As a core instrument in clinical anesthesia, first aid, and otolaryngology diagnosis and treatment, the choice of injection molding materials for laryngoscopes is directly related to patient safety, diagnosis and treatment effects, and medical compliance. Different from general-purpose plastics commonly used in ordinary industrial injection molding, laryngoscope injection molding must strictly adopt medical-grade plastics. This is not an "premium requirement" of the industry, but is jointly determined by its clinical application scenarios, safety standards and functional requirements, and is an insurmountable safety red line in medical device production.
The core application scenario of laryngoscopes is invasive contact. Their plastic components will directly contact the patient's oral mucosa and pharyngeal tissues, and some disposable laryngoscopes will temporarily contact body fluids. This particularity determines that the material must meet the core requirement of "biological safety and no harm", which is also the essential difference between medical-grade plastics and ordinary plastics. Medical-grade plastics have passed strict biocompatibility tests, complying with ISO 10993 and GB/T 16886 series standards. They have undergone full-item tests such as in vitro cytotoxicity and sensitization, with no harmful leachables, and will not cause adverse reactions such as mucosal swelling and allergies in patients. In contrast, ordinary plastics may contain harmful plasticizers, which will slowly leach out when in contact with the human body, posing risks such as chronic poisoning and failing to meet clinical needs.
After use, laryngoscopes need to undergo strict sterilization processes such as high-pressure steam and ethylene oxide. Ordinary plastics will deform, brittle, or even release toxic gases under high temperature and pressure. However, medical-grade plastics such as PC and PPSU, optimized through special formulas, can withstand multiple sterilizations, maintain stable performance after sterilization, and ensure safety during repeated use. At the same time, laryngoscope injection molding components have extremely high requirements for dimensional accuracy, surface smoothness and transparency. Medical-grade plastics have precise control over melt fluidity and shrinkage rate, which can produce components with uniform size, smooth surface and up-to-standard transparency, avoiding scratching the patient's mucosa and affecting the diagnosis and treatment field of vision. Ordinary plastics, however, have problems such as poor transparency and large dimensional errors, which may delay diagnosis and treatment.
Compliance requirements are a rigid constraint for the use of medical-grade plastics. China's "Regulations on the Supervision and Administration of Medical Devices" and YY 0499—2023 standard clearly stipulate that medical device components in contact with the human body must use materials that meet medical standards, and provide complete certification and test reports. The production of medical-grade plastics follows GMP standards, with full-process controllability and traceability, ensuring that laryngoscopes can be legally marketed through NMPA registration; if ordinary plastics are used, they will not only fail to pass compliance tests, but also face administrative penalties and safety risks.
In addition, medical-grade plastics can optimize formulas according to the type of laryngoscope, balancing practicality and economy. Disposable laryngoscopes can use cost-controllable medical PP materials, while high-end visual laryngoscopes can adopt PC materials with both high transparency and sterilization resistance, which cannot be replaced by ordinary plastics. In summary, the use of medical-grade plastics for laryngoscope injection molding is a reflection of the "patient safety first" principle, an inevitable combination of clinical needs, material characteristics and compliance requirements, and the foundation for protecting patient health and promoting the standardized development of the medical device industry.
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