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/2024-12/ISO 9001_Chinese_Changzhou.pdf
质量管理体系认证认证
证书编号:04624Q15809R1S
兹证明:
法博莱恩纱线(常州)有限公司
统一社会信用代码:91320412MA1NMF5W4P
质量管理体系符合:
GB/T 19001-2016 / ISO 9001:2015 标准
证书覆盖范围:
纺织品(纱线)、玻璃制品(纱线)的包覆加工
注册地址/实际地理地址:江苏省常州西太湖科技产业园兰香路 8 号研发车间
5 厂房
颁证日期:2024-10-26
有效期至:2027-10-25
初次颁证日期:2021-10-28
证书编号
受审核方
组织机构代码
认证范围
注册地址
生产办公地址
注册日期
有效期至
初次颁证日期
二维码
https://www.avient.com/sites/default/files/resources/ISO_13485_Certificate.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
validitystatement1: Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon
prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof.
FACILITY1_LINE4:
FACILITY1_LINE5:
FACILITY1_LINE6:
STANDARD: ISO 13485:2016
MANAGEMENT_TYPE2: The Quality Management System is applicable to:
DATE_LABEL_1TF:
DATE_VALUE_1TF:
DATE_LABEL_2TF:
DATE_VALUE_2TF:
DATE_LABEL_3TF: Certificate No:
DATE_VALUE_3TF: 54139
DATE_LABEL_4TF: Certification Date:
DATE_VALUE_4TF: 04 September 2019
DATE_LABEL_5TF: Effective Date:
DATE_VALUE_5TF: 01 September 2016
DATE_LABEL_6TF: Expiration Date:
DATE_VALUE_6TF: 01 September 2022
DATE_LABEL_7TF: Revision Date:
DATE_VALUE_7TF: 04 September 2019
MARK_3:
MARK_2:
SIGNATURE_NAME: Dominic Townsend, President
SIGNATURE_IMAGE: 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
AUDIT_COMPLIANCE:
MARK_1:
SCOPE_DESCRIPTION: DESIGN, COMPOUND AND SUPPLY OF THERMOPLASTICS FOR THE MEDICAL DEVICE INDUSTRY.
https://www.avient.com/sites/default/files/2020-07/case-study-one-pager-dynaflex-medical-face-mask.pdf
EUROPEAN MEDICAL
DEVICE MANUFACTURER
F A C E M A S K V E N T I L A T I O N
V A L V E
• ISO 9001 and USP VI compliant
• Compatible with overmolding onto PP
• Translucent and highly colorable
• Soft touch
• Provided valuable regulatory support and
documentation, enabling faster internal trials and
material qualification for this customer
• Worked together with customer to select the best
material from a broad portfolio of medical TPE
grades
• Trusted as a polymer supplier for multiple
healthcare applications
Dynaflex™ G2711 Thermoplastic Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/resources/CCG_ISO_9001_2015.pdf
https://www.avient.com/sites/default/files/2024-12/Certificate ISO 22000_Tangerang.pdf
View PDF
The SQS herewith attests that the organisation named below has a management system that meets the requirements of
the normative base mentioned.
70
01
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/A
pr
il
20
22
/V
er
si
on
2
.0
Certificate
P.T.
Cibodas
15138 Kecamatan Cibodas, Tangerang
Indonesia
Scope
Category I
Production of customer specific Masterbatches for
Food packaging materials on the dedicated extrusion
lines
Normative base
ISO 22000:2018 Food Safety Management Systems - Requirements
for any organization in the food chain
Reg. no. 46391
Page 1 of 1
Validity 25. 02. 2024 – 24. 02. 2027
Issue 25. 02. 2024
A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2025-03/ISO 13485 2025.pdf
3
Certificate
Certified sites according to appendix
Scope
concentrates and specialty compounds for the
Healthcare and Medical device market.
Normative basis
EN ISO 13485:2016 Medical devices – Quality Management System
Page 1 of 3
Appendix of main certificate H61173
Central function Scope Norm / Revision Reg. no.
Appendix of main certificate H61173
Locations Scope Norm / Revision Reg. no.
https://www.avient.com/sites/default/files/2023-01/45324-Certificate-13JAN2023.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
ABS Quality Evaluations
This is to certify that the Quality Management System of:
Avient Corporation
Avient Corporation - McHenry, IL
831 Ridgeview Drive
ISO 13485:2016
The Quality Management System is applicable to:
Certificate No: 45324
Certification Date: 24 February 2014
Effective Date: 13 January 2023
Expiration Date: 23 January 2026
Revision Date: 13 January 2023 Dominic Townsend, President
DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE
MEDICAL DEVICE INDUSTRY
This certificate may be found on the ABS QE Website (www.abs-qe.com).
WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
Page 2 of 2
ABS Quality Evaluations
Avient Corporation
ISO 13485:2016
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2022-12/reSound Ultra Low Carbon Footprint TPE Product Bulletin_0.pdf
Calculated using the ISO 14067:2018 standard,
the greenhouse gas (GHG) emissions are lowered
by carbon sequestration and Avient’s green
manufacturing practices.
PRODUCT BULLETIN
reSound RS0200-9001 80 reSound RS0200-9001 60
Manufacturing Plant Location Gaggenau McHenry Suzhou Gaggenau McHenry Suzhou
Cradle-to-Gate PCF* -0.46 -0.40 -0.40 -0.09 -0.03 -0.02
Hardness, Shore A 80 60
Overmold Substrate PP, PE PP, PE
TECHNICAL PROPERTIES
COMPARISON TO ALTERNATIVES
Greenhouse gas (GHG) emissions from cradle-to-gate production
1.844.4AVIENT
www.avient.com
Copyright © 2022, Avient Corporation.
Calculated according to ISO 14067:2018
https://www.avient.com/news/avient-site-taiwan-earns-iso-13485-accreditation-fourth-source-mevopur-medical-grade-materials
Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).
TAOYUAN, Taiwan – January 19, 2022 – Avient Corporation, a premier provider of specialized and sustainable material solutions and services, today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).
ISO 13485 certification is the culmination of two years’ work to create a completely segregated, dedicated healthcare operation similar to other MEVOPUR plants.