Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library

HAZEL ISO FIX DOOR V3 MAUVE DOOR, ISO FIX COVER V3 Certificate of Analysis (COA) - labeled as "Material"

Avient's PCF Calculator adheres to the globally recognized ISO 14067:2018 standard for calculating Product Carbon Footprint and has obtained additional third-party certification through TÜV Rheinland for ISO 14067 compliance.  

They are also certified to meet biocompatibility requirements for ISO 10993 and USP Class VI standards. Avient's Suzhou facility operates under ISO 13485 quality management system certification, complying with the leading standards in medical device manufacturing.

Global network of ISO 13485 certified manufacturing sites ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield

Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for identification and differentiation Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICHQ3D protocols to reduce product carbon footprint Flexible, durable, and colorable TPEs for improved grips and gaskets that comply with USP Class VI and ISO 10993

Mevopur™ Healthcare Colorants and Formulations: a range of medical grade concentrates and pre-colored formulations for a wide range of polymers used in applications such as remote patient monitoring, circulating blood contact, and invasive devices, with pre-tested biocompatibility according to ISO 10993, change control in place, production certified to ISO 13485-2016 and DMF/MAF files available Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: high-temperature solutions offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety

IATF Certificate Place and date: For the issuing office: Katy, TX, 10 December 2024 Revision 2 DNV - Business Assurance 1400 Ravello Drive, Katy, TX, 77449- 5164, USA Sherif Mekkawy Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. ACCREDITED UNIT: DNV Business Assurance USA Inc., 1400 Ravello Drive, Katy, TX, 77449-5164, USA - TEL: +1 281-396-1000. www.dnv.com Page 1 of 2 MANAGEMENT SYSTEM CERTIFICATE Certificate no.: 273138-2018-AQ-RGC-IATF IATF Certificate No: 0558323 Valid: 10 December 2024 – 09 December 2027 This is to certify that the management system of Polyone - Shenzhen Co., Ltd. No. 1, Qihang Industry Park, Haoxiang Road, Shajing Town, Baoan, Shenzhen, Guangdong, China 518104 (USI: C5M65R) and, if applicable, the remote supporting locations as mentioned in the Appendix accompanying this Certificate has been found to conform to the Quality Management System standard: IATF 16949:2016 This certificate is valid for the following scope: DESIGN AND MANUFACTURE OF PLASTIC COMPOUNDING MATERIAL EXCLUSION: NONE http://www.dnv.com Certificate no.: 273138-2018-AQ-RGC-IATF IATF Certificate No: 0558323 Place and date: Katy, TX, 10 December 2024 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.