Owner's Manual for formlabs models including: V1 FLBMEL01, BioMed Elastic 50A Resin, Elastic 50A Resin, 50A Resin, Resin
Technische Spezifikationen der SLA-3D-Drucker von Formlabs im Vergleich | Formlabs
BioMed Elastic 50A Resin | Formlabs
MEDICAL RESIN BioMed Elastic 50A Resin For Soft, Biocompatible, Transparent Medical Devices and Models BioMed Elastic 50A Resin is a soft, elastic, medical grade material for applications requiring comfort, biocompatibility, and transparency. This ISO 10993 and USP Class VI certified material is made in an FDA-registered, ISO 13485 facility and can be used in applications for long-term skin contact ( > 30 days ), and short-term mucosal membrane contact ( < 24hrs ). Elastic Biocompatible Medical Devices Soft Tissue Models to Assist in Surgeries V1 FLBMEL01 Prepared 20/09/2023 Rev. 02 24/06/2024 1 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 Mechanical Properties Ultimate Tensile Strength 3 Stress at 50% Elongation Stress at 100% Elongation Elongation at Break Tear Strength 4 Shore Hardness Compression Set 23 °C for 22 hours Compression Set 70 °C for 22 hours Bayshore Resilience Thermal Properties Glass transition temperature (Tg) METRIC 1 Post-Cured 2 METRIC 1 2.3 MPa 1 MPa 1.3 MPa 11 kN/m METRIC 1 -36 ºC 150% 50A 8% 11% 15% IMPERIAL 1 Post-Cured 2 IMPERIAL 1 339 psi 145 psi 189 psi 60.8 lb/in IMPERIAL 1 -32.8 ºF METHOD METHOD ASTM D412-06 (A) ASTM D412-06 (A) ASTM D412-06 (A) ASTM D412-06 (A) ASTM D624-00 ASTM 2240 ASTM D395-03 (B) ASTM D395-03 (B) ASTM D2632 METHOD DMA Disinfection Compatibility Chemical Disinfection 70% Isopropyl Alcohol for 5 minutes Samples printed with BioMed Elastic 50A Resin have been evaluated in accordance with the following biocompatibility endpoints: ISO Standard ISO 10993-5:2009 ISO 10993-23:2021 ISO 10993-10:2021 USP <88> Biological Reactivity Tests, In-vivo Description 3 Met requirements of test Met requirements of test Met requirements of test USP Class VI Certified 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 1 Material properties can vary with part geometry, print orientation, print settings and temperature. 2 Data was obtained from parts printed using Form 3B, 100 m, BioMed Elastic 50A settings, and using the BioMed Elastic 50A MFG guide. 3 Tensile testing was performed after 3+ hours at 23 °C, using a Die C specimen cut from sheets. 4 Tear testing was performed after 3+ hours at 23 °C, using a Die C tear specimen directly printed 2 SOLVENT COMPATIBILITY Percent weight gain over 24 hours for a printed and post-cured 1 x 1 x 1 cm cube immersed in respective solvent: Solvent Acetic Acid 5% Acetone Isopropyl Alcohol Bleach ~5% NaOCl Butyl Acetate Diesel Fuel Diethyl Glycol Monomethyl Ether Hydraulic Oil Skydrol 5 Hydrogen peroxide (3%) 24 hr weight gain, % 1.5 43.4 39.2 0.6 133.1 7.9 31.4 3.9 41.2 0.9 Solvent Isooctane (aka gasoline) Mineral oil (light) Mineral oil (Heavy) Salt Water (3.5% NaCl) Sodium Hydroxide solution (0.025% PH 10) Water Xylene Strong Acid (HCl conc) Tripropylene Glycol Methyl Ether (TPM) 24 hr weight gain, % 15.6 0.7 0.4 0.6 0.7 0.7 163.9 45.6 43.6 3Adobe PDF Library 17.0 Adobe InDesign 20.0 (Macintosh)