GB/T 26373-2020_English: PDF (GB/T26373-2020)
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Hygienic requirements for alcohol-based disinfectant
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[GB/T 26373-2010] Hygienic standard for alcohol disinfectants
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Standard ID | GB/T 26373-2020 (GB/T26373-2020) | Description (Translated English) | Hygienic requirements for alcohol-based disinfectant | Sector / Industry | National Standard (Recommended) | Classification of Chinese Standard | C50 | Classification of International Standard | 11.080 | Word Count Estimation | 10,121 | Date of Issue | 2020-06-02 | Date of Implementation | 2020-12-01 | Drafting Organization | Zhejiang Provincial Center for Disease Control and Prevention, China Center for Disease Control and Prevention, Environmental and Health-related Product Safety Institute, National Health Commission Health Supervision Center, Shanghai Center for Disease Control and Prevention, Shanghai Municipal Health Commission Supervision Institute, Hunan Provincial Center for Disease Control and Prevention , Heilongjiang Provincial Center for Disease Control and Prevention, Shenzhen Center for Disease Control and Prevention, Guangzhou Customs Technical Center | Administrative Organization | National Health Commission of the People's Republic of China | Proposing organization | National Health Commission of the People's Republic of China | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration | Standard ID | GB 26373-2010 (GB26373-2010) | Description (Translated English) | [GB/T 26373-2010] Hygienic standard for alcohol disinfectants | Sector / Industry | National Standard | Classification of Chinese Standard | C59 | Classification of International Standard | 11.080 | Word Count Estimation | 9,950 | Date of Issue | 2011-01-14 | Date of Implementation | 2011-06-01 | Quoted Standard | GB/T 191; GB 10343; Chinese Pharmacopoeia (two)2010 edition; Ministry of Health disinfection technical specifications; Ministry of Health disinfection product label instructions Practices 2005 Edition | Drafting Organization | Zhejiang Province Center for Disease Control | Administrative Organization | Ministry of Health | Regulation (derived from) | Announcement of Newly Approved National Standards No. 2 of 2011 (No. 167 overall) | Proposing organization | People's Republic of China Ministry of Health | Issuing agency(ies) | Ministry of Health of People's Republic of China; Standardization Administration of China | Summary | This Chinese standard specifies the ethanol disinfectant materials and technical requirements, scope of application, use, test methods, marking and packaging, transport and storage, labeling and instructions and precautions. This standard applies to alcohol as the main raw material of ethanol disinfectant, including ethanol and surfactants, food coloring, skin care ingredients and food flavors such as compatibility of disinfectant. This standard does not apply to alcohol and other ingredients mixed bactericidal disinfectant, does not apply to ethanol as solvent disinfectant. |
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.
......
GB 26373-2010 (GB/T 26373-2010)
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 59
GB 26373-2010
Hygienic Standard for Alcohol Disinfectants
ISSUED ON: JANUARY 14, 2011
IMPLEMENTED ON: JUNE 01, 2011
Issued by: Ministry of Health of PRC;
Standardization Administration of PRC.
It is converted into recommended standard according to No.7
announcement of Standardization Administration of PRC in 2017
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Requirements for Raw Materials ... 4
4 Technical Requirements ... 5
5 Application Scope ... 6
6 Use Methods ... 6
7 Inspection Methods ... 6
8 Marking and Packaging ... 7
9 Transportation and Storage ... 7
10 Labels and Instruction Manual ... 7
11 Precautions ... 7
Appendix A (Normative) Alcohol Disinfectant Stability and Test Method of
Alcohol Content ... 8
Hygienic Standard for Alcohol Disinfectants
1 Scope
This Standard specifies the raw material requirements and technical requirements,
application scope, use methods, inspection methods, marking and packaging,
transportation and storage, labeling and instruction manual and precautions for alcohol
disinfectants.
This Standard is applicable to alcohol disinfectants made with alcohol as the main raw
material, including disinfectants compatible BETWEEN alcohol AND surfactants, food
colorants, skin care ingredients, and food flavors.
This Standard is not applicable to the disinfectant compounded with alcohol and other
germicidal ingredients, nor is it applicable to disinfectants using alcohol as a solvent.
2 Normative References
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments
(excluding corrigendum) or revisions do not apply to this Standard, however, parties
who reach an agreement based on this Standard are encouraged to study if the latest
versions of these documents are applicable. For undated references, the latest edition
of the referenced document applies.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
GB 10343 Edible Alcohol
Pharmacopoeia of the People's Republic of China: Volume II (2010 Edition)
Technical Standard for Disinfection by the Ministry of Health of PRC
Management Practices for Label and Instruction Book of Disinfection Products by the
Ministry of Health of PRC (2005 Edition)
3 Requirements for Raw Materials
3.1 The alcohol used in the formula shall meet the requirements of "Alcohol" in the
See Appendix A.
7.2 Inspection of alcohol (C2H6O) content
See Appendix A.
7.3 Test of disinfection effect
Inspection shall be conducted in accordance with the provisions of the Technical
Standard for Disinfection by the Ministry of Health of PRC.
8 Marking and Packaging
Packaging marks shall comply with the provisions of GB/T 191; and the used
containers and materials shall comply with the corresponding sanitary standards and
relevant regulations.
9 Transportation and Storage
During transportation, there should be measures such as sun protection and rain
protection; it must not be mixed and transported with toxic, harmful, flammable and
explosive goods, or those that affect the quality of the product. Handling upside down
shall be avoided.
10 Labels and Instruction Manual
It shall meet the requirements of the Management Practices for Label and Instruction
Book of Disinfection Products by the Ministry of Health of PRC (2005 Edition).
11 Precautions
11.1 Disinfectant for external use must not be taken orally. Keep out of reach of children.
11.2 Flammable, keep away from sources of ignition.
11.3 Use with caution for those allergic to alcohol.
11.4 Protect from light and store in a cool, dry and ventilated place.
11.5 It should not be suitable for disinfecting the surface of fat-soluble objects.
......
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