Last Login: 10-26-22
Original title: Interpretation | How to distinguish between medical and non-medical disposable protective suit? Recently, with the development of COVID-19 pandemic, the demand for epidemic prevention materials such as medical protective suit has increased greatly abroad. Due to the different standards of different countries, the misuse of non-medical protective suit exported from China for medical use occurs from time to time. How to quickly and accurately distinguish between medical and non-medical disposable protective suit? Please come to understand with the publishing gentleman. Classification of protective suit Medical protective suit refers to the protective clothing used by medical staff (doctors, nurses, public health personnel, cleaning personnel, etc.) And people entering specific medical and health areas (such as patients, hospital visitors, people entering infected areas, etc.). Its function is to isolate germs,CE Certificate KN95 Mask, harmful superfine dust, acid and alkaline solutions, electromagnetic radiation, etc., to ensure the safety of personnel and to keep the environment clean. Expand the full text According to the service life,Medical Full Body Coverall, it can be divided into disposable protective suit and reusable protective suit. Divided by use: daily work clothes, surgical gowns, isolation gowns and protective suit. Disposable protective suit refer to the disposable protective articles worn by clinical medical staff when they contact patients with infectious diseases of Class a or under the management of Category A infectious disease. This paper discusses the medical/non-medical distinction of disposable protective suit. Disposable protective suit Medical/non-medical distinction Use the packaging information to distinguish and observe whether the product packaging information contains the words "medical" or "surgical" or "medical" in English, and whether it describes the applicable scenarios and medical uses of medicine. If there is relevant information, it can generally be judged as medical protective suit. Medical — Non-medical — Different standards and certification requirements are applicable to different countries/regions for distinguishing medical protective suit. The applicable standards and certification information of products can be obtained from the product packaging or the test report or certificate provided by the manufacturer. 01 Relevant Chinese standards As long as the implementation standard is marked with GB19082, it can be judged as medical disposable protective suit. 02 Relevant EU standards The EU medical protective suit applies to the scope of the Medical Device Regulation 93/42/EEC, which will be replaced by the new EU Medical Device Regulation EU2017/745 (MDR) on May 26, 2020. However, Quickly Delivery Disposable Protective Clothing ,KN95 Mask with Fast Shipping, on 25 March, the European Commission announced a proposal to postpone the implementation of the MDR regulation for one year and submitted it in early April so that the European Parliament and Council could adopt it by the end of May with additional and different requirements. The EU Personal Protective Equipment (PPE) Regulation, EU2016/425, applies to non-medical PPE. The main standards for the two regulations are shown in the table below. For the protective suit exported to EU, if the CE certificate has the corresponding directive 93/42/EEC or EU2017/745, and the notified body has obtained the authorization of 93/42/EEC or EU2017/745 through the CE certificate, it is a medical protective suit. CE certificate query method Click to enter the CE certificate inquiry webpage, and click the number of the notified body to be inquired, such as 1282. Inquire to see the specific information of the notified body and the authorization of the body. For protective suit products with "CE" label on the outer packaging and many EN standards, they can be used as suspected medical protective suit, and then combined with CE certificate inspection and judgment. 03 Relevant American standards Medical protective suit in the United States are regulated by the Food and Drug Administration (FDA). The primary technical regulation for medical protective suit is 21 CFR 878.4040, Surgical Apparel. Medical protective suit standards mainly include ANSI/AAMIPB70 "Liquid Barrier Properties and Classification of protective suit and Protective Cloths Used in Health Care Facilities" and NFPA 1999-2018 "Standard for protective suit Used in Emergency Medical Operations".
For protective suit exported to the United States, if there is a "FDA" mark on the package, the standard number is marked as "ANSI/AAMIPB70" and "NFPA1999-2018", it can generally be judged as medical protective suit. When it is judged as a suspected medical protective suit by using the above methods of product appearance distinction, we can open the protective suit package, check the appearance of the product and eliminate it. See if the product is complete 01 The disposable medical protective suit consists of a hat, a coat and trousers, and can be a jumpsuit or a split body. If the product does not have a cap, the product is not a disposable medical protective suit, otherwise, it cannot be determined. See if it is sealed. 02 See if there is any sealing treatment at the joint. Intuitively, there is no adhesive tape. Note that if there is no adhesive tape, it can be judged directly that it must not be a disposable medical protective suit, but if there is adhesive tape, it is not necessarily a disposable medical protective suit. Look at the product material 03 Front Reverse side Disposable medical protective suit must be made of nonwoven cloth covered with a layer of plastic film. The wrong material must not be a disposable medical protective suit, but the right material can not be judged to be a disposable medical protective suit. Look at the closing of cuffs and ankles. 04 Cuff Ankle mouth See if the cuffs and ankles are complete and elastic. If the cuffs and ankles are not closed,Antivirus Disposable Mask with CE Certificate, the product is not a disposable medical protective suit, otherwise, it can not be determined. The above is reposted from "Customs Release" and returned to Sohu to see more Responsible Editor:. zjyuan-group.com