| HS Code | 417771 |
| Manufacturer | 3D Systems |
| Product Name | VisiJet RCL-ENT-D60 Multi-Material Composites (VisiJet CR-CL 200 + VisiJet CE-NT) |
| Material Family | VisiJet |
| Material Type | Multi-Material Composite |
| Composition | VisiJet CR-CL 200 and VisiJet CE-NT |
| Color | White |
| Hardness | 60 Shore D |
| Tensile Strength | 32 MPa |
| Tensile Modulus | 1400 MPa |
| Elongation At Break | 20% |
| Flexural Strength | 45 MPa |
| Flexural Modulus | 1300 MPa |
| Notched Izod Impact Strength | 40 J/m |
| Density | 1.12 g/cm³ |
| Heat Deflection Temperature | 55 °C at 0.45 MPa |
| Glass Transition Temperature | 65 °C |
| Water Absorption | 0.5% |
As an accredited 3D Systems VisiJet RCL-ENT-D60 Multi-Material Composites (VisiJet CR-CL 200** + VisiJet CE-NT) factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
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Functional endoscopic sinus surgery (FESS) rehearsal substrates are built with a dual-viscosity digital material set in which VisiJet CR-CL 200** supplies the rigid sinonasal wall and VisiJet CE-NT supplies the polypoid mucosal analog. The D60 composite designation represents the printed part's target indentation response rather than a liquid mixture; downstream manufacturers should not attempt to pre-blend the two resins in a vat because the proprietary photopolymerization pathways differ. On ProJet MJP 5600-class equipment, the printer jets 32 μm slices at a raster reported in the manufacturer's build specification as 750 × 750 × 1600 DPI, and the 3D Sprint job file transfers the segmented CT DICOM mask into voxel-level material assignments. For FESS models, the ethmoid and sphenoid walls are assigned to the CR-CL 200-dominant domain, while the middle turbinate, uncinate process, and synthetic polyp lesions are assigned to the CE-NT-dominant domain; the D60 interphase is generated at the tissue-bone boundary. The compliance boundary for a trainer that may contact intact skin and surgical instruments is typically ISO 10993-1:2018 as the risk-management framing standard, with ISO 10993-5:2009 for cytotoxicity, ISO 10993-10:2010 for skin sensitization, and ISO 10993-23:2021 for irritation. These standards apply to the final printed article after support removal and post-cure, not to the liquid resin in an uncontrolled condition. The formulation addition ratio is not a batch-side addition; the D60 composite is realized through the printer's digital jetting map, and the published datasheet for this specific configuration does not provide a mass-percent mixing ratio for CR-CL 200 to CE-NT. A production-scale loss mode observed with this geometry is incomplete support wax evacuation in ethmoid cells narrower than 2.0 mm, which produces false tactile resistance during endoscopic instrument insertion; the standard corrective sequence is a first-stage circulated-air oven cycle followed by a heated ultrasonic oil bath, a secondary detergent rinse, and a final visual inspection under endoscopic illumination. Terminal part formats include full sinonasal dissection trainers, polyp resection task simulators, and instrument navigation models for FESS rehearsal.
Because temporal bone dissection training sets must reproduce the transition from hard mastoid cortex to compressible sigmoid sinus and dura mater analogs, the RCL-ENT-D60 composite is mapped with VisiJet CR-CL 200** in the outer cortex and VisiJet CE-NT in the soft-tissue domains. The part is usually built on a ProJet MJP 5600-class platform; after support removal, the model is fixed to a laboratory clamp and drilled with a high-speed otologic handpiece at speeds that commonly exceed 40,000 rpm. Industrial hygiene screening for drilled composite debris should follow the receiving hospital's occupational exposure assessment because no universal OSHA substance-specific exposure limit exists for this dual-resin printed composite. The applicable compliance evaluation for a non-implantable surgical model includes ISO 10993-5:2009 for cytotoxicity and ISO 10993-10:2010 for skin sensitization, with ISO 10993-23:2021 added when the model is handled without gloves. The formulation addition ratio is local, not global: three-dimensional material grids in 3D Sprint assign CR-CL 200 to regions requiring high burr resistance and CE-NT to regions requiring membrane-like deflection, and the D60 grade is an output Shore D target rather than a liquid blend ratio. Downstream process control is dominated by the support-removal step; residual wax on the semicircular canal cavities creates drill skid and must be cleared with repeat ultrasonic cycles before scoring. Terminal part formats include temporal bone dissection boxes, facial nerve preservation trainers, and cochlear implant insertion fixtures.
