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Proto3000 Formlabs BioMed Elastic 50A, V2 Resin

    • Название продукта: Proto3000 Formlabs BioMed Elastic 50A, V2 Resin
    • Сайт Factroy: Округ Юду, Ганьчжоу, Цзянси, Китай
    • Запрос цены: admin@ascent-chem.com
    • Производитель: Ascent Petrochem Holdings Co., Limited
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    Спецификации
    Код ТН ВЭД 729176

    Как аккредитованный завод Proto3000 Formlabs BioMed Elastic 50A, V2 Resin, мы соблюдаем строгие протоколы качества - каждая партия подвергается строгим испытаниям для обеспечения последовательных стандартов эффективности и безопасности.

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    Применение смолы Proto3000 Formlabs BioMed Elastic 50A, V2

    The Proto3000-supplied BioMed Elastic 50A V2 resin is processed without dilution at 100% as-received viscosity for patient-specific vascular and soft-tissue anatomical models used in endovascular procedure rehearsal. Computed tomography angiography data are segmented into hollow vascular trees with minimum wall thickness of 0.8 mm for peripheral arteries and 1.2 mm for aortic arch segments. The build is oriented to align the primary vessel axis at 15° to 30° from the build platform normal to reduce internal support fracture risk. Formlabs-compatible stereolithography platforms operating at 405 nm and 50 μm layer thickness are used. Support structures are removed before post-cure. The printed phantoms are washed in fresh 99% isopropyl alcohol for 10 minutes under agitation, followed by compressed air clearing of blind lumens. Post-cure in a Form Cure unit is run at 60 °C for 20 minutes. Cytotoxicity and skin sensitisation compliance references are ISO 10993-5 and ISO 10993-10 according to the manufacturer’s test summary. The terminal articles are translucent or clear flexible phantoms used with saline perfusion loops. On benchtop flow loops, wall delamination at branch intersections has been observed when solvent is trapped inside the lumen during post-cure. The affected batch is rejected if residual solvent odour persists after 24 h air drying. These models are not implantable or reusable in direct patient contact beyond simulation.

    Why Does Compression Set Govern Wearable Sensor Attachment Durability?

    In wearable medical device development, compression set is the limiting failure mode for soft sensor attachment cushions and respiratory mask seals. The resin is built neat at 100% solids without plasticizer or reactive diluent. Cushion geometries are printed with vent holes of 0.5 mm diameter to prevent suction-cup failure during layer separation. After support removal, parts are washed in fresh 99% isopropyl alcohol for 10 minutes and air-dried for at least 30 minutes before post-cure. Post-cure is performed at 60 °C for 20 minutes. Compression set testing per ASTM D395 Method B should be requested for any cushion compressed beyond 25% of original thickness for more than 8 h. Published data for V2 compression set at 50 °C is limited; supplier test reports should be obtained before specifying dynamic seals. Material-level biocompatibility references include ISO 10993-5 and ISO 10993-10; USP Class VI certification, where required, must be reconfirmed against the V2 formulation. The terminal products are low-rate CPAP mask cushion prototypes, electrocardiogram patch housings, and wearable sensor gaskets. Steam sterilisation is not recommended above 121 °C because repeated exposure may produce surface hazing and Shore A drift. Ethylene oxide sensitivity for this V2 formulation is not fully published; device manufacturers must generate residue and mechanical-change data before adopting EtO cycles.

