https://www.avient.com/resources/safety-data-sheets?page=5240
PC (ISO) WHITE CC
DOWNY BLUE 1
DOWNY BLUE 1.B
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。
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。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用:
(1) 接触人体组织或体液长达30天或更长时间;
(2)“整形”(整容或重建)手术;
(3) 生殖植入物或任何节育器械;或者
(4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2024-07/Colorants _ Additives for Appliances Brochure.pdf
We offer a wide range of color concentrates for different polymer grades, from standard to
engineering polymers, that fulfill the vertical burning (V-0; V-1; V-2) and horizontal burning (HB) tests.
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/2021-09/avient2020sustainabilityreport-9-2-21.pdf
Lima, Peru 1.
Combined,
these facilities have a total of 205 certifications to an ISO or Management System and
standards.
Sustainability Report | 2020 67Sustainability Report | 2020 67
https://endplasticwaste.org/en/news?
https://www.avient.com/resources/safety-data-sheets?page=5092
Geon(TM) DB4842B ISO STABLE HI VISC
155-191-119-1 FIBERLOC 81530
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=4228
ISO PURPLE TPU
UV FL YELLOW 1
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/sites/default/files/2021-09/supplier-code-of-conduct-es.pdf
Contiene normas alineadas mundialmente y está arraigado en la legislación
internacional.
Las
repercusiones negativas en el medio ambiente
y el clima deberán evaluarse para minimizarse o
eliminarse en origen
Cumpla con la Ley de Prácticas Corruptas en el
Extranjero de EE.
https://www.avient.com/sites/default/files/2021-09/supplier-code-of-conduct-fr.pdf
S’approvisionner de façon responsable en tantale, en
étain, en tungstène et en or ou leurs dérivés (métaux
3TG).
Systèmes de gestion
• Se conformer à toutes les exigences légales et
autres exigences applicables en mettant en œuvre,
lorsque cela est possible, des systèmes de gestion
internationalement reconnus
Améliorer continuellement les performances en
évaluant convenablement les risques et en mettant en
œuvre des mesures d’atténuation.
https://www.avient.com/sites/default/files/resources/19.2540_C%2520Colorant%2520Chromatics%25209001-2015%2520Certificate%2520EXP%25202021%25209-24-2018.pdf
Certificate of Registration 9001:2015 MSP
9001:2015–MSP-ANAB-US (2.0)
Page 1 of 2
Certificate of Registration
of Quality Management System
to ISO 9001:2015
The National Standards Authority of Ireland certifies that:
Colorant Chromatics Ab
Kroklundsvagen 346
AX-22 320 Odkarby
Aland
Finland
has been assessed and deemed to comply with the
requirements of the above standard in respect of the scope of
operations given below:
The Design, Manufacture and Sales of
Fluoropolymer Color Concentrates and
Compounds
Additional sites covered under this multi-site certification are listed on the
Annex (File No. 19.2540/C)
Approved by:
Geraldine LarkinChief
Executive Officer
Approved by:
Lisa Greenleaf
Operations Manager
Registration Number: 19.2540/C
Certification Granted: May 15, 1997
Effective Date: Oct 20, 2018
Expiry Date: Oct 19, 2021
National Standards Authority of Ireland, 20 Trafalgar Square, Nashua, New Hampshire, NH 03063, USA T +1 603 882 4412
9001:2015–MSP-ANAB-US (2.0)
Page 2 of 2
Annex to Certificate Number: 19.2540/C
Scope of Registration:
The Design, Manufacture and Sales of Fluoropolymer Color
Concentrates and Compounds
Activity Location
Central Management Group,
Design, Manufacture
Colorant Chromatics
Kroklundsvagen 346
AX-22 320 Odkarby
Aland
Finland
File No.: 19.2540/C
Headquarters, Sales, Distribution Colorant Chromatics Europe B.V.
Hastelweg 269 - 273
NL-5652 CV Eindhoven
The Netherlands
File No.: 19.2540/B
Sales, Distribution Colorant GmbH
Justus-Staudt-Strasse 1
Limburg-Offheim
Germany
65555
File No.: 19.2540/A
Design, Manufacture, Sales,
Distribution
Chromatics, Inc.
19 Francis J.
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/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-colorants-and-formulations
Slide 1: Medical textile manufacturer