Plastic products produced through medical injection molding are widely used in different industries because they can create identical parts in large quantities. Manufacturers use molds to maintain conformity with the approved prototypes and to meet the client’s requirements for mass production. However, the initial costs for custom molds make medical injection molding more suitable for mass orders or smaller parts. It is crucial to have an ISO-compliant manufacturer because this guarantees the compatibility and performance of the products within the overall integration. This article details the importance of ISO certification for fabricated medical products.
Reasons Why ISO-Certified Medical injection Molding Products Are Good?
Plastic medical injection molding has existed for nearly a century and has become a stable and reliable process. Using medical injection molding technology, advanced design tools, and digital control systems guarantees the production of high-quality medical devices. Contemporary software makes tool design easier, fine-tunes performance parameters quickly and reduces lead times for production, reducing costs in medical device manufacturing.
Scalability and Efficiency in Medical Device Production
Medical injection molding begins with the design of complex molds, which requires an initial capital outlay in product design and tooling. However, this technology can allow for the quick and inexpensive production of 100s of 1000s of similar medical parts once approved. Over time, higher production quantities recover the tooling cost, making it suitable for producing non-branded medical products such as containers, tubes, and disposable syringes. Medical injection molding provides a full range of solutions for various medical device needs.
Ideal for Enclosure Parts
Medical injection molding is the best solution for manufacturing cases and enclosures. Other options such as CNC machining or vacuum casting are possible. Still, they result in a longer time to produce the parts, high usage of raw materials and high cost of manufacturing per part. These alternatives are ideal for low production or special applications where it is not feasible to purchase tools. However, medical device medical injection molding differs from traditional medical injection molding because it has a shorter cycle time, lower cost per part, and uses medical grade material for manufacturing cases and enclosures.
Accelerated Product Development
Plastic medical injection molding is beneficial in the production of medical devices since it reduces the time taken to develop the products and the chances of making mistakes. This approach is especially helpful in Medical Device Contract Manufacturing, as it provides a competitive advantage in the market.
FDA Regulations and ISO Certification
All medical device manufacturers must follow FDA regulations to the letter. Plastic medical injection molding improves sterilization, durability, strength, and ease of handling. Stringent injection moulding supervision helps meet the requirements of ISO and FDA regulations.
Improved Device Weight Reduction
Injection-molded medical devices have less weight, a significant advantage over other molding techniques. These devices possess unique mechanical characteristics that not only improve performance but also reduce their overall weight to a great extent. For instance, lighter wearable medical devices allow patients who need constant monitoring to wear them during their daily activities.
Medical Applications of Plastic Medical Injection Molding
Since many plastic resins are available in the commercial market, manufacturers can select from a wide range of products. These resins are versatile in heat stability and chemical resistance, strength, lightweight construction, biodegradability, and biocompatibility. This makes plastic medical injection molding suitable for manufacturing prosthetics, replacement joints and other medical equipment that come into direct and continuous contact with the human body. Given the flexibility of the choice of plastic, it is easier to select the most suitable one for your medical device.
Customized Design and Versatility
Another advantage of medical injection molding for medical devices is the possibility of creating complex shapes and forms. Compared to other manufacturing processes, medical injection molding enables designers to combine several features into a single injection, thus simplifying the manufacturing process and minimizing the number of components that need to be assembled. This flexibility in design ensures that the quality of the medical devices is up to standard and that many medical devices are produced to meet the increasing demand in the market. Furthermore, medical injection molding allows for a high degree of complexity in the part’s design, such as undercuts, internal and external threads, and color, making it very versatile for manufacturers.
Durability and Reliability
Products made using medical injection molding are known to be very strong and resistant especially when used in the medical field. Components and enclosures from this process are immune to vibrations, harsh conditions, and even physical shocks that would otherwise cause them to crack or break. This durability makes medical devices long-lasting and dependable, ideal for the challenging environment of healthcare facilities.
Sterilization and Compliance
Medical products made through medical injection molding are FDA-compliant and undergo strict sterilization procedures. These devices are non-toxic, non-carcinogenic, non-inflammatory, non-thrombogenic, non-immunogenic, non-microbial, and non-viral. Medical injection molding technology ensures that medical devices resist contaminants and cleaning chemicals, thus making them suitable for repeated sterilization without affecting their functionality. Some products even contain antimicrobial agents during the molding process like silver ions to further enhance the protection against microbes and increase product durability and longevity to meet the highest hygiene standards.
Therefore, medical injection molding is the most suitable manufacturing process for medical devices because it allows for the production of complex designs, offers high durability and reliability, and meets sterilization and safety requirements. These advantages make medical injection molding a cost-effective, efficient, and high-quality solution for manufacturing critical parts for medical uses.
Summary
Plastics produced through medical injection molding are widely used in many industries worldwide. Compliance with ISO standards is essential in ascertaining the quality and interoperability of these products. ISO certification means that a manufacturing company follows specific standard operating procedures during the manufacturing process, which helps dismantle trade barriers and guarantee the compatibility of products across different countries. Although it is not compulsory to get an ISO certification, it shows that the company is willing to uphold the standards of quality and portability. Therefore, selecting a manufacturer with an ISO certification is crucial because it guarantees that your orders will be of high quality and that the manufacturer is committed to quality.
FAQ’s
Q1. What is ISO certification?
ISO certification is a mark that is awarded to companies that meet the international standards set by the International Organization for Standardization (ISO) in their business activities.
Q2. Why is ISO certification necessary?
ISO certification is crucial because it guarantees customers that a company complies with industry standards in producing its goods and services.
Q3. How can I be sure that a certain manufacturer is ISO-compliant?
To confirm whether a manufacturer is ISO certified, you can request the ISO certificate from the manufacturer or visit their website or other industry databases that contain information on ISO certifications.