Additional information
| Brand | Formlabs |
|---|---|
| Resin type | Form 4 |
| Compatible |
Formlabs BioMed resin is suitable for:
- Medical devices and device components
- Sterile clamps and holders
- Patient-contact components
- Incision and drilling templates based on 3D scans
- Orthopedic aids
Mechanical properties
Formlabs BioMed resins are comparable in stiffness to ABS plastic. If a more flexible and impact-resistant solution is required, we recommend Formlabs BioMed Durable. This is comparable to polyethylene (PE). For truly flexible parts, BioMed 80A and BioMed 50A are available.
Required 3D printer
Formlabs BioMed and dental resins require the “B” version (biomedical) of the 3D printers, the Formlabs Form 4B or the larger Formlabs Form 4BL. The included slicer software, Formlabs PreForm, also contains extra features specifically designed for these types of applications.
Certifications
Formlabs BioMed resins are manufactured according to EN ISO 13485:2016 and EN ISO 14971:2012 for medical applications. These certifications guarantee the necessary quality control and risk management.
Formlabs BioMed resins have the following biocompatibility certificates:
- 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, ISO 10993-18:2005 Not toxic (subacute / subchronic) ISO 18562-4:2017 Does not emit hazardous
- Water-soluble substances
- ISO 10993-11: 2017 No evidence of acute systemic toxicity
- ISO 10993-11: 2017/USP, General Chapter <151>, Pyrogen Test Non-pyrogenic
Mechanical values and certificates may vary by color. We recommend always checking the TDS at the bottom of this page for each color.
Disinfection
Parts printed with this resin can be washed/disinfected in 70% isopropyl alcohol. We recommend exposing parts to isopropyl alcohol for no longer than 5 minutes.
Cleaning and sterilization
- It is possible to clean parts with the main medical sterilization methods:
- Autoclave – 20 minutes at 134°C and 30 minutes at 121°C
- Ethylene oxide – immersion in 100% Ethylene oxide 55°C for up to 3 hours
- E-beam – 35 kGy E-beam radiation
- Gamma – 29.4 – 31.2 kGy gamma radiate
TDS & SDS for color variations
- Formlabs BioMed Clear: TDS – SDS
- Formlabs BioMed White: TDS – SDS
- Formlabs BioMed Black: TDS – SDS
- Formlabs BioMed Amber: TDS – SDS
Formlabs Biomed for the Form 3B and 3BL
This resin is also available for the previous generation Formlabs SLA 3D printers: Formlabs BioMed (Form 3)
