https://www.avient.com/sites/default/files/2020-07/PH -AVIENT LUXEMBOURG - 15608678 - ISO 14001.pdf
POLYONE FRANCE TOSSIAT
43, PLACE DE LA GARE
01250 TOSSIAT
FRANCE
Bureau Veritas Certification France certify that the Management System of the above
organization has been audited and found to be in accordance with the requirements of the
management system standard detailed below:
Standard
ISO 14001:2015
Scope of certification
THE DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES FOR
THERMOPLASTICS
Certification/Recertification Cycle Start Date: 03 May 2023
Subject to the continued satisfactory operation of the organization’s Management System,
this certificate expires on: 02 May 2026
Expiry date of previous cycle: NA
Certification/Recertification Audit date: 08 March 2023
Original Cycle Start Date: 15 July 2011
Certificate n°: FR081968-1
File n°:15608678 Revision date:24 April 2023
Laurent CROGUENNEC - President
Local Office: Bureau Veritas Certification France
Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense
Further clarifications regarding the scope of this certificate the applicability of the management system
requirements may be obtained by consulting the organization.
https://www.avient.com/sites/default/files/2020-07/ISO 45001 14 March 2026.pdf
F-27, MIDC,
Ranjangaon, Shirur,
Pune, Maharashtra 412 220
India
ISO 45001:2018
The Occupational Health and Safety Management is applicable to:
Certificate No: 55689
Certification Date: 15 March 2017
Effective Date: 09 March 2023
Expiration Date: 14 March 2026
Revision Date: 15 March 2023 Dominic Townsend, President
DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY
COMPOUNDS.
https://www.avient.com/sites/default/files/2020-07/ISO 14001 - 14 March 2026.pdf
F-27, MIDC,
Ranjangaon, Shirur,
Pune, Maharashtra 412 220
India
ISO 14001:2015
The Environmental Management System is applicable to:
Certificate No: 55688
Certification Date: 15 March 2017
Effective Date: 09 March 2023
Expiration Date: 14 March 2026
Revision Date: 21 March 2023 Dominic Townsend, President
DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY
COMPOUNDS
This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/2024-12/ISO-14001_English_Shanghai Zhangjiang.pdf
Park, China (Shanghai) Pilot Free Trade Zone,
Shanghai, China 201203
has been found to conform to the Environmental Management System standard:
ISO 14001:2015
This certificate is valid for the following scope:
Design and Manufacture of Colour and Additive Concentrates
http://www.dnv.com/assurance
https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
240625-2017-AQ-RGC-NA-PS
Initial certification date:
14 September 2017
Valid:
08 February 2025 – 07 February 2028
This is to certify that the management system of
PolyOne-Shanghai, China
88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode:
91310000607342402D)
has been found to conform to the Quality Management System standard:
ISO 13485:2016
This certificate is valid for the following scope:
Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates
Used for the Plastic Parts of Medical Devices
http://www.dnv.com
https://www.avient.com/sites/default/files/2023-03/Onflex-Cell Pack Cooling Tube-Application Snapshot.pdf
AVIENT SOLUTION
V E H I C L E B AT T E RY
M A N U FA C T U R E R
C E L L P A C K C O O L I N G T U B E
• Comply with ISO 3384-1:2011 for TPE compression set
• Comply with ISO 11359-2:1999 standard for linear thermal
expansion
• Good ethanediol resistance
• Good sealing performance
• Customized a Shore 60A hardness TPE
formulation with good physical property
retention
• Achieved good compression set and bonding
performance with PA12
• Qualified thermal expansion by customer
• Provided excellent ethanediol resistance under
both low and high temperature conditions
KEY REQUIREMENTS
CHEMICAL RESISTANCE + SEALING
LEARN MORE
OnFlex™ TPE Custom Formulation
Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2024-12/ISO-9001_English_Shanghai Zhangjiang.pdf
Park, China (Shanghai) Pilot Free Trade Zone,
Shanghai, China 201203
and the sites as mentioned in the appendix accompanying this certificate
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:
Design and Manufacture of Colour and Additive Concentrates
http://www.dnv.com/assurance
Certificate no.: 7071-1998-AQ-RGC-RvA
Place and date: Shanghai, 20 March 2024
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2024-07/Colorants _ Additives for Appliances Brochure.pdf
SUSTAINABILITY
Avient’s color and additive manufacturing sites
comply with ISO standards such as ISO 9001:2015
QMS, ISO 14001:2015 Environmental Management
System and ISO 45001:2018*.
