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Certification of biomedical devices

Click on: Are Biocompatible 3D Printer Resins Truly Safe? 

As mentioned in the previous publication link published by Northwestern University, Formlabs’ Dental SG and LT Clear printed in Form 2 SLA 3D printer were toxic, cytotoxic, despite being certified as biomedical devices. 

See below cells affected by exposure to Formlabs certified 3D resins as biomedical devices [Source: Science Direct]

Are Biocompatible 3D Printer Resins Truly Safe?

Biomedical certification of any photoreactive liquid 3D resins as if they would be manufactured medical devices does not make much sense, nor provides any warranty nor safety nor biocompatibility since 3D resins as supplied in liquid form are cytotoxic.   

Our biocompatible 3D resins have been specifically designed to fully comply with the Quality requirements for the manufacturing of medical devices (Class I, IIa, IIb and III of ISO13485).

Nevertheless, acknowledge that 3D resins manufacturers supply photoreactive photopolymer 3D resins, not finished biomedical devices, consequently their certification as suppliers of medical devices is not applicable, nor legally necessary nor justified, despite it is a common "pure marketing" practice in industry.

Photopolymer 3D resins are liquid photoreactive raw materials, which photopolymerise or react with light in the printers, which need to be postcured and postprocessed properly to ensure that they are fully cured and free of unreacted monomers, catalysts, byproducts, extractables, impurities and residuals, to convert them from reactive 3D resins into fully cured and safe biomedical devices.

Certifications which do not take into account the control and monitoring of the light power of both the printer and the light box, nor the cleaning process in detail, cannot ensure that medical devices are safe for use. Just rinsing parts with isopropanol does not provide any warranty for the safety and readiness for use of any biomedical device.

Manufacturers of medical devices are legally responsible and liable for the quality and safety of their products and for manufacturing them in clean rooms under good manufacturing practices. 

3Dresyns can consult you to select the safest 3D resins for each application and to design the safest products and post-processing protocols for ensuring maximum polymer conversion and minimum residuals and byproducts extractability by the body. Safety can only be ensured with proper radiometry controls of both the printer and the light box units, as well as with well defined cleaning protocols to ensure that impurities and residuals are extracted before use, during the device postprocessing stage, and not during its use by final users to avoid its potential absorption by the body, eg the mucous of the mouth in dental applications.

Safe and detailed printing, postcuring and postprocessing protocols are required to ensure that biomedical printed materials are safe for final users. In reality, consumers can be in risk of absorbing residuals and byproducts if the right radiometry and cleansing controls and protocols are not implemented by the manufacturers of biomedical devices.

Cutting corners by using third party photoreactive 3D resins "reactive raw materials" certifications, instead of certifying your products and processes will not cover your back since legally you will always be responsible of the quality and safety of the medical devices manufactured in your facilities.

Consequently, reliance on "non meaningful" third party raw materials certifications does not provide any legal coverage nor warranty since the safety and quality of any 3D printed biomedical device obviously legally relies on the device manufacturers, not on their raw materials suppliers.

Biomedical device manufacturers are responsible of choosing safe photopolymer 3D resins, which can be easily identified by their hazards and risk phrases statements shown in their Material Safety Data Sheets MSDSs. 

Biomedical device manufacturers are responsible of working with good manufacturing practices , which include the elimination of residuals, impurities and byproducts of their biomedical devices.

As clearly declared, 3D resins as sold are photoreactive liquid resins, which at least lowest effect cause skin, eye and mucous irritancy. Consequently, any photoreactive liquid resin cannot be considered safe biomedical devices, despite some suppliers advertise and market their 3D resins as biomedical devices. 

This marketing exercise is not only misleading but also creates false security for the biomedical device manufacturer and end users as it confers false legal security and malpractice coverage. 

You should acknowledge that there is always some unreacted monomer, resin, reaction byproducts and catalyst residuals trapped in the solid printed polymer material, which elimination is beyond the control and competence of any 3D resin supplier, that need to be removed and cleaned properly by the device manufacturer to avoid their extraction by eg the saliva and their absorption thru eg  the skin and/or mucous of the mouth.

Well defined scientific protocols and processes need to be implemented to maximise health & safety.

We supply cost effective “safe” 3D resins and can support you to fully comply with FDA and ISO. We are the first and only supplier of monomer free (without any monomer content as supplied) resins in the market.

Our goal is to develop safer and safer 3D resins to help you make biocompatible devices.

We can consult you to get the Certification that you need, especially now with the incoming changes in the FDA and ISO, related to the manufacturing of medical devices.

We can support and consult you with the design of the safest workflow to ensure fully compliance for the future more and more deterrent regulations.

Please feel free to contact us to consult about our services and your goals at: info@3Dresyns.com

Related links:

Are medical device raw material suppliers required to be ISO 13485 certified?