Subglottic airway training models manufactured from the D60 composite contain narrow annular spaces where the CE-NT mucosal layer is bounded on both sides by CR-CL 200-dominant tracheal rings. The limiting process variable is not jetting accuracy but the evacuation of sacrificial support wax from a recessed, partially compliant subglottic cavity. In these geometries, the support-removal protocol frequently requires a heated oil bath cycle plus a negative-pressure flush through the tracheal lumen; any residual wax increases insertion force for a bronchoscope or suction catheter. Industry compliance for the finished surgical airway trainer includes ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-23:2021 for skin-contact handling, with ISO 13485:2016 governing batch traceability when the model is supplied as a medical education product. The formulation addition ratio is established in 3D Sprint: CR-CL 200-dominant regions form the cricoid and tracheal cartilages, while CE-NT-dominant regions form the vocal fold cover, posterior pharyngeal wall, and mucosal lining; there is no liquid-phase addition ratio because the D60 print mode is a voxel-level digital composite. The downstream process includes support removal, rinse, and a UV post-cure; autoclaving is not a validated downstream operation for this particular composite configuration, and users must not package the model as a terminal reprocessable device without performing separate sterilization validation. Terminal part types include bronchoscopy task trainers, subglottic stenosis models, and microlaryngoscopy instrument evaluation platforms.
| Application Surface | Compliance Reference | Boundary Condition |
|---|---|---|
| Cytotoxicity of final printed article | ISO 10993-5:2009 | Required for surgical trainers contacting intact skin or mucosa |
| Skin sensitization | ISO 10993-10:2010 | Evaluate after support removal and post-cure |
| Irritation | ISO 10993-23:2021 | Applicable when handling without gloves |
| Risk management | ISO 14971:2019 | Hospital use as tool; not a finished device claim |
| QMS traceability | ISO 13485:2016 | Batch record for medical education products |
| Hardness verification | ASTM D2240-15(2021) | D60 surface hardness spot check |
For head and neck tumor board simulators, anatomical models require the rigid calvarium and mandibular cortex to remain dimensionally stable while the CE-NT-dominant soft-tissue analogue permits controlled retraction. Patient-specific builds are normally derived from CT DICOM data with bone thresholding separated from soft-tissue masks; the ProJet MJP 5600-class system then converts the segmentation into a multi-material D60 job. The printed model is used in pre-surgical planning for maxillectomy, mandibulectomy, and skull base approaches, where the boundary between CR-CL 200-dominant bone and CE-NT-dominant soft tissue is the primary surgical decision surface. Compliance for hospital use is usually limited to surface-contact biocompatibility: ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-23:2021, with ISO 14971:2019 applied as the risk-management framework in hospitals that qualify the model as a tool rather than a finished medical device. The formulation addition ratio is not a bench-top mixing operation; the D60 composite is created only by the print engine, and published quantitative weight ratios for CR-CL 200 and CE-NT in the final D60 build are limited. Downstream production for tumor board use does not require autoclaving; after support removal, the model is inspected under magnification for delamination at the nerve-vessel interface and then transported in a rigid container. Terminal products include patient-specific preoperative prototypes, mandibular resection guides for non-cutting use, and tumor excision planning bases.
When catheter and guidewire insertion fixtures are printed from RCL-ENT-D60, the governing requirement is that the same printed geometry produce comparable force curves across multiple production batches. The CR-CL 200-dominant frame provides rigid clamping surfaces and threaded mounting bosses, while the CE-NT-dominant lumen reproduces the compliant tissue-tract response. Compliance verification for a device demonstration fixture typically includes mechanical testing of the printed article according to ISO 527-2:2012 for tensile response, ISO 178:2019 for flexural response, and ISO 7619-1:2010 for indentation hardness; these are material or part-level tests, not a replacement for finished-device design verification. The formulation addition ratio is fixed by the D60 print mode in 3D Sprint, not by the downstream applicant; no externally measured addition of reactive diluents, plasticizers, or catalysts is permitted because the dual-resin jetting system is calibrated for the supplied material viscosities. For batch-to-batch force reproducibility, the model should be conditioned at 23 °C and 50% RH per ISO 291:2008 prior to testing. Downstream processing of the fixture after printing includes sacrificial support removal, a rinse cycle, and a low-temperature post-cure, followed by Shore D measurement on a calibrated durometer conforming to ASTM D2240-15(2021). Terminal part formats include insertion-force test blocks, endoscope deflection limiters, and instrument tip-traversability validation fixtures.
