Why biocompatible 3D resin suppliers do not need ISO certification

Biocompatible 3D resin suppliers, as raw material suppliers, do not need to be audited or certified by third parties, such as by external auditors or by ISO, for producing high quality biocompatible photopolymer 3D resins, nor for improving their processes and documenting their faults and errors while taking corrective and preventive measures to yield in higher quality of the offered services and products.

There are alternative Quality Manual Systems QMS to ISO with reduced cost, paperwork, and increased flexibility, which are ideal for raw material suppliers, not needing ISO certification to sell their products to medical device manufacturers.

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

ISO 13485, FDA 21 CFR 820, or any other QMS standard/regulation worldwide used for producing medical devices, do not require raw material suppliers, such as 3D resin supliers, to be certified.
Reference supportive publications:

About certification of medical devices

3D printed medical devices fall within the scope of specific EU product legislation, such as the EU Medical Device Regulation MDR 2017/745. Therefore, manufacturers of medical devices must ensure that their 3D printed products meet the requirements of the applicable EU legislation, carry out the necessary conformity assessment procedures, compose a technical file, draft the EU declaration of conformity and affix the CE marking, before placing them on the EU market.

Biocompatible 3D resins are photo reactive raw materials, not finished medical devices

Biocompatible photopolymer 3D resins as supplied are liquid photo reactive and photo curable raw materials, which photopolymerise or react with light in the printers to a greater or lesser extent, normally layer by layer, to cure or become printed solid materials with specific shapes and functionalities, which depending on their usage can comply or not with the quality requirements of certain biomedical devices and packaging, including dental, orthodontic, hearing, implant, prosthesis, food, pharmaceutical devices, and packaging.

Biocompatibility certifications of photo reactive liquid photopolymers "3D resins" considering them as medical or packaging devices are considered as "placing on the market unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner". For more info read: CE marking and Health & Safety concerns of "certified" 3D resins

Reference supportive publications:

Biomedical device manufacturers need to design high quality medical devices with compliant, certifiable, not necessarily certified, raw materials "3D resins", equipment, workflows, processes, and protocols to achieve their own certification of biocompatibility for each class of manufactured biomedical device.

Biocompatible 3D printed medical devices need to be manufactured properly without any potential leachables and extractables before usage, after appropriate design, printing, postcuring, and post processing manufacturing workflows to ensure maximum quality and safety for final users.

Medical device manufacturers, including dental and orthodontic clinics are legally responsible for their produced and traded medical devices since biocompatibility and safety depend on the appropriate use and compliancy of the chosen raw materials and equipment, but also on the manufacturing quality of the medical device as result of the overall medical device manufacturing quality, including the used software, hardware, printing, postcuring, and post processing design and equipment, protocols, workflow, and overall quality control system, since medical device manufacturers (not their raw material suppliers) are legally responsible for the final quality of their manufactured and traded medical devices.

Medical device manufacturers are legally responsible for assuring the quality, biocompatibility, and safety of their products and for ensuring that any potential leachables, extractables, unreacted monomers, residuals, reaction byproducts, and contaminants are eliminated before commercialization and usage.

The printing of technical 3D resins require technical printers and trained technicians since not all the printers meet the minimum specifications to print certain technical products.

Too low power printers (and light boxes) may provide limited biocompatibility since polymer conversion is reduced due to the too low light power used during printing (post curing and post processing). Similarly, opaque 3D resins are also affected when printed with too low and even with high light power printers, since light penetration is reduced due to they high opacity of such 3D resin systems.

