Medical protective clothing:
It is the medical protective articles worn by clinical medical personnel when contacting patients with Class A or infectious diseases managed according to class A infectious diseases.
Isolation Gown:
It is a protective appliance used by medical personnel to avoid being polluted by blood, body fluid and other infectious substances, or to protect patients from infection.
Different user indications
Wear isolation clothing:
1. Contact with infectious diseases such as patients with infectious diseases and multidrug-resistant bacteria infection.
2. When protective isolation is implemented for patients, such as diagnosis, treatment and nursing of patients with large-area burns and bone marrow transplantation.
3. It may be splashed by the patient's blood, body fluids, secretions and feces.
4. Whether it is necessary to wear isolation clothes when entering key departments such as ICU, NICU and protective ward depends on the purpose of medical personnel and their contact with patients.
5. Workers in various industries are used for two-way protection.
Wear medical protective clothing:
When contacting patients with airborne and droplet borne infectious diseases, they may be splashed by the patient's blood, body fluids, secretions and excreted filth.
Use different objects
Medical protective clothing:
It is to prevent medical staff from being infected, which belongs to one-way isolation and is mainly aimed at medical staff;
Isolation Gown:
It not only prevents medical staff or workers in various industries from being infected or polluted, but also prevents patients from being infected. It belongs to two-way isolation.
Different production requirements
Medical protective clothing:
It is an important part of medical protective articles. Its basic requirement is to block viruses, bacteria and other harmful substances, so as to protect medical staff from infection in the process of diagnosis, treatment and nursing; It meets the requirements of normal use functions and has good wearing comfort and safety. It is mainly used in industrial, electronic, medical, chemical and bacterial infection prevention environments. Medical protective clothing has the technical requirements of national standard GB 19082-2009 medical disposable protective clothing.
Isolation Gown:
There is no corresponding technical standard, because the main function of isolation clothes is to protect staff and patients, prevent the spread of pathogenic microorganisms and avoid cross infection. There are no requirements for tightness and waterproof, but only isolation. It is only required that the length of isolation clothes should be appropriate without holes. When wearing and taking off, pay attention to avoid pollution.
Product certification
1 China
In China, medical devices are usually divided into three categories based on risk: first, those with low risk and basically no risk belong to the first category, which shall be filed with the drug regulatory department of local and municipal bureaus. Second, medium risk medical devices shall be registered and approved by the drug regulatory department at the provincial level. Third, high-risk medical devices belong to three categories, and the National Bureau is directly responsible for organizing the examination and approval.
Medical protective clothing belongs to class II medical devices, which shall be registered and managed by the provincial drug regulatory department
2 United States
According to the risk level, the U.S. Food and Drug Administration (FDA) divides medical device products into three levels for management. Level 1 refers to ordinary products, level 2 refers to products that ensure their safety and effectiveness through special control, and level 3 refers to products that are generally used to support human life, prevent damage to human health, and have potential unreasonable risks of disease treatment and disability.
Medical protective clothing in the United States can be divided into non-surgical protective clothing and surgical protective clothing. Non surgical protective clothing belongs to class I medical devices, which are exempted from pre-market registration and directly registered by the organization. The surgical protective clothing belongs to class II medical devices and needs to be registered before listing, that is, it needs to apply for FDA 510k.
3 EU
The commodities related to safety, health, environmental protection and consumer protection in the EU Economic Zone market (such as electronics, machinery, medical devices, toys, personal protective equipment, communication, pressure equipment, etc.) have been compulsorily listed as "must carry CE mark, otherwise they are not allowed to enter the EU market for circulation".
Protective clothing belongs to personal protective equipment, English is personal protective equipment, abbreviated as PPE, and the EU safety directive for personal protective equipment is 89 / 686 / EEC. According to the provisions of PPE directive, PPE products are divided into three categories according to the complexity and protection level of PPE product design. Personal protective equipment sold in the European market must comply with applicable safety requirements and standards.
