GB 15979-2024 Disposable Sanitary Products: What Changed and What Is Tested

Since 1 July 2025, the Chinese hygiene standard for sanitary pads, panty liners, tampons, diapers, wet wipes and hygiene wet wipes has been GB 15979-2024, Hygienic requirements for disposable sanitary products, replacing GB 15979-2002. Whether other products such as underpads fall within it, and in which category, is decided by the standard text and the competent authority. This article explains what changed, which items SUNGO's accreditation covers, which accreditation mark the report can carry and what to prepare before sending samples; SUNGO's capabilities follow our accreditation schedules.

Key points first

• Edition: GB 15979-2024 is a mandatory national standard, published on 25 June 2024 and implemented on 1 July 2025. It fully replaces GB 15979-2002, which the national platform lists as abolished from 1 July 2025. The Chinese title changed from "hygienic standard" to "hygienic requirements".
• Structure: the new edition is organised as raw-material requirements, production-process requirements, product requirements and test methods. Physicochemical indicators were added to the product requirements, toxicology moved from an annex into the main text, and in the 2024 edition tampons have their own microbial indicators.
• What SUNGO tests: the CNAS scope of our Shanghai laboratory (L22083) lists four GB 15979-2024 items for the test object "disposable sanitary products": appearance (7.2.1), pH value (7.2.2), ethylene oxide residue (7.2.5) and microbiological testing (7.2.9).
• Accreditation mark: these four items are in the Shanghai CNAS scope and not in the Shanghai CMA schedule, so the report cannot carry the CMA mark.
• Outside our scope: fluorescent whitening agents, lead/arsenic/mercury, antibacterial/bacteriostatic performance, active ingredients and the production-process requirements are not in SUNGO's accreditation and need to be commissioned elsewhere. The toxicology tests are irritation and sensitisation biological tests; SUNGO subcontracts them to a suitably qualified laboratory. Under accreditation rules, subcontracting requires the client's prior consent, and the report identifies the subcontracted items and the subcontractor. SUNGO does not issue full-scope GB 15979-2024 reports, and the Hefei laboratory's accreditation does not include GB 15979.

The standard and its scope

Identity

GB 15979-2024's English title is Hygienic requirements for disposable sanitary products (ICS 11.080). The foreword states that it was proposed by, and is under the responsibility of, the National Disease Control and Prevention Administration (NDCPA). The national platform lists it under the "hygiene" category, and a Xinhua report carried on gov.cn on 19 July 2024 describes it as a mandatory national standard in the disinfection field managed by NDCPA. Per the foreword, the 2024 edition is the second revision. Whether a given product is regulated as a sanitary product or as a medical device is outside the scope of this article and is decided by the competent authority's classification.

Scope and definitions

Chapter 1 sets out requirements for raw materials, the production process and the product, plus packaging, transport, storage and labelling, and describes the corresponding test methods. It applies to disposable sanitary products that are sold and used.

The new definition (3.1) is: disposable daily-use articles in direct contact with the human body, used for physiological hygiene or for antibacterial or bacteriostatic purposes. The note lists three main groups: feminine menstrual products; excreta-related products (excluding toilet paper); and other products such as hygiene wet wipes, antibacterial agents and bacteriostatic agents. The 2002 definition covered articles in "direct or indirect contact" and its examples included caps, masks and condoms; the 2024 edition keeps only direct contact.

Among the new terms, hygiene wet wipes (3.2) cover only wipes in direct contact with hands, skin or mucosa, and antibacterial (3.3) and bacteriostatic (3.4) agents exclude preparations for specific sites such as the feet and eyes. Which category a given product falls into, and whether the ordinary or disinfected grade applies, follows the standard text and the product label.

Transition

Chapter 10 states that products manufactured or imported before the implementation date may be sold until the end of their labelled shelf life, provided they comply with GB 15979-2002. In practice, products manufactured or imported on or after 1 July 2025 should meet the 2024 edition.

