Nowadays, materials such as polyvinyl chloride are more and more widely used in medical equipment. While polyvinyl chloride materials have good physical properties, they are also materials that are used more frequently in disposable sterile medical devices. In recent years, the annual growth rate of the use of such disposable sterile medical devices has exceeded 20%, and it has maintained a steady growth trend in the current world economic storm. Tang Zhengge is also actively exploring the development of related fields.
PVC products usually used in medical care contain dihexyl phthalate (DEHP) plasticizer. The effect of this plasticizer is to increase the elasticity of PVC products. DEHP is not only the most economical, but also one of the most widely used plasticizers. Its function is to make PVC flexible and flexible.
Because plasticized polyvinyl chloride materials are easier to sterilize, more transparent than natural rubber and glass, and have better chemical stability and economic efficiency. Therefore, medical products made of plasticized PVC were used to replace the previous materials. This kind of product has good softness and elasticity, so it is more convenient to use, so it can avoid the damage caused by the patient's sensitive tissue and avoid the patient's discomfort.
Plasticizers are added to PVC to improve the flexibility, cold resistance, and light stability of PVC. However, due to the different uses of PVC products, the amount of plasticizer added has also changed. For example, the weight ratio of the plasticizer used in PVC for food packaging is about 28%, and the flexible plastic used for toys reaches 35% to 40%. Studies have shown that PVC containing phthalates is easy to release when it encounters grease or in a high temperature environment above 100°C. Due to the different perceptions of the harm to the human body of PVC containing phthalate esters, the scope and extent of its recognized influence are also different, so the restrictions on the use of PVC containing phthalate esters are different in different countries.
Two DEHP standards are involved in the national standards for medical devices. For blood bags mainly made of PVC using DEHP plasticizer, it is stipulated that when the nominal volume of the blood bag is between 300ml and 500ml, the alcohol output (DEHP) shall not exceed 10mg. /100ml, no more than 13mg/100ml when 150ml～300ml, no more than 14mg/100ml when less than 150ml. The standard also stipulates that the residual amount of vinyl chloride monomer is not more than 1ppm; the residual amount of ethylene oxide is not more than 10mg.
According to understanding, in most clinical use cases, the amount of DEHP released in medical devices produced by using diisooctyl phthalate (DEHP) plasticized polyvinyl chloride (PVC) within the nationally prescribed dose range will not There are adverse reactions.
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