GB 15979-2024 (GB15979-2024) & related versions
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GB 15979-2024
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
CCS C 59
Replacing GB/T 15979-2002
Hygienic Requirements for Disposable Sanitary Products
ISSUED ON: JUNE 25, 2024
IMPLEMENTED ON: JULY 1, 2025
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Hygienic Requirements for Raw Materials ... 7
5 Hygienic Requirements for Production Process ... 8
6 Hygienic Requirements for Products ... 9
7 Test Methods ... 12
8 Packaging, Transportation and Storage ... 14
9 Marking ... 14
10 Implementation of Standard ... 14
Appendix A (normative) Test Methods for Production Environment Hygienic
Requirements ... 15
Appendix B (normative) Microbiological Test Method ... 18
Appendix C (normative) Test and Evaluation Method for Disinfection Effect ... 25
Appendix D (normative) Test Method for Ethylene Oxide Residue in Products ... 26
Appendix E (normative) Test Methods for Bactericidal Performance, Bacteriostatic
Performance and Stability of the Products ... 30
Appendix F (normative) Toxicological Test Methods for the Products ... 58
Bibliography ... 60
Hygienic Requirements for Disposable Sanitary Products
1 Scope
This document specifies the hygienic requirements for raw materials, production process and
products, as well as the requirements for packaging, transportation, storage and marking of
disposable sanitary products, and describes the corresponding test methods.
This document is applicable to disposable sanitary products sold and used.
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through the normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
GB 5749 Standards for Drinking Water Quality
GB/T 8939 Sanitary Absorbent Pads (panty liner)
GB/T 15981 Evaluating Method for the Efficacy of Sterilization for Disinfection Equipment
GB/T 26367 Hygienic Requirements for Biguanides Disinfectants
GB/T 26369 Hygienic Requirement for Quaternary Ammonium Disinfectant
GB/T 27741 Paper and Board - Determination of Migratable Fluorescent Whitening Agents
GB/T 27947 Hygienic Requirements for Phenol Disinfectant
GB/T 28004.1 Disposable Diapers - Part 1: Disposable Diapers for Baby
GB/T 28004.2 Disposable Diapers - Part 1: Disposable Diapers for Adult
GB/T 38496 Toxicological Procedures and Methods of Safety Evaluation for Disinfectant
GB 38598 General Requirement for Label and Instruction Book of Disinfection Products
GB 50073 Code for Design of Clean Room
WS/T 10009 Test Methods of Disinfection Products
Pharmacopoeia of the People’s Republic of China (National Medical Products Administration,
3.5 production workshop
A place where disposable sanitary products are produced and processed.
NOTE: including weighing room (area), production and processing room (area), sub-packaging
(filling) room (area), inner packaging room (area), etc. Among them, the production
workshop of sub-packaging enterprises includes sub-packaging (filling) room (area) and
inner packaging room (area), etc.
[source: Hygienic Standard for Disinfection Product Production Enterprises (Version 2009),
Article 12, modified]
3.6 super absorbent materials
An absorber that can absorb several to hundreds of times its own mass of liquid water and has
the capabilities of retaining and storing water after absorption.
NOTE: the absorber is composed of polymer compounds, pulp and non-woven fabrics, etc.
4 Hygienic Requirements for Raw Materials
4.1 Raw materials shall comply with the requirements of relevant specifications and standards
for disinfection products and shall be non-toxic and harmless. The packaging of raw materials
shall clearly indicate the name of the contents, production organization, production date or
production batch No.; raw materials with special requirements shall indicate storage conditions
and shelf life.
4.2 Discarded or used disposable sanitary products shall not be used as raw materials or semi-
finished products.
