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    Certification and Registration

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    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.

     

    SATISFY specializes in testing and certification services for disposable hygiene products, including sanitary napkins, diapers, adult diapers, baby diapers, wet wipes and disinfectant wipes. With regulatory testing capabilities covering major global markets including China, the European Union, the United States, Australia/New Zealand and Japan, SATISFY is equipped with internationally recognized laboratories and experienced technical teams. We provide customized safety, environmental and quality assurance certification solutions throughout the entire process, supporting your product’s global market expansion with accurate compliance and certification services.


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