DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12

Additionally, Avient’s ISO 13485 manufacturing site in Singapore for its Mevopur™ formulations recently achieved ISO/IEC 17025 accreditation for Biological Evaluation of Medical Devices–Part 5: Tests for In-Vitro Cytotoxicity.  Mevopur™ Healthcare Colorants and Functional Additives: formulations pre-tested to support compliance with regulatory requirements, such as USP Class VI, ISO 10993, EP3.1, USP661.1, and ICH Q3D and manufactured across a global network of ISO 13485-certified facilities or under GMP certifications. PCF values are available for these products and are based upon a TUV-certified ISO-14067: 2018 process.

DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12

DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12

DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12

USP Class VI and ISO 10993-4/5 compliant ASTM ISO Shore A/D ASTM/ISO %

Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally. Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS

Standard colors for use in needle hubs (ISO 6009) Global network of ISO 13485 certified manufacturing sites ISO 6009 color range

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.