4.3 The following prohibited substances must not be added to the raw materials.
a) Drugs listed in Pharmacopoeia of the People’s Republic of China and their raw
materials with the same name shall not be added to antibacterial (bacteriostatic) agents
(disinfectants and antiseptics, traditional Chinese medicines and bacteriostatic agents
are excluded, as well as pharmaceutical excipients and purified water); preparations
used to generate active or passive immunity, such as: vaccines, serum or toxins and
their products, and preparations used to diagnose immune status, protein and peptide
preparations (except lysozyme and lysostaphin); prohibited chemical substances
(except iodine) listed in Safety Technical Specifications for Cosmetics; other
prohibited substances stipulated by the national health administrative department and
other substances with a definite hazard to human health.
b) Hygiene wet wipes and other disposable sanitary products with antibacterial
(bacteriostatic) functions shall not contain antibacterial drugs, antifungal drugs,
antiviral drugs, hormone drugs and their raw materials of the same name, etc., and
other prohibited substances stipulated by the national health administrative
department and other substances with a definite hazard to human health.
c) Non-woven fabrics, fabrics or other raw materials shall not contain prohibited
ingredients, for example, migratory fluorescent whitening agents.
4.4 In accordance with the product process regulations, select production water that complies
with the corresponding product quality standards. The production water for wet wipes, hygiene
wet wipes and antibacterial (bacteriostatic) agents shall comply with the requirements for
purified water in Pharmacopoeia of the People’s Republic of China. The production water for
other disposable sanitary products shall comply with the requirements of GB 5749 and relevant
enterprise specifications and ensure the safety and effectiveness of product use.
5 Hygienic Requirements for Production Process
5.1 The purchase, storage, distribution and use of raw and auxiliary materials shall satisfy the
product quality control requirements and comply with management system regulations.
5.2 The production environment hygiene indicator requirements are as follows.
a) The air in the antibacterial (bacteriostatic) agent production workshop shall comply
with the requirements of Hygienic Standard for Disinfection Product Production
Enterprises, and the purification workshop shall comply with the requirements of GB
50073; the total number of colonies in the air of other disposable sanitary products
production workshops shall be less than or equal to 2,500 CFU/m3 (the air sampler
method) or shall be less than or equal to 16 CFU/(plate 5 min) (the plate exposure
method).
b) The total number of colonies on workbench surfaces that are in direct contact with
unpackaged products shall be less than or equal to 20 CFU/cm2.
c) The total number of colonies on the hands of workers who are in direct contact with
unpackaged products shall be less than or equal to 300 CFU/hand (glove).
5.3 The initial contaminating bacteria of disinfection-grade disposable sanitary products shall
be less than or equal to 10,000 CFU/g or CFU/mL.
5.4 Disinfection methods used for disinfection-grade disposable sanitary products shall be
tested for disinfection effectiveness and shall comply with the following requirements:
a) Ethylene oxide disinfection: the killing log value of Bacillus subtilis black variant
(ATCC 9372) spores is greater than or equal to 3.00;
b) Ionizing radiation disinfection: the killing log value of Bacillus pumilus E601 (ATCC
27142) spores is greater than or equal to 3.00;
c) Pressure steam disinfection: the killing log value of Bacillus stearothermophilus
the requirements of Appendix A.
7.1.2 The test method for initial contaminating bacteria shall comply with the requirements of
Appendix B.
7.1.3 The test and evaluation method for the disinfection effect shall comply with the
requirements of Appendix C.
7.2 Test Methods for Product Hygienic Requirements
7.2.1 The appearance of the product is determined through the methods of visual inspection and
sniffing.
7.2.2 The pH of absorbent products, such as: sanitary napkins and sanitary pads, etc. shall be
determined in accordance with the method of GB/T 8939. If there are corresponding
determination standards on the pH of other products, conduct the determination in accordance
with the methods in the corresponding standards. If there is no corresponding determination
standard, conduct the determination in accordance with the method of WS/T 10009.
7.2.3 Migratory fluorescent whitening agent: sanitary napkins (pads) shall be determined in
accordance with the method of GB/T 8939; diapers shall respectively be determined in
accordance with the methods of GB/T 28004.1 and GB/T 28004.2; other sanitary products shall
be determined in accordance with the method of GB/T 27741.
7.2.4 The test of lead, arsenic and mercury shall be carried out in accordance with the methods
of Safety Technical Specifications for Cosmetics.
7.2.5 The test method for ethylene oxide residue in products shall comply with the requirements
of Appendix D.