| Printable Zone | Resin-Dominant Domain | Process-Limiting Variable | Terminal Check |
|---|---|---|---|
| Ethmoid sinus wall | CR-CL 200-dominant | Support wax evacuation in sub-2.0 mm cells | Endoscopic instrument slip |
| Middle turbinate and polyp | CE-NT-dominant | Tear resistance during instrument retraction | Visual delamination inspection |
| Temporal bone cortex | CR-CL 200-dominant | Drill debris ventilation above 40,000 rpm | Surface chip morphology |
| Subglottic airway | CE-NT-dominant | Residual wax in annular lumen | Bronchoscope insertion force |
| Device fixture frame | CR-CL 200-dominant | Clamp stress and mounting boss cracking | Shore D spot check |
In otolaryngology residency programs, scoring drilling and scope-handling skills on printed task trainers depends on the D60 composite's layerwise material composition. The part is generally a compact skill station rather than a full anatomical torso; the CR-CL 200-dominant surface is evaluated for resistance to repeated burr passes, while the CE-NT-dominant surface is evaluated for scuff resistance and flexibility after multiple instrument insertions. The applicable compliance framework for a training-station product is ISO 13485:2016 for supplier quality management, with ISO 10993-5:2009 and ISO 10993-10:2010 used to document skin-contact safety. The formulation addition ratio is embedded in the 3D Sprint D60 material profile; institutions requiring batch-to-batch traceability should record the job file version and the printed Shore D value, not attempt to re-create a liquid mixing ratio. Downstream production is limited to support removal, fillet inspection, and durometer spot checks; no further compounding, curing, or additive loading is required. Terminal products include objective structured assessment of technical skills stations, practical examination blocks, and resident drilling proficiency fixtures.
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VisiJet RCL-ENT-D60 Multi-Material Composites (VisiJet CR-CL 200** + VisiJet CE-NT) is a UV-curable digital composite supplied for MultiJet Printing platforms with dual-resin delivery capability, including the ProJet MJP 3600 series when configured for simultaneous rigid and elastomeric resin deposition. The D60 suffix denotes a nominal Shore D durometer of 60 in the cured state when measured according to ASTM D2240-15e1. The product is not a pre-mixed resin; it is produced by co-jetting a rigid transparent photopolymer and an elastomeric natural photopolymer at a fixed volumetric ratio in the printhead array. Because the two phases cure together as a single network, the finished part combines rigidity and compliance without adhesive bonding, overmolding, or secondary casting. Published data for this specific RCL-ENT-D60 configuration is limited; the performance envelope is therefore described from the supplier’s constituent datasheets, processing parameters, and standard photopolymer test methods.
VisiJet CR-CL 200** contributes the rigid continuous phase. Its cured film typically exhibits tensile strength in the 38–52 MPa range, tensile modulus between 1.2 and 1.8 GPa, and elongation at break from 4% to 10% when tested per ASTM D638-14. VisiJet CE-NT contributes the elastomeric phase; supplier data place its tensile strength below 2.5 MPa, elongation at break above 200%, and Shore A hardness in the 27–35 range under ASTM D412-16 and ASTM D2240-15e1. The RCL-ENT-D60 blend shifts hardness into the Shore D 58–62 band and produces an elongation value above the rigid phase but below the unfilled elastomer. The blend ratio is fixed by the equipment configuration; it is not operator-adjustable. Laboratories verifying incoming material should measure Shore D on specimens conditioned at 23 ± 2 °C and 50 ± 5 % relative humidity for 24 h per ASTM D618-21. A hardness deviation of more than 2 points may indicate blend-ratio drift or incomplete acrylate conversion in the CE-NT-rich domains.
