In terms of the packaging and labeling of protective footwear products, both our national standards and the US NFPA 1999 and the EU standards have made comprehensive and strict regulations.
According to the Chinese standard GB 19082-2009 "Technical Requirements for Medical Disposable Protective Clothing", the protective clothing consists of a hooded top and trousers, and is divided into a continuous-body structure and a split-body structure. It is not applicable to reusable protective clothing, and specifies the indicators such as flame resistance performance, water absorption grade, charge density, tensile elongation rate and water resistance of medical protective clothing.
The protective clothing applicable to the NFPA 1999 standard in the United States is divided into two types: disposable and reusable. It includes separate and integrated work clothes as well as those used by patients. Besides the conventional physical strength performance, flame resistance performance and other indicators, this standard also requires overall testing. The isolation layer and seams must pass tests for resistance to liquid and microbial penetration.
The EU standard EN 14126-2003 "Protective Clothing - Performance Requirements and Test Methods for Anti-infection Protective Clothing" is applicable to reusable and limited-use protective clothing, but not suitable for surgeons and patients wearing it during surgeries to avoid cross-infection. It requires that the seams of the protective clothing should meet the strength requirements in EN 14325. The entire protective clothing is classified into 6 categories based on its protective performance, from type 1 to type 6, with smaller numbers indicating higher protection; type 4 is the medical recommended requirement, and types with (B) are for biological protection. Generally, the type with B is preferred for protection.
Therefore, the key indicators for the inspection of medical protective suits focus on the liquid barrier performance, which mainly include anti-leakage water resistance, wetting capacity, resistance to synthetic blood penetration, and water absorption grade, etc. In addition, there are also tests for breaking strength and elongation rate, filtration efficiency, flame retardancy analysis, anti-static performance analysis, and so on.
