Certification and Registration
GB/T 27728.3 Particular Requirements for Disinfection Wet Wipes
Category:
Hygiene Products
GB/T 27728.3 Standard Description
GB/T 27728.3 Wet wipes and similar products The 3 Section: Specific Requirements for Disinfecting Wipes
GB/T 27728.3 Standard Introduction
With increasing consumer attention to hygiene and health, disinfectant wipes have been widely used in households, offices, public places and other environments due to their convenience and effectiveness. GB/T 27728.3 applies to disinfectant wipes used in daily life and is not applicable to medical applications. The standard defines relevant terms, classifies products, and specifies requirements for raw materials, intrinsic quality, microbial indicators and other aspects. It also standardizes test methods, inspection rules, labeling, packaging, transportation and storage requirements, providing comprehensive quality assurance and promoting the healthy development of the industry.
GB/T 27728.3 Scope of Application
GB/T 27728.3 applies to various disinfectant wipes manufactured from nonwoven fabrics, dry-laid paper or other raw materials for daily use. According to their intended use, these disinfectant wipes are classified as disinfectant wipes for human use and disinfectant wipes for object surfaces.
GB/T 27728.3 Requirements for Disinfecting Wipes
(1) Raw Material Requirements: Recycled materials and waste materials shall not be used.
(2) Disinfectant Requirements:
◎ Non-industrial grade raw materials should be used preferentially (unless there are special circumstances).
◎ Disinfectant wipes for human use and object surface use shall comply with GB 27951.
◎ Prohibited substances shall comply with GB 38850.
Intrinsic Quality Requirements:
Intrinsic Quality Requirements for Disinfectant Wipes for Human Use
Intrinsic Quality Requirements for Disinfectant Wipes Used on Object Surfaces
|
Indicator |
Requirements |
|
Liquid content |
≥1.7 times (only applicable to disinfectant wipes produced from nonwoven fabrics) |
|
pH Value |
3.5~8.5 |
|
Heavy metals (mg/kg) |
|
|
Lead |
≤10 |
|
Arsenic |
≤2.0 |
|
Cadmium |
≤5.0 |
|
Mercury |
≤1.0 |
|
Methanol (mg/kg) |
≤20 |
|
Benzene (mg/kg) |
≤20 |
|
Toluene (mg/kg) |
≤20 |
|
Xylene (mg/kg) |
≤20 |
|
Extractable Fluorescent Substances |
None |
|
Formaldehyde (mg/kg) |
≤75.0 |
|
Metal Corrosivity (assessed only for disinfecting wipes intended for use on metal surfaces) |
|
|
Stainless steel |
Essentially non-corrosive |
|
Carbon steel |
Essentially non-corrosive or mildly corrosive |
|
Aluminum |
Essentially non-corrosive or mildly corrosive |
|
Copper |
Essentially non-corrosive or mildly corrosive |
|
Note: Liquid content is only evaluated for disinfectant wipes produced from nonwoven fabrics. If the product packaging label or instructions specify a pH value, the actual pH value shall be within ±1.0 of the labeled center value. Intrinsic Quality Requirements for Disinfectant Wipes for Object Surfaces |
|
(3) Microbiological indicators:
Microbial contamination indicators
|
Indicator |
Requirements |
|
Total bacterial colony count (CFU/g) |
≤200 |
|
Coliform bacteria |
Should not be detected |
|
Pseudomonas aeruginosa |
Should not be detected |
|
Staphylococcus aureus |
Should not be detected |
|
Hemolytic streptococcus |
Should not be detected |
|
Total fungal colony count (CFU/g) |
≤100 |
(4) Microbial Killing Requirements:
Disinfectant wipes shall be tested for microbial killing performance according to the applicable use range and target microorganisms specified on the product label or instructions. The microbial killing effect shall comply with the requirements in the following table. If the product label or instructions claim killing effects against other specific microorganisms, corresponding microbial killing tests shall also be conducted.
|
Microorganism Type |
Disinfection target |
Killing Log Reduction Value |
|||
|
hands |
Skin |
Surface of an object |
Object Surface |
Suspension Method |
|
|
Staphylococcus aureus |
+ |
+ |
+ |
≥5.0 |
≥3.0 |
|
Escherichia coli |
+ |
± |
+ |
≥5.0 |
≥3.0 |
|
Pseudomonas aeruginosa |
± |
+ |
± |
≥5.0 |
≥3.0 |
|
Candida albicans a |
± |
± |
± |
≥4.0 |
≥3.0 |
|
Aspergillus niger a |
± |
± |
± |
≥4.0 |
≥3.0 |
|
Note 1: “Ten” indicates a mandatory test item, and "±" indicates an optional test item. Note 2: Either the suspension method or the carrier method may be selected as the test method. |
|||||
|
a If the product label or instructions indicate a killing effect against pathogenic fungi, killing tests against Candida albicans and Aspergillus niger shall be conducted. |
|||||
(5) Active ingredient content
◎ For general disinfectant wipes, the active ingredient content shall comply with the value specified on the product label or instructions and shall be within ±10% of the labeled center value.
◎ For specific disinfectant wipes, when the active ingredient is chlorine dioxide disinfectant, peroxide disinfectant or chlorine-containing disinfectant, the content shall be within ±15% of the labeled center value.
◎ Restrictions on substances used in disinfectant wipes for human use:
|
Restricted Substance |
Requirement |
|
Chlorhexidine gluconate or chlorhexidine acetate |
≤45 g/L |
|
Triclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether) |
≤20 g/L |
|
Benzalkonium bromide or benzalkonium chloride |
≤5 g/L |
|
Other restricted substances specified by national regulations |
Comply with relevant requirements |
Stability:
The shelf life of the product shall not be less than one year. During the validity period, the product shall comply with the following requirements:
|
Indicator |
Requirement |
|
Liquid Content |
≥1.7 times |
|
Decrease Rate of Active Ingredient Content (%) |
≤10 |
|
Microbial Killing Performance |
Comply with relevant standards |
(6) Toxicological Indicators:
For new disinfectant wipe products before initial market launch, or when major changes occur in raw materials or production processes, toxicological tests shall be conducted.
(7) Appearance Quality:
The surface of disinfectant wipes shall be clean and free from damage. No foreign matter or stains shall be present.
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