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

Printcolor and Deco Tech are trusted industry leaders in supplying USP Class VI certified pad printing inks for medical device manufacturing. These high-performance inks—specifically the Printcolor 711, 747, and 752 Series—are rigorously tested to meet the strictest global standards for biocompatibility and patient safety. Whether you're printing on syringes, diagnostic housings, catheter components, or medical-grade polymers, these inks ensure safe, durable, and compliant results.

WHAT IS USP CLASS VI?

USP Class VI is the most stringent biological reactivity classification established by the United States Pharmacopeia (USP). It ensures that plastics, elastomers, and printing inks used on medical devices are non-toxic and biologically inert. For pad printing inks to qualify, they must pass three major in vivo tests:

• Systemic Injection Test
• Intracutaneous Toxicity Test
• Implantation Test

These tests involve preparing extracts of the ink using saline, alcohol in saline, polyethylene glycol (PEG 400), and vegetable oil, which are then injected into mice or rabbits. Biological responses such as hemorrhage, necrosis, infection, discoloration, and encapsulation are observed over a 72–120 hour period to determine safety.

WHY IT MATTERS

Inks that pass USP Class VI testing are approved for direct and indirect contact with human tissue. This makes them suitable for:

• Class II and Class III medical devices
• Components used in invasive or implantable devices
• Products requiring sterilization or chemical resistance

Printcolor’s 711, 747, and 752 inks not only pass this testing, but consistently outperform industry benchmarks for adhesion, print clarity, and chemical durability on plastics like PP, PE, ABS, PC, and treated metals.

Each ink series includes full documentation, including technical data sheets, SDS sheets, and Class VI certification reports, available directly on this page.

Printcolor 711-8005 Black is a one-component pad printing ink specifically developed for printing on medical-grade plastics. Certified to USP Class VI standards, it passes System Toxicity, Intracutaneous Toxicity, and Biological Reactivity testing—ensuring safe use on plastics commonly found in medical devices.

• Ideal for syringes, catheters, IV housings, and diagnostic components
• Smooth ink transfer, fast drying, and solvent resistance
• Available exclusively through Deco Tech in North America

View the Printcolor Series 711-8005 - Pad Printing Ink Class VI Medical Certification

View the Printcolor Series 711-8005 - Class VI Pad Printing Ink - Technical Information

Printcolor 711-9005 White offers the same Class VI performance in a high-opacity white formulation. Designed for high-contrast printing on light or dark plastics used in medical device assembly and disposable diagnostic goods.

• Excellent opacity and chemical durability
• Reliable print definition on curved or textured plastic parts
• Fully certified for medical-grade use on a variety of injection molded plastics for the medical industry including PE, PP, PC, and ABS

View the Printcolor Series 711-9005 - Pad Printing Ink Class VI Medical Certification

View the Printcolor Series 711-9005 - Class VI Pad Printing Ink - Technical Information

This fast-curing UV ink is ideal for high-volume medical applications that require wet-on-wet printing. 747-8005 Black combines rapid processing speed with full Class VI certification—making it a top choice for microPrint automated pad printing lines.

• Cures instantly with UV exposure – no inter-color drying required
• Outstanding print definition, even on low-surface-energy substrates
• Approved for direct contact with medical-grade polymer components

View the Printcolor Series 747-8005 - Pad Printing Ink Class VI Medical Certification

View the Printcolor Series 747-8005 - Class VI Pad Printing Ink - Technical Information

Printcolor 747-9005 White offers all the benefits of 747 Black in a bright, high-opacity white. Engineered for sharp imaging and long-term adhesion on plastic medical parts requiring Class VI safety compliance.

• Ideal for cleanroom pad printing
• No crosslinking required between colors
• Broad material compatibility: PP, PE, PA, and copolymers

View the Printcolor Series 747-9005 - UV Cured Pad Printing Ink Class VI Medical Certification

View the Printcolor Series 747-9005 - UV Cured Class VI Pad Printing Ink - Technical Information

Printcolor 752-8005 Black is a versatile, two-component ink system certified to Class VI standards. It delivers exceptional durability, solvent resistance, and cross-linked adhesion on both untreated and pre-treated substrates.

