Cartridge Formlabs Biomed White Resin 1L

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BioMed White Resin is a solid biocompatible polymer for medical 3D printing. For long-term skin contact or short-term contact with the patient’s mucous membrane. ISO 13485 certificate, USP class VI certificate. Compatible with conventional solvent disinfection and sterilization methods.

Printer compatibility: Form 2, Form 3B/3B+, Form 3BL. Not suitable for printing on Form 3.

Resin Tank compatibility: Form 2, Form 2 LT, Form 3 Tank V1, Form 3 Tank V2/V2.1, Form 3L Tank.

Supports print resolution: Form 2, Form 3B – 50, 100 µm; Form 3BL – 100 µm.

Needs post-curing.

3DDevice is an official representative of Formlabs in Ukraine and Moldova.

Description

Medical polymer Formlabs Biomed White Resin

Medical polymer Formlabs Biomed White Resin is designed to increase the medical care quality, making modern tools available to every medical institution.

Formlabs is constantly expanding its range of materials for its 3D printers. The line of Formabs biomedical resins is designed for a wide range of applications where performance and biocompatibility are critical. BioMed Resin materials are developed and manufactured at an ISO 13485 certified plant and are compatible with conventional disinfection and sterilization methods.

Material for 3D printing in medicine

BioMed White Resin is a solid opaque biocompatible photopolymer designed for cases where prolonged skin contact or short-term contact with the patient’s mucosa is required. This unique medical polymer has been tested for pyrogenicity and acute systemic toxicity in accordance with US Pharmacopoeia standards and can be used in cases where short-term contact with tissues, bones and dentin is expected.

Models printed with BioMed White Resin can be treated with conventional solvent disinfection and sterilization methods. BioMed White Resin is manufactured at an ISO 13485 certified and USP Class VI certified facility, making it suitable for use in pharmaceuticals and drug delivery.

Printing resolution: 100 microns, 50 microns.

Final polymerization is required.

Medical polymer Formlabs BioMed White Resin

Application of Biomed White Resin resin

This material will make available of fast customized production:

  • End-use medical devices and their components.
  • Individual models and molds of implants to determine the size of implants.
  • Guides for cutting and drilling.
  • Surgical guides and templates.
  • Biocompatible molds, clamps, jigs and devices.
  • Anatomical models that can be used in the operating room.

BioMed White Resin properties:

Post-Cured1,2 Method
Tensile Properties
Ultimate Tensile Strength 45,78 MPa ASTM D 638-10 (Type IV)
Young’s Modulus 2020,16 MPa ASTM D 638-10 (Type IV)
Elongation 10% ASTM D 638-10 (Type IV)
Flexural Properties
Flexural Stress at 5% Strain 74,46 MPa ASTM D 790-15 (Method B)
Flexural Modulus 2020,16 MPa ASTM D 790-15 (Method B)
Hardness Properties
Hardness Shore D 80D ASTM D 2240-15 (Type D)
Impact Properties
Notched IZOD 15,11 J/m ASTM D 256-10 (Method A)
Unnotched IZOD 269,03 J/m ASTM D 4812-11
Thermal Properties
Heat Deflection Temp. @ 1.8 MPa 52,4 °C ASTM D 648-18 (Method B)
Heat Deflection Temp. @ 0.45 MPa 67,0 °C ASTM D 648-18 (Method B)
Coefficient of Thermal Expansion 90,1 mkm/m/°C ASTM E 831-13
Other Properties
Water Absorption 0,40 wt% ASTM D570-98

 

Sterilization Compatibility
E-beam 35 kGy E-beam radiation
Ethylene Oxide 100% Ethylene oxide at 55 °C for 180 minutes
Gamma 29.4 – 31.2 kGy gamma radiation
Steam Sterilization Autoclave at 134°C for 20 minutes
Autoclave at 121°C for 30 minutes
Disinfection Compatibility
Chemical Disinfection 70% Isopropyl Alcohol for 5 minutes

 

Biocompatible medical material

Samples printed with BioMed White Resin were evaluated according to the following biocompatibility standards:

ISO Standard Description3
ISO 10993-5:2009 Not cytotoxic
ISO 10993-10:2010/(R)2014 Not an irritant
ISO 10993-10:2010/(R)2014 Not a sensitizer
ISO 10993-11: 2017 No evidence of acute systemic toxicity
ISO 10993-11: 2017/USP, General Chapter <151>, Pyrogen Test Non-pyrogenic

 

The product was developed and is in compliance with the following ISO Standards:

ISO Standard Description
EN ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
EN ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices

 

Compatibility of BioMed White Resin with solvents

Percent weight gain over 24 hours for a printed and post-cured 1 x 1 x 1 cm cube immersed in respective solvent:

Solvent 24 hr weight gain, % Solvent 24 hr weight gain, %
Acetic Acid, 5 % 0,4 Mineral oil, heavy < 0,1
Acetone 2,9 Mineral oil, light < 0,1
Bleach ~5% NaOCl 0,3 Salt Water (3.5% NaCl) 0,4
Butyl Acetate 0,4 Skydrol 5 0,5
Diesel Fuel < 0,1 Sodium hydroxide solution
(0.025% pH = 10)
0,3
Diethyl glycol monomethyl ether 1,0 Strong Acid (HCl Conc) 0,2
Hydraulic Oil < 0,1 TPM 0,6
Hydrogen peroxide (3%) 0,3 Water 0,3
Isooctane < 0,1 Xylene 0,3
Isopropyl Alcohol 0,2
1 Material properties may vary based on part geometry, print orientation, print settings, temperature, and disinfection or sterilization methods used.
2 Data were measured on post-cured samples printed on a Form 3B with 100 µm BioMed White Resin settings, washed in a Form Wash for 5 minutes in 99% Isopropyl Alcohol, and post-cured at 60 °C, 60 minutes in a Form Cure.
3 BioMed White Resin was tested at NAMSA World Headquarters, OH, USA.

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Photopolymers

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