Cartridge Formlabs Biomed Black Resin 1L

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BioMed Black Resin is a solid biocompatible polymer for 3D printing in medicine. 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 – 50, 100 µm.

Needs post-curing.

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

Description

Biocompatible polymer Biomed Black Resin

Biocompatible polymer Formlabs Biomed Black Resin is designed specifically to improve the quality of care. Modern tools are available for every medical institution in just a few hours – with 3D printing using Formlabs medical polymers.

Formlabs is constantly expanding its range of materials for its 3D printers. The Formabs family of 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.

Additive production in medicine

BioMed Black Resin is a solid matte biocompatible photopolymer that is used in cases where expected a prolonged skin contact or short-term contact with the patient’s mucous membrane.

Models printed with BioMed Black Resin can be treated with conventional solvent disinfection and sterilization methods. BioMed Black Resin is manufactured by an ISO 13485 certified and USP Class VI certified company. Thus, the material is safe for use in pharmaceuticals and drug delivery.

Printing resolution: 100 microns, 50 microns.

Final polymerization is required.

Biocompatible polymer Formlabs BioMed Black Resin

Biomed Black Resin usage

Medical polymer Biomed Black Resin is a fast 3D printing of sterilizable and biocompatible objects:

  • Medical devices and their components.
  • Biocompatible molds.
  • Clamping and fastening devices.
  • The final models that involve contact with the skin.
  • Consumer goods.

Data properties of BioMed Black Resin:

Post-Cured1,2 Method
Tensile Properties
Ultimate Tensile Strength 37,51 MPa ASTM D 638-10 (Type IV)
Young’s Modulus 1523,74 MPa ASTM D 638-10 (Type IV)
Elongation 14% ASTM D 638-10 (Type IV)
Flexural Properties
Flexural Stress at 5% Strain 57,16 MPa ASTM D 790-15 (Method B)
Flexural Modulus 1668,53 MPa ASTM D 790-15 (Method B)
Hardness Properties
Hardness Shore D 77D ASTM D 2240-15 (Type D)
Impact Properties
Notched IZOD 24,77 J/m ASTM D 256-10 (Method A)
Unnotched IZOD 348,03 J/m ASTM D 4812-11
Thermal Properties
Heat Deflection Temp. @ 1.8 MPa 49,4 °C ASTM D 648-18 (Method B)
Heat Deflection Temp. @ 0.45 MPa 67,9 °C ASTM D 648-18 (Method B)
Coefficient of Thermal Expansion 106,9 mkm/m/°C ASTM E 831-13
Other Properties
Water Absorption 0,44 wt% ASTM D570-98

Sterilization and disinfection of Biomed Black Resin products

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 polymer for medical use

Samples printed with BioMed Black 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

 

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 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 % 0,3 Mineral oil, heavy 0,2
Acetone 3,1 Mineral oil, light 0,2
Bleach ~5% NaOCl 0,2 Salt Water (3.5% NaCl) 0,3
Butyl Acetate 0,4 Skydrol 5 0,6
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 0,2 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 Black 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 Black Resin was tested at NAMSA World Headquarters, OH, USA.

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