GB/T 26373-2020 PDF English
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| GB/T 26373-2020 | English | 105 |
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Hygienic requirements for alcohol-based disinfectant
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| GB 26373-2010 | English | 70 |
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[GB/T 26373-2010] Hygienic standard for alcohol disinfectants
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GB/T 26373-2020: PDF in English (GBT 26373-2020) GB/T 26373-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Replacing GB/T 26373-2010
Hygienic requirements for alcohol-based disinfectant
ISSUED ON: JUNE 02, 2020
IMPLEMENTED ON: DECEMBER 01, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Raw material requirements ... 6
5 Technical requirements ... 7
6 Application scope ... 8
7 Use methods ... 8
8 Packaging, transportation and storage ... 9
9 Symbols, labels and instructions ... 9
10 Inspection methods ... 9
Annex A (normative) Test method of ethanol and iso(n-)propanol content ... 11
Hygienic requirements for alcohol-based disinfectant
1 Scope
This Standard specifies the raw material requirements, technical requirements,
application scope, use method, packaging, transportation and storage, symbols,
labels and instructions, and inspection methods of alcohol-based disinfectants.
This Standard applies to alcohol-containing disinfectants made with ethanol
and/or iso(n-)propanol as germicidal ingredient, and disinfectants in which
ethanol and/or iso(n-)propanol are compatible with surfactants and skin care
ingredients.
This Standard does not apply to disinfectants that are compounded with ethanol
or iso(n-)propanol and other germicidal ingredients, and disinfectants that use
ethanol or iso(n-)propanol as solvents.
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/T 191 Packaging - Pictorial marking for handling of goods
GB/T 27949 Hygienic requirements for medical items disinfection
GB 27950 General requirements for hand disinfectant
GB 27951 Hygiene requirements for skin disinfectant
GB 27952 General requirements for ordinary objects surface disinfectant
GB 31640 National Food Safety Standard - Edible Alcohol
GB/T 38499 Evaluation method for stability of disinfectant
WS 310.2 Central sterile supply department (CSSD) - Part 2: Standard for
operating procedure of cleaning, disinfection and sterilization
WS/T 535 Rapid detection methods on site for disinfectant used in medical
and health institutions
5 Technical requirements
5.1 Physical and chemical indicators
5.1.1 pH value
The pH value shall comply with the provisions of product quality standards.
5.1.2 Active ingredient content
5.1.2.1 Ethanol disinfectant
The ethanol content shall not be less than 60 % (volume fraction) or 52 % (mass
fraction); ±10 % of the active ingredient content shall comply with the labeling
amount.
5.1.2.2 iso(n-)propanol disinfectant
The iso(n-)propanol content shall not be less than 60 % (volume fraction) or
50 % (mass fraction); ±10 % of the active ingredient content shall comply with
the labeling amount.
5.1.2.3 Compound alcohol disinfectant
The total content of compound alcohol shall not be less than 60 % (volume
fraction) or 50 % (mass fraction); ±10 % of the active ingredient content shall
comply with the labeling amount.
5.1.3 Stability
The product validity period shall be ≥12 months.
5.2 Microorganisms killing indicator
5.2.1 For hygienic hand disinfection and surgical hand disinfection, the
microorganisms killing indicator shall comply with the provisions of GB 27950.
5.2.2 For skin disinfection, the microorganisms killing indicator shall comply
with the provisions of GB 27951.
5.2.3 For ordinary objects surface disinfection, the microorganisms killing
indicator shall comply with the provisions of GB 27952.
5.2.4 For medical items disinfection, the microorganisms killing indicator shall
comply with the provisions of GB/T 27949.
8 Packaging, transportation and storage
8.1 The packaging shall be sealed.
8.2 Measures such as sun protection, rain protection, flame proof and explosion
proof shall be adopted during transportation; it shall not be transported with
toxic, harmful, flammable and explosive items or items that affect product
quality. It shall avoid turning upside down when loading and unloading.
8.3 The storage shall be protected from light; it shall be placed in a cool, dry
and ventilated place.
9 Symbols, labels and instructions
9.1 The packaging symbols shall comply with the provisions of GB/T 191.
9.2 The labels and instructions shall comply with the provisions of relevant
specifications and standards on the labels and instructions of disinfection
products.
9.3 Product precautions should have the following content:
a) Use with caution if you are allergic to alcohol-containing preparations;
b) Disinfectant for external use, do not take it orally, and place it in a place
that is out of reach of children;
c) Flammable, keep away from fire;
d) Not suitable for air disinfection;
e) Not suitable for the disinfection of the surface of fat-soluble objects;
f) Use original solution, should not use after dilution.
10 Inspection methods
10.1 pH value
Test according to “Disinfection Technical Specifications” (2002 edition).
10.2 Active ingredient content
When the specific gravity method is applicable, the ethanol content is tested
according to WS/T 535. When the specific gravity method is not applicable, the
Annex A
(normative)
Test method of ethanol and iso(n-)propanol content
A.1 Test method of ethanol content
A.1.1 General
The detection limit of this method is 0.03 %, the linear range of the method is
0.3 % ~ 2.0 %, the recovery rate of six additions is 98 % ~ 101 %, and the
average recovery rate of addition is 99.5 %.
A.1.2 Chromatographic reference conditions
A.1.2.1 Chromatographic column
2.0 m × 4 mm glass column; stationary phase: GDX-102 0.2 mm ~ 0.3 mm (60
mesh to 80 mesh); column temperature: 180 °C; sample inlet temperature and
detector temperature: 230 °C; carrier gas (N2) flow rate: 45 mL/min; hydrogen
flow rate: 45 mL/min; air flow rate: 450 mL/min.
A.1.2.2 Capillary column
DW-WAX: 30 m × 0.32 mm × 0.25 μm; column temperature: 60 °C, maintain
for 10 min; column inlet: 230 °C, detector temperature: 230 °C, carrier gas (N2)
flow rate: 1.0 mL/min; hydrogen flow rate: 40 mL/min; air flow rate: 400 mL/min;
split ratio: 60:1.
A.1.3 Preparation of standard solution
A.1.3.1 Volume fraction standard solution: prepare ethanol standard series with
ethanol concentration (in volume fraction) of 0.1 %, 0.2 %, 0.3 %, 0.5 %, 1.0 %
and 2.0 % respectively.
A.1.3.2 Mass concentration standard solution: prepare ethanol standard series
with ethanol mass concentration of 1 g/L, 2 g/L, 3 g/L, 5 g/L, 10 g/L and 20 g/L
respectively.
A.1.4 Content determination
A.1.4.1 Carry out pre-treatment of samples as needed.
A.1.4.2 For low-viscosity solution samples, it may take a certain volume, and
dilute with pure water before test. For other samples, it shall take a certain mass,
and test after made to constant volume with pure water.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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