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Global certification firm TÜV SÜD has released an industry-first 3D printing-specific guide to repeatedly producing medical products that are safe and fit for purpose.
Published as a white paper, the company’s guide outlines the standards that manufacturers need to meet at each workflow stage, as well as the credentials required to put these into practise. By condensing the relevant regulations into a simplified format, TÜV SÜD says that it aims to “outline feasible procedures” and “point out existing gaps,” to those working in both 3D printing and clinical settings.
Standardizing clinical 3D printing
According to TÜV SÜD, the standardization of additive manufacturing has only recently begun in earnest, but given the potential quality assurance and throughput benefits of doing so, it’s well worth striving for. While ISOs 9001 and 13485 are often used in medical production, and represent robust Quality Management Systems (QMSs), they fail to address 3D printing’s unique sector-specific challenges.
That’s why TÜV SÜD has published a process chain of its own, from qualification through to post-processing, which highlights the steps manufacturers need to take to remain compliant when 3D printing medical parts. Before entering production, the firm says that a ‘technically competent person’ must check for requirements around biocompatibility and sterility, that any parts created have to meet.
Once all regulatory demands have been identified, the manufacturing process itself needs to be qualified or validated, as is standard across the 3D printing industry. However, this is where TÜV SÜD’s workflow differs, in that it splits qualification into ‘conceptual’ and ‘process master validation.’ By subjecting their processes to such scrutiny, the company says that users are “practically guaranteed” quality results.
The conceptual phase of the firm’s workflow begins with process mapping, during which it suggests that manufacturers fully list input and output parameters, to identify any potential risks or efficiency gaps. This should then be followed by a risk assessment, that TÜV SÜD recommends be carried out in compliance with the general ISO 14971 process, as well as the Ishikawa diagram or Fault-Tree Analysis.
After a risk assessment has been completed, and manufacturers have identified all means of preventing the failure or contamination of prints, the company suggests entering a ‘validation planning’ stage. This process sees users lay out a clear roadmap of what needs to be validated, in addition to their intended testing methods, for which all relevant equipment must be listed for compliance.
Finally, the hands-on ‘master validation’ stage should see manufacturers conduct installation, operational and performance qualification procedures. While the detail behind these steps is laid out in full within the firm’s paper, it broadly recommends adopting ISO/ASTM 52920 during qualification and ISO/ASTM 52904 around LPBF.
Post-processing and personnel
In keeping with its ambition to unlock end-to-end quality assurance, TÜV SÜD’s guide includes recommendations for the post-processing of 3D printed medical parts as well. The firm maintains that the treatment of components can drastically affect their conformity, thus manufacturers should stick to ISO series 10993 during cleaning, sterilization and packaging, to avoid interfering with biological safety.
Prior to packaging, such medical products are often subjected to tests that assess their cytotoxicity, implantation effects, hemocompatibility and carcinogenicity. After these have been completed, TÜV SÜD suggests that manufacturers follow the EN 556 and ISO 11607 standards to ensure all products make it to market without their properties being compromised, while doing so “with the utmost care.”
Although this step completes the company’s safety-compliant workflow, it has also published a guide outlining the skills required to execute these processing steps effectively. In its paper, TÜV SÜD emphasizes that the manual nature of many 3D printing processes means that “personnel play a decisive role in the quality of products,” thus they must have the level of training outlined by standards like ISO/ASTM CD 52926-1.
In effect, these ISO standards maintain that engineers, test personnel and a supervisor of some sort are required to 3D print marketable medical products. While the company says that all roles need a “sophisticated understanding” of 3D printing, it retains that staff need to be proficient in other areas too so they can contribute to validation plans, and enable the production of “high-quality devices.”
For more information about TÜV SÜD’s medical 3D printing workflow, including staying compliant with upcoming ISOs, readers can access the full paper here.
TÜV SÜD’s regulatory expertise
Operating from its base in Munich, Germany, TÜV SÜD is a technical service provider that specializes in the qualification of advanced processes. Over the last few years, the firm has played an instrumental role in working with 3D printing firms to establish industry standards, that allow manufacturers to certify products, as a means of lending them greater market credibility.
In September 2020, for instance, TÜV SÜD set out to clarify the regulatory requirements surrounding 3D printed PPE, following the technology’s mass-use to produce masks due to the COVID-19 pandemic. In order to achieve this, the firm published clinical 3D printing checklists that helped manufacturers ensure they met the relevant safety and quality standards.
The company has also launched its own dedicated 3D printing compliance training courses. Comprising eight online modules, the digital training platform is designed to provide additive manufacturing engineers with a refresher course in the DIN, ISO and ASTM standards surrounding production safety, risk and quality management.
TÜV SÜD is not just involved in drafting guidance, but enforcing it as well, and it completed its first ever combined 3D printing audit on motorsport firm Sauber Engineering in November last year. Conducted as part of the company’s ‘Industrial AM Production Site Certification’ service, the visit saw Sauber Engineering being awarded the ISO 9001 and DIN SPEC 17071 certificates of compliance.
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Featured image shows an assortment of medical tools. Photo via TÜV SÜD.