Biocompatible PolyJet materials are rigid acrylic photopolymers, available in clear and opaque versions, that the material manufacturer has tested for biological safety. MED610 is a well-known example of the class. Mechanically they behave like the rigid PolyJet family. Their documentation typically covers material tests based on the ISO 10993 series, such as cytotoxicity, sensitization and irritation, and for some grades USP Class VI. Typical uses are surgical and drilling guides, dental devices with short-term contact and prototypes that touch the skin.
Biocompatibility is not a property of every part printed from such a material. The manufacturer's statement applies to the certified material when it is printed, cleaned and post-processed under the validated conditions it specifies. Whether a finished device is safe and compliant is decided by the device maker's own evaluation, and that regulatory responsibility stays with the customer. Uretyco offers these grades through its manufacturing partners as specialized materials; feasibility, grade, available documentation and lead time are confirmed during quote and order review.
Mechanical and physical properties
| Property | Typical value | Notes |
|---|---|---|
| Tensile strength | ≈ 50–65 MPa | ASTM D638, printed test bars. |
| Elongation at break | ≈ 10–25% | Brittle, like other rigid PolyJet materials. |
| Tensile modulus | ≈ 2.0–3.0 GPa | Stiff. |
| Flexural strength | ≈ 75–110 MPa | ASTM D790. |
| Notched Izod impact | ≈ 20–30 J/m | ASTM D256. Low; thin features break on impact. |
| Heat deflection temperature | ≈ 45–50 °C | At 0.45 MPa; rules out steam autoclaving. |
| Hardness | ≈ 83–86 Shore D | Hard surface. |
| Density | ≈ 1.17–1.18 g/cm³ | Cured material. |
| Water absorption | ≈ 1.1–1.5% | ASTM D570, 24 h; relevant for cleaning and disinfection in liquids. |
| Biocompatibility basis | Material tests based on ISO 10993; USP Class VI for some grades | Valid for the certified material under its specified process. |
| Contact type | Grade-specific | For example prolonged skin contact or short-term mucosal contact; not for implants. |
Typical datasheet values for rigid biocompatible PolyJet materials, measured on printed test bars. Real parts vary with grade, print mode, orientation, post-processing and age. Biocompatibility data describe the tested material under defined conditions; they are not a statement about a specific finished device.
What biocompatibility covers
A biocompatibility statement for a PolyJet material is tied to conditions set by the material manufacturer. They typically include:
- The exact certified grade, printed on its own. Parts that combine it with standard, colored or rubber-like materials fall outside the scope.
- Printing on qualified printers with the specified settings and support material.
- Support removal and cleaning by the specified methods, with parts kept separate from standard materials.
- Post-processing within the documented limits. Sanding, coating, bonding or adding other materials changes the part and must be evaluated.
- Sterilization only by methods that the material manufacturer documents and the device maker validates.
The material documentation supports, but does not replace, the device maker's own biological evaluation and approval route, for example under ISO 10993-1 and Regulation (EU) 2017/745 on medical devices (MDR). The customer remains responsible for the intended use, the risk assessment, cleaning and sterilization validation, and the conformity of the finished device. If your project requires a manufacturer with a specific quality-management certification, such as ISO 13485, state it in the quote request. Uretyco confirms before order confirmation whether a partner holding that certificate can be assigned; otherwise no order is placed.
Printing biocompatible PolyJet parts
Geometric design rules match the rigid PolyJet family. The differences lie in process control and in how parts are handled after printing:
- Walls and details: walls of about 1 mm and up print reliably. Because the material is brittle, guide bodies, flanges and tabs need enough material to resist handling and clamping.
- Single material: print the part from the certified material and its specified support only. Color, rubber-like or digital-material regions are outside the biocompatible scope.
- Cleanability: avoid closed cavities, long narrow channels and deep blind holes where support or cleaning agents could remain.
- Orientation: faces that touch support come out matte. Orient contact and reference faces so that their accuracy and finish suit the use.
- Guide holes: drill guides often use metal sleeves or reamed holes. Specify sleeve type, fit and position on a drawing.
- Identification: engraved or embossed text avoids inks and labels that would need a separate evaluation.
Tolerances and surface
Without a tolerance on the drawing, Uretyco's default for PolyJet parts is ±0.2 mm or ±0.2%; tighter values apply only when they are stated on the drawing and accepted in the quote. The fit of patient-specific guides depends on the accuracy of the source data and the design as much as on printing, so validate the fit on a test print where possible. Clear grades are translucent as printed. Polishing improves clarity, but it is a post-processing step that must stay within the documented conditions.
Finishing options
Every finishing step changes the part that the biocompatibility data describe. Keep finishing to what the use requires and agree each step before production.
| Finish | Effect | Notes |
|---|---|---|
| As printed and cleaned | Closest to the documented condition | Standard for guides and devices; faces that touched support are matte. |
| Glossy print mode | Smoother upward faces | Applies to upward faces; confirm that the print mode is within the documented conditions. |
| Polishing (clear grades) | Better clarity | Mechanical only; must fit the documented conditions and the device maker's validation. |
| Reaming and metal sleeves | Accurate guide holes | Mark them on a drawing; sleeves are separate components with their own documentation. |
| Paint, coating or adhesive | Color or protection | Not covered by the material's biocompatibility data; avoid unless separately evaluated. |
| Sterilization | Use in a sterile field | Usually done by the device maker or the clinic; steam autoclaving softens the material. |
Do not add sanding, coatings, adhesives or other materials to a biocompatible part without checking them against the material documentation and your own validation. State every finishing requirement at quote time so it can be reviewed before production.
Cost and lead-time drivers
Biocompatible grades cost more than standard PolyJet materials, and the controlled process adds work:
- Part volume, bounding box, orientation, support material and machine time, as for all PolyJet parts.
- The certified material itself, which is priced above standard rigid materials.
- Controlled support removal, cleaning and separate handling, plus any reaming, sleeves or polishing.
- Optional documents such as material documentation, a measurement report or a certificate of conformity, selected and priced at quote.
- Lead time: material availability and partner assignment are confirmed during quote and order review, and regulated-use requests may be reviewed by an engineer before acceptance.
Biocompatible PolyJet vs. other options
| Material and process | Biocompatibility basis | Heat and sterilization | Strength and toughness | Typical use |
|---|---|---|---|---|
| Biocompatible PolyJet | Certified grade; material tests based on ISO 10993 | HDT ≈ 45–50 °C; no steam autoclaving | Low; brittle | Surgical guides, dental devices, skin-contact prototypes |
| Standard PolyJet (clear or rigid) | None | HDT ≈ 45–50 °C | Low; brittle | Models and prototypes without body contact |
| Dental and biocompatible SLA resins | Certified grade; claims vary by grade | Grade-dependent; some grades tolerate steam sterilization | Low to moderate, grade-dependent | Surgical guides, splints, dental appliances |
| Medical-grade machined plastics such as PEEK | Medical grades with supplier documentation | PEEK withstands repeated steam sterilization | High | Instruments, device components, reusable parts |
| Medical-grade silicone (LSR) | Grades tested to ISO 10993 or USP Class VI | Withstands steam sterilization | Flexible | Seals and soft contact parts |
Choose biocompatible PolyJet for short-use, patient-specific or complex parts where fine detail matters. When a part must be steam-sterilized, carry load or be reused, a certified SLA resin that tolerates sterilization or a machined medical-grade thermoplastic is usually the better route.
When not to choose biocompatible PolyJet
Implants or any long-term contact inside the body: these materials are not intended for it. Parts that must withstand steam autoclaving or temperatures above about 45–50 °C. Load-bearing, reusable or impact-loaded instruments. Multi-color, rubber-like or digital-material parts that must remain biocompatible, because only the certified material is covered. Projects without a defined intended use, contact classification and regulatory plan: the material alone does not make a device compliant.