What changed: comparing the two editions

The 2024 foreword lists 16 main technical changes. The table groups them by topic; clause numbers in brackets are taken from the texts of the two editions.

SAC's interpretation summarises the revision under five headings. Among them, it says that pH and migratory fluorescent whitening agent residue were added as physicochemical indicators according to risk level, and that the microbial contamination indicators and toxicological safety requirements were adjusted.

For test requests, the product microbiological methods remain in Annex B, but in the 2024 edition the main text points to them from clause 7.2.9. SUNGO's CNAS scope lists the items by their 2024 clause numbers (7.2.x), so the application form should cite the 2024 clauses.

The four accredited items: requirements, methods and assessment

Appearance (6.1; method 7.2.1)

Requirement: the product should be clean and consistent with its inherent characteristics, with no shedding of fibres or particles and no abnormal odour or foreign matter. Method: visual inspection and smell. Compared with 2002, the new edition explicitly adds the "no shedding of fibres or particles" wording.

pH value (6.2 Table 1; method 7.2.2)

The pH indicator in Table 1 applies only to "sanitary products labelled with a pH value"; the indicator is "within ±1 of the labelled mean". If the label states no pH value, this indicator does not apply.

Clause 7.2.2 gives three routes: absorbent products such as sanitary pads and panty liners use the GB/T 8939 method; other products with their own pH test standard use that standard; the rest use WS/T 10009. SUNGO's scope lists GB 15979-2024 clause 7.2.2; GB/T 8939 and WS/T 10009 are not listed in our scope as standalone standards.

Ethylene oxide residue (6.2 Table 1; method 7.2.5 / Annex D)

For "sanitary products disinfected with ethylene oxide", Table 1 sets indicators at two points in time: no more than 250 μg/g after disinfection, and no more than 10 μg/g when placed on the market. Products not disinfected with ethylene oxide are not subject to this indicator. Clause 4.6 of the 2002 edition addressed the residue at the time of leaving the factory; the 2024 edition uses the two indicators "after disinfection" and "on the market".

The Annex D principle: the product is cut up and extracted with deionised water, and the extract is analysed by gas chromatography with a flame ionisation detector, quantified against a working curve prepared from ethylene oxide standard gas; each extract is measured twice in parallel. Annex D also requires sampling from the same disinfection batch immediately after ethylene oxide disinfection, with measurements at 24 h after disinfection and then every few days until the residue falls below the Table 1 value. If you are building an aeration profile, plan the sampling time points around your process.

Note that this is the sanitary-product method. Ethylene oxide residues on medical devices are normally assessed under GB/T 16886.7, a separate framework from Annex D.

Microbiological testing (6.4 Table 5; method 7.2.9 / Annex B)

Table 5 gives three indicators by product category and grade: total bacterial colony count, specified microorganisms and other pathogenic microorganisms, and total fungal colony count. The table below is taken from Table 5 of the standard; the standard text prevails.

Footnote a: specified microorganisms are coliforms, Pseudomonas aeruginosa, Staphylococcus aureus and haemolytic streptococci. Footnote b: where a related infection is suspected, testing for the relevant target pathogen is carried out. The term "pyogenic pathogens" that is common in the industry comes from the 2002 edition, where it covered Pseudomonas aeruginosa, Staphylococcus aureus and haemolytic streptococci, with coliforms in a separate column.

Annex B covers sample preparation (B.1), initial contamination and total bacterial count (B.2, pour-plate count), the four specified microorganisms (B.3 to B.6, each by enrichment, isolation, Gram staining and confirmatory tests), total fungal count (B.7) and qualitative fungal detection (B.8).

Three details affect results. First, if the sample has antibacterial or bacteriostatic activity, a suitable neutraliser must be used; if none is available, membrane filtration is used to remove the inhibitory components before the test solution is prepared. Second, for products with a lot of absorbent resin that do not release enough liquid, the diluent volume can be increased and the dilution factor adjusted in the count. Third, if the first total bacterial or fungal count exceeds the requirement, the retained samples are retested twice; the product passes only if both retests comply, and fails if either exceeds.