    Silicone Replacement in Soft Robotic Gripper Pad Prototyping

    The resin replaces cast silicone in low-volume soft robotic gripper pads where mould lead time prevents rapid design iteration. Apparent hardness is tuned by lattice geometry. Wall thickness of 1.0 mm to 2.0 mm and strut spacing of 2.5 mm to 4.0 mm produce contact compliance similar to solid Shore 50A elastomer. No diluent or filler is added. Particulate fillers are not recommended because they increase viscosity and block narrow lattice channels. Printed lattices are washed in tripropylene glycol monomethyl ether to reduce thin-wall swelling relative to isopropyl alcohol. The solvent bath is monitored and replaced when water uptake exceeds 5% or when transmittance drops below the equipment manufacturer’s limit. Post-cure is run at 60 °C for 20 minutes, followed by 24 h conditioning at 23 °C and 50% relative humidity. Mechanical acceptance should reference ASTM D412 for tensile elongation and ASTM D624 for trouser tear. Published data for latticed geometries at varying wall thickness is limited, so a buyer-defined tear strength threshold based on supplier ASTM D624 data is required before volume production. The terminal articles are direct-printed pads with undercut suction channels for handling surgical instrument trays and other medical logistics equipment. The material is not intended for direct tissue contact in this application, and cleaning validation remains the responsibility of the integrating facility.

    When a Catheter Hub Prototype Requires Overmould-Like Elastic Recovery at 50A

    Catheter hub and strain relief prototypes are printed from the resin where a soft overmould-like section must recover from repeated insertion and removal without adhesive bonding. The strain relief is designed with a taper from 3.2 mm outer diameter at the hub to 1.8 mm at the catheter shaft. Minimum wall thickness is held at 0.6 mm. Mechanical interlocking ring features with interference of 0.1 mm to 0.2 mm are printed into the inner bore to retain the shaft without adhesive. The build uses 50 μm layer thickness. Support removal is completed before post-cure. Washing is performed in 99% isopropyl alcohol for 10 minutes; parts are then post-cured at 60 °C for 20 minutes. Extended post-cure beyond the manufacturer-specified cycle does not linearly increase tensile strength and may reduce elongation at break. Material-level references include ISO 10993-5 and ISO 10993-10. Final catheter device validation must be completed by the legal manufacturer under ISO 10555-1. Steam sterilisation may be excluded from process validation if heat-related hardness shift is observed. Published data on EtO compatibility for the V2 resin is limited. The terminal products are functional catheter hub and strain relief prototypes used for bench testing of delivery system ergonomics, insertion force, and connection integrity. The resin is not appropriate for long-term implantable hub components.

    For solvent-sensitive microfluidic cell culture setups, the resin is printed as gasket films with thickness of 0.3 mm to 0.6 mm and compressed between poly(methyl methacrylate) plates. The compression force is controlled with a torque driver set to 0.5 N·m to 1.0 N·m. The gasket is post-cured at 60 °C for 20 minutes and soaked in phosphate-buffered saline for 24 h to remove leachable monomers before cell seeding. ISO 10993-5 extraction testing is referenced for the post-processed gasket. The resin must not be soaked in acetone or methyl ethyl ketone because these solvents swell the acrylate network beyond 10% linear dimension and compromise channel sealing. Terminal parts are elastomeric gaskets for organ-on-chip perfusion units and microfluidic manifold seals. Published data for dynamic cell viability in this V2 resin under continuous flow beyond 48 h is limited. Media perfusion loops should therefore include a preliminary leachables extraction run and blank media control before biological experiment start-up.

    Prosthetic Liner Wear Simulation and Socket Fit Verification

    In prosthetic socket evaluation, the material is used for transparent diagnostic liners rather than final skin-contact liners. Variable wall thickness from 2.0 mm to 5.0 mm is printed to map pressure distribution under gait loading. Layer height is set at 50 μm for fine inner contours or 100 μm where build speed takes priority and surface finish is secondary. Supports are removed before washing. Washing uses 99% isopropyl alcohol for 10 minutes, with particular attention to blind socket ends where solvent can pool. Post-cure at 60 °C for 20 minutes is followed by conditioning at 23 °C and 50% relative humidity for 24 h before mechanical testing. References include ASTM D395 for compression set, ASTM D412 for tensile elongation, and ISO 10993-10 for skin sensitisation. The resin does not fully replicate silicone liner viscoelasticity at high strain rates, so dynamic gait studies should be considered fit-for-purpose only after comparison with control liner data. The material is not suitable for skin contact longer than 24 h without final device validation. Published data for high-cycle prosthetic liner fatigue is limited. Terminal products are transparent socket liners used in pressure mapping and friction testing during prosthetic fit checks.

