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This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB/T 26373-2010 Hygienic standard for alcohol disinfectants, with respect to which, the following main technical changes have been made:
——the application scope of this standard is modified (see Clause 1; Clause 1 of Edition 2010);
——the normative references are modified (see Clause 2; Clause 2 of Edition 2010);
——the term “alcohol-based disinfectant” and its definition are added (see 3.1);
——the raw material requirements are modified (see Clause 4; Clause 3 of Edition 2010);
——the raw material requirements for isopropanol/n-propanol are added (see 4.2);
——“sensory property” is deleted (see 4.1 of Edition 2010);
——pH index is added (see 5.1.1);
——the range of ethanol content in ethanol disinfectant is modified (see 5.1.2.1; 4.2.1 of Edition 2010);
——the requirements for total alcohol content of isopropanol/n-propanol disinfectant and compound alcohol disinfectant are added (see 5.1.2.2 and 5.1.2.3);
——the microorganism killing index is modified and shall be determined by reference to the requirements of corresponding standards based on the product usage (see 5.2; 4.3 of Edition 2010);
——the descriptions of application scope, application method, precautions, packaging, transportation and storage as well as identification are modified (see Clauses 6, 7, 8 and 9; Clauses 5, 6, 8, 9, 10 and 11 of Edition 2010);
——the detection method for stability is deleted (see A.1 of Edition 2010);
——the detection method for ethanol content is modified (see A.1; A.2 of Edition 2010);
——the detection method for isopropanol/n-propanol content is added (see A.2).
This standard was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.
Drafting organizations of this standard: Zhejiang Provincial Center for Disease Control and Prevention, National Institute of Environmental Health, China CDC, the Center of Health Supervision National Health Commission of the People’s Republic of China, Shanghai Municipal Center for Disease Control & Prevention, Health Supervision Institute, Shanghai Municipal Health Commission, Hunan Provincial Center for Disease Control and Prevention, Heilongjiang Provincial Center for Disease Control and Prevention, Shenzhen Center for Disease Control and Prevention and Guangdong Inspection and Quarantine Technology Center.
Chief drafters of this standard: Hu Guoqing, Li Yan, Lu Ye, Sun Shouhong, Duan Yabo, Zhu Renyi, Sun Yuqing, Chen Guiqiu, Lin Ling, Zhu Zili, Li Ye, Lu Longxi, Lin Junming, Shi Wen, Cai Ran, Liao Ruyan, Sun Jiansheng, Wu Gang, Wang Guoyang, Sun Wensheng, Wang Jinqiang, Shen Xing, Shi Shaoyi and Zhou Xiaoqin.
The previous edition of this standard is as follows:
——GB/T 26373-2010.
Hygienic requirements for alcohol-based disinfectant
1 Scope
This standard specifies the raw material requirements, technical requirements, application scope, application methods, packaging, transportation and storage, identification, labels and instructions as well as inspection methods for alcohol-based disinfectants.
This standard is applicable to alcohol-based disinfectants with ethanol and/or isopropanol/n-propanol as sterilization ingredient(s), and ethanol and/or isopropanol/n-propanol disinfectants compatible with surfactant and skin care ingredients.
This standard is not applicable to the ethanol or isopropanol/n-propanol disinfectants compounded with other sterilization ingredients, nor those with ethanol or isopropanol/n-propanol as the solvent.
2 Normative references
The 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 - Pictorial marking for handling of goods
GB/T 27949 Hygienic requirements for medical items disinfection
GB 27950 Hygienic requirements for hand antiseptic agents
GB 27951 Hygiene requirements for skin disinfectant
GB 27952 Hygienic requirements for surface disinfectants
GB 31640 National food safety standard - Edible alcohol
GB/T 38499 Evaluation method for stability of disinfectant
WS 310.2 Central sterile supply department (CSSD) - Part 2: Standard for operating procedure of cleaning, disinfection and sterilization
WS/T 535 Rapid detection methods on site for disinfectant used in medical and health institutions
Pharmacopoeia of the People's Republic of China (Edition 2015)
Technical standard for disinfection (Edition 2002) issued by the Ministry of Health of the People's Republic of China (WEIFAJIANFA [2002] No.282)
Hygienic code for disinfectant product manufacturer (Edition 2009) issued by the Ministry of Health of the People's Republic of China (WEIJIANDUFA [2009] No.53)
3 Terms and definitions
For the purposes of this document, the following term and definition apply.
3.1
alcohol-based disinfectant
disinfectant with ethanol and/or isopropanol/n-propanol as the sterilization ingredient(s)
4 Raw material requirements
4.1 Ethanol
It shall meet the requirements for “ethanol” specified in Pharmacopoeia of the People’s Republic of China (Edition 2015). The ethanol using edible alcohol as raw material shall meet the requirements of GB 31640.
4.2 Propanol
Isopropanol shall meet the requirements for "isopropanol" specified in Pharmacopoeia of the People’s Republic of China (Edition 2015). n-propanol shall meet the requirements of enterprise quality standards for it.
4.3 Production water
Production water shall meet the requirements of Article 30 of Hygienic code for disinfectant product manufacturer (Edition 2009).
4.4 Other ingredients in formula
For the disinfectants used for disinfection of hands and skin, industrial raw materials should not be used; otherwise, safety proof materials shall be provided, such as detection report on physical and chemical indexes of raw materials or detection report on toxic and auxiliary ingredients of raw materials or toxicological detection report of raw materials.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Raw material requirements
5 Technical requirements
6 Application scope
7 Application method
8 Packaging, transportation and storage
9 Identification, labels and instructions
10 Inspection methods
Annex A (Normative) Detection methods for contents of ethanol and isopropanol/n-propanol
