Pad Printing Inks that are USP Class VI Tested and Certified for Medical Device Pad Printing on Various Substrates

The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneously Toxicity tests which allow these three inks to be certified for the use in printing on various plastic materials used in manufacturing of Medical Devices.

The United States Pharmacopeia (USP) is a private (non-governmental) organization that "promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies." Those standards include in vivo animal biological reactivity tests for "elastomeric, plastic and other polymeric materials with direct or indirect patient contact." USP monograph (88) describes the classification of plastics into six classes based on responses to a series of in vivo tests for which extracts, materials and routes of administration are specified. USP Class VI requires the most stringent testing of these six classes. Extracts of the test material are prepared in saline, alcohol in saline, polyethylene glycol (PEG 400), and vegetable oil. The extracts (diluted in the case of the PEG extract) and blanks are injected into mice and rabbits, which are observed several times over a 72-hour period. The animals' response to the sample extracts and the blank are compared to determine test passage.

The systemic Injection test and a Intracutaneous-test are the first two testing methods used to determine which products (inks in this case) are deemed compliant with the USP Class VI. Furthermore, USP Class VI includes an implantation test wherein strips of the test material and a negative control are implanted in rabbits for a period of not less than 120 hours. Hemorrhage, necrosis, discolorations, and infections are macroscopically observed and degree of encapsulation is scored and compared with the negative control to determine test passage.

Technical data sheets, SDS sheets and Class VI certifications are hyperlinked on this page (bottom right side next to each of the available products). infections are macroscopically observed and degree of encapsulation is scored and compared with the negative control to determine test passage.

711-8005 BLACK pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

711-9005 WHITE pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

747-8005 BLACK UV cured pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

747-9005 WHITE UV cured pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

752-8005 BLACK pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

752-9005 WHITE pad printing ink certified for Class VI Medical use. The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneous Toxicity tests which allow are certified inks to be safely printed on various plastics used in Medical Devices.

For many years now, Printcolor and Deco Tech have been providing several of our 700 Series pad printing inks as USP Class VI tested and approved for pad printing or screen printing on various plastic medical devices. This includes Printcolor’s UV cured pad printing ink Series 747, as well as Printcolor’s standard inks in Series 711 and 752 (which are our two most popular pad printing inks). The UPS Class VI biological reactivity testing includes; System Toxicity, and Intracutaneously Toxicity tests which allow these three inks to be certified for the use in printing on various plastic materials used in manufacturing of Medical Devices.

The United States Pharmacopeia (USP) is a private (non-governmental) organization that "promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies." Those standards include in vivo animal biological reactivity tests for "elastomeric, plastic and other polymeric materials with direct or indirect patient contact." USP monograph (88) describes the classification of plastics into six classes based on responses to a series of in vivo tests for which extracts, materials and routes of administration are specified. USP Class VI requires the most stringent testing of these six classes. Extracts of the test material are prepared in saline, alcohol in saline, polyethylene glycol (PEG 400), and vegetable oil. The extracts (diluted in the case of the PEG extract) and blanks are injected into mice and rabbits, which are observed several times over a 72-hour period. The animals' response to the sample extracts and the blank are compared to determine test passage.

The systemic Injection test and a Intracutaneous-test are the first two testing methods used to determine which products (inks in this case) are deemed compliant with the USP Class VI. Furthermore, USP Class VI includes an implantation test wherein strips of the test material and a negative control are implanted in rabbits for a period of not less than 120 hours. Hemorrhage, necrosis, discolorations, and infections are macroscopically observed and degree of encapsulation is scored and compared with the negative control to determine test passage.

Technical data sheets, SDS sheets and Class VI certifications are hyperlinked on this page (bottom right side next to each of the available products). infections are macroscopically observed and degree of encapsulation is scored and compared with the negative control to determine test passage.