    Application trackKey standard/test methodProcessing boundaryPublished data status
    Anatomical vascular phantomsISO 10993-5, ISO 10993-1060 °C cure, 20 min; no trapped solvent in lumensSupplier file available
    Wearable sensor cushionsASTM D395 Method B, ISO 10993-10Compression set beyond 25% strain requires validationLimited at 50 °C
    Soft robotic gripper padsASTM D412, ASTM D624Lattice wall 1.0–2.0 mmLimited for lattice geometry
    Catheter hub prototypesISO 10993-5, ISO 10555-1Wall ≥ 0.6 mmFinal device validation required
    Microfluidic gasketsISO 10993-5 extractionAvoid ketone solventsLimited for > 48 h dynamic culture
    Prosthetic liner analogsASTM D395, ISO 10993-10Condition 23 °C/50% RHNot for > 24 h skin contact
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    Сертификация и соответствие требованиям
    Более подробное введение

    Proto3000 supplies the Formlabs BioMed Elastic 50A, V2 Resin as a 405 nm photopolymer elastomer formulated for stereolithographic fabrication of compliant patient-contact components. The material is dispensed in 1 L cartridges compatible with Formlabs Form 3B, Form 3B+, and Form 3BL systems. Manufacturer-published mechanical property data for the V2 formulation list Shore hardness of 50A per ASTM D2240-15, ultimate tensile strength of 7.7 MPa per ASTM D638-14, elongation at break of 160% per ASTM D638-14, and tear strength of 13 kN/m per ASTM D624-00. The polymer is intended for validated workflows requiring soft, resilient surfaces under repeated flexural loading rather than rigid structural housings.

    Which ASTM D638 and ASTM D624 thresholds distinguish the V2 formulation from the previous Elastic 50A release?

    The V2 designation indicates a formulation revision rather than a change in Shore durometer class. Published tear strength and elongation values for V2 are the primary differentiation points when compared with the first-generation BioMed Elastic 50A resin. Direct comparison with earlier datasheets requires attention to specimen printing orientation, layer thickness, post-cure dose, and conditioning history, because elastomer network conversion is sensitive to all four variables. The acceptance window for V2 is therefore defined by the combination of 50A Shore hardness, 160% elongation at break, and 13 kN/m tear strength after the manufacturer default post-cure.

    Manufacturer-published mechanical data for Formlabs BioMed Elastic 50A, V2 Resin
    PropertyTest methodPublished value
    HardnessASTM D2240-15Shore 50A
    Ultimate tensile strengthASTM D638-147.7 MPa
    Elongation at breakASTM D638-14160%
    Tear strengthASTM D624-0013 kN/m

    The values in the table are representative for post-cured specimens printed at 100 µm layer thickness on a Form 3B or Form 3BL using the validated resin profile. Lot-specific certificates should be reviewed before device builds because photopolymer network conversion varies with build volume location, laser power calibration, and post-cure chamber loading.

    Pre-print cartridge agitation is required because pigment and oligomer fractions settle during storage at 10 °C to 30 °C. Resin temperature below 18 °C raises viscosity and increases the probability of recoating defects on the flexible film. On production lines, cartridges should be allowed to equilibrate to 22 °C to 25 °C before printing. Washing in 99% isopropyl alcohol in a Form Wash removes uncured resin from high-elongation surfaces. Extended solvent immersion beyond the validated resin profile interval causes swelling and temporarily lowers Shore A hardness. Support removal should occur before final post-cure so that witness marks do not become locked into the crosslinked surface.