Two more points: initial contamination of disinfected-grade products is a production-process requirement (5.3, method 7.1.2) and is not among the clauses listed in SUNGO's scope; for the target-pathogen testing under footnote b, Annex B gives no corresponding method, so please check with the laboratory first if you need it. For medical devices, bioburden before sterilisation is determined under ISO 11737-1, a different method framework from initial contamination in this standard; see How to Determine Bioburden: Key Points of ISO 11737-1.

Product requirements outside our scope

The following are requirements of the standard but are not in SUNGO's accreditation. They need to be commissioned from a suitably qualified body:

• Migratory fluorescent whitening agents (7.2.3), for products containing paper;
• Lead, arsenic and mercury (7.2.4), for wet wipes, hygiene wet wipes, antibacterial and bacteriostatic agents and similar;
• Bactericidal performance, bacteriostatic performance and stability (7.2.6, Annex E), for hygiene wet wipes and products with antibacterial or bacteriostatic ingredients;
• Content of active ingredients and restricted substances such as chlorhexidine gluconate, 2,4,4'-trichloro-2'-hydroxydiphenyl ether and benzalkonium bromide (7.2.7);
• Production-process requirements: production environment (Annex A), initial contamination (7.1.2) and disinfection efficacy evaluation (Annex C).

The toxicology tests (6.3, 7.2.8, Annex F) – skin irritation, eye irritation, vaginal mucosa irritation and skin sensitisation, selected by product category – are biological tests outside SUNGO's accreditation; SUNGO subcontracts them to a suitably qualified laboratory. Under accreditation rules, subcontracting requires the client's prior consent, and the report identifies the subcontracted items and the subcontractor.

SUNGO accreditation scope table

Each row matches a line in SUNGO's scope schedules. The first four rows are the sanitary-product items discussed here; the last two relate to GB 15979 but differ in test object or accreditation and are listed for comparison.

Where the testing is done and under which accreditation

The four GB 15979-2024 items are tested in Shanghai, and reports are issued by Shanghai SUNGO Medical Technology Co., Ltd.; the laboratory is at No. 958 Kangqiao East Road, Pudong, Shanghai. Hefei SUNGO Medical Technology Co., Ltd. is a separate legal entity, and its accreditation does not include GB 15979.

The four items are in the Shanghai CNAS scope, so the report can carry the CNAS mark. They are not in the Shanghai CMA (240015340087) schedule, so it cannot carry the CMA mark. CMA covers only the items in its schedule, and the certificate states that it is valid within the People's Republic of China. The "GB 15979 Annex B" entry in the Shanghai IAS (TL-1019) scope carries no year, and whether it applies to the 2024 edition has not been confirmed, so the 2024 reports described in this article are CNAS reports only. For what each accreditation covers, see SUNGO Medical Device Testing Scope: CNAS, CMA and IAS in Shanghai and Hefei.

On our website these products sit under other device testing. Ethylene oxide residue is also part of our sterilization-related services.

Preparing your submission

• Category and grade: Table 5 indicators depend on the product category and on ordinary or disinfected grade; tampons have their own line.
• Labelled pH value: the indicator is "within ±1 of the labelled mean", so it cannot be assessed without the labelled value. Also say whether the product is absorbent or another form, so the 7.2.2 route can be set.
• Ethylene oxide batch and date: Table 1 distinguishes "after disinfection" from "on the market"; tell us which point your samples represent.
• Antibacterial ingredients and absorbent materials: under Annex B these decide the neutraliser or membrane filtration and the diluent volume.
• Same batch, unopened minimum sales packs: clause B.1 of Annex B samples at least 6 minimum sales packs from 3 shipping cartons of the same batch, one third for testing and two thirds retained, with more taken if that is not enough. