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. 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. To access Avient’s news library online, please visit www.avient.com/news.  

Standard colors for use in needle hubs (ISO 6009) See our extensive library of resources about our growing company. ISO 6009 color range

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

Obtaining the RC14001® certification is unique as it encompasses security, product safety, and transportation elements, setting itself apart from the individual ISO 14001 and ISO 45001 certifications.”   To access Avient’s news library online, please visit www.avient.com/news.  

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.   To access Avient's news library online, please visit www.avient.com/news.    

– 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. To access PolyOne’s news library online, please go to www.polyone.com/news.

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. To access Avient’s news library online, please visit www.avient.com/news.

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.  To access PolyOne’s news library online, please go to www.polyone.com/news.

2 /Ju n- 20 19 /V er si on 1 .0 Certificate Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate 618684 Singapore Singapore Scope Administration, Site management, Manufacture, Laboratory, Procurement, Maintenance, infrastructure, Warehouse and Transport Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45483 Validity 01. 03. 2022  – 28. 02. 2025 Issue 01. 03. 2022  A.Grisard, President SQS F.

Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients. They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with: •    ISO 10993-1 and USP parts , (including class VI) •    European Pharmacopoeia, monograph 3.1.15 •    USP and •    elemental analysis, as per ICH Q3D To access Avient’s news library online, please visit www.avient.com/news.