GB/T 26371-2020 PDF English
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GB/T 26371-2020 | English | 110 |
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Hygienic requirements for peroxide disinfectants
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GB 26371-2010 | English | 279 |
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[GB/T 26371-2010] Hygienic standard for peroxide disinfectants
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GB/T 26371-2020: PDF in English (GBT 26371-2020) GB/T 26371-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Replacing GB/T 26371-2010
Hygienic requirements for peroxide disinfectants
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 ... 7
5 Technical requirements ... 7
6 Scope of application ... 9
7 Use method ... 9
8 Packaging, transportation and storage ... 10
9 Labeling requirements ... 10
10 Test method ... 11
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces GB/T 26371-2010, “Hygienic standard for peroxide
disinfectants”. Compared with GB/T 26371-2010, the major changes of this
Standard are as follows:
-- Modify the scope of the standard (see Chapter 1; Chapter 1 of version
2010);
-- Modify normative references (see Chapter 2; Chapter 2 of version 2010);
-- Modify some terms and definitions (see Chapter 3; Chapter 3 of version
2010);
-- Modify the requirements for raw material glacial acetic acid (see Chapter
4; Chapter 4 of version 2010);
-- Modify the product active ingredient content index and product stability
index (see Chapter 5; 5.2 of version 2010);
-- Add the product pH index, and the index requirements for lead, arsenic,
and mercury when hydrogen peroxide is used for disinfection of mucous
membrane (see 5.2);
-- Add the microbial killing indicators when sterilizing medical devices (see
5.3);
-- Modify the technical requirements for air disinfection and killing of
microorganisms (see Chapter 5; 5.3 of version 2010);
-- Modify the provisions of the scope of application (see Chapter 6; Chapter
6 of version 2010);
-- Add the content of the use method (see Chapter 7);
-- Add labeling requirements (see Chapter 9).
This Standard is proposed and managed by the National Health Commission
of the People's Republic of China.
The drafting organizations of this Standard: Chinese People's Liberation Army
Center for Disease Control and Prevention, Heilongjiang Provincial Center for
Disease Control and Prevention, Guangdong Provincial Center for Disease
Control and Prevention.
Hygienic requirements for peroxide disinfectants
1 Scope
This Standard specifies the raw material requirements, technical requirements,
application scope, use methods, packaging, transportation and storage,
labeling requirements and inspection methods of peroxide disinfectants.
This Standard applies to liquid disinfectants whose main active ingredients are
hydrogen peroxide and peracetic acid.
This Standard does not apply to peroxide disinfectants that are used in
conjunction with devices or equipment such as heating, pressurization, and
vaporization.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
GB 190, Packing symbol of dangerous goods
GB/T 191, Packaging - Pictorial marking for handling of goods
GB/T 610, Chemical reagent - General method for the determination of
arsenic
GB/T 1616, Hydrogen peroxide for industrial use
GB/T 9728, Chemical reagent - General method for the determination of
sulphate
GB/T 9735, Chemical reagent - General method for the determination of
heavy metals
GB 15258, General rules for preparation of precautionary label for chemicals
GB 15603, Rule for storage of chemical dangers
GB 15981, Evaluating method and standard for the efficacy of disinfection
and sterilization
The surface of various appliances, articles and facilities for public places and
house.
Note: Public places include schools, kindergartens, medical and health
institutions.
4 Raw material requirements
4.1 Glacial acetic acid: The common subject surface disinfection, air
disinfection, industrial disinfection, and disinfection for infectious focus shall
comply with industrial-level regulations; the medical device disinfection shall
comply with the regulations of the “Pharmacopoeia of the People’s Republic of
China” (2015 edition).
4.2 Hydrogen peroxide shall meet the requirements of GB/T 1616.
4.3 Peracetic acid shall meet the requirements of GB/T 19104.
4.4 The production water shall meet the requirements in the “Pharmacopoeia
of the People's Republic of China” (2015 edition) for purified water, or meet the
relevant standards or regulations such as the “Sanitary Standards for
Disinfection Product Manufacturers” (2009 edition).
5 Technical requirements
5.1 Appearance
Colorless or light-yellow liquid, no layering, no precipitation. Products that
contain peracetic acid have a pungent odor and an acetic acid odor.
5.2 Physical and chemical indicators
The hydrogen peroxide disinfectant shall meet the requirements of Table 1.
Hydrogen peroxide and peracetic acid compound disinfectant is calculated as
peracetic acid. The peracetic acid disinfectant shall meet the requirements of
Table 2.
Stability: valid period ≥ 12 months. Accelerated test or natural storage test; the
reduction rate of active ingredient content is ≤15%, and shall not be lower than
the lower limit of the marked value in this Standard.
Table 1 -- Physical and chemical indexes of hydrogen peroxide
disinfectant
Item Index
Hydrogen peroxide (based on H2O2) 85% ~ 115% of the marked value
7.5 Food processing tools and devices disinfection
Perform in accordance with relevant disinfection standards or specifications
such as “Disinfection technical specifications” (2002 edition).
7.6 Medical device disinfection, dialysis machine pipeline cleaning and
disinfection, dialyzer sterilization, endoscope disinfection and
sterilization
Perform in accordance with the methods that are specified in relevant national
standards or specifications, such as GB/T 27949, WS/T 367, and product
instructions.
7.7 Disinfection for infectious focus
Perform in accordance with GB 19193, GB 27953 and other regulations.
8 Packaging, transportation and storage
8.1 The packaging of peracetic acid shall comply with the packaging regulations
for dangerous goods and comply with the regulations of GB 19105. Use dark
(or opaque) polyethylene plastic barrels or plastic-lined tankers for packaging;
the lid of the packaging container shall have ventilated air vents that do not leak
liquid.
8.2 The peroxide disinfectants shall be transported in accordance with the
requirements of transport vehicles that are classified in the “Catalog of
Dangerous Chemicals”. During transportation, they shall be protected from
sunlight or heat, and cannot be mixed with flammable products and reducing
agents.
8.3 The peroxide disinfectants shall meet the relevant regulations in GB 15603.
They shall be stored in a ventilated, dark and cool warehouse, and stored in
accordance with corresponding chemical storage regulations.
9 Labeling requirements
9.1 Product label and manual
It shall comply with relevant specifications and standards for label and manual
of disinfection products.
9.2 Labeling on the package of peroxide disinfectants
...... Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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