The medical industry is one of the largest industries that needs to be restricted and run through strict standards to maintain the quality of pharmaceutical products and other medical device equipment. Plastic parts are manufactured using the process known as injection modeling. The plastic is passed through clamps, using temperature controllers (heat and cooling), and then cooled down into solid plastic products. Along with the benefit of producing hundreds of products simultaneously, the injection molds are reusable, so the production remains cost-effective.
While designing medical devices, engineers need to maintain the specified standards—from choosing the material to passing through the manufacturing process to getting the end product. In this article, we will provide descriptive information about the standards that factories producing medical injection molding products must meet and the importance of medical injection molding.
What Are ISO Standards?
ISO is known as the Global standard for goods and other services with constant benchmarks and defined standards for businesses and product consumers. The standards create solutions for a secure future, help enterprises for sustainable development, provide cross-building liability, and make people’s lives better, easier, and safer. These ISO Standards cover various sectors, including quality control, environmental impacts, device controllers, and medical treatment tools.
Common And Basic Medical Injection Molding Standards
Let’s get straight to what are the standards that factories producing medical injection molding products must meet.
1 – ISO 13485 (Qms) For Medical Devices:
ISO13485 standard depicts and controls quality management systems while manufacturing high-grade medical products. It is one of the common standards that is not restricted to only plastic injection production but also covers other technologies that are involved in medical equipment making. From design qualification to final production, operational qualification to distribution, and product collection to performance qualification, it controls all the risks and regulates the mechanism to improve the quality and detect any single defect in the injection mold. Engineers document and handle every step. This lessens the chance of any damage exposure in the final product.
2- ISO 10993 Medical Device Biocompatibility check:
The standard operates to check whether the medical device is compatible with the body of organisms (humans or animals) or not. When the injection comes indirectly into the body, it may cause infections like immune system interruption or cancer if they are not sterilized or pass through nontoxic cleaning chemicals. This is the most crucial standard that includes techniques of sterilization, cytotoxicity, carcinogenicity, reproductive intoxication, and other welfare requirements. Moreover, it is also significant for designers and helps pick up suitable materials for medical injection molding products.
3- ISO 14644 Cleanroom Regulations:
While manufacturing the medical device, keeping the environment clean is vital to controlling any bacterial interruption or other Airborne particles. The ISO 14644 standard carefully detects any sensitive exposure to medical injection molds and outlines specific instructions for designing, manufacturing, and maintaining optimal clean rooms. There are different classes of clean room regulations from 1 to 9, and class 1 is the most restricted in terms of cleanliness requirements. Designers and manufacturers have to use classes 7 and 8 to avoid any contamination during injection mold production.
4- ISO 14971 Risk Management:
ISO 14971 is a device risk management standard that provides a framework to analyze, evaluate, review, and control the production and monitor post-production technicalities. Risk Management works in a very versatile way in that it provides connectors that do not allow the wrong components to connect. Moreover, it efficiently improves the ability of labels and displays for the viewers and generates automatic device functions to use error detectors while doing the task manually.
It also incorporates other safety mechanisms like Shield elements, software interlocks, and physical safety guards. Additionally, the safety alerts alarm if there is a low battery or default device operation that can harm the workers. It also provides warning and caution statements highlighting user-related instructions during manufacturing.
5- ISO 14155 Clinical Investigation:
ISO 14155 refers to the clinical investigations to design, conduct, and report the medical devices’ regularities in human subjects by assessing the safety and security of the bodies. The investigation depends on the possible circumstances and the natural clinical investigation per national regulations. These have general requirements that protect the safety and well-being of humans and ensure that experimentation is on the credibility of the results under sponsor and investigator assistance and agreements. Restrictive experiments are done under ethics committees and are not applied to vitro diagnostic devices.
6- ASTM F2503 – Standard Practice for Marking Medical Devices and Other Items
It is specifically for the magnetic resonance environment. This standard helps us understand the marking of medical devices. Besides this, it guarantees safety during the magnetic resonance imaging (IMR) process. So, the product made using injection molding must be highly precise. They must reduce the risks of MRI. These risks may include potential migration or heating of metallic components. So, if the product complies with ASTM F2503, it will ensure that the product is safe for MRI procedure.
Conclusion:
Illustrating what are the standards that factories Producing medical injection modeling products must meet, I must say that these standards have regulated the medical industry so far to provide safety, quality, and other instructive restrictions to maintain an optimal treatment environment. From choosing the material to biological test manufacturing, Ho injection mold reliably supplies the key standards to sustain balance and check on every step. These essential maintenance games the trust and confidence of Healthcare professionals, patients, and other medical authorities in the medical industry.
FAQs
Q1- What are the acceptance standards for medical injection molding?
Ans: The acceptance standards for injection molding include defect-free product surfaces from short shots, any shrink marks, weld lines, bubbles, burn marks, tearing, cracking, and other splay marks.
Q2- Which is the most essential IOS Standard for medical injection molding?
Ans: The most essential ISO injection standard is 13485, which is a quality standard. It involves three quality checks: Design, operational, and performance qualifications.
Q3- What are the components of injection molds?
Ans: The standard parts include fluid Hooper, barrel, screw motion, heaters, nozzles, adjustment clip molds, and clamps.
We provide medical mold design, manufacturing, medical injection molding service, medical product assembly machine design and manufacturing service. If you need help, please fill below form or contact us via email to info@medicalmolding.cn