7.2.6 The test methods for bactericidal performance, bacteriostatic performance and stability of
the products shall comply with the requirements of Appendix E.
7.2.7 Chlorhexidine gluconate and chlorhexidine acetate shall be determined in accordance with
the methods specified in GB/T 26367 and relevant national standards; 2,4,4’-trichloro-2’-
hydroxydiphenyl ether shall be determined in accordance with the methods specified in GB/T
27947 and relevant national standards; benzalkonium bromide and benzalkonium chloride shall
be determined in accordance with the methods specified in GB/T 26369 and relevant national
standards; the contents of other active ingredients shall be determined in accordance with the
methods specified in WS/T 10009 and relevant national standards; those that cannot be
determined using chemical determination methods will not be determined here.
7.2.8 The toxicological test methods for the products shall comply with the requirements of
Appendix F.
7.2.9 The microbiological test methods for the products shall comply with the requirements of
Appendix B.
Appendix A
(normative)
Test Methods for Production Environment Hygienic Requirements
A.1 Air Sampling and Test Methods
A.1.1 Sample collection
If the indoor area is less than or equal to 30 m2, set up three points on the diagonal: inside,
middle and outside; the inside and outside points are 1.0 m away from the wall. If the indoor
area is greater than 30 m2, set up five sampling points in the east, west, south, north and middle,
and the surrounding four sampling points are 1.0 m away from the wall. The production
enterprise may also increase the quantity and placement locations of culture media in
accordance with the actual layout of the production lines.
Air sampler method: choose from a six-stage impactor air sampler or other proven air samplers.
When sampling, place the sampler at a height of 0.8 m ~ 1.5 m in the center of the room, operate
in accordance with the sampler instruction manual, and each sampling time shall not exceed 30
minutes.
Plate exposure method: when sampling, place a plate (with a diameter of 9 cm) containing
nutrient agar culture medium at the sampling point (with a height of 0.8 m ~ 1.5 m), aseptically
open the plate cover, place it upside down on the edge of the plate, expose the plate to the air
for 5 minutes, then, cover the plate and send it for testing in time.
The air sampler method is preferred for air sampling.
A.1.2 Test of total number of bacterial colonies
Before sampling, place the prepared nutrient agar culture medium at 36 C 1 C and incubate
it for 18 ~ 24 hours. Take it out and check whether there is any contamination and remove the
contaminated culture medium.
Within 4 hours, send the collected petri plates to the laboratory, at 36 C 1 C, incubate them
for 48 hours, observe the results, and count the number of colonies on the plates.
The plate exposure method shall be reported as the average number of colonies per plate:
CFU/(plate 5 min).
For the air sampler method, the total number of colonies shall be calculated using Formula
(A.1):
Where,
Y---the total number of bacterial colonies in the air, expressed in (CFU/m3);
n---the number of colonies on each plate, expressed in (CFU);
v---the sampling rate, expressed in (L/min);
t---the sampling time, expressed in (min);
1,000---the conversion factor.
A.2 Sampling and Test Methods for Workbench Surface and Worker’s Hand
Surface
A.2.1 Sample collection
A.2.1.1 Workbench: place a sterilized specification board with an inner diameter of 5.0 cm
5.0 cm on the surface of the object under test, use a cotton swab soaked in sterile physiological
saline (or corresponding neutralizer) to respectively smear it horizontally and vertically for 5
times, then, cut off or break off the part of the cotton swab that comes into contact with hands,
and aseptically put the cotton swab into a sampling tube containing 10.0 mL of physiological
saline (or corresponding neutralizer) and submit it for testing.
A.2.1.2 Worker’s hands (gloves): ask the examinee to put his five fingers together, use a cotton
swab soaked in physiological saline (or corresponding neutralizer) on the curved surface of the
right finger, rub it back and forth from the root to the tip of the finger twice, then, cut off or
break off the part of the cotton swab that comes into contact with hands, and put the cotton
swab into a sampling tube containing 10.0 mL of physiological saline (or corresponding
neutralizer) and submit it for testing.
