https://www.avient.com/sites/default/files/2021-04/certificate-of-incorporation-on-change-of-name-avient-colorants-ireland-limited-14-april-2021.pdf
G1QCertificate
Number: 82756
Certificate of Incorporation on Change Of Name
For Registrar of Companies
I hereby certify that
CLARIANT PLASTICS & COATINGS (IRELAND) LIMITED
having, by a Special Resolution of the Company,
and with the approval of the Registrar of Companies,
changed its name, is now incorporated as a
LTD - Private Company Limited by Shares
under the name
AVIENT COLORANTS IRELAND LIMITED
and I have entered such name on the Register accordingly.
https://www.avient.com/sites/default/files/2020-10/mulch-films-case-study-french.pdf
BIODÉGRADABLE ET
COMPOSTABLE
F I L M S D E P A I L L A G E
• Conforme à la norme européenne EN17033 et certifiée OK
Compost
• Disponibles en noir ou blanc en standard
avec différentes certifications TÜV Austria
(OK Compost, etc
• Prise en charge totale de la certification du
produit final pour les normes EN13432 et
EN17033
• Formulé avec des pigments testés et
approuvés par un organisme certifié
OnColor™ Bio-Colorants
PRINCIPALES EXIGENCES
POURQUOI AVIENT ?
https://www.avient.com/resources/safety-data-sheets?page=4561
Geon(TM) DB5261 Neutral TT Iso Stable
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/company/policies-and-governance/it-systems-use-policy
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance
Global ISO Certificate Library
https://www.avient.com/news/avient-highlight-achievements-global-growth-latest-innovations-plastindia-2023
First, the Pune production site achieved GMP Certification in 2022 and became the first specialty formulator of polymer materials in India to become certified with an ISO 22000 Food Safety Management System.
https://www.avient.com/sites/default/files/resources/Changzhou_ISO14001.pdf
质量管理体系认证认证
Certificate No.:04621E14082R0S
We hereby certify that the organization:
Fiber-Line Asia Pacific (Changzhou)
Co., Ltd.
Unified social credit code: 91320412MA1NMF5W4P
is in conformity with Environmental Management System Standard:
GB/T24001-2016 / ISO14001:2015
The certificate is valid to the following product(s)/service:
Textile (Yarn), Glass Products (Yarn) Coating
Processing and Related Management Activities
Registration Address/ Physical Address: R&D Workshop 5, No. 8, Lanxiang Road,
West Taihu Science and Technology Industrial Park, Changzhou City, Jiangsu
Province, P.
https://www.avient.com/sites/default/files/2021-09/mevopur-colors-and-additives-for-ivd-devices-application-bulletin-cn.pdf
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
可用作各种聚合物的母粒或即用型配方
为方便起见,可在一个产品中实现功能性和颜
色的组合
•
•
•
法规支持
经过预测试的原材料:
- ISO 10993-1
- USP 第、章(VI类)
- USP (指南),6.2.3 可萃取元素;
USP
- ICHQ3D/USP 2 可萃取金属
- 欧洲药典 3.1 聚烯烃(如适用)
FDA发布的注册药品主文件(III类)和/或医疗
器械主文件
为符合(新)法规(如IVDR)的批准或过渡提
供文档支持
•
•
•
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。
https://www.avient.com/sites/default/files/2024-05/Mevopur-Surgical Gown-Case study snapshot_0520.pdf
Medical textile manufacturer
LEARN MORE
MEDICAL TEXTILE
MANUFACTURER
S U R G I C A L D R A P E S & G O W N S
• Pre-tested for ISO 10993 biocompatibility standard
• Available in standard blue or other customized colors
• Compatible with ETO sterilization
• Suitable for use in non-woven SMS spunbond layer
• Offered standard blue and custom colors
such as green
• Pre-tested raw materials for biocompatibility
ISO10993 standard
• Manufactured under ISO 13485 certified
medical sites with change control in place
MevopurTM Healthcare Colorants and
Formulations
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives_Laser Welding Additives for Medical Devices Application Bulletin.pdf
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Available as additive concentrates, ready-to-use
additive formulations or ready-to-use additive/
colorant formulations for different polymers
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*
APPLICATION BULLETIN
* FDA/EU compliance information available upon request; exceptions may occur
Healthcare use limitations apply—see below.