GB 27950-2020 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 27950-2020 | English | 145 |
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General requirements for hand disinfectant
| Valid |
| GB 27950-2011 | English | 70 |
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Hygienic requirements for hand antiseptic agents
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: GB 27950-2020
GB 27950-2020: General requirements for hand disinfectant---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/GB27950-2020
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Replacing GB/T 27950-2011
General requirements for hand disinfectant
Issued on. APRIL 09, 2020
Implemented on. NOVEMBER 01, 2020
Issued by. State Administration of Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 5
4 Requirements for raw material... 6
5 Technical requirements... 7
6 Inspection methods... 8
7 Method of use... 9
8 Identification... 9
Appendix A (Normative) Testing method of validity period of use after product
put into use... 11
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 replaces GB 27950-2011 "Hygienic requirements for hand
disinfectants". Compared with GB 27950-2011, the main technical changes of
this standard are as follows.
- ADD normative references;
- In terms and definitions, ADD the "Quick-dry hand disinfectant" and
"Disposable hand disinfectant";
- MODIFY the requirements for raw material;
- MODIFY the technical requirements;
- MODIFY the inspection method;
- MODIFY the surgical hand disinfection method to perform in accordance
with WS/T 313.
- ADD the normative appendix A "Method for testing the validity period of
products after use".
This standard was proposed by and shall be under the jurisdiction of the
National Health Commission of the People's Republic of China.
Drafting organizations of this standard. Hunan Provincial Center for Disease
Control and Prevention, Xiangya Hospital of Central South University,
Comprehensive Supervision Bureau of Hunan Provincial Health Commission,
Anhui Academy of Medical Sciences, Institute of Environmental and Health-
related Product Safety of Chinese Center for Disease Control and Prevention,
Zhejiang Provincial Diseases Prevention and Control Center, Chinese People's
Liberation Army Air Force Medical Center, Shenzhen Center for Disease
Control and Prevention, Xinjiang Uygur Autonomous Region Center for Disease
Control and Prevention, Turpan City Center for Disease Control and Prevention,
Peking University First Hospital, Changsha First Hospital, General People's
Liberation Army Hospital, Shaoshan People's Hospital, Shaoshan Health
Center.
The main drafters of this standard. Chen Guiqiu, Xu Qinghua, Wu Anhua, Li
Aibin, Chen Peihou, Ban Haiqun, Hu Guoqing, Cao Jingui, Zhu Zili, Yin Jin,
Song Jiangnan, Gao Qiong, Li Shikang, Yi Liang, Yang Hongcai, Song Yan,
Guan Xiaodong, Li Liuyi, Pan Huiqiong, Guo Xiaomin, Zhao Zhihong, Nie
Xinzhang, Huang Yehui, Liu Aibing, Shi Shaoyi, Song Hengzhi, Mo Jiwei, Liu
Xuejun, Guo Jiguang, Zhang Zhichao, Fang Weizheng, Zhou Hailin.
This standard replaces the standard previously issued as follows.
- GB 27950-2011.
General requirements for hand disinfectant
1 Scope
This standard specifies the raw material requirements, technical requirements,
inspection methods, methods of use, identification of hand disinfectants.
This standard applies to disinfectants for sanitary hand disinfection and surgical
hand disinfection.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 15982 Hygienic standard for disinfection in hospitals
WS/T 313 Standard for hand hygiene for healthcare workers in healthcare
settings
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Hand antisepsis
Treatment process of killing or removing hand microorganisms and
achieving a harmless state.
Note. It can be divided into sanitary hand antisepsis and surgical hand
antisepsis.
3.2
Hand disinfectant
Chemical preparation applied to hand antisepsis.
3.3
Alcohol-based hand rub
Hand disinfectant containing alcohol and skin care ingredients.
3.5
Hygienic hand antisepsis
The process of rubbing your hands with a hand disinfectant to reduce the
temporary bacteria in the hands.
3.6
Surgical hand antisepsis
The process that, before the surgery, the medical staff rubbed and washed
hands with running water and hand washing liquid, then used hand
disinfectant to remove or kill temporary resident bacteria and reduce resident
bacteria.
4 Requirements for raw material
4.1 The raw materials shall meet the quality requirements of the
Pharmacopoeia of the People's Republic of China (2015 edition) or medical
grade or food grade or other corresponding standards.
5 Technical requirements
5.1 Active ingredient content
The content of active ingredients shall meet the requirements of national
standards or quality standards of the corresponding products.
5.2 pH value
The pH value of the hand disinfectant shall be within ± 1 of the marked value.
5.3 Validity period
5.4 Microbial kill indicator
The effect of microbial killing indicators according to the characteristics of the
hand disinfectant product shall meet the requirements of Table 1.
5.5 Safety index
5.5.1 Toxicological requirements
The toxicological indicators are as shown in Table 2.
5.5.2 Limit requirements for lead, arsenic, mercury
Lead < 10 mg/kg, arsenic < 2 mg/kg, mercury < 1 mg/kg.
5.5.3 Requirements for banned substances
Hand disinfectant formulations must not add hormones, antibiotics, antifungal
drugs and their namesake ingredients [except for the disinfection and antiseptic
drugs as listed in the Pharmacopoeia of People's Republic of China (2015
edition)] and the banned substances prescribed by the national health and
health authorities.
6 Inspection methods
6.1 Active ingredient content
It is determined according to the "Technical specifications for disinfection "
(2002 edition) and national standards and other relevant methods.
6.2 pH
It is determined according to the method of "Technical specifications for
disinfection" (2002 edition)
6.3 Validity period
6.4 Microbial killing test
Carry out the test according to "Technical specifications for disinfection" (2002
edition).
6.5 Safety index testing
6.5.1 Toxicological safety test
Carry out the test according to "Technical specifications for disinfection" (2002
edition).
6.5.2 Determination of lead, arsenic, mercury content
7 Method of use
7.1 Hygienic hand antisepsis method
Take an appropriate amount (about 2.0 mL) of hand disinfectant on the palm.
Rub your hands together to evenly coat each part. Rub and disinfect for 1.0 min.
8 Identification
8.1 The marking shall comply with the provisions of GB/T 191.
8.2 The label and instruction manual shall mark the validity period of the product
and the validity period after the product is put into use.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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