上海What are the quality testing standards for injection molded medical equipment products in Dalian?

What are the quality testing standards for injection molded medical equipment products in Dalian? It has a wide range of applications in the medical industry, which can help medical personnel better carry out their work and improve the quality and efficiency of medical services. With the continuous development and improvement of medical device technology, injection molded medical device products will be widely used and developed in the future, bringing more and better products and services to the medical industry.

With the continuous development and growth of China's medical device industry, the market prospects for injection molded medical device products are broad. The continuous growth of consumer demand for medical device products in our country, the continuous improvement of medical and health care, and the continuous advancement of medical technology provide good market opportunities for the development of injection molded medical device products.

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

1. Physical performance testing

dimensional accuracy 

The size of the product must meet the design requirements, and the allowable tolerance range is usually small. For example, there are clear standards for the diameter and length of the syringe barrel, as well as the outer diameter and length of the needle, to ensure its compatibility with other medical devices and accuracy in use.

Appearance quality

The surface should be smooth, free of burrs, cracks, bubbles, deformations, and other defects. For transparent injection molded products such as infusion tubes, syringe syringes, etc., good transparency is also required to observe the flow and remaining amount of liquid.

mechanical property 

Including indicators such as strength, toughness, hardness, etc. For example, the handle of surgical instruments needs to have sufficient strength and toughness to withstand the forces during use without breaking or deforming; The catheter needs to have a certain degree of flexibility to bend and guide inside the body, but it should not be too soft and affect the pushing performance.

2. Chemical performance testing

Material composition analysis

Ensure that the composition of injection molding materials meets the relevant standards for medical devices and does not contain harmful substances. For example, for medical device products made of polyvinyl chloride materials, it is necessary to test whether the content of plasticizers exceeds the standard, as some plasticizers may have potential harm to human health.

chemical stability

The product should remain stable in different chemical environments, such as when in contact with different drugs, disinfectants, human body fluids, etc., it should not undergo chemical reactions that may cause a decrease in material properties or the production of harmful substances. For example, when storing different drugs, infusion bags cannot interact with the drugs, affecting their efficacy or producing toxic substances.

Extractable and Dissolved Substance Detection

Simulate products to detect substances that may be released under actual usage conditions, including organic matter, heavy metals, etc. The content of these substances must be controlled within a safe range to prevent harm to patients.

3. Biocompatibility testing

Cell toxicity test

By co culturing extracts of medical device products with cells, observing the growth and morphological changes of cells, and evaluating the toxic effects of the products on cells. Generally, a cell survival rate of at least a certain percentage is required to consider the product to have good biocompatibility.

Skin irritation test

Used to evaluate whether a product will cause an irritant reaction when in contact with the skin, usually on animal or human skin. If the product causes adverse reactions such as skin redness, itching, and ulceration during the testing process, it does not meet the biocompatibility requirements.

Sensitization test

Detect whether the product may cause allergic reactions by conducting sensitization tests on animals or humans to observe whether allergic symptoms occur. For injection molded medical devices that come into direct contact with human tissue or enter the human body, sensitization testing is particularly important.

4. Aseptic testing

Sterility assurance level

For disposable injection molded medical equipment products, such as syringes, infusion sets, etc., it is necessary to ensure that the products reach a certain level of sterility assurance during the production process. Usually, sterilization process is used for treatment, followed by sterility testing to ensure that the product remains sterile within its shelf life.

Microbial limit testing

Detect the microbial content on the surface or inside of the product, including bacteria, fungi, etc. Different types of medical device products have different microbial limit standards, for example, the microbial limit requirements for implantable medical devices are more stringent.

Injection molded medical device products mainly use injection molding machinery to inject melted plastic materials into molds, and after cooling and solidification, obtain medical device products with specific shapes and functions. This production process has the advantages of low cost, high production efficiency, and stable product quality, and is therefore widely used in the field of medical devices.

The quality and safety of medical device products are crucial to human life and health. During the production and manufacturing process of injection molded medical devices, it is necessary to strictly control key factors such as the quality of raw materials, the accuracy of mold design, and the parameters of the production process to ensure that the product quality meets national standards and relevant regulations of the medical device industry.