GB 15979-2024Hygienic requirements for disposable sanitary products (English PDF)

1 Scope

GB 15979 governs the hygiene of disposable sanitary products - sanitary towels and tampons, nappies, wet wipes, disposable face masks, gloves and the paper products used in contact with skin or mucosa. It sets the requirements for the raw materials, for the production environment and process, and for the finished product, with limits on total bacterial count, coliforms, pathogenic bacteria, fungi and residual substances, followed by the test methods in six normative annexes, the packaging, transport and storage, the marking and the implementation timetable. It is one of the most widely applied consumer hygiene standards in China. Issued on 25 June 2024, in force since 1 July 2025, replacing GB 15979-2002. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the edition it replaces are taken from there. The clause text, the tables and the numeric limits are not reproduced on this page - they are in the document itself, which is delivered in full in English translation.

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

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.

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 Test Methods...

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 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