GB 38456-2020 PDF EnglishUS$170.00 · In stock · Download in 9 seconds
GB 38456-2020: Hygienic requirements for antibacterial and bacteriostatic lotion Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsGB 38456-2020: Hygienic requirements for antibacterial and bacteriostatic lotion---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB38456-2020GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080 C 50 Hygienic requirements for antibacterial and bacteriostatic lotion ISSUED ON: NOVEMBER 17, 2020 IMPLEMENTED ON: DECEMBER 01, 2021 Issued by: State Administration for Market Regulation; Standardization Administration of the People's Republic of China. Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Terms and definitions ... 4 4 Requirements for raw materials ... 5 5 Technical requirements ... 6 6 Testing methods ... 8 7 Packaging, transportation and storage ... 9 8 Labels and Instructions ... 10 Bibliography ... 11 Hygienic requirements for antibacterial and bacteriostatic lotion1 ScopeThis Standard specifies the raw materials, technical requirements, testing methods, packaging, transportation, storage, label and instructions requirements for antibacterial and bacteriostatic lotion. The Standard applies to antibacterial and bacteriostatic lotion products for use on intact skin, vaginal and oral mucosa.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 191, Packaging and storage marks GB 15979, Hygienic standard for disposable sanitary products GB 38598, General requirement for label and instruction book of disinfection products Pharmacopoeia of the People's Republic of China Technical specification for cosmetics safety 1 Technical specification for disinfection 2 (Edition 2002) Hygienic standard for manufacturers of disinfection products 2 (Edition 2009)3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply. 3.1 antibacterial lotion A liquid preparation that is directly contact with human skin or mucous membranes (excluding human feet, eyes, nails, armpits, scalp, hair, nasal mucous membranes, 1 The document was issued by the former State Food and Drug Administration. 2 The document was issued by the former Ministry of Health of the People's Republic of China. anorectal and other specific parts), not for the purpose of treating diseases or improving symptoms of skin and mucous membranes, with certain sterilization effect, and the killing rate is greater than or equal to 90%. 3.2 bacteriostatic lotion A liquid preparation (except suppository and soap) that is directly contact with human skin or mucous membranes (excluding human feet, eyes, nails, armpits, scalp, hair, nasal mucous membranes, anorectal and other specific parts), not for the purpose of treating diseases or improving symptoms of skin and mucous membranes, with certain sterilization effect, and the inhibition rate is greater than or equal to 50%. 3.3 killing rate In the microbial killing test, the value of the reduction of microorganisms expressed as a percentage. [WS/T 466-2014, definition 4.27] 3.4 inhibition rate In the microbial inhibition test, the value of the microbial antibacterial effect expressed as a percentage.4 Requirements for raw materials4.1 Raw materials shall meet the quality requirements of the currently valid Pharmacopoeia of the People's Republic of China for food level, medical level, cosmetics and other corresponding standards. 4.2 Production water shall meet the requirements of Hygienic standard for manufacturers of disinfection products (Edition 2009). 4.3 Product formulations must not contain: a) Drugs and raw materials with the same names listed in the currently effective Pharmacopoeia of the People's Republic of China; b) Preparations made from microorganisms, cells, animal or human-derived tissues and body fluids and biological techniques for the prevention, treatment and diagnosis of human diseases, such as vaccines, blood products, biotechnological drugs, probiotics, immune Regulators, diagnostic products, etc. (except deep castor enzyme and lysostaphin); c) Prohibited substances listed in the currently valid Technical specification for cosmetics safety (except iodine); 6.4.1 Testing of total number of bacterial colonies Test according to the method in GB 15979. 6.4.2 Testing of coliform bacteria Test according to the method in GB 15979. 6.4.3 Testing of staphylococcus aureus Test according to the method in GB 15979. 6.4.4 Testing of hemolytic streptococcus Test according to the method in GB 15979. 6.4.5 Testing of pseudomonas aeruginosa Test according to the method in GB 15979. 6.4.6 Testing of total fungal colonies Test according to the method in GB 15979. 6.5 Test methods for toxicological safety Test according to the method in Technical specification for disinfection (Edition 2002).7 Packaging, transportation and storage7.1 Packaging The packaging shall be tight to prevent moisture. Packaging marks shall meet the requirements of GB/T 191. 7.2 Transportation It shall be airtight during transportation. Shipping containers shall be anti-corrosive. Loading and unloading shall be handled with care. Throwing is strictly prohibited. It shall be protected from sun, rain and moisture during transportation. 7.3 Storage 7.3.1 Store in a cool, dry and dark place. 7.3.2 Stacking shall be more than 10 cm above the ground. Stack height shall not exceed 12 boxes. The distance from the wall shall be more than 20 cm. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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