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Printcolor · USP Class VI Certified Pad Printing Inks · Switzerland
USP Class VI Medical Pad Printing Inks
Printcolor Series 711, 747 and 752 include specific black and white USP Class VI certified pad printing inks for medical devices. Compare fast-drying solvent, UV-curable and one- or two-component systems by substrate, cure method, sterilization and chemical-resistance requirements, then review the applicable certificates and technical data.
Medical Device Pad Printing
Cleanroom-compatible equipment and certified ink systems for controlled medical-device marking applications.
USP Class VI Certified
Specific black & white /USP formulations
FDA-Compliant
Manufacturer classification from Printcolor
TOXiCON Tested
Systemic, intracutaneous & implantation testing
Swiss Made
Printcolor medical ink systems manufactured in Switzerland
USP Class VI Medical Ink Explained
What Does USP Class VI Certification Mean?
“Medical-grade pad printing ink” is a common industry and search term, but the important qualification is the certification attached to the specific ink formulation. Printcolor's medical /USP black and white formulations have been evaluated under the USP Class VI biological-reactivity framework for medical and surgical applications. For manufacturers searching for USP Class VI medical pad printing inks, the important distinction is that certification applies to the specific formulation — not automatically to every color in the broader ink series.
USP General Chapter <88> describes in-vivo biological-reactivity testing that includes systemic injection, intracutaneous and implantation testing. Printcolor states that its certified medical ink systems were tested through TOXiCON and are biocompatible and FDA-compliant. Deco Tech therefore describes these products as USP Class VI certified and FDA-compliant — not “FDA approved.”
Printcolor identifies medical-device Classes II and III, invasive or implantable-device components, and products requiring sterilization or chemical resistance among the applications where Class VI qualification can matter. Final acceptance still depends on the finished device, substrate, pretreatment, curing conditions and the manufacturer's validation protocol.
01
Systemic Injection Test
Evaluates systemic biological response to extracts prepared from the material under test.
02
Intracutaneous Test
Evaluates localized tissue response following intracutaneous exposure to material extracts.
03
Implantation Test
Evaluates biological response to the material under implantation conditions.
Why It Matters
Certification, adhesion and process validation all matter.
A Class VI certificate answers an important biocompatibility question about the tested formulation. It does not tell you whether the ink will adhere to your exact resin, survive your cleaning chemistry, tolerate your sterilization cycle or cure correctly on your production line. That is why this page also compares ink chemistry, substrates, documentation and application requirements.
Compare Certified Ink Systems
Compare Printcolor Series 711, 747 and 752
All three families have certified black and white /USP formulations, but they do not process the same way. Compare the chemistry, curing method, substrate range and resistance requirements before choosing the starting system for application testing.
Need help selecting? Send Deco Tech the substrate, pretreatment, cure method,
sterilization or cleaning exposure, number of colors and production requirements.
Printcolor Series 711 · Medical /USP
View full Series 711 technical information →
Series 711: Fast-Drying Solvent System
Series 711 is Printcolor's fast-drying, high-opacity one-component pad printing system. For medical applications, 711-8005/USP Black and 711-9005/USP White are the specific USP Class VI certified formulations. Printcolor lists plastics, glass and metal among compatible substrate groups.
Process
Fast-drying solvent
Certified Colors
Black / White
Typical Substrates
ABS · rigid PVC · PC
Printcolor Series 747 · UV · Medical /USP
View full Series 747 technical information →
Series 747: UV-Curable System
Series 747 is Printcolor's UV-curable pad printing system for applications where rapid curing, cleanroom production or wet-on-wet multicolor printing is important. The certified medical formulations are 747-8005/USP Black and 747-9005/USP White.
Process
UV-curable
Certified Colors
Black / White
Typical Substrates
Rigid PVC · ABS · PA · PC
Printcolor Series 752 · One- or Two-Component · Medical /USP
View full Series 752 technical information →
Series 752: Universal One- or Two-Component System
Series 752 can be processed as a one- or two-component system and is intended for demanding applications on plastics and metals. Printcolor highlights strong chemical resistance and suitability for aggressive sterilization processes. The certified medical formulations are 752-8005/USP Black and 752-9005/USP White.
