There are clear regulations and testing methods for the performance and indicators of medical protective suit/surgical gowns in different countries and regions. For example, GB national standards in China, ASTM standards of the American Society for Testing and Materials, ISO international standards, EN standards, etc. In addition to the requirements for specifications, models, and safety design of the clothing itself, medical protective suit needs to have protection, comfort, safety, and good physical mechanical properties.
Protection is the most important performance requirement of medical protective suit, mainly including liquid barrier and filtration efficiency. Liquid barrier refers to the ability of medical protective suit to resist water penetration, blood penetration, and surface wetting. It prevents viruses carried by patients' blood, body fluids, and other secretions from infecting medical personnel during medical or surgical procedures. GB 19082 refers to the international standard ISO 16603 for testing the resistance to blood penetration, and the technical requirements for medical protective suit in China are at the forefront of the world.
Filtration efficiency refers to the percentage of particulate matter (solid, liquid, or mixture of solid and liquid substances suspended in the air, such as microorganisms, dust, smoke, and fog) filtered by protective clothing. The GB standard specifies that the filtration efficiency of key parts of the protective clothing material and the seams for non-oily particles should not be less than 70%.
The main indicator of comfort is breathability. In order to enhance the protection effect, the fabric of protective clothing is usually laminated or coated, which is not conducive to sweat and heat dissipation when worn for a long time. Improving the breathability of medical protective suit can improve the wearing experience of medical personnel, reduce the feeling of stuffiness and physical discomfort caused by long-term work. In addition, skin irritancy is also a comfort indicator requirement in the GB standard, and protective clothing should not cause discomfort or irritation to the wearer's skin.
The physical mechanical properties mainly refer to the strength and durability of the materials used in medical protective suit. It prevents the transmission of bacteria and viruses through tears, punctures, and damages caused by external forces, thereby weakening the protective effect. The GB standard has specific requirements for the tensile strength and elongation at break of the protective clothing material, and the EU standard EN 14126:2003 (Performance requirements and test methods for protective clothing against infective agents) requires the protective clothing material to have certain abrasion resistance, tear resistance, and puncture resistance.
Safety is the consideration of the safety of medical personnel, patients, and the surrounding environment. For example, the anti-static performance required by the GB19082 standard is to prevent the adverse effects of static electricity adsorbing dust and bacteria on patients and surrounding personnel, and to prevent sparks generated by static electricity from igniting volatile gases in the operating room and affecting the accuracy of precision instruments. Microorganisms, non-flammability, residual ethylene oxide after sterilization, etc., are also important safety indicators.