KEY CHARACTERISTICS • Designed for Nd:YAG lasers operating between 1060-1070 nm • Available for different polymers including PP, PE, PC, PBT, POM, ABS, MABS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Can be designed for dark marking on natural or white/light colored background or light marking on black/dark background 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 • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request.

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.

ISO 845

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

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

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

Geon(TM) DB5261 Neutral TT Iso Stable

⁴Certificates can be found at https://www.avient.com/company/policies-and-governance/global-iso-certificate-library