Process
One- or two-component
Certified Colors
Black / White
Typical Substrates
ABS · rigid PVC · PC · treated PE/PP
Substrate Compatibility
Compatible Substrates by Ink Series
Use the lists below to quickly compare the substrate families identified for Series 711, 747 and 752. Always confirm adhesion and resistance on the exact resin, surface condition, pretreatment and production process used for the medical component.
Series 711
Fast-Drying One-Component
ABS / SAN / Copolymers
Rigid PVC
Soft PVC
Polystyrene
PMMA / Acrylic
Polycarbonate
PET-A
Coated Surfaces
Powder-Coated Surfaces
Series 747
UV-Curable
Rigid PVC
ABS / SAN / Copolymers
Polyamide / Nylon
Polycarbonate
Polystyrene
Soft PVC
PMMA / Acrylic
PET-A
Pre-Treated PE
Pre-Treated PP
Coated Surfaces
Duroplasts
Glass / Ceramics
Series 752
One- or Two-Component Universal
ABS / SAN / Copolymers
Rigid PVC
Polycarbonate
PMMA / Acrylic
Coated Surfaces
PET-A
PET-G / PET-GAG
Polyamide / Nylon
Pre-Treated PE
Pre-Treated PP
Polypropylene:
Series 752 can also be used on non-pretreated PP with Series 700-PP according to Printcolor's
technical guidance; in that configuration the ink must be processed as a two-component system with hardener.
Medical Device Validation
The certified formulation is the starting point. The finished printed device still has to meet your process and validation requirements.
Certification vs. Finished-Device Validation
Certification Is One Part of Device Qualification
The Class VI certificate applies to the tested ink formulation. Medical-device performance can still change with the exact resin, molding additives, surface energy, pretreatment, ink-film thickness, cure, cleaning chemistry and sterilization process.
Confirm adhesion
Test the actual production resin and surface condition, not just the generic polymer family.
Confirm cure
Validate the real drying or UV-curing parameters used on the production equipment.
Confirm resistance
Evaluate the cleaners, disinfectants, abrasion and chemicals the printed device will encounter.
Confirm sterilization
Test the finished print against the actual sterilization method and number of cycles required by the device program.
Deco Tech can help with the ink-selection side of the process.
Send us the substrate, surface treatment, print requirements, sterilization or cleaning exposure
and production conditions so we can recommend the appropriate Printcolor system for testing.
Certified Medical Formulations
Certified Black and White /USP Formulations
Printcolor identifies six commonly used medical formulations across Series 711, 747 and 752. The certification is tied to these specific black and white /USP products. Standard mixing colors, Pantone matches and other custom shades should only be represented as Class VI certified when supported by their own applicable documentation.
Series 711
Fast-Drying
711-8005/USP
Black
711-9005/USP
White
Series 747
UV-Curable
747-8005/USP
Black
747-9005/USP
White
Series 752
One- or Two-Component
752-8005/USP
Black
752-9005/USP
White
Certificates & Technical Documentation
Documentation for Engineering, Quality and Regulatory Review
Buyers evaluating a Class VI ink usually need more than a product description. The 711, 747 and 752 panels above link directly to the available USP Class VI certificates and technical data sheets. Deco Tech can also provide the applicable Safety Data Sheet and help organize the documentation needed to evaluate a Printcolor medical ink system. For medical-device programs, this keeps certification, processing guidance and workplace-safety information together during qualification.
01
USP Class VI Certificate
Confirms the applicable /USP formulation and the biological-reactivity certification associated with that product.
02
Technical Data Sheet
Use the TDS for substrate guidance, processing parameters, auxiliaries, drying or curing, and resistance information.
03
Safety Data Sheet
Use the current SDS for handling, storage, hazard and workplace-safety information for the supplied ink and auxiliaries.
Medical Device Applications
Common Medical Device Marking Applications
Printcolor identifies syringes, catheters, IV components, diagnostic housings, inhalers, medical controls, labware, laboratory components and surgical instruments as typical applications for its USP Class VI certified ink systems. These applications may require fine graduations, permanent legends, identification marks, symbols or branding on small, curved and difficult-to-print medical components.
Syringes & Graduations
Measurement marks, functional graphics and identification on molded syringe components.
Catheters & Tubing
High-contrast markings on small-diameter tubes and catheter-related components.
Diagnostic Housings
Legends, symbols and product identification on molded diagnostic-device components.
Inhaler Components
Technical markings and branding on plastic medical-device assemblies.
