Certification and Registration
GB 15979 Hygienic standard for disposable sanitary products
Category:
Hygiene Products
GB 15979 Standard Description
GB 15979 Hygienic standard for disposable sanitary products
GB 15979 Standard Introduction
GB 15979 applies to various disposable sanitary products. Disposable sanitary products refer to various daily-use products that directly contact the human body and are used once for physiological hygiene or health care purposes (antibacterial or bacteriostatic purposes). The main categories include:
◎ Feminine hygiene products: sanitary napkins, panty liners and tampons
◎ Excretion hygiene products: including diapers, nappies, diaper pads, urine pads and underpads, excluding toilet paper
◎ Other hygiene products: antibacterial agents, bacteriostatic agents, wet wipes, sanitary wet wipes, disposable gloves or finger cots (excluding medical gloves or finger cots), tissues, soft cotton wipes, sanitary cotton products (sticks, swabs and balls, excluding medical cotton products), breast pads, underwear, cosmetic cotton products (paper and wipes)
◎ Other sanitary products listed in the Catalogue of Disinfection Product Classification
GB 15979 Hygienic Requirements for Raw Materials
Compliant and Safe: Raw materials shall comply with relevant standards for disinfection products, be non-toxic and harmless, and have complete packaging labels (including product name, manufacturer, production date/batch number, and storage conditions and shelf life when necessary).
Prohibited Sources: Waste or used disposable sanitary products shall not be used as raw materials or semi-finished materials.
Substances Not Allowed to Be Added:
|
Substances that must not be added |
|
|
Prohibited Substances |
● Drugs and raw materials with the same names listed in the Pharmacopoeia of the People’s Republic of China (excluding disinfectant and antiseptic drugs, traditional Chinese medicines and bacteriostatic agents, and excluding pharmaceutical excipients and purified water) ● Vaccines, sera, toxins and their products (preparations used for active or passive immunization) ●Vaccines, sera, toxins and their products (preparations used for active or passive immunization) ● Prohibited chemical substances listed in the Safety and Technical Standards for Cosmetics (excluding sulfides) ● Other substances explicitly harmful to human health specified by national health administrative authorities |
|
Hygienic Wet Wipes and Other Disposable Sanitary Products with Antibacterial/Bacteriostatic Functions |
● Antibiotics, antifungal agents, antiviral agents and hormone drugs ● Their corresponding raw materials and other substances explicitly harmful to human health prohibited by national health administrative authorities |
|
Nonwoven Fabrics, Textiles or Other Raw Materials |
● Extractable fluorescent whitening agents and other additives or chemicals prohibited by national or industry standards |
Water Requirements:
(1) Water used for wet wipes and bacteriostatic agents shall comply with purified water requirements of the Pharmacopoeia of the People’s Republic of China.
(2) Water used for other disposable sanitary products shall comply with GB 5749 and enterprise standards to ensure safety and effectiveness.
GB 15979 Hygiene Requirements for the Production Process
Raw Material Management: The procurement, storage, distribution and use of raw materials shall comply with product quality control requirements and enterprise management systems.
Microbial Indicators for Production Environment:
|
Production Environment |
Microbial Indicators |
|
Antibacterial/Bacteriostatic Agent Production Workshop |
Hygienic Specifications for Manufacturers of Disinfection Products |
|
Clean Workshop |
GB 50073 |
|
Other Disposable Sanitary Product Workshops |
Total bacterial count ≤2500 CFU/m³ (air sampling method) or ≤16 CFU/(dish·5 min) (settle plate exposure method) |
|
Work Surface (direct contact with unpackaged products): |
Total bacterial count ≤20 CFU/cm² |
|
Operator Hands (direct contact with unpackaged products): |
Total bacterial count ≤300 CFU/per hand (or glove) |
Initial Contamination Limits: Disposable sanitary products with disinfection grade: Initial contamination microorganisms ≤10000 CFU/g or CFU/mL.
Sterilization Process Effectiveness (Log Reduction Value ≥3.00):
(1) Ethylene oxide sterilization: Bacillus subtilis spores (ATCC 9372) shall be used for evaluation according to GB/T 15981.
