Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All the technical contents of this national standard are compulsive.
Appendix A in this standard is normative.
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: Zhejiang Center for Disease Control and Prevention, Center for Health Inspection and Supervision of Ministry of Health, Jilin Center for Disease Control and Prevention and Zhejiang Health Supervision Station.
Participating drafting organizations of this standard: Shanghai Likang Disinfectant Hi-Tech Co.,Ltd.
Chief drafting staffs of this standard: Hu Guoqing, Sun Shouhong, Huang Xinyu, Ren Jiabao, Bian Xuelian and Sun Wensheng.
Hygienic Standard for Alcohol Disinfectants
乙醇消毒剂卫生标准
1 Scope
This Standard specifies raw material requirements, technical requirements, application scope, application methods, inspection methods, marking, packaging, transportation and storage, label, instruction and precautions of alcohol disinfectants
This Standard is applicable to alcohol disinfectant mainly made of alcohol as raw materials, including disinfectants for alcohol, surface active agent, edible color, skin care ingredients and edible essence.
This Standard is neither applicable to disinfectants of alcohol compounding with other bactericidal ingredients nor to disinfectants taking alcohol as solvent.
2 Normative References
The following normative documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding corrections), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest editions of these documents are applicable. For undated references, its latest edition applies.
GB/T 191 Packaging-Pictorial Marking for Handling of Goods
GB 10343 Edible Alcohol
Pharmacopoeia of People's Republic of China (Second) 2010 edition
Ministry of Health of the People's Republic of China Technical Specification for Disinfection
Ministry of Health of the People's Republic of China Management specification for label instruction of disinfection products 2005 edition
3 Raw Material Requirements
3.1 Alcohol used in the formula shall be in accordance with the requirements for alcohol in "Pharmacopoeia of People's Republic of China" (Volume II) (2010 edition); edible alcohol as raw material shall be in accordance with the requirement of GB 10343.
3.2 Production water shall be deionized water.
3.3 Other compositions in the formula shall be in accordance with the requirements of relevant standards and requirements (including purity and specification) of the nation.
3.4 Disinfectants for disinfection of hand and skin shall not use industrial grade raw material.
4 Technical Requirements
4.1 Sensory Properties
It is colorless transparent liquid without impurities and precipitations and has alcohol's intrinsic smell.
4.2 Physical and chemical indices
4.2.1 Alcohol content
70%～80%(volume fraction).
4.2.2 Stability
Validity period of completely packed disinfectants under specified product storage conditions shall be 12 months at least.
4.3 Microorganism killing indexes
Dilute to the application dose specified in the instruction according to the requirements of the product instruction. Undertake test according to the quantification bacterialcid assay in the "Technical Specification for Disinfection" (2002 edition) by Ministry of Health. The disinfection effect shall be in accordance with those specified in Table 1.
Table 1 Technical requirements for killing microorganisms
Representative bacterial strain Effective concentration Action time
min Killing logarithm value
Hygiene hand disinfection Surgical hand disinfection Skin disinfection Object surface disinfection Supporters method Suspension method
Colibacillus Stock solution ≤1 ≤3 — ≤3 ≥3.00 ≥5.00
Staphylococcus aureus Stock solution ≤1 ≤3 ≤3 ≤3 ≥3.00 ≥5.00
Pseudomonas aeruginosa Stock solution — — ≤3 — ≥3.00 ≥5.00
Candida albicans Stock solution ≤1 ≤3 ≤3 — ≥3.00 ≥4.00
5 Application Scope
5.1 Alcohol disinfectants are mainly used for hand and skin disinfection but also may be used for surface disinfection of medical instruments such as thermometer and sphygmomanometer and precise instruments as well.
5.2 Alcohol disinfectants should not be used for air disinfection or immersion disinfection of medical appliances.
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
All the technical contents of this national standard are compulsive.
Appendix A in this standard is normative.
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: Zhejiang Center for Disease Control and Prevention, Center for Health Inspection and Supervision of Ministry of Health, Jilin Center for Disease Control and Prevention and Zhejiang Health Supervision Station.
Participating drafting organizations of this standard: Shanghai Likang Disinfectant Hi-Tech Co.,Ltd.
Chief drafting staffs of this standard: Hu Guoqing, Sun Shouhong, Huang Xinyu, Ren Jiabao, Bian Xuelian and Sun Wensheng.
Hygienic Standard for Alcohol Disinfectants
乙醇消毒剂卫生标准
1 Scope
This Standard specifies raw material requirements, technical requirements, application scope, application methods, inspection methods, marking, packaging, transportation and storage, label, instruction and precautions of alcohol disinfectants
This Standard is applicable to alcohol disinfectant mainly made of alcohol as raw materials, including disinfectants for alcohol, surface active agent, edible color, skin care ingredients and edible essence.
This Standard is neither applicable to disinfectants of alcohol compounding with other bactericidal ingredients nor to disinfectants taking alcohol as solvent.
2 Normative References
The following normative documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding corrections), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest editions of these documents are applicable. For undated references, its latest edition applies.
GB/T 191 Packaging-Pictorial Marking for Handling of Goods
GB 10343 Edible Alcohol
Pharmacopoeia of People's Republic of China (Second) 2010 edition
Ministry of Health of the People's Republic of China Technical Specification for Disinfection
Ministry of Health of the People's Republic of China Management specification for label instruction of disinfection products 2005 edition
3 Raw Material Requirements
3.1 Alcohol used in the formula shall be in accordance with the requirements for alcohol in "Pharmacopoeia of People's Republic of China" (Volume II) (2010 edition); edible alcohol as raw material shall be in accordance with the requirement of GB 10343.
3.2 Production water shall be deionized water.
3.3 Other compositions in the formula shall be in accordance with the requirements of relevant standards and requirements (including purity and specification) of the nation.
3.4 Disinfectants for disinfection of hand and skin shall not use industrial grade raw material.
4 Technical Requirements
4.1 Sensory Properties
It is colorless transparent liquid without impurities and precipitations and has alcohol's intrinsic smell.
4.2 Physical and chemical indices
4.2.1 Alcohol content
70%～80%(volume fraction).
4.2.2 Stability
Validity period of completely packed disinfectants under specified product storage conditions shall be 12 months at least.
4.3 Microorganism killing indexes
Dilute to the application dose specified in the instruction according to the requirements of the product instruction. Undertake test according to the quantification bacterialcid assay in the "Technical Specification for Disinfection" (2002 edition) by Ministry of Health. The disinfection effect shall be in accordance with those specified in Table 1.
Table 1 Technical requirements for killing microorganisms
Representative bacterial strain Effective concentration Action time
min Killing logarithm value
Hygiene hand disinfection Surgical hand disinfection Skin disinfection Object surface disinfection Supporters method Suspension method
Colibacillus Stock solution ≤1 ≤3 — ≤3 ≥3.00 ≥5.00
Staphylococcus aureus Stock solution ≤1 ≤3 ≤3 ≤3 ≥3.00 ≥5.00
Pseudomonas aeruginosa Stock solution — — ≤3 — ≥3.00 ≥5.00
Candida albicans Stock solution ≤1 ≤3 ≤3 — ≥3.00 ≥4.00
5 Application Scope
5.1 Alcohol disinfectants are mainly used for hand and skin disinfection but also may be used for surface disinfection of medical instruments such as thermometer and sphygmomanometer and precise instruments as well.
5.2 Alcohol disinfectants should not be used for air disinfection or immersion disinfection of medical appliances.
