https://www.avient.com/sites/default/files/2024-07/TPE Whitepaper_0.pdf
In addition, the formulation meets ISO 15759 requirements for medical infusion equipment and is manufactured in an ISO 13485 facility.
https://www.avient.com/sites/default/files/2021-11/0514-02-dec2021.pdf
Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. 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). Presented this 28th day of February 2020. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to 2021年12月31日 Revised 2021年9月21日 0514-02s SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 Test Method or Standard: Test Description: 0514-02c
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/resources/0514_02%2520PDI%2520ISO17025%2520Chemical_Extension%2520Cert2019.pdf
Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. 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). Presented this 30th day of March 2018. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to 2019年12月31日 Revised 2019年10月8日 0514-02.pdf SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Test Method or Standard: Test Description: 0514-02c.pdf
https://www.avient.com/sites/default/files/2023-11/AS9100 REV D_Hatfield PA.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 Date: 2024年4月26日 Certificate Issue Date: 2021年4月27日 Certified Since: 2018年4月27日 Dr. Onus Managing Director DEKRA Certification, Inc. 1120 Welsh Road, Suite 210 North Wales, PA 19454 USA (215) 997-4519 www.dekra.us/en/audits DEKRA Certification Inc. is an accredited Aerospace Registration Management Program Certification Body, under the ICOP scheme.
https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%25209001_2015%2520EXP%25202021.pdf
Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 9001:2015 The Quality Management System is applicable to: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS. This certificate may be found on the ABS QE Website (www.abs-qe.com). Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%252014001_2015_EXP%25202021_0.pdf
Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 14001:2015 The Environment Management System is applicable to: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS. This certificate may be found on the ABS QE Website (www.abs-qe.com). Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
https://www.avient.com/sites/default/files/2022-12/15719637-22-AVIENT ESPAÑA SL-INGLES.pdf
1/1 Certification/Renovation Audit:Certification/Renovation Audit: 14-10-202214-10-2022 Original approval date:Original approval date: -- 11 Bureau Veritas Iberia S.L.Bureau Veritas Iberia S.L. Certificate Number:Certificate Number: Certificate expiration date:Certificate expiration date: Effective date:Effective date: 31-10-202231-10-2022 30-10-202530-10-2025 Expiry date of previous cycle:Expiry date of previous cycle: 30-10-202230-10-2022 31-10-201631-10-2016 ES133794ES133794 Scope of certification:Scope of certification: MANUFACTURING OF MASTERBATCHES, ADDITIVESMANUFACTURING OF MASTERBATCHES, ADDITIVES AND COMPOUNDS FOR PIGMENTING THERMOPLASTICAND COMPOUNDS FOR PIGMENTING THERMOPLASTIC MATERIALS USED IN FOOD INDUSTRYMATERIALS USED IN FOOD INDUSTRY ISO 22000:2018ISO 22000:2018 POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN - NAVARRA - ESPAÑA AVIENT ESPAÑA, S.L.AVIENT ESPAÑA, S.L. C/ Valportillo Primera 22-24, Edificio Caoba, 28108 Alcobendas - Madrid, España This certificate is valid, subject to the general and specific terms and conditions of certification servicesThis certificate is valid, subject to the general and specific terms and conditions of certification services STANDARDSTANDARD Bureau Veritas certification certifies that the Management System Bureau Veritas certification certifies that the Management System has been audited andhas been audited and found to be in accordance with found to be in accordance with the requirements of standard:the requirements of standard: Awarded toAwarded to CertificationCertification https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9 https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9 https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9 https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9 https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9 https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9 https://e-cer.bureauveritas.com/WJLVJDYG9LKV98RP6JCHF8NPSKES0NHDXDPLOWOT1TB290DE4LNZC0JCBAI2BVWEAZ1GJWC8BMDC2TXFBGVDXP3YXG0JLAVMFN3HLEWBLUWJGXCY5PAJ8QKKSTVJYSZ9M9 2022-12-15T10:52:43+0100 Authenticity and Integrity 2022-12-15T10:53:51+0100 BUREAU VERITAS CERTIFICATION
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.pdf
China TEL: +86 21 32799000 Zhu Hai Ming Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. TEL:+31(0)102922689. www.dnvgl.com/assurance Certificate No: 7071-1998-AQ-RGC-RvA Initial certification date: 28 April, 1998 Valid: 29 March, 2021 – 29 March, 2024 This is to certify that the management system of PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z. Park, Pudong, 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 Masterbatch Certificate No: 7071-1998-AQ-RGC-RvA Place and date: Shanghai, 19 March, 2021 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2024-12/ISO9001_English_Suzhou ColorMatrix.pdf
CNSUZ3-SUH9-20240123104552 QUALITY MANAGEMENT SYSTEM\,, CERTIFICATE Certificate No. 00124Q30506R5S/3200 We hereby certify that Color Matrix Plastic Colorants (Suzhou) Co., Ltd Business Registration Number: 91320505799067336K Registered I Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China by reason of its Quality Management System has been awarded this certificate for compliance with the standard ISO 9001:2015 The Quality Management System Applies in the following area: Production Activities of Plastic Colorant & Additive (UV Blockers, Anti-Oxidation, Anti-Aging) Certified since: 2009年1月8日 Valid from: 2024年1月16日 Valid until: 2027年1月4日 the expiry date of last certification cycle: 2024年1月4日 the date of recertification audit: 2023年12月21日 to 2023年12月22日 After a surveillance cycle, the certificate is valid only when used together with an Acceptance Notice of Surveillance Audit issued by CQC. Please access www.cqc.com.cn for checking validity of the certificate. This certificate and its relevant information can query in the website of Certification and Accreditation Administration of the People's Republic of China ( www.cnca.gov.cn)