Name: Formlabs BioMed White Resin, 5L
Brand: Formlabs
SKU: RS-RPS-BMWH-01
Price: 1301.00 EUR
Availability: InStock

Formlabs BioMed White Resin, 5L

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Stock: In Stock
Product code: 00-00013585
Weight Brutto: 5.50kg
SKU: RS-RPS-BMWH-01

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Formlabs BioMed White Resin (5 L) is a rigid, opaque-white SLA photopolymer formulated specifically for medical-grade biocompatible applications — surgical drilling guides, patient-specific fixtures, pharmaceutical molds, and point-of-care assemblies — carrying USP Class VI certification, documented ISO 10993 biocompatibility testing, and full production traceability from a FDA-registered, ISO 13485-certified manufacturing facility.

Ultimate Tensile Strength	46 MPa
Hardness Shore D	80 D
Biocompatibility Standard	USP Class VI, ISO 10993-5/10/11, Non-pyrogenic (USP <151>)
Compatible Printers	Form 4B, Form 4BL, Form 3B, Form 3BL, Form 2

The image below shows a representative set of components produced with BioMed White Resin: a surgical guide sleeve fitted over a bone-axis insert, an anatomically contoured contact fixture, a custom drilling template, and a small anatomical-geometry model. All pieces demonstrate the crisp surface resolution and structural rigidity the material delivers in real clinical manufacturing workflows.

White 3D-printed surgical guides, bone contact molds, and biocompatible medical fixtures produced with Formlabs BioMed White Resin, displayed on a blue background

Medical-Grade Credentials: USP Class VI, ISO 13485, FDA-Registered Facility

Most consumer photopolymers are formulated for form and fit — not for contact with living tissue. BioMed White Resin inverts that priority. Every batch is manufactured inside a dedicated ISO Class 8 clean room within Formlabs's FDA-registered Ohio facility, under an ISO 13485:2016 Quality Management System that is also certified to the EU Medical Device Regulation (EU MDR). This is not a self-declared claim: third-party biocompatibility testing was conducted at NAMSA World Headquarters (OH, USA) against the full ISO 10993 test panel.

Biocompatibility Test Panel

Parts printed and post-cured according to the validated protocol have been evaluated against five independent biocompatibility endpoints. The test results confirm the material is not cytotoxic, not an irritant, not a sensitizer, free of acute systemic toxicity, and non-pyrogenic under the USP <151> Pyrogen Test — the standard required for parenteral drug delivery devices and many implant-adjacent instruments. The dual ISO 13485 and ISO 14971 compliance structure further ensures that risk management for printed parts aligns with medical device regulatory expectations across the EU and the US.

5 L Cartridge: Built for Production-Scale Workflows

The 5 L format is engineered for higher-volume manufacturing environments — hospital additive manufacturing labs, dental device producers, and medical device manufacturers who require consistent material performance across multi-week production runs without the frequent interruptions that come with smaller refill cycles. Because the resin is also USP Class VI certified, it meets the contact requirements for pharmaceutical and drug delivery applications, broadening the material's scope well beyond conventional surgical tooling.

The Intertek certification mark below confirms Formlabs's ISO 13485:2016 compliance — an independent third-party audit that verifies the robustness of the quality management system behind every litre of BioMed White Resin produced.

Expert Verdict: BioMed White Resin occupies a well-defined and irreplaceable niche: it is the go-to Formlabs material when the application demands proof of biocompatibility rather than just a material data sheet. The combination of ISO 10993 third-party testing, USP Class VI and USP <151> Pyrogen certification, four validated sterilization pathways, and ISO 13485 production traceability means procurement and regulatory teams can attach the required documentation to a clinical submission without commissioning independent biocompatibility testing — a significant cost and time saving at the regulatory stage. Practical note: for biocompatibility compliance to remain valid, the resin tank, build platform, wash unit, and cure unit used for BioMed White Resin must be dedicated to this material exclusively and must never be shared with other resin formulations. Cross-contamination from even trace amounts of non-biocompatible materials can void certification compliance regardless of the resin itself being correct.

