GB/T 27728.3-2024Wet wipes and similar products - Part 3: Particular requirements for disinfection wet wipes (English PDF)

1 Scope

The document sets the requirements, the inspection rules and the requirements for marking, packaging, transport and storage of disinfection wet wipes, defines the related terms, gives the product classification and describes the matching test methods.

It applies to the production, inspection and sale of disinfection wet wipes for everyday use made from non-woven fabric, airlaid paper or other raw materials. It does not apply to disinfection wet wipes for medical settings or for medical devices.

3 Terms and definitions

Disinfection is the killing or removal of pathogenic micro-organisms on a transmission medium so that the medium becomes harmless. Sterilization is the killing or removal of all micro-organisms on a transmission medium. A disinfectant is a preparation used to kill micro-organisms on a transmission medium so that the disinfection or sterilization requirement is met. The three definitions are taken from the 2002 edition of the Technical Standard for Disinfection.

An object surface means the general surfaces of places such as schools, childcare institutions, public places and homes, together with walls and floors. A note lists everyday items whose surfaces are covered: tables and chairs, bedside cabinets, sanitary fittings, door and window handles, stair rails, bus seats and grab handles, and children's toys.

A disinfection wet wipe is a wet wipe carried on non-woven fabric, textile, wood pulp composite, wood pulp paper or similar material, to which production water, a disinfectant and other auxiliary ingredients are added in suitable quantity, and which disinfects, cleans and kills germs on the object it treats, such as the hands, the skin or an object surface.

The killing log value is the reduction in the number of micro-organisms between before and after disinfection when that number is expressed as a logarithm; the definition is taken from the 2002 edition of the Technical Standard for Disinfection.

4 Product classification

By the object they are used on, disinfection wet wipes fall into wipes for the human body and wipes for object surfaces.

5.1 General requirements and raw materials

The general requirements for disinfection wet wipes follow GB/T 27728.1.

A wipe for the human body does not use recovered or waste material as its carrier. The disinfectant used in any disinfection wet wipe is of non-industrial grade, except where no non-industrial grade exists; the disinfectant of a wipe for the human body meets GB 27951 and the disinfectant of a wipe for object surfaces meets GB 27952. Substances prohibited in a disinfectant follow GB 38850.

5.2.2 Inherent quality

Table 1 fixes the inherent quality of a wipe for the human body: liquid content not less than 1.7 times; pH value 3.5 to 8.5; lead not more than 10 mg/kg, arsenic not more than 2.0 mg/kg, cadmium not more than 5.0 mg/kg and mercury not more than 1.0 mg/kg; methanol, benzene, toluene and xylene each not more than 20 mg/kg; migratable fluorescent substances absent; formaldehyde not more than 75.0 mg/kg; methylisothiazolinone and methylchloroisothiazolinone not detected; the sum of dibutyl phthalate, benzyl butyl phthalate and di(2-ethylhexyl) phthalate not more than 0.001 2 %; and acrylamide not more than 0.1 mg/kg. Two footnotes state that liquid content is assessed only on a disinfection wet wipe made from non-woven fabric, and that where the package label or the instructions carry a declared value the pH lies within 1.0 unit of the declared centre value.

Table 2 fixes the inherent quality of a wipe for object surfaces. Liquid content, the four heavy metals, methanol, benzene, toluene, xylene, migratable fluorescent substances and formaldehyde carry the same limits as in Table 1. Metal corrosivity is added: practically no corrosion on stainless steel, and practically no corrosion or slight corrosion on carbon steel, aluminium and copper. Two footnotes state that liquid content is assessed only on a wipe made from non-woven fabric, and that metal corrosivity is assessed only on a wipe used on metal object surfaces, a wipe intended for a specific metal surface being assessed on that material alone.

5.2.3 Microbiological indicators

Table 3 fixes the microbial contamination indicators: total bacterial colony count not more than 20 CFU/g; coliforms not detected; the pyogenic pathogens Pseudomonas aeruginosa, Staphylococcus aureus and haemolytic streptococci not detected; total fungal colony count not detected.