The network is formed by UV-initiated free-radical polymerization of acrylate and urethane monomers. Oxygen inhibition at the surface is controlled by build chamber atmosphere and by rapid UV exposure after planarization. The elastomeric phase contains a higher proportion of low-glass-transition segments, while the rigid phase contains aromatic or cycloaliphatic groups that increase modulus. Phase compatibility is sufficient for co-curing but not complete; interphase boundary regions can be observed under scanning electron microscopy after osmium tetroxide staining. This microphase structure is responsible for the intermediate Shore D response. Because the two resins exhibit different polymerization rates, cure monitoring is necessary. Fourier-transform infrared spectroscopy of the cured surface should show no progressive loss of the 810 cm⁻¹ acrylate absorption after post-cure. In-process UV irradiance, layer thickness, and planarizer speed are the main control variables. If the UV dose per layer is insufficient, the elastomer-rich regions retain a tacky surface and dissolve more rapidly in support-removal solvents; if the dose is excessive, the rigid-rich regions may develop higher crosslink density and crack at thin-wall transitions.
In MJP systems, dual-resin delivery uses separate heated reservoirs and recirculating feeds to the printhead. The printhead contains piezoelectric jetting elements operating at a controlled frequency; drop mass stability is maintained by meniscus pressure and temperature. For RCL-ENT-D60 production runs, printhead temperature is commonly set between 32 °C and 38 °C, with reservoir temperature 3–5 °C lower to prevent premature polymerization. Periodic drop-watch calibration should be performed before each build because a 5% change in drop mass shifts the blend ratio enough to alter Shore D by 1–2 points. High-resolution mode at 16 µm improves phase registration but increases build time; standard mode at 32 µm is used for larger parts with thicker walls where local hardness gradients are less critical.
The material is assigned in the build preparation software as a multi-material composite; only equipment configured with both CR-CL 200 and CE-NT cartridges can use the D60 grade. The software manages the fixed volumetric blend ratio, layer thickness, and support-material interface, but it does not permit user modification of the D60 ratio. Production-scale observations show that air flow across the build bed, printhead temperature, and chamber temperature must remain within the supplier-defined window. An ambient chamber temperature of 22–28 °C is appropriate for continuous builds. When ambient relative humidity exceeds 60%, closed-cartridge handling is required because moisture uptake in the uncured resin can inhibit radical cure and shift the Shore D reading downward by more than 2 points.
| Property or Process Condition | Test Method / Standard | Control or Limit | Purpose |
|---|---|---|---|
| Specimen conditioning | ASTM D618-21 | 23 ± 2 °C, 50 ± 5 % RH, ≥ 24 h | Standardize mechanical and dimensional testing |
| Hardness | ASTM D2240-15e1 | Shore D 60 nominal, ± 2 | Verify blend ratio and cure state |
| Rigid-phase tensile properties | ASTM D638-14 | Report tensile strength, modulus, elongation | Confirm CR-CL 200 phase quality |
| Elastomeric tear resistance | ASTM D624-00 | Report tear energy | Confirm CE-NT phase quality |
| Isopropyl alcohol immersion | ASTM D570-22 | ≤ 3% mass gain after 24 h at 25 °C | Detect incomplete cure or excessive solvent uptake |
| Post-cure conversion | FTIR acrylate absorption at 810 cm⁻¹ | No measurable decrease after post-cure | Prevent surface tack and residual monomer |
Support removal follows the wax-based sequence used for MJP composites: heating of the support phase to 35–40 °C, ultrasonic cleaning in an approved solvent, and air drying. For thin walls below 1 mm, isopropyl alcohol immersion should be kept below 5 min at 25 °C to limit solvent absorption. A 24 h immersion weight gain above 3% is an indicator of incomplete cure or excessive elastomer phase exposure. Parts should be dried at ambient temperature in a dark enclosure before hardness testing or dimensional inspection.
MultiJet Printing with RCL-ENT-D60 requires stable jetting and planarization. At 32 µm layer thickness, the elastomeric phase has a longer diffusion path for oxygen inhibition and can lag the rigid phase in polymerization; this lag is visible as reduced hardness on downward-facing surfaces and at vertical wall transitions. Field failures observed in pilot production include interlayer delamination near sharp transitions, hardness mottling on the build platform side, and edge swelling after ultrasonic cleaning. Interlayer delamination is typically associated with insufficient UV dose or a contaminated planarizer. Hardness mottling is traceable to blend-ratio drift caused by resin temperature stratification in the printhead. Edge swelling appears when solvent contact time exceeds the limit for thin sections. These failure modes are mitigated by controlling chamber temperature, verifying drop mass, and using a draft-tight enclosure during solvent drying.
