GB/T 26373-2020Hygienic requirements for alcohol-based disinfectant (English PDF)

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.

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 […]

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. […]