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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. Series 786 adds a highly resistant two-component medical-grade pad printing ink platform whose complete 14-color MS base set was represented in a NAMSA USP Class VI test composite, expanding custom color options for medical device printing and marking applications.

Cleanroom pad printing operation for medical device components using a microPrint machine
Medical Device Pad Printing Cleanroom-compatible equipment and certified ink systems for controlled medical-device marking applications.
USP Class VI Certified / Tested Specific /USP formulations + Series 786 MS color system
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 or test documentation attached to the specific ink formulation. Printcolor's medical /USP black and white formulations in Series 711, 747 and 752 have been evaluated under the USP Class VI biological-reactivity framework. Series 786 is documented differently: NAMSA tested a composite formulation containing equal parts of all 14 Series 786 MS base colors, and the tested composite met USP Class VI requirements under the documented test conditions.

USP General Chapter <88> describes in-vivo biological-reactivity testing that includes systemic injection, intracutaneous and implantation testing. These are the biological-reactivity evaluations buyers commonly mean when searching for a biocompatible pad printing ink or USP Class VI medical ink. Printcolor's medical portfolio includes certified /USP formulations as well as the Series 786 NAMSA-tested MS color system. Final device compliance and validation remain the responsibility of the medical-device manufacturer.

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 USP Class VI Medical Ink Systems

Series 711, 747 and 752 provide specific black and white /USP formulations with different processing characteristics. Series 786 adds a separate two-component MS mixing-color platform for medical applications requiring broader custom color capability. Compare chemistry, curing, substrates, sterilization exposure and resistance requirements before 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

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
View full Series 711 technical information →
Printcolor Series 747 · UV · Medical /USP

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
View full Series 747 technical information →
Printcolor Series 752 · One- or Two-Component · Medical /USP

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
View full Series 752 technical information →
New Class VI Color Capability

Series 786: USP Class VI Tested MS Colors for Custom Medical Ink

Printcolor Series 786 is a highly resistant two-component pad printing ink for medical, diagnostic and laboratory applications. NAMSA tested a composite made from equal parts of all 14 Series 786 MS base colors; under the documented conditions, that composite met USP Class VI requirements.

View Series 786 Colors
Substrate Compatibility

Compatible Substrates by Ink Series

Compare substrate families identified for Series 711, 747, 752 and 786, including medical printing ink options for polypropylene (PP), polyethylene (PE), polycarbonate (PC), ABS, PMMA/acrylic, PVC, polyamide/nylon, metals and coated surfaces. Always confirm adhesion and resistance on the exact resin, surface condition, pretreatment and production process.

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
Series 786 Highly Resistant Two-Component
PMMA / Acrylic Rigid PVC Coated Surfaces Polyamide / Nylon Polyethylene Polypropylene Tritan™ / Copolyester Duroplasts / Thermosets ABS / SAN / Copolymers Metal Powder Coatings
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.
Pad printed medical device components with graduations, symbols and identification markings
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
Series 786 · USP Class VI Tested MS Colors

Series 786 USP Class VI Tested MS Colors for Custom Medical Pad Printing Ink

Series 786 expands Printcolor's medical ink offering beyond the specific black and white /USP formulations. NAMSA tested a printed and cured composite containing equal parts of all 14 Series 786 MS base colors, and the tested composite met USP Plastic Class VI requirements under the documented test conditions. This gives Deco Tech a documented MS base-color platform for custom color medical ink development while preserving the qualification tied to the actual test formulation.

Printcolor Series 786 · Two-Component · MS Mixing System

Custom Color Matching for Medical Device Printing

Because the successful test composite represented the complete Series 786 MS base-color palette, Deco Tech can formulate Pantone®, corporate and product-specific custom colors using those same MS components. This is especially useful when a medical device marking ink must combine exact color matching with high chemical resistance, mechanical durability and documented Class VI test information.

Test LaboratoryNAMSA
Test StandardUSP Chapter <88>
MS Base Colors14 represented
786-1005786-1005/HD786-1105786-1205 786-2005786-3005786-3005/HD786-3105 786-3305786-4005786-5005786-6005 786-8005786-9005
Important qualification: The NAMSA study evaluated one composite formulation containing equal parts of the 14 MS colors. It does not mean every possible custom mixing ratio has been individually tested or certified. Finished-device suitability and regulatory validation remain the manufacturer's responsibility.
Printcolor Series 786 USP Class VI tested MS mixing colors chart with Printcolor logo
Printcolor's Series 786 sales information identifies the MS base-color set represented in the USP Class VI test composite. Manufacturer branding is intentionally preserved.
Certificates & Technical Documentation

Documentation for Engineering, Quality and Regulatory Review

Engineering, quality and regulatory teams evaluating USP Class VI pad printing ink typically need the applicable certificate or test report, technical data sheet and safety data sheet. The 711, 747 and 752 sections link to their available /USP documentation. For Series 786, Deco Tech can provide Printcolor product information, sales information and the NAMSA test certificate supporting the tested MS color system.

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.

Manufacturer & Standards References

Verify the medical ink and Class VI requirements at the source.

Deco Tech provides the application guidance and North American support on this page. For manufacturer-level medical ink information and the underlying biological-reactivity standard, use the primary references below.

Medical Device Applications

Common Medical Device Marking Applications

Medical device printing ink and medical device marking ink may be used for graduations, permanent legends, identification, symbols and branding on syringes, catheters, tubing, diagnostic housings, inhalers, labware and surgical components. Ink selection should account for substrate adhesion, cleaning chemistry, sterilization resistance and the required biocompatibility documentation.

01 Syringes & Graduations Measurement marks, functional graphics and identification on molded syringe components.
02 Catheters & Tubing High-contrast markings on small-diameter tubes and catheter-related components.
03 Diagnostic Housings Legends, symbols and product identification on molded diagnostic-device components.
04 Inhaler Components Technical markings and branding on plastic medical-device assemblies.
05 Labware & Laboratory Parts Identification and functional marking on laboratory and diagnostic components.
06 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.

What is different about Printcolor Series 786 for USP Class VI applications?

Series 786 is documented as a USP Class VI-tested MS color system rather than as only specific black and white /USP SKUs. NAMSA tested a composite formulation containing equal parts of all 14 Series 786 MS base colors, and the tested composite met USP Class VI requirements under the documented conditions. This supports custom color development from the same MS component set, but individual custom mixing ratios are not represented as separately tested or certified unless their own documentation says so.

Can Series 786 be custom color matched for medical device printing?

Yes. Deco Tech can formulate Pantone®, corporate and product-specific colors from the Series 786 MS mixing system. The NAMSA study evaluated one composite containing equal parts of all 14 MS base colors, so individual custom mixing ratios should not be described as separately tested or certified unless their own documentation specifically supports that claim. Finished-device validation remains the manufacturer's responsibility.

Which Printcolor medical ink should I use: 711, 747, 752 or 786?

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 resistance requirements. Series 786 is a highly resistant two-component system with an MS mixing-color platform when broader custom color capability is needed. Final selection must be confirmed on the actual substrate and process.

What substrates can Printcolor Class VI pad printing inks print on?

Across Series 711, 747, 752 and 786, Printcolor identifies substrates including PP, PE, PC, ABS, rigid and soft PVC, PMMA / acrylic, PA / nylon, PET-related materials, coated surfaces, metals and other technical substrates. Compatibility varies by series and surface condition, so the exact production resin and pretreatment must be tested.

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. Deco Tech can also provide the Series 786 Printcolor product information, sales information and NAMSA test certificate supporting the tested MS color system, along with applicable SDS documentation.

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

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.

Discuss My Medical Project
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.