    When post-cure irradiance, temperature, or soak time falls outside the validated window

    Post-curing is performed in a Form Cure chamber at 60 °C according to the resin profile loaded on the printer. The exact soak duration should not be shortened in production. Under-curing leaves residual reactive species in the elastomer network and can reduce tear strength while increasing the risk of dermal sensitisation from leachable monomer. Over-curing above 80 °C accelerates oxidative chain scission at exposed surfaces and can embrittle thin flexure zones. Unlike rigid photopolymers, the V2 material does not benefit from maximal conversion because a controlled residual viscoelastic phase contributes to elongation recovery. Process deviation tracking should log chamber temperature, full irradiance cycle completion, and post-cure load density because stacked parts can shadow the 405 nm source and generate within-batch hardness drift of several Shore A points.

    The material is manufactured under ISO 13485:2016 quality management and is evaluated according to ISO 10993-5:2009 cytotoxicity, ISO 10993-10:2021 sensitisation, and ISO 10993-23:2021 irritation. The resin is suited for medical device components requiring long-term skin contact and short-term mucosal contact. The manufacturer does not claim suitability for long-term implantable use, permanent tissue contact, or load-bearing orthopedic applications. Final device manufacturers remain responsible for device-level validation, including bioburden control under FDA 21 CFR 820 or applicable regional quality system requirements.

    Solvent interaction, water absorption, and isopropyl alcohol immersion limits

    Repeated surface disinfection with 70% ethanol or 70% isopropanol is generally compatible for patient-contact surfaces, but full immersion in alcohol beyond the wash profile can increase solvent uptake and reduce tear resistance until the part is reconditioned at 23 °C and 50% relative humidity. Water absorption is measurable but largely reversible after drying; parts subjected to 37 °C water immersion should be conditioned before final mechanical inspection to avoid false reductions in Shore A hardness. The resin is not formulated for continuous contact with aggressive polar solvents, chlorinated hydrocarbons, or aqueous alkaline cleaners above pH 11. If disinfection by quaternary ammonium compounds is required, compatibility should be verified on test coupons because surface-active agents can migrate into the elastomer and alter frictional behaviour.

    Relative to Formlabs BioMed Flex 80A, the Elastic 50A, V2 grade moves Shore hardness from 80A to 50A and trades tensile stiffness for higher elongation and tear compliance. BioMed Flex 80A is typically selected for stiffer snap-fit housings and load-bearing clips, while Elastic 50A is assigned to cushions, gaskets, and patient-contact pads where distributed pressure and repeated flexure are required. Compared with standard non-biocompatible Flexible 80A, the BioMed Elastic 50A carries the additional ISO 10993 test suite and is manufactured under medical-device quality controls. The V2 resin is not a direct substitute for rigid BioMed Clear or BioMed White in optical or hard-tissue guides because its low modulus cannot maintain dimensional stability under torque or compressive load.

    Steam sterilisation does not eliminate the need for lot-specific biocompatibility verification

    Steam sterilisation cycles may be compatible with short-term patient-contact parts, but repeated exposure to 121 °C saturated steam can produce hydrolytic ageing in the elastomer network. Published data for the V2 material after multiple autoclave cycles is limited, so the manufacturer does not provide a generic reusable-device claim. If steam, ethylene oxide, or hydrogen peroxide plasma sterilisation is required, the finished device developer must test post-sterilisation Shore A hardness, tear strength, and dimensional change on production-representative coupons. Load-bearing flexures should be tested after worst-case sterilisation loading, not only after ambient conditioning, because residual moisture can plasticise the surface and alter friction against skin or mucosa.

    Production-scale lines using Form 3B and Form 3BL platforms should monitor build volume edge effects. Parts printed near the perimeter of the Form 3BL platform can exhibit slightly lower laser exposure than centre positions, which may translate into local hardness differences in large batch layouts. For compliant gaskets and cushion pads, part orientation should place high-flexure zones away from the peel plane to reduce support scarring and anisotropic tear initiation. Unsupported walls below the resolved feature threshold for the selected layer height are not recommended for patient-contact surfaces because local under-conversion can create extractable sites. After post-cure, a visual inspection under 2× magnification is used to detect support debris, pinholes, or surface tears before packaging. Parts should be stored in sealed polyethylene bags away from ultraviolet light and allowed to reach ambient temperature before sterile barrier assembly.

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