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GB 27950-2011

Chinese Standard: 'GB 27950-2011'
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BASIC DATA
Standard ID GB 27950-2011 (GB27950-2011)
Description (Translated English) Hygienic requirements for hand antiseptic agents
Sector / Industry National Standard
Classification of Chinese Standard C59
Classification of International Standard 11.080
Word Count Estimation 7,734
Date of Issue 2011-12-30
Date of Implementation 2012-05-01
Quoted Standard GB 15982; Chinese Pharmacopoeia 2005; disinfection technical specifications Ministry of Health; Hygienic Standard for Cosmetics Ministry of Health; disinfection product label instructions management practices Ministry of Health
Drafting Organization Hunan Provincial Center for Disease Control
Administrative Organization Ministry of Health
Regulation (derived from) Announcement of Newly Approved National Standards No. 23 of 2011
Proposing organization People's Republic of China Ministry of Health
Issuing agency(ies) Ministry of Health of People's Republic of China; Standardization Administration of China
Summary This Chinese standard specifies the technical requirements of hand sanitizer, test methods, the use of methods, label instructions and precautions. This standard applies to iodine, alcohols, guanidine, quaternary ammonium salts, phenols as raw materials, water or ethanol as a solvent to prepare for hand disinfection disinfectant. This standard does not apply for skin disinfection disinfectant.

GB 27950-2011
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 59
Hygienic requirements for hand antiseptic agents
手消毒剂卫生要求
ISSUED ON: DECEMBER 30, 2011
IMPLEMENTED ON: MAY 01, 2012
Issued by: Ministry of Health of the People's Republic of China;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Technical requirements ... 5 
5 Inspection methods ... 6 
6 Use methods ... 7 
7 Labels and user manual ... 8 
8 Precautions ... 8 
Hygienic requirements for hand antiseptic agents
1 Scope
This Standard specifies technical requirements, inspection methods, use
methods, label manual and precautions for hand antiseptic agents.
This Standard is applicable to antiseptic agents that take iodine, alcohols,
guanidine, quaternary ammonium salts, phenols as raw materials, and water or
ethanol as a solvent for hand antisepsis.
This Standard is not applicable to antiseptic agents for skin disinfection.
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
Pharmacopoeia of the People's Republic of China (2005)
Disinfection Technical Specifications -- Ministry of Health
Cosmetic Hygienic Specifications -- Ministry of Health
Specification for Management of Label Instructions for Disinfection Products
-- Ministry of Health
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 hand antisepsis
The process of killing or removing pathogenic microorganisms in the hand and
meeting disinfection requirements. It can be divided into hygienic hand
antisepsis and surgical hand antisepsis.
3.2 hand antiseptic agent
5.2 Physical-chemical indicators
5.2.1 pH measurement
Measure according to the relevant methods in Disinfection Technical
Specifications.
5.2.2 Active ingredient content
Measure according to the relevant methods in Disinfection Technical
Specifications and national standards.
5.2.3 Stability test
Measure according to the relevant methods in Disinfection Technical
Specifications.
5.2.4 Determination of lead, mercury and arsenic limits
Measure according to the relevant methods in Cosmetic Hygiene Regulations.
5.3 Killing microorganism test
Measure according to the relevant methods in Disinfection Technical
Specifications.
5.4 Toxicological safety test
Measure according to the relevant methods in Disinfection Technical
Specifications.
6 Use methods
6.1 Hygienic hand antisepsis
Take the right amount of hand antiseptic agent on the palm. Rub hands together
to evenly coat each part. Act 1.0min.
6.2 Surgical hand antisepsis
After washing hands surgically, apply an appropriate amount of hand antiseptic
agent and apply it evenly to the skin of the hands, forearms and 1/3 of the skin
under the upper arm. Act 3min~5min.

