Medical-grade content certification
According to ISO 10993 series criteria, all titanium alloys-including Ti6Al4V-cobalt chromium alloys, and other materials used for metal 3D printing-must pass biocompatibility testing, including cytotoxicity, allergenicity, genetic toxicity, etc. To guarantee that the composition and performance satisfy medical criteria, material providers must furnish complete material traceability documentation.
Quality control of powders
Regular testing of the important properties of metal powder, like particle size distribution, sphericity, and oxygen content, is necessary. For orthopedic implants, for instance, the oxygen level of titanium alloy powder must be regulated below 0.15% to prevent it from influencing the mechanical characteristics of the material.
Important process parameter observation
Throughout the printing process, real-time tracking of temperature, laser power, scanning speed, and other parameters is needed. Using laser selective melting (SLM) technology as an example, variations in laser power above 5% could lead to pore flaws that must be promptly corrected by a closed-loop control system.
Software and equipment verification
Regular calibration of printing equipment, conducted by an ISO 17025 certified laboratory, ensures printing accuracy. At the same time, the slicing program must be tested according to ASTM F3049 to ensure that the produced outputs align with the design documentation.
Macro performance assessment
Dimensional accuracy: The porosity error must be regulated within ± 2% by using industrial CT to identify intricate features like porous titanium alloy stents.
Surface roughness: found by an optical profilometer to guarantee that the implant surface's Ra value is not more than 3.2 μ μm, therefore preventing inflammatory reactions.
Microstructure examination
Metallographic investigation: Examine the printed part's grain structure to make sure there are no flaws, such as inclusions or fissures.
X-ray diffraction techniques assess the internal stress distribution of printed goods, thereby preventing fracture during usage.
In vitro tests
Co-culture the printed extract with osteoblasts to find an over 85% cell growth rate.
Compatibility of blood: Hemolyzed tests will help you to guarantee a red blood cell rupture rate less than 5%.
Clinical research and animal tests
Animal implantation is implanting printed orthopedic scaffolds using big animals (like sheep) as models and then monitoring for more than six months without any rejection reactions and a bone integration rate of over seventy percent.
Trials in clinical research: Real-world data must be gathered and used as a registration basis following ethical evaluation for tailored medical devices.
5 Certification and Registration: Following Legal Processes
Methods of domestic certification
Technical review, risk analysis report, clinical assessment data, etc.: three forms of medical device registration must be turned in; the review period normally runs six to twelve months.
Tailored instrument filing: Both doctors and patients must sign an informed consent form and submit it to the province drug regulating agency for individual needs.
Guidelines for international certification
To obtain CE certification for the EU, it is necessary to follow the MDR 2017/745 rules and pass the ISO 13485 quality control system certification.
FDA certification for the US: Comparison data with predicated devices has to be sent using the 510(k) or De Novo route.
Post-listing traceability and control: a "safety lock" for the whole lifetime adverse event monitoring
Establish a Medical Device Adverse Event (MDR) reporting system to continuously monitor printed device issues, such as initiating a recall process within 24 hours if a batch of printed goods exhibits unusual porosity.
traceability system
Through blockchain technology, realize complete traceability of material batches, printing settings, patient information, and other data. From powder procurement to patient insertion, the traceability system built by German business EOS has attained closed-loop management.
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