https://www.avient.com/sites/default/files/2020-07/avient-abac-hungarian-200721.pdf
Francisco Nakasato, 1700
13295-000 Itupeva São Paulo,
Brazília
Telefonszám: +55 11 4593 9200
Európa
Regionális Központ Pommerloch,
Luxemburg
19 Route de Bastogne Pommerloch,
Luxembourg, L-9638
Telefonszám: +352 269 050 35
Fax: +352 269 050 45
www.avient.com
http://www.avient.com
https://www.avient.com/sites/default/files/2020-07/avient-abac-turkey-200721.pdf
Francisco Nakasato, 1700
13295-000 Itupeva Sao Paulo,
Brezilya
Telefon: +55 11 4593 9200
Avrupa
Bölge Merkezi Pommerloch,
Lüksemburg
19 Route de Bastogne Pommerloch,
Lüksemburg, L-9638
Telefon: +352 269 050 35
Faks: +352 269 050 45
www.avient.com
http://www.avient.com
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.