(2) Ionizing radiation sterilization: Brevundimonas diminuta E601 (ATCC 27142) shall be used.
(3) High-pressure steam sterilization: Geobacillus stearothermophilus (ATCC 7953) shall be used for evaluation according to GB/T 15981.
GB 15979 Physical and Chemical Requirements
Physical and Chemical Indicators:
|
Item |
Indicator |
Applicable Scope |
Test Standard |
|
pH Value |
Within ±1 of the labeled average value |
Sanitary products with labeled pH values |
GB/T 8939 |
|
Extractable Fluorescent Whitening Agents |
Not detected |
Paper-containing sanitary products |
GB/T 27741 |
|
Lead (calculated as Pb) |
≤10 mg/kg or mg/L |
Wet wipes, sanitary wet wipes, antibacterial/bacteriostatic agents and other sanitary products |
Safety and Technical Standards for Cosmetics |
|
Arsenic (calculated as As) |
≤2 mg/kg or mg/L |
Wet wipes, sanitary wet wipes, antibacterial/bacteriostatic agents and other sanitary products |
Safety and Technical Standards for Cosmetics |
|
Mercury |
≤1 mg/kg or mg/L |
Wet wipes, sanitary wet wipes, antibacterial/bacteriostatic agents and other sanitary products |
Safety and Technical Standards for Cosmetics |
|
Ethylene Oxide Residue |
After disinfection ≤250 μg/g; at market release ≤10 μg/g |
Sanitary products disinfected by ethylene oxide |
Appendix D Test Method |
|
Stability |
Shelf life ≥1 year |
Sanitary wet wipes, antibacterial/bacteriostatic agents and other sanitary products containing antibacterial/bacteriostatic ingredients |
— |
For products used on hands, skin and mucous membranes, the concentration limits of restricted substances shall comply with the following requirements:
|
Product Categories a |
Toxicology Test Items |
||||
|
Skin irritation test b |
Eye irritation test |
Vaginal Mucosal Irritation Test c |
Skin hypersensitivity test |
||
|
Women’s menstrual hygiene products |
— |
— |
+ |
+ |
|
|
Excrement hygiene products |
+ |
— |
— |
+ |
|
|
Wet wipes, sanitary wipes, anti- ( suppress ) Microbial agent |
Only contact with hands and skin |
+ |
— |
— |
± d |
|
Contact with oral mucosa only |
— |
+ |
— |
||
|
Only contact with the vaginal mucosa |
— |
— |
+ |
||
|
Contact with skin and oral mucosa |
— |
+ |
— |
||
|
Contact with skin and vaginal mucosa |
— |
— |
+ |
||
|
Contact with skin, oral mucosa, and vaginal mucosa |
— |
+ |
+ |
||
|
Breast pads, disposable underwear, sanitary gloves or finger cots, cosmetic cotton (paper/wipes), baby paper products, tissues, soft cotton wipes, sanitary cotton products (sticks/swabs/balls), etc. |
Only contacting skin |
+ |
— |
— |
+ |
|
Only contacting mucous membranes |
— |
+ |
|||
|
Contacting skin and mucous membranes |
— |
+ |
|||
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a Other disposable sanitary products shall be tested with reference to the requirements. b Products that repeatedly contact the skin during use shall undergo repeated complete skin irritation testing. Products labeled as requiring cleaning after use shall undergo an acute single complete skin irritation test with an exposure time of 2 hours. c Products labeled for occasional use on vaginal mucosa or use at intervals of several days shall undergo a single vaginal mucosal irritation test. Products intended for continuous use shall undergo repeated vaginal mucosal irritation testing. d Products intended for pregnant women or infants shall undergo skin sensitization testing. |
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GB 15979 Toxicology Test Items
Toxicological tests shall be conducted according to the following table:
|
Product Categories a |
Toxicology Test Items |
||||
|
Skin irritation test b |
Eye irritation test |
Vaginal Mucosal Irritation Test c |
Skin hypersensitivity test |
||
|
Women’s menstrual hygiene products |
— |
— |
+ |
+ |
|
|
Excrement hygiene products |