A.2.2 Test of total number of bacterial colonies
Within 4 hours, send the collected samples to the laboratory. After thoroughly shaking and
mixing (it is advisable to use a vortex oscillator to shake) each sampling tube, take 1.0 mL of
the sample solution, put into sterilized plates, pour in the nutrient agar culture medium,
inoculate each sample into two plates in parallel, culture them at 36 C 1 C for 48 hours, and
count the number of colonies on the plates.
The total number of colonies on the workbench surface shall be calculated using Formula (A.2):
Where,
Y1---the total number of colonies on the workbench surface, expressed in (CFU/cm2);
Y0---the average number of colonies on the plates, expressed in (CFU);
Appendix B
(normative)
Microbiological Test Method
B.1 Product Collection and Sample Processing
From 3 transport packages of the same batch No., take at least 6 minimum sales packaging
samples (if the quantity of samples cannot satisfy the test requirements, then, the sampling
quantity shall be increased accordingly), of which, 1/3 samples are used for testing and 2/3
samples are used for retention. The minimum sales package sampled shall not be cracked and
shall not be opened before the testing.
Under air cleanliness level 5 purification conditions, aseptically open at least 2 packages for
testing; conduct sampling from each package, and accurately weigh-take 10.0 g 1.0 g of
sample. Cut it into pieces and add to 200 mL of sterile physiological saline, thoroughly mix it
to obtain a physiological saline sample solution (if the product is too light, weigh-take 2.5 g
0.2 g of sample and add to 50 mL of sterile physiological saline). For liquid products, draw-
take 10.0 mL of the original solution and use it directly as the sample solution.
If the sample under test has bacteriostatic or antibacterial effects, a suitable neutralizer shall be
selected for neutralization, and the dilution gradient shall not exceed 1 : 100. If there is no
corresponding neutralizer, the membrane filtration method shall be adopted to remove the
bacteriostatic or antibacterial components that affect the growth of microorganisms in the
sample, then, prepare the sample solution in accordance with the above-mentioned method.
If the sample under test contains a large amount of water-absorbent resin material and thus
sufficient sample solution cannot be sucked out, the amount of diluent can be increased by 50
mL each time, until enough sample solution for testing can be sucked out. When calculating the
total bacterial colonies and the total fungal colonies, adjust the degree of dilution accordingly.
B.2 Test Methods for Initial Contaminating Bacteria and Total Number of
Bacterial Colonies
B.2.1 Operation steps
After the physiological saline or neutralizer sample solution obtained in accordance with B.1
naturally settles, take the supernatant, and if necessary, perform a 10-fold serial dilution. Select
the appropriate degree of dilution for colony counting. Inoculate a total of 2 plates, add 2.0 mL
of the sample solution to each plate, then, pour 15 mL ~ 20 mL of melted nutrient agar medium
that has cooled to about 40 C ~ 45 C into each plate and evenly mix them. After the agar
solidifies, turn the plate over and incubate at 36 C 1 C for 48 hours, and count the number
of colonies on the plates.
B.2.2 Colony counting
Plates with flake-like growth of bacterial colonies should not be used. Make sure that the two
with no or slightly metallic luster, or pink colonies with a darker center.
B.3.1.3 Staining microscopic examination and identification: take 1 ~ 2 suspected colonies for
Gram staining microscopic examination, meanwhile, inoculate lactose fermentation tube,
incubate at 36 C 1 C for 18 ~ 24 hours, and observe the acid and gas generation.
B.3.2 Result reporting
If the lactose bile salt fermentation tube generates acid and gas, the lactose fermentation tube
generates acid and gas, and there are typical coliform colonies on the eosin methylene blue
plate, then, the Gram stain is negative and contains no bacilli, and it can be reported that
coliform bacteria are detected in the sample under test.
B.4 Test Method for Pseudomonas Aeruginosa
B.4.1 Operation steps
B.4.1.1 Enrichment culture: take 5.0 mL of the sample solution, add it to 50 mL of SCDLP
(Soya Casein Digest Lecithin Polysorbate) culture medium, thoroughly mix it, and incubate at
36 C 1 C for 18 ~ 24 hours. If Pseudomonas aeruginosa grows, a thin bacterial film will
appear on the surface of the culture solution, and the culture solution will often appear yellow-
green or blue-green.
