Disposable Coverall:Isolation clothing is not equal to protective clothing

In addition to protective clothing, isolation clothing is a new concept.

In the classified catalogue of medical devices issued by the State Food and drug administration, medical protective clothing is "clothing processed from one or more fabrics that can isolate virus aerosols, virus containing liquids, etc. when taken off, the outer surface of the protective clothing will not contact the human body". The intended use is "for occupational protective clothing worn by medical staff in medical institutions to prevent the transmission of virus from patients to medical staff with air or liquid". Medical protective clothing belongs to the national class II medical devices.

In the classification catalogue of medical devices, isolation clothing refers to "usually made of nonwoven as the main raw material, cut and sewn. It is provided non sterile and can be used for one time". The intended use is "for general isolation in outpatient, ward and Laboratory of medical institutions". The isolation clothing belongs to the national first-class medical device.

↑ adult protective clothing.

↑ adult isolation clothing.

According to the article "interpretation of medical isolation clothing standards" issued on the official website of the National Standardization Administration Committee, Yu Gang popular science, a researcher of China Institute of standardization, introduced that there are no national and industrial standards for medical isolation clothing at present. American Standard ASTM f3352-19 defines medical isolation clothing as protective clothing (clothing) used to protect medical staff, visitors and patients from microbial and body fluid transfer in the case of patient isolation. Medical isolation clothing can also be used to protect visitors in the medical environment.

"ASTM F3352-19 stipulates that medical isolation clothing is designed to protect medical staff, patients and visitors from the effects of blood, body fluids and other potential infectious substances during patient care or patient treatment. The main emphasis here is on blood and body fluids, and there is no mention of viruses transmitted through air, such as COVID-19." Yu Gang told Red Star reporters that there is no evidence to prove that isolation clothing can prevent New Coronavirus.

Yu Gang wrote in the article: "ASTM f3352-19 stipulates' 360 ° coverage ', that is, at least ensure that the front, side and rear of the arm and body are fully covered from the knee to the neck (excluding the neck). We can see that the protection range of medical isolation clothes is from the knee to the neck (excluding the neck) Instead of covering the whole body from head to foot, the head, neck, hands and feet are not within the scope of protection. "

↑ interpretation of steel.

The production and use requirements of the two are different. Most of the "protective clothing" sold online are "isolation clothing"

According to the regulations on the supervision and administration of medical devices, class I medical devices are subject to product filing management, and class II and class III medical devices are subject to product registration management.

For those engaged in the production of class I medical devices, the manufacturer shall file with the food and Drug Administration Department of the local municipal people's government and submit relevant supporting materials. For the production of class II medical devices, the production enterprise shall apply to the food and Drug Administration of the people's Government of the province, autonomous region or municipality directly under the central government for production license and submit relevant supporting materials and the registration certificate of the medical devices produced.

Red Star News also asked a number of online store sellers selling children's protective clothing. Many "protective clothing" sold out have become "isolation clothing" when providing relevant certificates and specific purchases.

A number of sellers have posted the business license, the first class medical device filing information form and the first class medical device Filing Certificate on the sales page. According to relevant regulations, only isolation clothing can be produced, which can not meet the production requirements of class II medical device protective clothing. One of the online stores specializes in selling protective clothing buyers. As of the press time of the reporter, the other party has not responded to the production basis standards and manufacturer qualifications.