https://www.avient.com/sites/default/files/2024-08/LATAM CAI Certifications Bulletin _Portuguese_.pdf
ISO 9001:2015 Cert.
No. 65799 ISO 9001:2015 Cert.
Para saber mais sobre o catálogo de certificados ISO da Avient, visite o nosso avient.com. © 2024, All Rights Reserved Avient Corporation https://www.avient.com/company/policies-and-governance-0/global-iso-certificate-library
https://www.avient.com/knowledge-base/article/securing-supplies-medical-plastic-solutions?rtype[]=1164
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.
https://www.avient.com/knowledge-base/article/securing-supplies-medical-plastic-solutions?pname[]=17814
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.
https://www.avient.com/knowledge-base/article/securing-supplies-medical-plastic-solutions
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.
https://www.avient.com/sites/default/files/2024-04/Fiber-Line LLC AS9100D Certificate Exp April 26 2027.pdf
AS9100 Certication DEKRA CERTIFICATE Certificate Number: 131789.01 The Aerospace Quality Management System and implementation of: Fiber-Line, LLC With Central Functions At: 3050 Campus Drive Hatfield, PA 19440 United States The certification has been performed in accordance with the requirements of AS9104/1:2012, including its implementation, and meets the requirements of the standard: AS9100D (Based on and including ISO 9001:2015) Scope: The value added design and development of synthetic fiber products for use in public and private sectors.
Certification Structure: Single Certificate Expiry: April 26, 2027 Certificate Issued: April 27, 2024 Certified Since: April 27, 2018 Dr.
Onus Managing Director DEKRA Certification, Inc. 1945 The Exchange SE #300 Atlanta, GA 30339 USA (215) 997-4519 https://www.dekra.us/en/audits/ DEKRA Certification Inc. is an accredited Aerospace Registration Management Program Certification Body, under the ICOP scheme. https://www.dekra.us/en/audits/
https://www.avient.com/sites/default/files/2023-11/ISO 9001 2015_Hickory NC.pdf
This is to certify that Fiber-Line, LLC 280 Performance Drive SE, Hickory, North Carolina 28602 USA Quality Management System ISO 9001:2015 Manufacture of textile components to cable manufacturers.
Certificate No.: CERT-0116814 Original Certification Date: November 24, 2010 File No.: 1616267 Certification Effective Date: April 1, 2021 Issue Date: March 30, 2021 Certificate Expiry Date: March 31, 2024 ________________________________________________________________________________ ISO 9001 Registered by: QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.
This registration is subject to the SAI Global Terms and Conditions for Certification.
https://www.avient.com/sites/default/files/2025-07/ISO IEC 17025 Mechanical Avon Lake.pdf
No. 0514.01) 12/11/2023 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 AVIENT CORPORATION – ANALYTICAL SOLUTIONS 33587 Walker Road Avon Lake, OH 44012 Stephanie Mims Phone: 440 930 3499 MECHANICAL Valid To: September 30, 2025 Certificate Number: 0514.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following rubber and plastics tests: Test Description Test Method or Standard Brittleness Temperature (Impact) ASTM D746; ISO 812 Charpy Impact ISO 179-1 Color Determination by Spectrophotometer ASTM D2244, E1331; ISO 7724 Conditioning of Plastics for Testing ASTM D618; ISO 291 Deflection Temperature Under Flexural Load ASTM D648; ISO 75-1, -2 Durometer Hardness (Shore A and D) ASTM D2240; ISO 7619-1 Flexural Properties ASTM D790; ISO 178 Flow Rate (Extrusion Plastometer) ASTM D1238 (Procedures A and B); ISO 1133 Impact Resistance (Izod) ASTM D256; ISO 180 Instrumented Impact ASTM D3763; ISO 6603-2 Specific Gravity/Density ASTM D792 (Method A); ISO 1183-1 Specular Gloss ASTM D523; ISO 2813 Tackiness of Interior Materials BO 061-01 Tear Resistance ASTM D624, D1004; ISO 34 Tensile Properties ASTM D412 (Method A), D638, D882; ISO 37, 527-1, -2, -3, -4, -5 Xenon-Arc Exposure Testing ASTM D2565, G155; SAE J1885 (Withdrawn January 2008), J1960 (Withdrawn January 2008), J2412, J2527; BO-116-01 For the tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation.
This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.01 Valid to September 30, 2025 0514-01 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 Test Method or Standard Test Description 0514-01c
https://www.avient.com/sites/default/files/2024-01/16824-8%23ISO 9001 Certificaat Fiber-Line International B.V. %28PDF%29.pdf
16824-8#ISO 9001 Certificaat Fiber-Line International B.V.
Franken Managing Director Registration number 1682418.1 Start date certificate 2910112024 Certificate valid until 2910112027 Date of first certificate 2910112009 Certificate for the quality management system according to NENNENNENNEN1111ENENENEN1111ISOISOISOISO 9001:9001:9001:9001:2015201520152015 The certification body TÜV NORD Nederland hereby confirms that the certification 1682418.12910112024 took place in accordance with its certification regulations for the organisations 29101120272910112009 FiberFiberFiberFiber1111Line International B.V.Line International B.V.Line International B.V.Line International B.V.
The certification is subject to annual evaluation by TÜV NORD Nederland.
https://www.avient.com/company/policies-and-governance/cpsia-information
The timetable for testing, certification and enforcement as outlined on the CPSC web site (see link in adjacent column), generally requires compliance in advance of testing and certification.
PDI is accredited under ISO 17025 by A2LA (the American Association for Laboratory Accreditation) to perform testing as an independent laboratory body.
Global ISO Certificate Library
https://www.avient.com/news/specialty-and-sustainable-healthcare-material-solutions-avient-medtec-china-2023
Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines.
They can be customized to meet specific regulatory demands such as USP Class VI, FDA CFR, and ISO 10993.
Versaflex™ HC 2110-57B TPEs comply with ISO 10993-4, ISO 10993-5, and USP Class VI and are suitable for Ethylene Oxide (EtO) sterilization without residue or allergens.