Medical 3D printing — biocompatible resin

Anatomical models, training devices, laboratory fixtures and bioprocessing parts · BioMed Clear resin on a Formlabs Form 4B · sterilisable parts, intended for research.

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3D printed anatomical model on the Osmoz 3D workbench, next to a resin printer

Form 4B · BioMed Clear

Our Formlabs Form 4B is dedicated to biocompatible resins. BioMed Clear is USP Class VI certified, evaluated to ISO 10993-1 and ISO 18562, and manufactured by Formlabs in an ISO 13485 facility with an FDA Device Master File. Every part is washed and post-cured following the manufacturer's validated protocol — it is that complete chain, not the material alone, that underpins biocompatibility.

01USP Class VI

02ISO 10993-1

03Sterilisable

04Validated protocol

What we do — and what we don't

Research, laboratory and training

Parts in contact with organic matter, samples, culture media or biological fluids: models, fixtures, bioprocessing parts, device prototypes. That is our ground, and it is a wide one.

A chain controlled end to end

A resin tank and consumables dedicated to BioMed, with no cross-contamination from other resins. IPA wash and post-cure at the validated parameters. Traceability of the resin batch and print parameters on request.

No patient contact, no CE-marked device

We do not make implants, CE-marked medical devices, or parts intended for direct contact with a person. If your project requires it, let's talk: a dedicated production line can be studied, but it is never automatic.

Workshop — Formlabs Form 4B

Biocompatible resin · dedicated tank · post-cure 60 °C / 60 min

Applications

Anatomical and planning models

Faithful reproduction of a geometry from imaging or CAD data, to prepare an intervention, visualise a case or support a demonstration. BioMed Clear is transparent, so internal structures stay visible.

Exemple : translucent planning model, sub-millimetre detail, delivered in 48 h.

Training and simulation devices

Training and simulation parts for teaching institutions and manufacturers: repeated handling, cleaning with isopropyl alcohol, fast replacement when they wear out.

Exemple : a series of identical training parts, reproducible from batch to batch.

Laboratory fixtures and tooling

Sample holders, tube racks, bench jigs, adapters for existing instruments. Rigid, transparent, sterilisable, and remade to measure when the protocol changes.

Exemple : bespoke sample holder for an existing measurement bench.

Bioprocessing and fluidics

Chambers, fittings and device bodies in contact with liquid media. The low water absorption of BioMed Clear (0.54 %) and its wear resistance suit repeated use.

Exemple : transparent fluidic chamber for visualising a flow.

Device prototypes

Validate the shape, ergonomics and assembly of a device before industrialisation, in a material that is already biocompatible — without waiting for injection tooling. A published example: our portable toothbrush prototype, taken from functional proto to presentable version.

Exemple : three iterations of a device body in one week.

Low-volume runs and dedicated line

For a recurring need, we can set up a dedicated production chain: frozen parameters, reserved consumables, output rate and traceability matched to your volume. To be planned together, upfront.

Exemple : regular batch of identical parts, parameters frozen from batch to batch.

See our projects

The material, with the figures

Post-cured values from the Formlabs technical data sheet (20 min wash in 99 % IPA, post-cure at 60 °C for 60 min). Real properties depend on geometry, print orientation and the sterilisation method used.

Resin	TensileMPa	ModulusMPa	Elong.%	FlexuralMPa	HDT°C	HardnessShore
BioMed ClearBiocompatibleTransparent, rigid — low water absorption (0.54 %), wear resistant	52	2080	12	84	67	78D

What frames the production

BiocompatibilityUSP Class VIevaluated to ISO 10993-1 · ISO 18562

Validated protocol99 % IPA · 60 °C20 min wash · 60 min post-cure

Sterilisationcompatibleautoclave · EO · gamma · e-beam

Traceabilityon requestresin batch · parameters

Max volume200 × 125 × 210 mmper print

The questions we get asked

Are the parts delivered sterile?

No. We deliver clean parts, washed and post-cured following the protocol validated by Formlabs, but **not sterile**. Sterilisation is the client's responsibility, since they control the process and its validation. The material is compatible with autoclaving (134 °C for 20 min, or 121 °C for 30 min), ethylene oxide, gamma radiation and e-beam, as well as disinfection with 70 % isopropyl alcohol.

Do you manufacture medical devices?

No. The certification covers the resin and the Formlabs facility, not our workshop: we are not ISO 13485 certified and we do not manufacture CE-marked medical devices. We produce parts for research, laboratory work, training and prototyping. If your project implies manufacturer status, we will say so in our very first exchange.

What if the part has to be in contact with a person?

That is not our default scope, and we do not accept it automatically. We are happy to discuss it, though: depending on the use, the contact duration and the volume, a dedicated production line can be studied. For contact types and durations, the Formlabs documentation is authoritative, not our website.

Who validates the compliance of the final part?

The client. We guarantee the material used, compliance with the post-processing protocol and, on request, traceability of the batch and parameters. Assessing the part in its final use — biocompatibility of the finished product, risk analysis, sterilisation — is for whoever puts the product into service.

Can you handle a regular volume?

Yes. For a recurring need, we set up a dedicated production chain: frozen parameters, reserved tank and consumables, output rate matched to your volume. Let's discuss it upfront — that is what makes consistent lead times possible.

What do you need from us for a quote?

A 3D file (STEP preferred, or STL), the real use of the part, the quantity, and the intended sterilisation method if there is one. If you have no file, we can model from drawings, photographs or an existing part — see our SLA 3D printing page for the other resins available.

A research or laboratory project?

Describe your part and its real use: we reply within 24 h with a material recommendation, a lead time and a quote.

Request a quote