Applications Where Material Integrity Is a Clinical Requirement

Surgical drilling guides and templates require dimensional accuracy and surface finish that holds tolerances through the sterilization cycle — BioMed White Resin's rigid 2000 MPa Young's Modulus and low water absorption (0.40 wt%) ensure that geometry does not drift between printing and intraoperative use. Biocompatible molds and production jigs benefit from the same stiffness, while the high-contrast opaque white colour aids visual inspection of contact surfaces and interfaces. In pharmaceutical settings, the USP Class VI classification opens the path to drug delivery device components and container-closure system elements.

The image below illustrates the range of geometric and structural complexity achievable with a single 5 L cartridge: a precision drilling guide with curved anatomy-following profile, a lattice-mesh implant shield, a threaded bone screw prototype with fine helix geometry, and a high-fidelity foot anatomy model accurate enough for pre-operative planning.

3D-printed white medical device components produced with Formlabs BioMed White Resin: surgical drilling guide, lattice mesh implant shield, threaded bone screw model, and detailed foot anatomy for pre-operative planning

Four Validated Sterilization Methods

Reusable surgical instruments and multi-patient-contact components must survive the sterilization cycle without dimensional change or surface degradation. BioMed White Resin parts have been validated against all four sterilization modalities used in hospital environments: E-beam radiation (35 kGy), ethylene oxide (100% EtO at 55 °C for 60 min), gamma radiation (29.0–31.1 kGy), and steam autoclave (132 °C / 4 min, 5 cycles — US protocol; 134 °C / 4 min, 5 cycles — EU protocol). For routine disinfection between uses, 70% isopropyl alcohol for 5 minutes is the validated chemical method.

Tech Tip: When selecting a sterilization method, match the thermal cycle to the part's wall geometry. The material's Heat Deflection Temperature at 1.8 MPa is only 52.4 °C, while at 0.45 MPa it reaches 67.0 °C. Steam autoclave at 132–134 °C exceeds both values — parts with thin walls (< 1.5 mm) or long unsupported spans can exhibit minor warping under autoclave conditions. For dimensionally critical surgical guides where sub-0.1 mm tolerance fidelity is required, E-beam or ethylene oxide sterilization is the safer choice. Always inspect parts for cracks after every sterilization cycle and discard any component showing signs of damage.

Handling, Storage, and Safety (Uncured Resin)

Uncured BioMed White Resin is classified under EU CLP Regulation (EC) 1272/2008 as a skin irritant (H315), eye irritant (H319), skin sensitizer (H317), and respiratory irritant (H335). It is also an aquatic hazard (H411). Always handle the uncured material with chemical-resistant gloves, safety glasses, and in a well-ventilated area. Store cartridges at temperatures below 38 °C, away from direct sunlight, heat sources, and open flames. The flash point of the liquid resin exceeds 93.5 °C. Once fully post-cured, parts are non-hazardous and may be disposed of as regular solid waste. For transport, the 5 L cartridge is classified as UN 3082, Hazard Class 9, Packing Group III (Marine Pollutant).

Technical Specifications of Formlabs BioMed White Resin

Physical Properties (Liquid Resin)

Physical State	Liquid
Color	White opaque
Density	1.15 g/cm³
Dynamic Viscosity	1100 cps @ 30 °C
Flash Point (closed cup)	> 93.5 °C
Flammability	Not flammable
Volume	5 L
Product Code	FLBMWH01

Tensile Properties (Post-Cured)

Ultimate Tensile Strength	46 MPa (ASTM D638-14, Type IV)
Young's Modulus	2000 MPa (ASTM D638-14, Type IV)
Elongation at Break	10% (ASTM D638-14, Type IV)

Flexural Properties (Post-Cured)

Flexural Stress at 5% Strain	74 MPa (ASTM D790-15, Procedure B)
Flexural Modulus	2020.16 MPa (ASTM D790-15, Procedure B)

Hardness Properties (Post-Cured)

Hardness Shore D	80 D (ASTM D2240-15, Type D)

Impact Properties (Post-Cured)

Notched Izod Impact	15 J/m (ASTM D256-10, Method A)
Unnotched Izod Impact	269 J/mm (ASTM D4812-11)

Thermal Properties (Post-Cured)

Heat Deflection Temp. @ 1.8 MPa	52.4 °C (ASTM D648-18, Method B)
Heat Deflection Temp. @ 0.45 MPa	67.0 °C (ASTM D648-18, Method B)
Coefficient of Thermal Expansion	90.1 μm/m/°C (ASTM E831-13)

