ISO 845

Color and functional additive masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased appeal and performance

Standard colors for needle hubs, cannula hubs, and wings matching ISO 6009 color coding

They are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety. 

CERTIFIED FOR ACCURACY AND RELIABILITY Our PCF Calculator is third-party certified by TÜV Rheinland and aligns with the ISO 14067:2018 standard for quantifying and reporting the carbon footprint of a product.

Avient Colorants Germany GmbH Hohenrhein 1 56112 Lahnstein Germany Scope Production of Color Concentrates and Compounds Normative base ISO 50001:2018 Energy Management System Reg. no. 46089 Validity 17. 12. 2020 – 16. 12. 2023 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

WIRE &CABLE COMPANY O P T I C A L C A B L E S H E A T H • Excellent resistance to fungi and mildew • Good UV resistance • Meet flame retardant standard IEC 60332-3C • Provided an anti-fungi solution with an ISO 846 rating of 0, showing no growth under microscope • Formulated solution to meet flammability performance demands for IEC60332-2 or GBT 18380.22-2008 compliance • Complied with Biocidal Product Regulation (EU) No528/2012 (BPR) ECCOH™ Thermoplastic Formulation KEY REQUIREMENTS WHY AVIENT?

Versaflex - CPAP tubing film CPAP TUBING C O R R U G A T E D T U B I N G F I L M • Replacement for polyolefins • Good spring-back • Bondable cuffs • Clear & clean look • Minimize humidity and condensation within the tube • No noticeable odor • FDA, ISO 10993 & USP VI compatible • Provided TPE solution to meet market expectations for improved user comfort & aesthetics • Reduced tube noise and improved drape compliance with new material solution versus polyolefins • Offered solution with improved thermal properties to combat humidity Versaflex™ CL2250 KEY REQUIREMENTS WHY AVIENT?

Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45484 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.