A disinfection wet wipe is tested against the micro-organisms matching the field of use and the class of micro-organism declared on its label or in its instructions, and where the label claims action against other specified micro-organisms the matching killing test is also run.

Table 4 fixes the microbicidal indicators against the object of disinfection. For Staphylococcus aureus the test is compulsory for the hands, the skin and object surfaces. For Escherichia coli it is compulsory for the hands and object surfaces and optional for the skin. For Pseudomonas aeruginosa it is compulsory for the skin and optional for the hands and object surfaces. For Candida albicans and Aspergillus niger it is optional for all three objects. The killing log value for the three bacteria is not less than 5.0 by the suspension method and not less than 3.0 by the carrier method; for the two fungi it is not less than 4.0 by the suspension method and not less than 3.0 by the carrier method. Notes state that the suspension method and the carrier method are alternatives, and that a product labelled as killing pathogenic fungi is tested against Candida albicans and Aspergillus niger.

5.2.4 Active ingredient content, stability and toxicology

The active ingredient content matches the content declared on the label or in the instructions and lies within 10 % of the declared centre value; for a chlorine dioxide, peroxide or chlorine-releasing disinfectant it lies within 15 % of the declared centre value. Table 5 sets limits in grams per litre on restricted substances in the expressed liquid of a wipe for the human body: chlorhexidine gluconate or chlorhexidine acetate not more than 45; 2,4,4'-trichloro-2'-hydroxydiphenyl ether not more than 20; benzalkonium bromide or benzalkonium chloride not more than 5; other substances restricted by the State to conform to the rules laid down for them.

A stability test is run before a new product first reaches the market and whenever the raw materials or the production process change substantially. The shelf life is not less than one year, and within it Table 6 requires a liquid content of not less than 1.7 times, a fall in active ingredient content of not more than 10 %, and microbicidal indicators meeting 5.2.3.2. A footnote makes the fall in active ingredient content and the microbicidal indicators alternatives, the microbicidal test being run when the fall in active ingredient content does not conform.

A toxicological test is run before a new product first reaches the market and whenever the raw materials or the production process change substantially. Table 7 fixes the indicators. The acute oral toxicity test is compulsory for the hands, the skin and object surfaces, with the result practically non-toxic. The single complete skin irritation test is compulsory for the skin and object surfaces and optional for the hands; the repeated complete skin irritation test is compulsory for the hands and optional for the skin and object surfaces; both results are no irritation or slight irritation. One mutagenicity test is compulsory for all three objects, with a negative result. The skin sensitization test is optional for all three, with no reaction or a very slight reaction. Footnotes state that a product touching the skin in use takes the single test, that a product used repeatedly takes the repeated test which then replaces the single test, and that the gene mutation test and the chromosome aberration test are alternatives.

The wipe surface is clean and undamaged and carries no foreign matter and no stains.

6 Test methods

The general requirements are measured by the methods of GB/T 27728.1. The disinfectant of a wipe for the human body is measured by GB 27951 and that of a wipe for object surfaces by GB 27952.

Liquid content is measured on a specimen made up of one wipe taken with tweezers from each of the top, middle and bottom of one complete pack, or of the actual number of wipes where the pack holds fewer than three. The specimen is weighed at once on a balance reading to 0.01 g, rinsed with distilled or deionized water until free from foam, dried in an oven at 85 °C +/- 2 °C for 4 h without touching the oven walls, cooled to room temperature in a desiccator and weighed again. Liquid content is calculated by formula (1) and expressed as a multiple; in the legend t is the liquid content, m1 the mass before drying in grams and m0 the mass after drying in grams. Three specimens from three different complete packs are measured per sample and the arithmetic mean is taken, rounded to one decimal place.

The pH value is measured by the pH meter method of GB/T 1545-2008. The test liquid is prepared by squeezing the liquid from several wipes, with clean uncontaminated plastic gloves on, into a 50 mL glass beaker, in a quantity that wets the measuring electrode.

