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/2024-03/Global Supplier Quality Manual_2024.pdf
Minimum requirements are adopted from the ISO 9001
standard.
Avient shall communicate additional requirements
regarding automotive (IATF 16949) and healthcare (ISO 13485) applications based on the raw
material’s end-use application.
Avient categorization
for a “supplier”
FDA Food & Drug Administration
IATF International Automotive Task Force
Interested Party Term referenced in ISO 9001.
https://www.avient.com/sites/default/files/resources/0514_02%2520PDI%2520ISO17025%2520Chemical_Extension%2520Cert2019.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 17025:2005
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 30th day of March 2018.
_______________________
Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 0514.02
Valid to December 31, 2019
Revised October 08, 2019
0514-02.pdf
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005
Test Method or Standard:
Test Description:
0514-02c.pdf
https://www.avient.com/sites/default/files/2021-04/colormatrix-optica-specialty-toners-for-pc-product-bulletin.pdf
MARKETS AND APPLICATIONS
ColorMatrix Optica is formulated for
PC resins used in the production of:
• Automotive interiors
• Appliance housings
• Consumer goods
• Food packaging
• Finished materials such as
PC sheet
• Electrical & Electronics
REGULATORY
• No heavy metals or restricted
ingredients
• In-house chemical testing and
verification system compliant with
ISO ISO/IEC 17025:2005
• Dedicated product stewardship
team globally and locally
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS
• Medical devices
• Drug delivery devices
• Labware
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number level, reducing risk of change
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP
biological evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
* FDA/EU compliance information available upon request
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured under ISO 13485 procedures
• Documented change control beyond
CAS number, reducing risk of change
• Can be used on common injection molding
and extrusion machines—set-up support by
a technical assistance team
• Available for use in polyolefins, styrenics
and copolymers
• Can be combined with colorants
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1
- USP and (incl. class VI)
- European Pharmacopeia, monograph 3.1.3/
3.1.5 (polyolefin packaging materials)
- USP (polyethylene)
- Elemental impurities as per ICH Q3D
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact according to USA FDA and
EU norms
APPLICATION BULLETIN
Sustainability Spotlight
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
China
has been assessed and certified as meeting the requirements of
麟 ISO 13485:2016
EN ISO 13485:2016
’骥鑫馨瓤) For the foiowing actratEes
Design and manufacture of medical grade thermoplastic elastomers
for non-active medical devices and active medical devices
遴;舞蒸;撇蒸 (non-implantable)
:护、::于 b入沙黔娜;舞睡莎:器器舞蟒檬非拟拐称群亘爸竺舀‘。
https://www.avient.com/sites/default/files/2024-12/ISO9001 2015 Certificate for Shenzhen Plant%282024-2027%29.pdf
No. 1, Qihang Industry Park, Haoxiang Road, Shajing Town, Baoan, Shenzhen, Guangdong,
China 518104
has been found to conform to the Quality Management System standard:
GB/T 19001-2016 / ISO 9001:2015
This certificate is valid for the following scope:
Development and Manufacture of Masterbatch, Pigment Concentration, Plastisol;
Manufacture of Plastic Compounding Material
http://www.dnv.com/assurance
证书制作地点及日期:
证书认可签发机构:
上海, 2024年10月 10日 DNV - Business Assurance
中国上海市长宁区虹桥路1591号9号楼A座 邮编:
200336 电话: +86 21 32799000
朱海明
管理代表
未履行认证协议中规定条款会导致此证书失效,获证组织必须定期接受监督审核并经审核合格此证书方继续有效。
获得认可的单位: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
本证书信息可在国家认证认可监督管理委员会官方网站(WWW.CNCA.GOV.CN) 上查询
管理体系认证证书
证书号码:
3033-2006-AQ-RGC-RvA
首次签发日期:
2018年11月 07日
有效期限:
2024年11月 08日 – 2027年11月 07日
兹证明
普立万聚合体(深圳)有限公司
中国广东省深圳市宝安区沙井镇蚝乡路启航工业园1号 518104
统一社会信用代码:9144030076498189X0
质量管理体系符合 :
GB/T 19001-2016 / ISO 9001:2015标准
此证书对下列范围有效:
色母粒,色浆,增塑溶胶的开发和制造;塑料改性材料的制造
http://www.dnv.com/assurance
WWW.CNCA.GOV.CN)上查询
https://www.avient.com/sites/default/files/2023-10/31307-Certificate-20SEP2023.pdf
Purchasing, Customer Service, Logistics,
Quality, Design and Sampling; Corporate HQ, Management of QMS
Activity: Manufacture of Engineered Thermoplastics
Page 3 of 7
ABS Quality Evaluations
Avient Corporation
ISO 9001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Manufacture of Colorants for Plastics Activity: Manufacture of thermoplastic compounds
Page 4 of 7
ABS Quality Evaluations
Avient Corporation
ISO 9001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Activity: Manufacturing, Shipping and Receiving Activity: Compound and supply of thermoplastics for the medical device
industry
Page 5 of 7
ABS Quality Evaluations
Avient Corporation
ISO 9001:2015
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.