https://www.avient.com/sites/default/files/resources/US_Clinton_RC14001_2020Exp.pdf
ABS Quality Evaluations
Certificate Of Conformance
PolyOne Corporation
1260 Carden Farm Drive
Clinton, TN 33716
U.S.A.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
http://www.abs-qe.com/cert_validation
PolyOne Corporation
has been assessed by ABS Quality Evaluations,Inc. and found to be in conformance with the requirements set forth by:
Certificate No: 55287
https://www.avient.com/sites/default/files/resources/US_North%2520Baltimore_RC14001_2020Exp.pdf
ABS Quality Evaluations
Certificate Of Conformance
PolyOne Corporation
733 E.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
http://www.abs-qe.com/cert_validation
PolyOne Corporation
has been assessed by ABSQuality Evaluations,Inc. and found to be in conformance with the requirements set forth by:
Certificate No: 55421
https://www.avient.com/sites/default/files/2020-10/mulch-films-case-study.pdf
Mulch films case study
BIODEGRADABLE &
COMPOSTABLE
M U L C H F I L M S
• Compliance with European Standard EN17033 or OK
Compost
• Black and white color standards available
under different TÜV Austria certifications
(OK Compost and more)
• Full support for end-product certification for
both EN13432 and EN17033
• Formulated with pigments tested and
approved by certified body
OnColor™ Bio-Colorants
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-05/certincorporation-64590-17may2021.pdf
Certificate of Incorporation
AVIENT NEW ZEALAND LIMITED
64590
NZBN: 9429040671338
This is to certify that HOECHST (NEW ZEALAND) LIMITED was incorporated under the Companies Act
1955 on the 3rd day of May 1963
and changed its name to HOECHST NEW ZEALAND LIMITED on the 30th day of January 1974
and was reregistered to become a company under the Companies Act 1993 on the 3rd day of April
1995
and changed its name to CLARIANT (NEW ZEALAND) LIMITED on the 27th day of June 1997
and changed its name to AVIENT NEW ZEALAND LIMITED on the 17th day of May 2021.
Registrar of Companies
17th day of May 2021
Certificate generated 17 May 2021 09:10 AM NZST
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/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/2021-09/avient-norwalk-ohio-iatf16949-certification.pdf
https://www.avient.com/sites/default/files/2021-01/avient-pakistan-private-revised-certificate.pdf
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。