EC) 1907/2006 and amendments)
• UL94 file for MB (QMQS.E73454) and formulations
(QMQS.E103015)
• “Toys declaration” Directive 2009/48/EC
• Waste Electrical & Electronic Equipment (WEEE)
* Contact us for more detailed information about our ISO certifications.
https://www.avient.com/sites/default/files/2022-05/MEVOPUR LQ for Silicone Elastomers_CN.pdf
可根据要求提供多种定制化
颜色解决方案
根据ISO 13485/GMP质量体系生产,并拥有变
更控制管理
原材料红外光谱分析和常规批次检测
根据ISO 10993第18部分对正己烷、异丙醇及
水中的可萃取性进行评估
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法规支持
原材料根据ISO 10993-1和USP第、
章(VI类)对原材料进行生物评估的预测试
向FDA提交所有标准颜色的DMF/MAF文件
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应用
医疗器械,如导管和连接器、注射器针头及无
针连接器
与皮肤接触设备,如可穿戴设备或医疗器械的
柔软触感表面
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MEVOPUR LQ 配方可用于要求严苛的应用,包
括:
MEVOPUR™-LQ 不透明红(PMS198C)
产品编号:FZ3M415008
MEVOPUR™-LQ 透明红
产品编号:FZ3M415009
MEVOPUR™-LQ 不透明蓝(PMS292C)
产品编号:FZ5M415008
MEVOPUR™-LQ 透明蓝
产品编号:FZ5M415009
MEVOPUR™-LQ 不透明黄(PMS1205C)
产品编号:FZ1M415005
MEVOPUR™-LQ 透明黄
产品编号:FZ1M415006
MEVOPUR™-LQ 不透明绿(PMS346C)
产品编号:FZ6M415008
MEVOPUR™-LQ 透明绿
产品编号:FZ6M415009
MEVOPUR™-LQ 不透明紫(PMS2655C)
产品编号:FZ4M415003
MEVOPUR™-LQ 透明紫
产品编号:FZ4M415004
定制化选择
也可以根据您的需求
定制颜色,
请联系我们。
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/2021-09/mevopur-colors-for-needle-hubs-bulletin-cn.pdf
MEVOPUR Colors for Needle Hubs Bulletin_CN
* 可根据要求提供FDA/EU合规信息
应用公告
MEVOPUR™用于针头和导管座的 标准颜色
为了帮助我们的客户满足医疗行业标准要求,埃
万特开发了一系列符合ISO 6009标准颜色编码的
针座、导管座和翼梁的标准颜色。
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
可将颜色与添加剂相结合,以增强产品性能
和防护性能
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法规支持
经过预测试的原材料:
- 美国药典(USP)23,第87和88章(VI类)
萃取和生物学评价
- ISO 10993,第4、5、10、11和18部分,
萃取和生物学评价
- 美国药典和欧洲药典中针对USP 、
ICH Q3D可萃取金属和EP3.1聚烯烃的测试的
其他监管支持信息
FDA器械主文件
食品接触符合FDA/EU*要求
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针头的标称外径
(mm) 颜色说明 RAL 潘通色号 透明产品代码 不透明产品代码
0.4 中灰色 7035 423 C PP7M665125 PP7M665127
0.45 褐色 8017 7588 C PP8M665294 PP8M665296
0.5 橘黄色 2003 173 C PP2M665298 PP2M665300
0.55 中紫色 4005 7676 C PP4M665290 PP4M665292
0.6 深蓝色 5010 288 C PP5M665894 PP5M665896
0.7 黑色 9005 黑色 C PP9M664950 PP9M664952
0.8 深绿色 6001 7483 C PP6M665687 PP6M665689
0.9 黄色 1021 115 C PP1M665211 PP1M665213
1.1 乳白色 1015 7401 C PP0M665290 PP0M665292
1.2 粉色 3015 502 C PE3M665725 PP3M665727
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。