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GB 27950-2011
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 59
Hygienic requirements for hand antiseptic agents
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.
......
(Above excerpt was released on 2020-04-25, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/GB27950-2011