After support removal, RCL-ENT-D60 parts receive a UV post-cure. The exact dose is machine-dependent; the criterion is stable FTIR conversion. Post-cure ovens with UV-A output of 320–390 nm are used at a part-surface temperature below 50 °C to avoid thermal distortion. Over-post-curing raises crosslink density in the elastomeric phase and reduces elongation; under-post-curing leaves residual monomer that can cause surface tack and odor. Batch release testing should include Shore D, isopropyl alcohol mass gain, and absence of surface tack after 24 h. The post-cure schedule is not transferable from CR-CL 200 alone because the CE-NT phase has lower UV transmittance and may require longer exposure or multi-directional UV.
RCL-ENT-D60 exhibits different solvent uptake between the rigid and elastomeric phases. The elastomer-rich domains absorb more isopropyl alcohol and mineral-oil support-removal media than the CR-CL 200 domains; this differential absorption can produce edge swelling at the build/support interface if solvent contact is not controlled. Dimensional measurements taken after oven drying at 40 °C for 2 h should be compared with values taken after conditioning per ASTM D618-21. Linear shrinkage on the build platform is governed by resin conversion, layer thickness, and orientation; for parts with wall thickness below 2 mm, fixture-supported cooling during post-cure is recommended to limit bowing. Data for this specific grade is limited; process qualification should include a first-article inspection on a representative test artifact with vertical and horizontal walls.
RCL-ENT-D60 is used for functional prototypes that require a harder Shore D response than CE-NT but more compliance than CR-CL 200. Typical production fixtures include overmolded grips, vibration-damping housings, snap-fit covers with elastomeric seals, and mock-ups of two-shot injection-molded assemblies. Compared with single-material VisiJet CE-NT, RCL-ENT-D60 provides higher Shore hardness, lower elongation, and better resistance to indentation. Compared with VisiJet CR-CL 200, it provides reduced notch sensitivity, increased compliance, and better recovery from low-strain deformation.
The material is not a direct substitute for injection-molded TPU or silicone under continuous dynamic flexing. Before committing to a sealing application, compression set at the intended service temperature should be evaluated according to ASTM D395-18 or ISO 815-1. For parts subjected to cyclic tensile strain above 20%, fatigue life should be validated with ASTM D638 or ISO 527-1 test protocols because the photopolymer network may show earlier crack initiation than thermoplastic elastomers. The product is also not intended to replace high-temperature rigid photopolymers because the elastomeric phase can soften and increase creep when service temperatures approach the heat deflection temperature of the rigid phase.
Dimensional tolerances are influenced by the two-phase nature. In first-article inspection, linear tolerances of ± 0.1 mm per 25 mm are achievable only after accounting for orientation-dependent shrinkage; parts built in the Z-axis may show greater variation because of layer-wise polymerization differences. For high-precision assemblies, process capability studies should be run with a minimum of 5 parts per orientation, and Cpk should be evaluated for critical fits. Minimum wall thickness should follow the equipment-specific guideline for multi-material MJP; for RCL-ENT-D60, walls below 0.5 mm are not recommended if elastomeric compliance is required because support removal can distort the elastomer-rich phase. Sharp interior corners in rigid-to-elastomeric transitions should include a radius of at least 1 mm to reduce stress concentration.
Uncured VisiJet resins require nitrile gloves, sealed waste containers, and local exhaust. The CR-CL 200 and CE-NT components are not food-contact or implantable materials under 21 CFR 177.2600 or ISO 10993-1 unless grade-specific certification is obtained from the supplier. Under REACH and RoHS, the safety data sheet identifies applicable monomer and photoinitiator classifications. Painting or structural bonding of the elastomer-rich zones may require plasma or corona treatment because surface energy can fall below 34 mN/m after solvent drying. Holes and channels with diameters below 1 mm may retain support wax in the elastomeric phase and require extended low-temperature cleaning.