MATERIAL DATA SHEET
BioMed Amber
BioMed Amber Resin for Short-Term Bodily Contact
BioMed Amber Resin is designed for the manufacture of biocompatible 3D printed
parts with high dimensional accuracy, stiness, and strength. This material is
developed specifically for Formlabs printers, rigorously tested, and manufactured
in a clean room at our own ISO 13485 certified facility for consistent cross-batch
quality. The parts printed with BioMed Amber Resin are compatible with common
solvent disinfection and sterilization methods.
Drilling templates Fixation trays
Implant guides Implant sizing templates
Medical device components Surgery planning tools
V1
Prepared 11 . 04 . 2019
Rev 01 11 . 04 . 2019
FLBMAM01
To the best of our knowledge the information contained herein is accurate. However, Formlabs, Inc. makes no warranty,
expressed or implied, regarding the accuracy of these results to be obtained from the use thereof.
Material Properties Data
Tensile Properties
Ultimate Tensile Strength
Young’s Modulus
Elongation
Flexural Properties
Flexural Strength
Flexural Modulus
Hardness Properties
Hardness Shore D
Disinfection Compatibility
Chemical Disinfection
Sterilization Compatibility
METRIC IMPERIAL METHOD
Post-Cured
1,2
Post-Cured
73 MPa 11 ksi ASTM D638-10 (Type IV)
2.9 GPa 420 ksi ASTM D638-10 (Type IV)
12.3% 12.3% ASTM D638-10 (Type IV)
103 MPa 15 ksi ASTM D790-15 (Method B)
2.5 GPa 363 ksi ASTM D790-15 (Method B
67 D 67 D ASTM D2240-15 (Type D)
70% Isopropyl Alcohol for 5 minutes
1,2
Steam Sterilization
Autoclave at 134 °C for 20 minutes
Autoclave at 121 °C for 30 minutes
BioMed Amber Resin has been evaluated in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process, and ISO 7405:2009/(R)2015, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry, and
passed the requirements for the following biocompatibility risks:
ISO Standard
EN ISO 10993-5:2009
ISO 10993-10:2010/(R)2014
ISO 10993-10:2010/(R)2014
Description
Not Cytotoxic
Non Irritation
Not a sensitizer
3
The product was developed and is in compliance with the following ISO Standards:
ISO Standard
EN ISO 13485:2016
EN ISO 14971:2012
Description
Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
Medical Devices – Application of Risk Management to Medical Devices
NOTES:
1
Material properties may vary based on part
geometry, print orientation, print settings,
temperature, and disinfection or sterilization
methods used.
2
Data for post-cured samples were measured on
Type IV tensile bars printed on a Form 2 printer
with 100 µm BioMed Amber Resin settings,
washed in a Form Wash for 20 minutes in 99%
3
BioMed Amber Resin was tested at NAMSA
World Headquarters, OH, USA.
Isopropyl Alcohol, and post-cured at 60°C for 30
minutes in a Form Cure.
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