Labware & Laboratory Parts
Identification and functional marking on laboratory and diagnostic components.
Surgical Components
Technical and identification markings for medical and surgical-use parts.
Deco Tech Application Review
Select the Ink Around the Actual Device and Process
Send us the substrate or resin, surface treatment, curing method, sterilization or cleaning exposure, number of colors and production volume. Deco Tech can help narrow the appropriate Printcolor system before application testing begins.
Part
Exact substrate / resin
Surface
Pretreatment or coating
Process
Solvent-dry or UV cure
Resistance
Cleaning / chemical exposure
Validation
Sterilization requirements
Production
Colors & annual volume
Deco Tech has distributed Printcolor in North America since 1997 and supports medical-device ink selection, application testing, documentation and production process development.
Send Us the Application
Medical Ink FAQ
Technical Questions About Class VI Ink Selection
These are the questions manufacturing, quality and engineering teams most often need answered when evaluating a medical-device pad printing ink.
What is a USP Class VI medical pad printing ink?
It is a specific printing-ink formulation that has been evaluated under the USP Class VI biological-reactivity framework. Printcolor's certified medical /USP inks are intended for medical and surgical applications and have undergone systemic injection, intracutaneous and implantation testing through TOXiCON.
Are all Printcolor Series 711, 747 and 752 colors USP Class VI certified?
No. The medical Class VI products shown on this page are the specific black and white /USP formulations: 711-8005/USP, 711-9005/USP, 747-8005/USP, 747-9005/USP, 752-8005/USP and 752-9005/USP. Do not assume a standard mixing color or custom color match carries the same certification without supporting documentation for that formulation.
Which Printcolor medical ink should I use: 711, 747 or 752?
Series 711 is the fast-drying one-component solvent-based starting point. Series 747 is the UV-curable option when rapid curing, cleanroom production or wet-on-wet multicolor printing is important. Series 752 is the universal one- or two-component system for demanding applications where broader substrate flexibility, chemical resistance or aggressive sterilization requirements may drive the selection.
What substrates can Printcolor Class VI pad printing inks print on?
Across the three systems, Printcolor lists substrates including PP, PE / HDPE, PC, ABS, rigid and soft PVC, polystyrene, PMMA / acrylic, PA / nylon, PET, coated surfaces, treated metals and additional technical materials. Compatibility varies by series, and low-surface-energy plastics may require pretreatment. Use the substrate section above to compare 711, 747 and 752.
Are Printcolor Class VI inks FDA approved?
We do not describe them as FDA approved. Printcolor's current manufacturer terminology is USP Class VI certified, biocompatible and FDA-compliant. Final device compliance and validation remain the responsibility of the medical-device manufacturer.
Are these inks suitable for cleanroom pad printing?
Printcolor specifically highlights Series 747 as suitable for cleanroom environments. The complete printing cell, ventilation, handling practices, curing equipment and validation requirements still need to be designed around the customer's cleanroom and manufacturing process.
Will a Class VI pad printing ink withstand sterilization?
Printcolor describes its USP Class VI systems as sterilization resistant and specifically positions Series 752 for demanding applications that may involve aggressive sterilization. The actual ink, substrate, cure and sterilization method must be tested together under the device manufacturer's production conditions.
Can Deco Tech provide USP Class VI certificates, TDS and SDS documents?
Yes. The available Class VI certificates and technical data sheets are linked in the 711, 747 and 752 sections above. Contact Deco Tech for the applicable Safety Data Sheet or for a documentation package tied to the specific ink and auxiliaries being evaluated.
Are these Class VI products screen printing inks?
The certified formulations covered on this page are Printcolor pad printing inks. If your medical-device application uses screen printing, send Deco Tech the substrate, required color, sterilization or chemical exposure and regulatory requirements so the appropriate screen-printing ink system can be reviewed separately.
Medical Ink Selection Support
Discuss My Medical Project
Need Help Qualifying an Ink for Your Medical Device?
Send Deco Tech the exact substrate or resin, pretreatment, artwork, cure method, sterilization or chemical exposure, color and production requirements. We can help identify the best Printcolor system to start with and provide the applicable technical documentation for evaluation.
Technical basis:
Product positioning, certified formulations, medical applications and substrate guidance on this page
are based on current Printcolor manufacturer information and the applicable Printcolor technical data.
Final suitability must be validated on the finished application.