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Biomed Clear Resin

BioMed Clear is a biocompatible photopolymer resin designed for long-term skin or mucosal contact, suitable for various medical applications including device components and drug delivery systems. It is USP Class VI certified, compatible with sterilization methods, and manufactured in an ISO 13485 facility. The material exhibits strong mechanical properties and has passed multiple biocompatibility tests according to ISO standards.

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Giacomo Fais
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0% found this document useful (0 votes)
34 views2 pages

Biomed Clear Resin

BioMed Clear is a biocompatible photopolymer resin designed for long-term skin or mucosal contact, suitable for various medical applications including device components and drug delivery systems. It is USP Class VI certified, compatible with sterilization methods, and manufactured in an ISO 13485 facility. The material exhibits strong mechanical properties and has passed multiple biocompatibility tests according to ISO standards.

Uploaded by

Giacomo Fais
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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MEDICAL RESIN

BioMed Clear
Biocompatible Photopolymer Resin for Formlabs SLA Printers
BioMed Clear Resin is a rigid material for biocompatible applications requiring long-
term skin or mucosal membrane contact. This USP Class VI certified material is suitable
for applications that require wear resistance and low water absorption over time.
Parts printed with BioMed Clear Resin are compatible with common sterilization
methods. BioMed Clear Resin is manufactured in our ISO 13485 facility and is supported
with an FDA Device Master File.

Medical devices and device components Ventilator and PPE components

Bioprocessing equipment Drug delivery devices

Research and Development

V1 FLBMCL01 * Regional availability may vary.

Prepared 06 . 12 . 2020 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
Rev. 04 24 . 04 . 2023 results to be obtained from the use thereof.
MATERIAL PROPERTIES DATA BioMed Clear Resin
METRIC 1
IMPERIAL 1
METHOD
Post-Cured 2 Post-Cured 2
Tensile Properties
Ultimate Tensile Strength 52 MPa 7.5 ksi ASTM D638-10 (Type IV)
Young’s Modulus 2080 MPa 302 ksi ASTM D638-10 (Type IV)
Elongation 12% 12% ASTM D638-10 (Type IV)
Flexural Properties
Flexural Strength 84 MPa 12.2 ksi ASTM D790-15 (Method B)
Flexural Modulus 2300 MPa 332 ksi ASTM D790-15 (Method B)
Hardness Properties
Hardness Shore D 78D 78D ASTM D2240-15 (Type D)
Impact Properties
Notched Izod 35 J/m 0.658 ft-lbf/in ASTM D256-10 (Method A)
Unnotched Izod 449 J/m 8.41 ft-lbf/in ASTM D4812-11
Thermal Properties
Heat Deflection Temp. @ 1.8 MPa 54 °C 129 °F ASTM D648-18 (Method B)
Heat Deflection Temp. @ 0.45 MPa 67 °C 152 °F ASTM D648-18 (Method B)
Coefficient of Thermal Expansion 82 µm/m/°C 45 µin/in/°F ASTM E831-14
Other Properties
Water Absorption 0.54% 0.54% ASTM D570-98 (2018)

Sterilization Compatibility Disinfection Compatibility


E-beam 35 kGy E-beam radiation 70% Isopropyl Alcohol
Chemical Disinfection
for 5 minutes
100% Ethylene oxide at 55 °C
Ethylene Oxide
for 180 minutes
Gamma 29.4 - 31.2 kGy gamma radiation
Autoclave at 134°C for 20 minutes
Steam Sterilization
Autoclave at 121°C for 30 minutes
For more details on sterilization compatibilities, visit formlabs.com/medical

Samples printed with BioMed Clear Resin have been evaluated in accordance with ISO 10993-1:2018, ISO 7405:2018,
ISO 18562-1:2017 and have passed the requirements associated with the following biocompatibility endpoints:

ISO Standard Description 3 ISO Standard Description 3


ISO 10993-5:2009 Not cytotoxic ISO 10993-3:2014 Not mutagenic
ISO 10993-10:2010/(R)2014 Not an irritant ISO 18562-2:2017 Does not emit particulates
ISO 10993-10:2010/(R)2014 Not a sensitizer ISO 18562-3:2017 Does not emit VOCs
ISO 10993-17:2002, Not toxic (subacute / Does not emit hazardous
ISO 18562-4:2017
ISO 10993-18:2005 subchronic) water-soluble substances
ISO 10993-11: 2017/USP,
No evidence of acute
ISO 10993-11: 2017 General Chapter <151>, Non-pyrogenic
systemic toxicity
Pyrogen Test

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

1 Material properties may vary based on 2 Data were measured on post-cured samples printed on a Form 3 BioMed Clear Resin
part geometry, print orientation, print 3B printer with 100 µm BioMed Clear Resin settings, washed was tested at NAMSA
settings, temperature, and disinfection in a Form Wash for 20 minutes in 99% isopropyl alcohol, and World Headquarters,
or sterilization methods used. post-cured at 60 °C for 60 minutes in a Form Cure. OH, USA.

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