牡丹江What should be paid attention to in the design of injection molded medical equipment products in Dalian?

Dalian injection molded medical equipment products play an important role in the medical field, and their efficient, precise, and safe characteristics make them the preferred process for medical equipment manufacturing. With the continuous advancement of technology, injection molded medical device products will achieve greater breakthroughs in materials, processes, and quality control, providing the medical industry with higher quality products and services.

The quality of raw materials directly affects the performance of the final product. Before injection molding production, strict inspection of raw materials is required to ensure that they meet medical grade standards. In the injection molding production process, real-time monitoring of process parameters such as temperature, pressure, and speed is required to ensure the stability of product quality. At the same time, it is necessary to regularly inspect and maintain the molds to prevent product defects caused by mold wear and tear.

What should be paid attention to in the design of injection molded medical equipment products in Dalian?

Functional and performance requirements

Meet medical functional requirements: Clearly define the expected use and function of the product, design accurately to achieve specific medical purposes, such as precise control of drug dosage for syringes and smooth liquid delivery for infusion sets.

Ensure stable and reliable performance: Based on the usage environment and conditions, ensure that the product performance is stable within the specified period. For example, the casing of a cardiac pacemaker needs to withstand the internal environment for a long time to maintain insulation and protective performance.

Material selection

Biocompatibility: Select biocompatible materials that meet relevant standards, such as medical grade polypropylene, polycarbonate, etc., to prevent adverse reactions in the human body.

Physical and chemical properties: The material should have appropriate strength, toughness, hardness, corrosion resistance, temperature resistance, etc. to meet the requirements of product use and processing, such as good grip and strength for surgical instrument handles.

Compliance with regulatory requirements: Adhere to medical device regulations and standards, select approved materials, and retain documents such as material quality certificates and testing reports.

ERGONOMICS

Usability: Considering the usage habits and operational needs of medical staff and patients, design products that are easy to operate and comfortable. For example, the layout of the blood glucose meter buttons should be convenient for patients to operate, and the design of the syringe grip should comply with ergonomics.

Visualization and recognizability: The product appearance design should be easy to identify and operate, and important components or operating parts can be distinguished by color, shape, etc. For example, different functional buttons on medical devices are marked with different colors.

Feasibility of Manufacturing Process

Mold design: Design a product structure that is easy to manufacture and demold, avoiding complex internal structures or sharp angles, to reduce the difficulty and cost of mold manufacturing, and improve production efficiency. For example, use a detachable structure to facilitate mold cleaning and maintenance.

Injection molding process parameters: Understand the injection molding characteristics of materials, design product wall thickness, flow channels, etc. reasonably, ensure smooth injection molding process, avoid defects, such as uniform distribution of wall thickness to prevent shrinkage and deformation.

Compliance with regulations and standards

International and domestic regulations: Familiarize with and comply with the medical device regulations of the country and region where the product is located, such as the requirements of the US FDA, EU MDR, and China NMPA, to ensure that the product is marketed in compliance.

Industry standards: Referring to international standards such as ISO 13485 and corresponding domestic standards, standardize product design, development, production and other processes to ensure product quality and safety.

cost control

Material cost: Select cost-effective materials while meeting performance requirements, and reduce costs by optimizing material selection and procurement channels.

Production efficiency: consider how to improve production efficiency during design, such as adopting the first mock examination multi cavity mold design, simplifying production process, etc., to reduce production costs.

Medical device materials must comply with biocompatibility standards such as ISO 10993 to ensure non toxicity, non allergenicity, and non irritation to the human body. Medical devices may come into contact with disinfectants, drugs, or bodily fluids during use, therefore materials need to have good chemical resistance. Medical devices may come into contact with disinfectants, drugs, or bodily fluids during use, therefore materials need to have good chemical resistance.

Injection molding technology is widely used in the manufacturing of diagnostic equipment, such as disposable blood collection tubes, test tubes, culture dishes, etc. These products require high transparency and dimensional stability for easy observation and measurement. In the field of treatment, injection molded products include syringes, infusion sets, catheters, surgical instruments, etc. These products need to have good mechanical properties and biocompatibility to ensure the safety and effectiveness of the treatment process.