B.4.1.2 Isolated culture: pick the culture from the thin bacterial film of the culture solution,
streak and inoculate Cetyltrimethyl ammonium bromide agar plate, incubate at 36 C 1 C
for 18 ~ 24 hours, and observe the colony characteristics. Pseudomonas aeruginosa grows well
on this culture medium; the colonies are flat and amorphous, diffusing to the periphery, or
spreading; the surface is moist, the colonies are gray-white, and water-soluble pigments are
often diffused in the culture medium around the colonies. In the absence of Cetyltrimethyl
ammonium bromide agar, acetamide culture medium can also be used for isolation. Streak and
inoculate the bacteria suspension on a flat plate, incubate at 36 C 1 C for 18 ~ 24 hours, and
observe the colony characteristics. Pseudomonas aeruginosa grows well on this culture medium;
the colonies are flat with uneven edges, and the medium around the colonies is slightly pink.
B.4.1.3 Staining microscopic examination: take a smear of suspicious colonies on the
identification medium for Gram staining. If the microscopic examination shows Gram-negative
bacteria, the following tests are also required.
B.4.1.4 Oxidase test: take a small piece of clean white filter paper and place it in a sterilized
plate, use a sterile glass rod to pick out the suspicious colonies on the identification medium
and apply it on the filter paper. Then, add a drop of newly prepared 1% dimethyl-p-
phenylenediamine test solution on it. Within 30 seconds, if pink or purple appears, the oxidase
test is positive; if the color does not change, it is negative. Commercial oxidase test strips or
reagents may also be used for testing.
B.4.1.5 Pyocyanin test: take 2 ~ 3 suspicious colonies on the identification medium,
respectively inoculate them on the slant of the medium for pyocyanin determination and
incubate at 36 C 1 C for 24 hours. Add 3 mL ~ 5 mL of chloroform, thoroughly oscillate it
to dissolve the possible pyocyanin in the culture. When the chloroform turns blue, use a pipette
to move it to another test tube and add 1 mL of 1.0 mol/L hydrochloric acid; shake and let it
stand for a while. If the upper layer appears pink or purple, it is positive, indicating the presence
of pyocyanin.
B.4.1.6 Nitrate reduction gas generation test: inoculate the suspicious colonies on the
identification medium into the nitrate saline peptone water medium and incubate at 36 C 1
C for 24 hours. If there is air in the small, inverted tube of the culture medium, it is considered
positive.
B.4.1.7 Gelatin liquefaction test: take the pure culture of the suspicious colonies on the
identification medium, puncture and inoculate it into the gelatin medium, incubate at 36 C 1
C for 24 hours, take it out and place it at 4 C ~ 10 C. If it is still liquid, it is positive, and if
it is solidified, it is negative.
B.4.1.8 42 C growth test: take the suspicious culture on the identification medium, inoculate
it on a common agar slant medium, and incubate at 42 C for 24 ~ 48 hours. If Pseudomonas
aeruginosa grows, it is positive.
B.4.1.9 Other tests: if biochemical identification reagents or biochemical identification cards
are used, suspicious colonies shall be identified in accordance with the instructions of the
commercial reagents.
B.4.2 Result reporting
After enrichment and isolated culture, if the sample under test is confirmed to be Gram-negative
bacilli, and the oxidase and pyocyanin tests are both positive, it can be reported that
Pseudomonas aeruginosa is detected in the sample under test. If the pyocyanin test is negative,
but the liquefied gelatin, nitrate reduction gas generation and 42 C growth tests are all positive,
it can still be reported that Pseudomonas aeruginosa is detected in the sample under test.
B.5 Test Method for Staphylococcus Aureus
B.5.1 Operation steps
B.5.1.1 Enrichment culture: take 5.0 mL of the sample solution, add it to 50 mL of SCDLP
culture solution, thoroughly mix it, and incubate it at 36 C 1 C for 18 ~ 24 hours.
