Chemical companies standpoints about certifiability of 3D resins
The biggest chemical companies in the World which are already producting photopolymer 3D resins for Stereolithography, such as BASF, Mitsubishi, Covestro (DSM-Somos), etc, do not certify their liquid photopolymer resins as medical devices (including food and medical packaging), despite having all the available resources, since certification of raw materials as medical devices it is nonsense, inappropriate, and illegitimate.
Manufacturers of medical devices are and willl always be legally responsible and liable for the quality, safety and certification of their products. Their raw material suppliers, in this case, the manufacturers of 3D resins, cannot replace the responsibility for certification of the biomedical device manufacturers.
The certification and quality of medical devices are responsibility of the medical device manufacturers, not of their raw material or resin suppliers.
Biomedical device manufacturers have to ensure that their products are safe. Their manufacturing processes have to take into account the whole manufacturing workflow for each specific biomedical application requirements, including the suitability and safety of:
- the chosen 3D resin,
- the chosen 3D printer, and
- the chosen post processing system
Printers and light boxes suffer a natural light power decay upon time. Prevention protocols of their natural light power decay upon time need to be implemented for ensuring that printed materials are consistently produced and are safe for final users.
Uncured monomers, byproducts, contaminants, residual etc can leach out and be absorbed by the human body unless they are eliminated before commercialisation. Control and prevention of the residual content of extractables and leachables are responsibility of the biomedical device manufacturer.
Manufacturing protocols need to ensure that appropriate printing and postprocessing, including cleaning processes, are used before commercialisation to ensure that medical devices are safe for usage. Extractables and leachables need to be eliminated berfore usage to prevent any risk for human health.
Shallow certifications and manufacturing processes which do not cover all the mentioned aspects or just include shallow postprocessing recommendations, such as "rinse parts with isopropanol" do not provide any warranty for the safety and readiness for use of any biomedical device.