+ |
— |
— |
+ |
|
|
Wet wipes, sanitary wipes, anti- ( suppress ) Microbial agent |
Only contact with hands and skin |
+ |
— |
— |
± d |
|
Contact with oral mucosa only |
— |
+ |
— |
||
|
Only contact with the vaginal mucosa |
— |
— |
+ |
||
|
Contact with skin and oral mucosa |
— |
+ |
— |
||
|
Contact with skin and vaginal mucosa |
— |
— |
+ |
||
|
Contact with skin, oral mucosa, and vaginal mucosa |
— |
+ |
+ |
||
| Breast pads, disposable underwear, sanitary gloves or finger cots, cosmetic cotton (paper/wipes), baby paper products, tissues, soft cotton wipes, sanitary cotton products (sticks/swabs/balls), etc. | Only contacting skin |
+ |
— |
— |
+ |
| Only contacting mucous membranes |
— |
+ |
|||
| Contacting skin and mucous membranes |
— |
+ |
|||
|
a Other disposable sanitary products shall be tested with reference to the requirements. b Products that repeatedly contact the skin during use shall undergo repeated complete skin irritation testing. Products labeled as requiring cleaning after use shall undergo an acute single complete skin irritation test with an exposure time of 2 hours. c Products labeled for occasional use on vaginal mucosa or use at intervals of several days shall undergo a single vaginal mucosal irritation test. Products intended for continuous use shall undergo repeated vaginal mucosal irritation testing. d Products intended for pregnant women or infants shall undergo skin sensitization testing. |
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The test methods for skin irritation tests, eye irritation tests, vaginal mucosal irritation tests and skin sensitization tests shall comply with the corresponding methods specified in GB/T 38496 and WS/T 10009, and shall meet the following requirements:
|
Item |
Requirement |
|
Skin Irritation Test |
No irritation or mild irritationᵃ |
|
Eye Irritation Test |
No irritation or mild irritationᵇ |
|
Vaginal Mucosal Irritation Test |
No irritation or extremely mild irritation |
|
Skin Sensitization Test |
No sensitization observed or extremely mildᶜ |
|
ᵃ, ᵇ, ᶜ For disposable sanitary products intended for infants, skin irritation tests and eye irritation tests shall show no irritation, and no skin sensitization shall be observed. |
|
Microbiological indicators
Microbiological indicators shall comply with the following requirements:
|
Product Categories |
Microbiological indicators |
||
|
Total bacterial colony count CFU/g or CFU/mL |
Specific microorganisms a and other pathogenic microorganisms b |
Total fungal colony count CFU/g or CFU/mL |
|
|
Women’s menstrual hygiene products |
|
|
|
|
Standard grade |
|
|
|
|
Hygiene plug ( Built-in tampon ) |
≤100 |
Not detectable |
≤20 |
|
Other feminine hygiene products |
≤200 |
Not detectable |
≤100 |
|
Disinfection grade |
≤20 |
Not detectable |
Not detectable |
|
Excrement hygiene products |
|
Not detectable |
|
|
Standard grade |
≤200 |
Not detectable |
≤100 |
|
Disinfection grade |
≤20 |
Not detectable |
Not detectable |
|
Hygiene wipes, anti- ( suppress ) Microbial agent |
≤20 |
Not detectable |
Not detectable |
|
Wet wipes, breast pads, disposable underwear, sanitary gloves or finger cots, cotton pads ( Paper, tissue ) , paper, paper towels, soft cotton wipes, sanitary pads ( sticks, sticks, balls, etc. ) Wait |
≤200 |
Not detectable |
≤100 |
|
a Specified microorganisms refer to coliforms, Pseudomonas aeruginosa, Staphylococcus aureus and hemolytic Streptococcus. b When related infection is suspected, corresponding target pathogenic microorganism testing shall be conducted. |
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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. SATISFY provides 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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