B.5.1.2 Isolated culture: take 1 ~ 2 inoculation loops from the above-mentioned enrichment
suspension, streak and inoculate Baird Parker medium (preferred) or blood agar medium and
incubate it at 36 C 1 C for 24 ~ 48 hours. On Baird Parker medium, they are round, smooth,
convex, moist, with a diameter of 2.0 mm ~ 3.0 mm, gray to black in color, surrounded by a
turbid zone, and a transparent zone on the outer layer. When touched with an inoculation needle,
the colonies appear to have the softness of buttery gum. Occasionally, similar non-lipolytic
colonies will be encountered, but there are no turbid and transparent zones. Typical colonies on
blood agar plates are golden yellow, large and protruding, round, opaque, with a smooth surface
B.6.1.4 Streptokinase test: draw-take 0.2 mL of potassium oxalate plasma (0.01 g of potassium
oxalate plus 5.0 mL of rabbit plasma, mix it well, precipitate by centrifugation, and take the
supernatant), add 0.8 mL of sterilized physiological saline, mix it well, then, add 0.5 mL of 24-
h broth culture of the bacteria to be tested and 0.25 mL of 0.25% calcium chloride, mix it well,
place it in a 36 C 1 C water bath, and observe once every 2 minutes (generally, it can
coagulate within 10 minutes). After the plasma has coagulated, continue to observe and record
the melting time. If it does not melt within 2 hours, continue to leave it for 24 hours for
observation. If the clot is completely melted, it is positive, and if it still does not melt within 24
hours, it is negative (in accordance with the instructions of the commercial reagents).
B.6.1.5 Bacitracin sensitivity test: smear the suspension of the tested bacteria to a blood agar
plate, use sterilized tweezers to take each piece of paper containing 0.04 unit of bacitracin and
place it on the surface of the plate. Meanwhile, use known positive strains as the control and
place them at 36 C 1 C for 24 ~ 48 hours, those with bacteriostatic zones are considered
positive.
B.6.1.6 Other tests: if biochemical identification reagents or biochemical identification cards
are used, suspicious colonies shall be identified in accordance with the instructions of the
commercial reagents.
B.6.2 Result reporting
Conduct microscopic examination of Gram-positive chain-like arranged cocci, if hemolytic
rings appear on the blood agar plate, and the streptokinase and bacitracin tests are positive, it
can be reported that hemolytic streptococci are detected in the sample under test.
B.7 Test Method for Total Number of Fungal Colonies
B.7.1 Operation steps
After the physiological saline or neutralizer sample solution obtained in accordance with B.1
naturally settles, take the supernatant, and if necessary, perform a 10-fold serial dilution. Select
the appropriate degree of dilution for fungal colony counting. Inoculate a total of 2 plates, add
2.0 mL of the sample solution to each plate, then, pour 15 mL ~ 20 mL of melted Sandcastle
weak agar medium or modified Sandcastle weak agar medium cooled to 40 C ~ 45 C into
each plate and evenly mix them. After the agar has solidified, turn the plates over and incubate
them at 25 C 1 C (for Sandcastle weak agar medium) or 28 C 1 C (modified Sandcastle
weak agar medium) for 72 hours. Respectively observe at 24 hours, 48 hours and 72 hours, and
count the number of colonies on the plate. If colonies are found to spread, the previous colony
count shall prevail.
B.7.2 Colony counting
Plates with flake-like growth of bacterial colonies should not be used. Make sure that the two
plates comply with the counting requirements and perform bacterial colony counting. In
accordance with Formula (B.2), calculate the results:
......
| Standard ID | GB 15979-2024 (GB15979-2024) | | Description (Translated English) | Hygienic requirements for disposable sanitary products | | Sector / Industry | National Standard | | Classification of Chinese Standard | C59 | | Classification of International Standard | 11.080 | | Word Count Estimation | 42,425 | | Date of Issue | 2024-06-25 | | Date of Implementation | 2025-07-01 | | Administrative Organization | National Disease Prevention and Control Bureau | | Proposing organization | National Center for Disease Control and Prevention | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration |
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