Constant power printers and light boxes without suffering from light power decay upon usage are needed to ensure and warranty the quality and safety of 3D printed biomedical devices:

printers and light boxes with too low light and variable power can yield to low polymer conversions leaving excessive unreacted monomers and extractables due to undercuring, which compromise safety and biocompatibility since free unreacted monomers can leach out and be extracted during usage
3D printed biomedical devices need to be fully cured and free of extractables before commercialization and usage since residual leachables and extractables can be extracted, eg by the saliva of the mouth in dental and orthodontic applications
Extractables can have a bitter taste and cause irritation and other potential hazards, which depend on the hazards of the chosen liquid 3D resin as supplied. Read the MSDS of the 3D resin to identify the health hazards of the liquid 3D resin as supplied to identify the potential risks and hazards for users unless full curing and cleansing is ensured before usage
a thermal oven
quality control instrumentation to ensure that biomedical devices comply with the relevant quality and safety specifications

3Dresyns supplies professional Instructions for Use IFU for biocompatible resins but cannot guarantee the properties and printability of its products since biocompatibility, and the physical, mechanical, or any other properties, such as printability depend on the chosen equipment (printer, light box, Quality Control equipment, etc) and manufacturing quality by the medical device manufacturer (the printer user), which are beyond the control of the raw material suppliers.

Reliance of raw material certifications cannot warranty the Quality of medical devices, nor replace the certification of medical device manufacturers.

Summary

When instructions are followed without cutting corners prints with excellent gloss, transparency, surface quality, light fastness, mechanical strength, and safety can be successfully made. The cleansing yield depends on the cleaning time and chosen temperature. The higher the temperature the shorter the time needed for fully cleansing the prints. Some 3D resins have been designed to withstand high temperature (eg boiling water / 100ºC) without mechanical degradation and yellowing. At the boiling temperature of water or higher the cleansing yield is increased resulting in increased polymer conversion and removal of extractables, leachables, contaminants, and byproducts.
Some 3D resins can suffer a significant decrease of mechanical strength when boiled in water. In these cases, use lower temperatures (eg 60~70ºC and longer cleaning time to prevent any potential decrease of mechanical strength. Excessive temperature and time of dipped prints in water or in Cleaning Fluid UNW2 Bio can decrease the gloss and clarity of some 3D printed resins.

Biocompatible prints will not be ready for use until maximum polymer conversion and full cleansing are achieved. Biocompatible prints should be free of extractables and leachables. The safety and biocompatibility of prints are responsibility of medical device manufacturers since their quality and safety depend on the design, implementation, quality assurance and "in house" production of their products with the right printing and post processing equipment, protocols, and controls.

3D resins as supplied are liquid photoreactive systems, which can be compliant after proper printing and post processing, but not certified as pretending to be medical devices, since 3D resins are raw materials, not printed medical devices.

Depending on how medical devices are printed and post processed they may end up being safe or not. Full elimination of unreacted monomers, leachables, and extractables needs to be ensured by medical and dental device manufacturers before commercialization for preventing any potential health hazards and ensuring maximum safety for final consumers.

The optimum printing and post processing settings for fully curing biocompatible prints need to be carefully determined by the the medical device manufacturer since the degree of cure (the conversion of monomer to polymer), depends on many variables beyond the control of the raw material supplier, such as the chosen printer and light box specifications (light power, wavelength, etc) and printing settings (z layers, exposure times, total energy dosage, etc): the overall printing and post processing manufacturing quality of medical devices produced by medical device manufacturers.

Attention needs to be drawn to monitor and prevent the light power decay upon usage of printers and light boxes to prevent excessive and uncontrolled quantities of uncured monomers trapped in the medical devices.

3Dresyns can help you to choose (and if needed to design) compliant 3D resins and certified production workflows to meet the final specifications and requirements of your in house printed and produced biomedical devices, including dental, orthodontic, and implant devices.

3Dresyns offers consulting services to help medical device manufacturers to design and implement appropriate protocols and workflows to manufacture biomedical devices compliant and certifiable by the relevant applicable regulations (FDA and ISO, class I, II, III, IV, etc). For more info read:

For more info about biocompatible 3D printed resins read:

Learn more about the effect of printer and printing specifications on the properties of tested standards:

Learn more about Sterilization of 3D printed resins for medical devices