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.

Biocompatibility: Our PEEK solutions have passed ISO 10993 biocompatibility testing, ensuring safety and reliability for medical applications. Passed ISO 10993 biocompatibility testing, suitable for medical use

Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

Avient’s PCF calculation method follows the ISO 14067:2018 standard and is certified by TÜV Rheinland.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is manufactured in the United States with global commercial availability.  

These expanded offerings add medical-grade LDPE, nylon, PEBA, PS and PVC to the globally available palette of specialty healthcare colorants, and are pre-certified to meet or exceed biocompatibility requirements for ISO 10993 and/or USP Class VI protocols. All thirteen medical-grade carrier materials in the portfolio are pre-certified to meet or exceed ISO 10993 and/or USP Class VI requirements for applications ranging from medical packaging to device housings. 

– June 24, 2014 – PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer (TPE) solutions, today announced that its Versaflex™ CE 3620 material meets all ISO 10993-10:2010 testing requirements with no signs of irritation. Several Versaflex CE materials have been used in wearable electronics applications without irritation for a number of years, and the recent ISO testing results underscore this track record.

Homepage // News Center // PolyOne Wilflex Screen Printing Inks Receive Key 2014 Regulatory Certifications KENNESAW, Georgia – PolyOne Corporation, a premier global provider of specialized polymer materials, services and solutions announced today that it has received several sustainability-related compliance and regulatory product certifications for Wilflex™ Textile Printing Inks. These certifications enable printers to meet regulatory and quality specifications, creating value for customers without sacrificing production performance.

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.