The four heavy metals are measured by 1.6 of Chapter 4 of the Safety and Technical Standards for Cosmetics, 2015 edition, with microwave digestion for sample preparation; one wipe is taken with tweezers from the middle layer of a multi-wipe pack, or the wipe of a single-wipe pack is taken directly, and the specimen is cut up before testing. Methanol, benzene, toluene and xylene are measured by the headspace method of GB/T 36985-2018. Migratable fluorescent substances are measured by Annex C of GB/T 27728.1-2024. Formaldehyde is measured by the high performance liquid chromatography method of GB/T 34448-2017. Methylisothiazolinone and methylchloroisothiazolinone are measured by GB/T 26517 or by item 4 of Chapter 4 of the Safety and Technical Standards for Cosmetics, 2015 edition, on the liquid part of the wipe alone, the cosmetics standard governing in arbitration. Phthalates are measured by GB/T 37860 and acrylamide by GB/T 37859.

Metal corrosivity is measured on the production liquid of a wipe used on metal object surfaces by 2.2.4 of the Technical Standard for Disinfection, 2002 edition. Microbial contamination indicators are measured by 2.1.11.2 of the same document. For the microbicidal indicators, enough sample is taken, the outer pack is opened, clean gloves are worn and the liquid is squeezed into a glass vessel in a quantity that meets the test; the suspension method or the carrier method of 2.1.1 of the same document is then applied according to the class of micro-organism declared on the label or in the instructions.

The active ingredient content is measured on the expressed liquid prepared as in 6.14; where the germicidal factor or the carrier adsorbs the germicidal factor, the production liquid may be used instead. 2,4,4'-trichloro-2'-hydroxydiphenyl ether is measured by Annex D of GB/T 27947-2020. The quaternary ammonium salts benzethonium chloride, benzalkonium bromide and benzalkonium chloride are measured by GB/T 26369 or by the Safety and Technical Standards for Cosmetics, 2015 edition, the latter governing in arbitration, and other quaternary ammonium salts by GB/T 39873. Guanidine disinfectants are measured by GB/T 26367, alcohol disinfectants by GB/T 26373, peroxide disinfectants by GB/T 26371, chlorine-releasing disinfectants by GB/T 36758 and chlorine dioxide disinfectants by GB/T 26366; other active ingredients follow the Technical Standard for Disinfection, 2002 edition, and the related standards, and an active ingredient that cannot be measured by a chemical method is not measured. A note states that the result for benzalkonium chloride is the sum of the results for dodecyl, tetradecyl and hexadecyl dimethyl benzyl ammonium chloride.

Stability is measured according to the shelf life declared on the label or in the instructions, by 2.2.3 of the Technical Standard for Disinfection, 2002 edition, or by the related standards, comparing liquid content, active ingredient content or microbicidal effect before and after storage; accelerated storage may follow GB/T 38499. Liquid content is measured by 6.3 and active ingredient content by 6.15; where no chemical method is available the microbicidal indicators are measured by 6.14.

For the toxicological tests, the acute oral toxicity test uses the expressed liquid prepared as in 6.14; the single and repeated complete skin irritation tests and the skin sensitization test use the product itself and the one mutagenicity test uses the expressed liquid, all following the matching methods of the Technical Standard for Disinfection, 2002 edition. Appearance quality is checked visually.

7 Inspection rules

Products are inspected batch by batch before delivery and leave the works only when they conform. Type inspection is run at least once every two years on products of the same raw material and process, and also when the raw material or process changes substantially, when a product is first put into production or production resumes after a stoppage of more than six months, and when the production site changes. Raw materials form the item of agreed inspection, covered by an inspection report from the enterprise or the raw material supplier, and inspected at the decision of the enterprise or by agreement between supplier and buyer.

Delivery inspection covers the routine items; type inspection covers the general requirement items and the particular requirement items other than raw materials. The general requirement items follow GB/T 27728.1, and the particular requirement items are listed in Table 8 for wipes for the human body and Table 9 for wipes for object surfaces, each table giving the item, whether it belongs to delivery inspection and to type inspection, and the clause numbers of the requirement and of the test method. In Table 8 the delivery inspection items are liquid content, pH value, migratable fluorescent substances and appearance quality; the other items, apart from stability and toxicology which belong to neither list, belong to type inspection. In Table 9 the delivery inspection items are liquid content, migratable fluorescent substances and appearance quality, with the same treatment of stability and toxicology.

