Soft instrument is a kind of infection control instrument that can block water, bacteria, air permeability, wearable and foldable, and has two-way protection function, which conforms to the classification of surgical instruments, excluding ordinary medical textiles. On August 31, 2017, the State Food and Drug Administration of China issued the classified catalogue of medical devices, which came into effect on August 1, 2018. In the document, the surgical gowns and surgical drapes are listed as class II medical devices.
Performance requirements for disposable surgical gowns and surgical drapes
YY / T 0506.2-2016 "Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments" sets specific requirements for the performance of surgical gowns and surgical drapes. Hospitals must strictly follow the regulations when purchasing surgical gowns and surgical drapes.
Handling standards for soft devices
In the "Basic Standards and Management Specifications of Medical Disinfection Supply Centers (Trial)" issued by the state, the medical disinfection supply centers are determined as independent medical institutions, excluding the disinfection supply centers, disinfection supply rooms and disinfection supply organization for medical equipment production and operation enterprises, which are set up by medical equipments inside.The medical disinfection supply center mainly undertakes the cleaning, disinfection, sterilization and supply of sterile items such as reusable medical equipment, appliances, clean surgical gowns, and surgical drapes for medical institutions, and carries out quality control , issues monitoring and testing result of the treatment process, the whole process can be traced back to ensure quality.