What class of medical device is a sterile medical drape?
Dec 01, 2025
Source: Cainiu Health
Dr. Li Feng
Introduction
Under normal circumstances, sterile medical drapes are Class II medical devices. Before use, check the integrity of the packaging; if any damage, air leakage, or expiration is found, discontinue use immediately. Use as soon as possible after opening and avoid prolonged exposure to air. After use, dispose of according to regulations for medical waste—do not discard casually or reuse.
Generally, sterile medical drapes are classified as Class II medical devices. The detailed analysis is as follows:
Sterile medical drapes come into direct contact with damaged skin, mucous membranes, or wound surfaces, requiring strict control of microbial contamination risks. These drapes are used in surgical and nursing procedures to isolate bodily fluids and protect wounds. If sterility requirements are not met, they may easily cause infections and worsen the patient's condition. Their production must follow specific quality standards, with regulated processes from raw material disinfection to final product sterilization. During use, they must meet the requirements of medical procedures—distinct from non-sterile Class I devices, yet not subject to the stringent standards required for implanted Class III devices. Therefore, they fall under the regulatory category of Class II devices, which are considered moderate-risk.
Prior to use, check the integrity of the packaging; if there is any damage, air leakage, or expiration, discontinue use immediately. Use promptly after opening and avoid prolonged exposure to air. After use, dispose of according to regulations for medical waste—do not discard casually or reuse. Store in a dry, clean, and well-ventilated environment, away from moisture and sources of contamination, to ensure sterility requirements are still met at the time of next use.
