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GB 15979-2024: Hygienic requirements for disposable sanitary products
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
brea...