Typical applications
- Patient-specific surgical and drilling guides.
- Dental surgical guides and try-in parts.
- Prototypes of wearables and other skin-contact products for user studies.
- Anatomical and planning models used close to the patient.
- Fixtures and components for laboratory and medical device testing.
Specifying biocompatible PolyJet on Uretyco
- 1Describe the intended use
State the device type, the contact type and duration, and whether parts will be cleaned or sterilized, so the request can be reviewed before acceptance.
- 2Specify the certified grade
Name the biocompatible material class, clear or opaque, or the exact grade your validation is based on.
- 3Upload STL, 3MF or STEP and a drawing
Mark contact faces, guide holes, sleeves and critical dimensions. Remove patient names and other personal data from the files.
- 4Define post-processing and documents
List polishing, sleeve or cleaning requirements, the documents you need and any certified-manufacturer requirement.
- 5Review the quote
Feasibility, grade, documents and lead time are confirmed during quote and order review.
FAQ
Is a part printed from a biocompatible material automatically biocompatible?
No. The material manufacturer's statement covers the certified material under defined printing, cleaning and post-processing conditions. Whether a finished part is suitable depends on its design, process, contact type and duration, and is confirmed by the device maker's own evaluation.
Can biocompatible PolyJet parts be sterilized?
Not by steam autoclaving, because the material softens at about 45–50 °C. Some low-temperature methods may be compatible where the material manufacturer documents them, but their effect on fit and material must be validated by the device maker for each device.
Which documents can I get?
Documents are optional and selected at quote, for example material documentation, a measurement report or a certificate of conformity. State what your regulatory file needs. If a required document cannot be provided, Uretyco says so before order confirmation.
How should patient-specific files be prepared?
Remove names and other personal data from file names, models and drawings, and use an internal case number instead. Anonymized files keep personal health data out of the manufacturing process.
Related resources
- PolyJet ClearTransparent PolyJet for models without body contact.
- Dental Resin (SLA)Certified SLA resins for dental use.
- PEEKHigh-performance plastic with medical grades.
- Liquid Silicone Rubber (LSR)Soft parts in medical-grade silicone.
- Certificates and Inspection ReportsOptional documents selected at quote.
- KVKK, GDPR and Personal DataHow personal data in uploads is handled.
Related materials
Plastics
Dental Resin
Photopolymers for dentistry: accurate model resins and biocompatible grades for guides, splints and temporary crowns. Use in the mouth depends on the certified resin, a validated printer and post-processing workflow, and the device maker's regulatory duties.
Metals
Cobalt Chrome
Hard, wear- and corrosion-resistant cobalt-chromium-molybdenum alloy. Usually laser powder-bed printed or investment cast for dental, medical and wear parts; machinable, but slowly.
Plastics
PEEK
High-performance semi-crystalline polymer for continuous service up to about 250 °C, with outstanding chemical, wear and hydrolysis resistance. Machines to tight tolerances; stock costs roughly 10–15× ABS.
Plastics
PolyJet Rigid
Rigid, UV-cured acrylic photopolymer jetted in very thin layers. Very smooth surfaces, fine detail, color and multi-material options for visual prototypes and master patterns; not meant for load-bearing or hot parts.
Plastics
Castable Resin
Photopolymer that burns out cleanly in the investment casting flask, so a printed pattern replaces a wax model. For jewelry, dental frameworks and small precision castings in gold, silver, bronze and cobalt chrome; patterns need a resin burnout schedule.
Plastics
PolyJet Clear
Rigid, near-colorless acrylic photopolymer jetted in very thin layers. Polished, it becomes clear enough for see-through housings, light-guide mock-ups and flow models. It is brittle and softens at about 45–50 °C, so it does not suit optics or loaded parts.
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