric Louys
Chairman Certification Committee
CERTIFICATE
EN ISO 50001 : 2018
Energy Management System
VINÇOTTE nv
Jan Olieslagerslaan 35, 1800 Vilvoorde, Belgium
This is to certify that Avient
Located at Rue Melville Wilson 2
5330 Assesse
Belgium
has established and maintains an energy management system according the requirements of
EN ISO 50001 : 2018 “Energy Management System” for:
Design and manufacture of colour and additive concentrates, thermoplastic resins and
speciality compounds
This certificate is based on the result of an energy audit documented in the audit report 61231731.
Certificate number: 24 EN 47
Valid from 1 February 2024 to 31 January 2027
Further clarifications regarding the scope of this certificate and the applicability of EN ISO 50001 : 2018
requirements may be obtained by consulting the organization.
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/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/2025-03/65537-Certificate-05MAR2025.pdf
Page 1 of 5
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ISO 14001:2015ISO 14001:2015
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Certificate No: 65537
Avient CorporationAvient Corporation
At the below facilities
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Avient Corporation
Avon Lake Corporate
Responsible Care Corporate Support Activities in Sr.
Toluca 2000 Toluca Estado de
México 50200 Mexico
ISO 14001:2015ISO 14001:2015
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Certificate No: 65537
Avient CorporationAvient Corporation
At the below facilities
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Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
Unit 3 Dodworth Business Park,
Dodworth Barnsley South Yorkshire
S75 3SP United Kingdom
ISO 14001:2015ISO 14001:2015
Certificate Of ConformanceCertificate Of Conformance
ANNEXANNEX
Certificate No: 65537
Avient CorporationAvient Corporation
At the below facilities
FACILITY NAMEFACILITY NAME FACILITY ACTIVITYFACILITY ACTIVITY ADDRESSADDRESS
Copyright as of the Effective Date, ABS Quality Evaluations, Inc.