Other Properties (Post-Cured)

Water Absorption	0.40 wt% (ASTM D570-98)

Biocompatibility Endpoints

ISO 10993-5:2009	Not cytotoxic
ISO 10993-10:2010/(R)2014 — Irritation	Not an irritant
ISO 10993-10:2010/(R)2014 — Sensitization	Not a sensitizer
ISO 10993-11:2017 — Systemic Toxicity	No evidence of acute systemic toxicity
ISO 10993-11:2017 / USP <151> Pyrogen Test	Non-pyrogenic
USP Class VI	Certified
Long-term skin contact (> 30 days)	Supported
Short-term bone / tissue / dentin / mucosal contact (< 24 h)	Supported

Regulatory Compliance

EN ISO 13485:2016	Medical Devices Quality Management Systems — manufactured in compliance
EN ISO 14971:2012	Medical Devices Risk Management — manufactured in compliance
Manufacturing Facility	FDA-registered, ISO 13485 and EU MDR certified, ISO Class 8 clean room (Ohio, USA)

Sterilization Compatibility

E-beam Radiation	35 kGy
Ethylene Oxide (EtO)	100% EtO at 55 °C for 60 min
Gamma Radiation	29.0–31.1 kGy
Steam Sterilization (US)	Autoclave at 132 °C for 4 min, 5 cycles
Steam Sterilization (EU)	Autoclave at 134 °C for 4 min, 5 cycles

Disinfection Compatibility

Chemical Disinfection	70% Isopropyl Alcohol for 5 minutes

Solvent Compatibility — 24 h Weight Gain (%)

Acetic Acid 5%	0.4%
Acetone	2.9%
Bleach ~5% NaOCl	0.3%
Butyl Acetate	0.4%
Diesel Fuel	< 0.1%
Diethyl glycol monomethyl ether	1.0%
Hydraulic Oil	< 0.1%
Hydrogen Peroxide (3%)	0.3%
Isooctane	< 0.1%
Isopropyl Alcohol	0.2%
Mineral Oil, heavy	< 0.1%
Mineral Oil, light	< 0.1%
Salt Water (3.5% NaCl)	0.4%
Skydrol 5	0.5%
Sodium Hydroxide Solution (0.025%, pH = 10)	0.3%
Strong Acid (HCl Conc.)	0.2%
TPM	0.6%
Water	0.3%
Xylene	0.3%

Compatible Hardware

Compatible Printers	Form 4B, Form 4BL, Form 3B, Form 3B+, Form 3BL, Form 2
Compatible Build Platforms	Form 4 Build Platform, Form 4 Flex Build Platform, Form 3 Build Platform, Form 3 Build Platform 2, Form 3 Stainless Steel Build Platform, Form 3L Build Platform, Form 3L Build Platform 2L, Form 4L Build Platform, Form 4L Flex Build Platform
Compatible Resin Tanks	Form 4 Resin Tank, Form 2 Resin Tank (PDMS), Form 2 LT Tank, Form 3 Resin Tank V2.1, Form 3L Resin Tank V3
Validated Wash Units	Form Wash, Form Wash V2, Form Wash L, Form Wash L V2, Ultrasonic Wash Unit
Validated Cure Units	Form Cure, Form Cure L, Fast Cure, Form Cure V2, Form Cure L V2

Printing & Post-Processing Parameters

Layer Thickness — Form 2, Form 3B/3B+, Form 3BL	50 μm, 100 μm
Layer Thickness — Form 4B, Form 4BL	100 μm
Wash Solvent	99% Isopropyl Alcohol (IPA)
Wash Duration	5 min (Form Wash) / 2 min (Ultrasonic, ≥ 36 W/L)
Air Dry After Washing	≥ 30 min at room temperature
Post-Cure — Form Cure / Form Cure L	60 min at 60 °C
Post-Cure — Form Cure V2 / Form Cure L V2	10 min at 60 °C
Post-Cure — Fast Cure	6 min at Light Intensity 5

Storage & Transport

Storage Temperature	< 38 °C — away from direct sunlight, heat sources, and open flames
Storage Conditions	Well-ventilated place; keep container tightly closed and locked
UN Transport Number	UN 3082
Transport Hazard Class	9
Packing Group	III
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