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All the technical contents of this standard are compulsory.
This standard was drafted in accordance with regulations given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the Ministry of Health of the People's Republic of China.
Drafting organizations of this standard: Hunan Center for Disease Control and Prevention, Xiangya Hospital Central-south University, Shenzhen Center for Disease Control and Prevention, Shenzhen ADF Industry Development Co., Ltd. and Shandong Lircon Disinfection Science Technology Incorporated Company.
Chief drafting staffs of this standard: Chen Guiqiu, Huang Yuelong, Wu Anhua, Zhu Zili, Wu Gang, Zhu Hanquan, Zhu Yingkai, Song Jiangnan, Zhuang Shifeng, Liang Jinjun, Li Shikang and Gao Qiong.
Contents
1 Scope 1
2 Normative References 1
3 Terms and Definitions 1
4 Technical Requirements 2
5 Inspection Methods 3
6 Use Methods 3
7 Labels and Instructions 4
8 Precautions for Use 4
Hygienic Requirements for Hand Antiseptic Agents
手消毒劑衛(wèi)生要求
1 Scope
This standard specifies the technical requirements, inspection methods, use methods, labels & instructions and precautions for use of hand antiseptic agents.
This standard is applicable to hand antiseptic agents using iodines, alcohols, guanidines, quaternaries and phenols as raw materials and water or ethanol as solvent.
This standard is not applicable to skin antiseptic agents.
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 15982 Hygienic Standard for Disinfection in Hospitals
The Pharmacopoeia of the People's Republic of China (2005)
Technical Specification for Disinfection Ministry of Health of the People's Republic of China
Hygienic Regulations for Cosmetics Ministry of Health of the People's Republic of China
Regulations on the Management of the Disinfection Product Labels & Instructions Ministry of Health of the People's Republic of China
3 Terms and Definitions
For the purpose of this standard, the following terms and definitions apply.
3.1
Hand antisepsis
The process kills or eliminates the pathogenic microorganism on hands and meets the antisepsis requirements. It includes hygienic hand antisepsis and surgical hand antisepsis.
3.2
Hand antiseptic agent
The chemicals used for hand antisepsis.
3.3
Hygienic hand antisepsis
Prophylactic antisepsis process of hands.
3.4
Surgical hand antisepsis
Antisepsis process on the medical personnel's hands and forearms before operation.
4 Technical Requirements
4.1 Raw material requirements
4.1.1 The raw material shall meet the quality requirements of "Pharmacopoeia of People's Republic of China", medical grade, food grade or chemically pure; and it is forbidden to use industrial grade.
4.1.2 The formula shall be free from various prescription drug ingredients, such as hormone, antibiotics, antifungal drugs, etc. as well as prohibited substances specified by the Ministry of Health.
4.1.3 Deionizer water or distilled water shall be adopted for production.
4.2 Product quality requirements
4.2.1 Sensory properties
Antiseptics shall be uniform and free from lamination, precipitation, suspended substances or peculiar smell.
4.2.2 Physical and chemical indexes
4.2.2.1 Quality standard
Physical and chemical indexes of antiseptics, such as active ingredient content, pH value, etc., shall meet the product quality standard. The period of validity ≥12 months.
4.2.2.2 Active ingredient limit
The active content of biguanides antiseptics shall ≤4.5%, benzalkonium bromide or benzalkonium chloride ≤0.5%, 2, 4, 4'-trichloro-2'-hydroxydiphenyl ether ≤2.0%.
4.2.2.3 Impurity limit
Lead<40mg/L, mercury <2mg/L, arsenic <10mg/L.
4.2.3 Germicidal index
The germicidal index shall meet those specified in Table 1.
Table 1 Germicidal Index
Microorganism category Action time
min Germicidal logarithmic value
Hygienic hand antisepsis Surgical hand antisepsis Suspension method Carrier method
Colibacillus 8099 1.0 3.0 ≥5.00 ≥3.00
Staphylococcus aureus
ATCC6538 1.0 3.0 ≥5.00 ≥3.00
Candida albicans
ATCCl0231 1.0 3.0 ≥4.00 ≥3.00
Natural bacterium 1.0 3.0 ≥1.0
4.2.4 Toxicological safety requirements
Toxicological indexes of hand antiseptic agents are detailed in Table 2.
Contents
1 Scope
2 Normative References
3 Terms and Definitions
4 Technical Requirements
5 Inspection Methods
6 Use Methods
7 Labels and Instructions
8 Precautions for Use