• For use on PE, PP, ABS, PC, metalized plastics, and coatings
• 1K (single-component) or 2K (hardened) for demanding environments
• Ideal for high-wear medical products like housings and handles

View the Printcolor Series 752-8005 - UV Cured Pad Printing Ink Class VI Medical Certification

View the Printcolor Series 752-8005 - UV Cured Class VI Pad Printing Ink - Technical Information

The white version of the 752 Series ensures strong contrast, edge definition, and biocompatibility on complex or multi-material assemblies. Used in OEM medical device manufacturing and labware marking.

• Class VI certified for critical device applications
• Extended open time for long production runs
• Excellent resistance to sterilization and alcohol wipes

View the Printcolor Series 752-9005 - UV Cured Pad Printing Ink Class VI Medical Certification

View the Printcolor Series 752-9005 - UV Cured Class VI Pad Printing Ink - Technical Information

What Are Class VI Medical-Grade Pad Printing Inks?

Class VI pad printing inks are specialty ink formulations that have passed USP Class VI biocompatibility testing, certifying them for safe use on components that may come into direct or indirect contact with the human body. These inks are designed for printing on medical plastics, surgical instruments, diagnostic housings, syringes, and other regulated devices.

Why Is USP Class VI Certification Important?

USP Class VI is the highest standard for biological reactivity testing. It ensures that pad printing inks are non-toxic, non-irritating, and biocompatible—making them suitable for medical-grade manufacturing. It includes systemic injection tests, intradermal reactivity, and implantation evaluations using saline, PEG, and oil-based extracts.

Which Printcolor Inks Are Certified to Class VI Standards?

Printcolor Series 711, 747, and 752 are all USP Class VI certified and available in black and white formulations.

• 711 Series – One-component ink for medical plastics
• 747 Series – UV-curable ink for wet-on-wet printing in cleanroom settings
• 752 Series – Two-component ink with excellent chemical resistance for plastics and metals

Each series has passed all required toxicological tests, including those outlined by the United States Pharmacopeia.

What Materials Can Be Printed with Class VI Inks?

Printcolor Class VI inks are suitable for printing on:

• Polypropylene (PP)
• Polyethylene (PE & HDPE)
• Polycarbonate (PC)
• ABS
• Nylon
• Treated metals and coatings
• Thermoplastics and duromaterials

When combined with surface preparation (e.g., corona or plasma treatment), adhesion and permanence on low-surface-energy substrates improve dramatically.

What Are Common Applications for Class VI Pad Printing Inks?

These inks are trusted for use on:

• Syringes, catheters, tubes, IV components
• Inhalers, pill counters, diagnostic test kits
• Medical-grade housings, handles, and control panels
• Labware, centrifuge cartridges, specimen containers
• Surgical instruments and printed measurement marks

Do Class VI Inks Require Post-Printing Sterilization?

While the inks themselves are Class VI certified, post-print sterilization (e.g., gamma irradiation, ethylene oxide, or autoclave) may still be necessary depending on the device’s end-use. Printcolor inks are tested to maintain adhesion and integrity even after common sterilization methods.

KEY BENEFITS OF PRINTCOLOR CLASS VI PAD PRINTING INKS

• ✅ USP Class VI Certified (Systemic Injection, Intracutaneous, Implantation)
• ✅ FDA-Grade Formulations (Tested for Direct & Indirect Human Contact)
• ✅ Available in 1K, 2K, and UV-Curable Options
• ✅ Compatible with PE, PP, PC, ABS, and Treated Metals
• ✅ Proven Cleanroom Performance (747 UV Series)
• ✅ Long-Term Durability, Sterilization Resistant
• ✅ Full Documentation: Safety Data Sheets, COAs, and Certification Reports

We provide ink samples, certification documents, and technical support for all Printcolor Class VI ink series.

Contact the Deco Tech team today at 714-639-DECO or email sales@decotechgroup.com for regulatory consultation or ink selection assistance.