GB 27950-2011
Hygienic requirements for hand antiseptic agents
ICS 11.080
C59
National Standards of People's Republic of China
Hygienic requirements for hand disinfectants
Published on December 30,.2011
2012-05-01 Implementation
Ministry of Health of the People's Republic of China
Issued by China National Standardization Administration
Foreword
All technical contents of this standard are mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the Ministry of Health of the People's Republic of China.
This standard was drafted by. Hunan Provincial Center for Disease Control and Prevention, Xiangya Hospital of Central South University, Shenzhen Center for Disease Control and Prevention, Shenzhen
Anduofu Industrial Development Co., Ltd. and Shandong Lierkang Disinfection Technology Co., Ltd.
The main drafters 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, Gao Qiong.
Hygienic requirements for hand disinfectants
1 Scope
This standard specifies the technical requirements, inspection methods, use methods, label instructions and precautions for hand disinfectants.
This standard applies to hand disinfection made with iodine, alcohols, guanidines, quaternary ammonium salts, phenols, and water or ethanol as solvents
Disinfectant.
This standard does not apply to disinfectants used for skin disinfection.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB 15982 Hygienic standard for hospital disinfection
Pharmacopoeia of the People's Republic of China (2005)
Disinfection Technical Specifications Ministry of Health
Ministry of Health
Disinfection product label manual management regulations Ministry of Health
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Hand disinfection handantisepsis
The process of killing or removing pathogenic microorganisms in the hand and meeting the disinfection requirements. Can be divided into sanitary hand disinfection and surgical hand disinfection.
3.2
Hand antiseptic agent
Chemical preparation applied to hand disinfection.
3.3
Hygienic handantisepsis
The process of preventive disinfection of hands.
3.4
Surgical hand disinfection surgical handantisepsis
The process of disinfection of medical staff hands and forearms before surgery.
4 Technical requirements
4.1 Raw material requirements
4.1.1 The raw materials should meet the quality requirements of the "Pharmacopoeia of the People's Republic of China", medical grade, food grade or chemically pure, and industrial grade should not be used.
4.1.2 The formulation shall not contain various prescription drug ingredients such as hormones, antibiotics, antifungal drugs and prohibited substances prescribed by the Ministry of Health.
4.1.3 Use deionized or distilled water for production water.
4.2 Product quality requirements
4.2.1 Sensory traits
The disinfectant is not evenly layered, there is no precipitation and suspended matter, and there is no odor.
4.2.2 Physical and chemical indicators
4.2.2.1 Quality standards
The physical and chemical indicators such as the effective ingredient content and pH value of the disinfectant comply with the product quality standards. Product validity period ≥ 12 months.
4.2.2.2 Active ingredient limits
The effective content of guanidine disinfectant should be ≤4.5%, benzalkonium bromide or benzalkonium chloride ≤0.5%, 2,4,4'-trichloro-2'-hydroxydiphenylpropyl ether
≤2.0%.
4.2.2.3 Impurity limits
Lead <40mg/L, mercury <1mg/L, arsenic <10mg/L.
4.2.3 Killing microorganism index
The index of killing microorganisms shall meet the requirements of Table 1.
Table 1 Microbial kill indicators
Microbial species
Action time
min
Kill log
Hygienic hand disinfection surgical hand disinfection suspension method carrier method
E. coli 8099 1.0 3.0 ≥5.00 ≥3.00
Staphylococcus aureus
ATCC6538
1.0 3.0 ≥5.00 ≥3.00
Candida albicans
ATCC10231
1.0 3.0 ≥4.00 ≥3.00
Natural bacteria 1.0 3.0 ≥1.0
4.2.4 Toxicological safety requirements
The toxicological indicators of hand disinfectants are shown in Table 2.
Table 2 Toxicological indicators
Project judgment index
Acute oral toxicity test is actually non-toxic or low-toxic
Multiple complete skin irritation tests without irritation or mild irritation
Subacute toxicity test (repeated use) No toxic effects observed
Mutagenicity test negative
4.2.5 Expiration date after opening the bottle
4.2.5.1 The effective content of disinfectant shall not be lower than the lower limit of the marked effective content of the finished product within the valid period of use.
4.2.5.2 The service life of volatile alcohol products after opening is no more than 30d.
4.2.5.3 The service life of non-volatile products after opening is no more than 60 days.
5 Inspection methods
5.1 Examination of sensory traits
Check the color and clarity of the disinfectant by visual inspection.
5.2 Physical and chemical indicators
5.2.1 pH value determination
Measure according to the relevant methods in the "Disinfection Technical Specification".
5.2.2 Active ingredient content
According to "disinfection technical specifications" and national standards and other relevant methods for determination.
5.2.3 Stability test
Measure according to the relevant methods in the "Disinfection Technical Specification".
5.2.4 Determination of lead, mercury and arsenic limits
Measure according to the relevant method of "Cosmetics Hygiene Specification".
5.3 Microbial killing test
Measure according to the relevant methods in the "Disinfection Technical Specification".
5.4 Toxicological safety test
Measure according to the relevant methods in the "Disinfection Technical Specification".
6 How to use
6.1 Sanitizing hands
Take an appropriate amount of hand disinfectant on the palm of your hand and rub your hands together to evenly coat each part for 1.0 mi......
Related standard:   GB 27950-2020  GB 27948-2020
Related PDF sample:   GB 27950-2020  GB 27948-2020
   
 
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