GB/T 26371-2020Hygienic requirements for peroxide disinfectants (English PDF)

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).

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

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

7 Use method

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