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About Certification of biomedical devices

Biomedical certifications of photoreactive liquid photopolymers or 3D resins considering them as medical devices do not make much sense, nor provide any warranty, nor safety nor biocompatibility assurance since photopolymer 3D resins are cytotoxic before and even after printing unless they are custom designed in tune with appropriate printer specifications, printing settings, cleaning and postcuring processes to ensure their full cure, cleansing and safety. Well designed scientific workflows, processes and protocols are necessary to achieve the required biocompatibility for each class of biomedical device . 

As example, click in the following links to discover these recent published findings about the toxicity of Formlabs Dental 3D resins even after printing and postprocessing: 

Fig. 2

As clearly highlighted in the mentioned scientific paper published by the Northwestern University (Chicago, USA), Formlabs’ Dental SG and LT Clear printed in Form 2 SLA 3D printer were toxic, despite being certified as biomedical devices. 

Photopolymer 3D resins are liquid photoreactive raw materials, which photopolymerise or react with light in the printers, normally layer by layer, to cure or become printed solid materials with a specific shape. They need to be postcured and postprocessed and "cleaned" properly to ensure that they are fully cured or free of extractable external contaminants, unreacted monomers, residuals and reaction byproducts.

Scientific protocols need to be designed and implemented properly to ensure that extractable catalysts, monomers, byproducts, impurities and residuals are either avoided or their usage is minimised during the resin design stage, to fully trap, eliminate and/or extract before commercialisation to reduce the potential risk of extraction and absorption during usage.

All 3D resins need to be carefully designed with the right tuning additives to reduce and avoid their extraction during usage and ensure maximum convesion from a photoreactive liquid 3D resin into a fully cured and "safe" biomedical device.

Biocompatible 3D resins need to be custom designed in tune with reliable printing setups and workflows to fully comply with the Quality requirements for the manufacturing of medical devices (Class I, IIa, IIb and III of ISO13485). Not all the printers meet the required minimum specifications for printing medical devices and passing certification´s standards.

Acknowledge that 3D resins manufacturers supply photoreactive photopolymer 3D resins, not finished biomedical devices, consequently their certification as suppliers of medical devices, even taking into account the right printing setup and workflow, is not applicable nor legally necessary nor justified, despite unfortunately it is a commonly practiced marketing exercise with the aim of replacing the certification by the medical device manufacturers.  

Manufacturers of medical devices are and willl always be legally responsible and liable for the quality and safety of their products and for their certification.

Certifications which do not take into account the whole workflow for each specific biomedical application requirements, nor the customisation of the 3D resin to each 3D printer specifications, nor the control, monitoring nor prevention of the natural light power decay upon time of both the printer and the light box, nor the cleaning process in detail, cannot ensure that medical devices are safe for usage. Certifications not covering all the mentioned aspects or  just mention "rinsing parts with isopropanol" do not provide any warranty for the safety and readiness for use of any biomedical device.

3Dresyns can consult you and help you to design the safest 3D resin and printer setup and workflow for each biomedical application and the safest printing and post-processing protocols for ensuring maximum polymer conversion and minimum residuals and byproducts content and extractability during usage by the human body. Safety can only be ensured with light power measurements and control of both the printer and the light box units, as well as with well defined cleaning processes and protocols to prevent external contamination by production malpractice and 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 light power controls and cleansing protocols are not implemented by the manufacturers of biomedical devices.

Cutting corners by using misleading "certifications" of some raw materials suppliers, instead of certifying your own medical devices and processes will not cover you legally since you will always be responsible of the quality and safety of the medical devices manufactured in your facilities. No one can cover your back from malpractice nor can replace your responsibility as manufacturer.

Consequently, reliance on "non meaningful" 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 manufacturer, not on their raw materials suppliers.

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

As clearly declared, 3D resins as sold are photoreactive liquid resins, which may cause skin, eye and mucous irritancy. Consequently, any photoreactive liquid resin cannot be considered safe biomedical devices, despite some 3D resins suppliers advertise and market their 3D resins as biomedical devices. This marketing exercise is not only misleading but also creates confusion giving a false sense of security and legal security and 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, which need to be either not used and replaced by safer alternative ingredients, cured, removed and cleaned properly by the device manufacturer to avoid their later extraction by eg the saliva and their absorption by the skin and/or mucous of the mouth. And the most important thing is that it leaves the users of biomedical devices at risk of absorption of toxic products.

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

We can supply custom designed biomedical 3D resins, protocols and support to help you to fully comply with FDA and ISO. We are the first and only supplier of monomer free resins in the market. (without any monomer content as supplied). 

Our goal is to develop safer and safer 3D resins and processes to help you make safe 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 design customised resins and the safest workflows and protocols to ensure fully compliance with the different certification requirements of your chosen biomedical device.

Click here to learn more "About 3Dresyns certifications"

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