用途：消字號產(chǎn)品主要用于外用衛(wèi)生消毒，檢測指標主要為抑菌、殺菌作用，不具備調(diào)節(jié)人體生理功能的功效，不能出現(xiàn)或暗示治療效果。常見的消字號產(chǎn)品包括漱口水、婦科抑菌凝膠、抑菌粉、抑菌液、婦科洗液、止癢膏、痔瘡膏、口腔潰瘍噴劑、香皂、除臭劑、腳氣膏、洗衣液、衛(wèi)生巾等。械字號產(chǎn)品則是醫(yī)療器械，直接或間接用于人體，主要用于疾病的診斷、預(yù)防、監(jiān)護、治療或緩解，如醫(yī)用敷料、醫(yī)用冷敷貼、醫(yī)用凝膠等。

　　Usage: Disinfectant products are mainly used for external hygiene and disinfection. The testing indicators are mainly antibacterial and bactericidal effects, and do not have the effect of regulating human physiological functions. They cannot show or imply therapeutic effects. Common Xiaozi products include mouthwash, gynecological antibacterial gel, antibacterial powder, antibacterial liquid, gynecological lotion, antipruritic cream, hemorrhoid cream, oral ulcer spray, soap, deodorant, foot gas cream, laundry detergent, sanitary napkin, etc. Mechanical products are medical devices, which are directly or indirectly used in the human body, mainly for the diagnosis, prevention, monitoring, treatment or relief of diseases, such as medical dressings, medical cold packs, medical gel, etc.

　　申報主體：消字號的申報主體只需經(jīng)營范圍包含“消毒用品銷售”即可；而械字號除了經(jīng)營范圍包含以外，還需要有廠房并具備相對應(yīng)的生產(chǎn)許可證，普通的公司不具備申請的資格。

　　Declaration subject: The declaration subject of the disinfection name only needs to have a business scope that includes "sales of disinfection products"; In addition to the scope of business, the equipment brand also needs to have a factory and corresponding production license, and ordinary companies do not have the qualification to apply.

　　作用方式：消字號產(chǎn)品通過化學方式對人體或物體、空氣等產(chǎn)生作用，通常含有植物或化學成分。械字號產(chǎn)品則通過物理方式產(chǎn)生作用，不含有植物或藥物等成分。

　　Mode of action: Disinfected products have a chemical effect on the human body, objects, air, etc., usually containing plants or chemical components. The equipment brand products are produced through physical means and do not contain ingredients such as plants or drugs.

　　監(jiān)管要求：消字號產(chǎn)品需經(jīng)過檢測、整理申報材料、申請初審和終審等程序。械字號產(chǎn)品的生產(chǎn)車間必須有專門的凈化車間，并通過醫(yī)療器械專用體系認證，需經(jīng)過國家食品藥品監(jiān)督管理局備案等要求。

　　Regulatory requirements: Anti brand products must undergo testing, sorting of application materials, initial and final review procedures. The production workshop of equipment brand products must have a dedicated purification workshop and be certified by the medical device special system, and must go through requirements such as filing with the National Food and Drug Administration.

　　消字號和械字號的定義：

　　The definitions of disinfection number and equipment number:

　　消字號：屬于衛(wèi)生消毒用品范疇，檢測指標主要為抑菌、殺菌作用。其原料需符合中國藥典和化妝品要求，只能用于外用消毒殺菌，不具備調(diào)節(jié)人體生理功能的功效。

　　Disinfectant name: belongs to the category of hygiene and disinfection products, and the main testing indicators are antibacterial and bactericidal effects. Its raw materials must comply with the requirements of the Chinese Pharmacopoeia and cosmetics, and can only be used for external disinfection and sterilization. It does not have the effect of regulating human physiological functions.

　　械字號：指醫(yī)療器械，直接或間接用于人體的儀器、設(shè)備、器具等。其效用主要通過物理方式獲得，目的是疾病的診斷、預(yù)防、監(jiān)護、治療或緩解

　　Equipment number: Refers to medical devices, instruments, equipment, appliances, etc. directly or indirectly used for the human body. Its utility is mainly obtained through physical means, with the aim of diagnosing, preventing, monitoring, treating, or alleviating diseases

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　　This article provides assistance in the maintenance of endoscopic equipment. For more related content, please click: http://www.xiaomijiaju.com I hope this article can be helpful to you. Thank you for reading!