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GB 27950-2020: General requirements for hand disinfectant
GB 27950-2020
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 
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
Pharmacopoeia of the People's Republic of China (2015 edition)
Technical specifications for cosmetic safety (2015 edition)
Technical specification for disinfection (2002 edition) [Ministry of Health
(WJF [2002] No.282)]
Hygienic code for disinfection products manufacturers (2009 edition)
[Ministry of Health (WJF [2009] No.53)]
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.
Note: The dosage form includes liquid, gel, foam.
3.4
Waterless antiseptic agent
Hand disinfectant which is mainly used for disinfection of surgical hands and
does not need to be washed with water after disinfection.
Note: The dosage form includes liquid, gel, foam.
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
Carry out the test according to "Technical specifications for disinfection" (2002
edition).
6.5.2 Determination of lead, arsenic, mercury content
6.5.2.1 Lead
It is tested according to the test method of " Technical specifications for
cosmetic safety " (2015 edition).
6.5.2.2 Arsenic
It is tested according to the test method of " Technical specifications for
cosmetic safety " (2015 edition).
6.5.2.3 Mercury
It is tested according to the test method of " Technical specifications for
cosmetic safety " (2015 edition).
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.
7.2 Surgical hand antisepsis method
The surgical hand antisepsis method shall be carried out according to the
requirements of WS/T 313.
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. It shall comply with the
relevant codes and standards of the label instruction manual of the disinfected
product.
8.3 At the same time, the product manual shall indicate the precautions:
a) Disinfectant for external use shall not be taken orally and shall be placed
out of the reach of children;
b) Avoid use with antagonists;
Appendix A
(Normative)
Testing method of validity period of use after product put into use
A.1 Purpose
Observe the validity period of use of the hand disinfectant product after it is put
into use.
A.2 Scope of application
This test method is applicable to the test of the validity period of use of the hand
disinfectant product after it is put into use.
A.3 Test equipment
Biosafety cabinet or clean laboratory (cleanliness level above 1000), graduated
pipette (1.0 mL, 2.0 mL, 5.0 mL), diluent, nutrient agar medium, plate,
neutralizer, electric mixer, content testing instrument, as shown in the
corresponding standard method or "Technical specification for disinfection"
(2002 edition).
A.4 Test method
A.4.1 Select the representative room (in the hospital or simulated hospital
conditions) as the test room. Take 3 batches, 3 bottles per batch, totally 9 bottles
of disinfectants which had finalized package. Place them in the test room. Use
hand disinfectant 5 times a day for 5 time periods, each time interval is about 1
h. The amount and method of use is according to the product instructions (when
the disinfectant balance is less than 10%, stop taking samples). At the day 0 ,
the day (T - 30), the day T (T is the effective period of use after the product is
put into longest use in the instruction manual), respectively, use 2 sterilized test
tubes for aseptic operation to take 2 mL. Number it and fill in the sampling
record. Send it to the laboratory within 4 h for testing. One sample is used to
test the total number of bacteria, whilst the other sample is used to test the
content of active ingredients in the disinfectant.
A.4.2 In the biosafety cabinet or clean laboratory, follow the requirements of GB
15982 to test the total number of bacteria; take the average value as result.
Follow the corresponding standard of the disinfection product or "Technical
specification for disinfection" (2002 edition), to test the content of the active
ingredient; take the average value as result. Calculate the rate of decline in
active ingredients.