A batch is the quantity of products of the same raw material, the same process and the same specification delivered at one time. For the microbiological indicators, enough units for the tests and for the retained sample are drawn at random from the batch. The other indicators are sampled by the double sampling plan of GB/T 2828.1, the sample unit being the carton. The acceptance quality limit is 4.0 for heavy metals, methanol, benzene, toluene, xylene, migratable fluorescent substances, formaldehyde, methylisothiazolinone, methylchloroisothiazolinone, phthalates, acrylamide, active ingredient content and stability, and 6.5 for liquid content, pH value, metal corrosivity and appearance quality. The plan is the normal double sampling plan at special inspection level S-3, set out in Table 10.

Table 10 sets, for each batch size in cartons, the first and second sample sizes and the acceptance and rejection numbers at the two acceptance quality limits. In the extracted text the rows and columns of this table could not be paired with certainty, so its figures are not reported here.

An item is judged conforming when it meets the matching clause: the general requirements against GB/T 27728.1, the inherent quality against 5.2.2, the microbial contamination indicators against 5.2.3.1, the microbicidal indicators against 5.2.3.2, the active ingredient content against 5.2.4, stability against 5.2.5, the toxicological indicators against 5.2.6 and appearance quality against 5.2.7; otherwise it is judged non-conforming.

A batch is judged non-conforming when any one of the microbicidal indicators, the microbial contamination indicators or the toxicological indicators does not conform. For the other indicators the first sample is of the size the plan gives: the batch is accepted when the number of non-conforming units found is not greater than the first acceptance number of Table 10 and rejected when it is not less than the first rejection number. Where the number falls between the two, the second sample of the size the plan gives is inspected and the non-conforming units of the two samples are added together; the batch is accepted when the cumulative number is not greater than the second acceptance number and rejected when it is not less than the second rejection number.

8 Marking, packaging, transport and storage

The sales package carries the product name including the words disinfection wet wipe; the product class and field of use, for example a wipe for the human body suitable for the hands and intact skin; the number of this document; the main raw materials, meaning the carrier, the production water, the disinfectant and other auxiliary ingredients, with the fibre composition stated for a wipe labelled as dispersible, flushable or disposable in a toilet; the contact time and the classes of micro-organism killed; the killing log value or killing rate and the test method used, suspension or carrier; the name of the active ingredient and its content range, being the declared centre value within 10 %, or within 15 % for a chlorine dioxide, peroxide or chlorine-releasing disinfectant, with the name and the quantity added stated where the content cannot be measured; the method of use and the precautions; the production date and shelf life, or the batch number and use-by date; the product size, expressed as length and width; the number of wipes; the conformity mark; and the name, full address and telephone number of the manufacturer or the party responsible for the product. A note encourages other wipes to state the fibre composition on the sales package as well.

The transport package carries at least the product name, the name and address of the manufacturer or the party responsible for the product, and the quantity of product.

Packaging keeps out dust, damp and mould. Material in direct contact with the product is non-toxic, harmless and clean; the pack is intact and the packaging material is tight and strong enough to keep the product free from contamination under normal transport and storage.

Transport uses clean vehicles that keep the finished product from contamination; packs are kept intact in handling and are not thrown down from a height. Products are stored in a dry, ventilated and clean place, kept from rain, snow and damp air.

Relationship to previous standards Relationship to previous standards

The frontispiece records a partial replacement: GB/T 27728.3-2024 replaces the part of GB/T 27728-2011 Wet wipes dealing with disinfection wet wipes. The remaining subject matter of GB/T 27728-2011 is taken up by the other parts of the series.

The foreword records that the series was first published in 2006 as GB/T 20808-2006 Tissue paper (including wet wipes), was revised for the first time in 2011 as GB/T 27728-2011 Wet wipes, and that the present document is the second revision. It also records that GB/T 27728 has so far issued Part 1 General requirements, Part 2 Particular requirements for wet wipes for babies and children, and Part 3, the present document.