What are the manufacturing standards for injection molded medical equipment products in Dalian?

Dalian injection molded medical equipment products have the advantages of high precision, efficient production, and wide material selection, and have been widely used in the medical field. Through strict quality control, the quality and safety of injection molded medical device products can be ensured, providing protection for patients' health. Strictly inspect medical grade plastic materials used for injection molding to ensure compliance with relevant national and industry standards. The inspection items include the physical properties, chemical properties, biocompatibility, etc. of the material.

What are the manufacturing standards for injection molded medical equipment products in Dalian?

International standard:

ISO 13485 Quality Management System: This is an international standard for the medical device industry that requires manufacturers to establish and maintain a quality management system that covers the entire process from product design and development, production, sales to after-sales service, ensuring that products comply with regulatory requirements. For example, in terms of file management, it is necessary to strictly manage and control various records, technical documents, etc. in the production process to ensure product traceability.

ISO 14971 Risk Management: This standard requires manufacturers to assess and manage potential risks associated with medical devices. In the manufacturing process of injection molded medical device products, it is necessary to identify risk factors that may affect product quality and safety, such as the selection of raw materials, control of injection molding process parameters, design and manufacturing of molds, etc., and take corresponding risk control measures.

Regional specific standards:

FDA 21 CFR Part 820 (USA): The medical device quality system regulations of the US Food and Drug Administration (FDA) apply to products sold in the US market. For injection molded medical device products, quality control, equipment maintenance, personnel training, and other aspects during the production process need to comply with the requirements of this standard.

CE certification (Europe): For the European market, medical devices must obtain CE certification and comply with relevant EU standards. This involves multiple requirements for product safety, performance, labeling, and identification. For example, the product label needs to clearly indicate the product's name, model, specifications, production date, expiration date, and other information.

Material related standards:

ISO 10993 (biocompatibility testing): Injection molded medical device products need to comply with biocompatibility testing standards based on specific materials and applications. This standard mainly evaluates the biological reactions of medical devices to the human body after contact, including testing for cytotoxicity, allergenicity, irritability, and other aspects. For example, the plastic material used to manufacture disposable syringes needs to undergo biocompatibility testing to ensure that it does not have adverse effects on the human body during use.

Physical and chemical performance standards of materials: Injection molding materials should meet certain physical performance requirements, such as strength, hardness, toughness, wear resistance, etc., to ensure that the product can withstand corresponding mechanical stress and wear during use. At the same time, the chemical properties of the material also need to meet standards, such as corrosion resistance, aging resistance, etc., to ensure that the product can maintain stable performance under different environmental conditions.

Product performance standards:

Dimensional accuracy standards: The dimensional accuracy requirements for injection molded medical device products are very high and need to comply with relevant standards and specifications. For example, the diameter of the syringe barrel, the size of the piston, the inner and outer diameters of the catheter, etc. all need to be strictly controlled within the specified tolerance range to ensure the performance and safety of the product.

Product appearance standard: The appearance of the product should be free of obvious defects such as flaws, scratches, bubbles, and burrs. The appearance quality not only affects the aesthetics of the product, but may also affect its performance and safety. For example, the surface of the drip chamber of the infusion set should be smooth, free of bubbles and impurities to ensure the accuracy and safety of infusion.

Functional standards: According to different medical device products, corresponding functional standards need to be met. For example, the casing of a pacemaker needs to have good sealing to prevent bodily fluids from entering and affecting the normal operation of the device; Medical catheters need to have a certain degree of flexibility and resistance to twisting in order to smoothly pass through curved areas when inserted into the human body.

The injection molding process can achieve high-precision part molding, ensuring the dimensional accuracy and consistency of medical device products. For some medical devices with strict size requirements, such as syringes, catheters, etc., injection molding technology can meet their high-precision manufacturing requirements. Injection molding machines can achieve automated production and improve production efficiency. One injection molding can produce multiple parts, reducing subsequent processing steps and lowering production costs.