Surgical gowns, as a necessary protective clothing during surgery, are used to reduce the risk of medical staff contacting pathogenic microorganisms, and at the same time, it can also reduce the risk of pathogenic microorganisms spreading between medical staff and patients. It is a safe barrier for the sterile area during surgery.

1. Technical standards for surgical gowns

The United States is the first country in the world to implement surgical gown and dressing standards. The U.S. Occupational Safety and Health Administration (OSHA) issued regulations in 1991 to reduce the risk of medical staff being exposed to blood-borne diseases. Regulations require medical staff to use appropriate personal protective equipment (person-alprotective equipment, PPE) to avoid contact with sources of infection. The regulations point out that surgical gowns need to develop different protection levels based on the volume or total amount of blood and body fluids produced during the operation, and the duration of the operation, which mainly include the following three aspects: (1) The area exposed to the blood, Including the face, limbs, etc., and the way of exposure, including pressure and flowing fluids, water droplets, etc.; (2) Exposure of blood and body fluids; (3) The duration of the operation, from short-term intravenous injection to long-term cardiothoracic Surgery.

European Union countries have also adopted and implemented the medical equipment guidelines (93/42EEC), which took effect in June 1998 and has become a mandatory law of the European Union countries. Among them, the corresponding surgical gown product standard EN13795 divides surgical gowns into standard type and reinforced type. The protection area of surgical gowns is the same as the American standard. It is divided into main protection area and secondary protection area. The test index is based on hydrostatic pressure. And dry and wet bacteria penetration test as a standard test of barrier performance to replace the blood and microbial penetration test in the American standard.

2. Regulatory requirements for surgical gowns

At present, the main international standards for surgical protective clothing are AAMI PB-70 (established in October 2003) stipulated by the Association for the Advancement of Medical Instrumentation (AAMI) organization, which is suitable for sanitary protective clothing. Barrier performance testing; the standard EN 13795 established by the European Committee for Standardiza-tion (established in November 2004); the standard ISO16542 established by the International Organization for Stand-ardization (ISO) (established in 2005) ).

As an important barrier to protect patients and medical staff and prevent cross-infection of pathogenic bacteria, surgical gowns have been recognized globally for their functional characteristics and protection requirements.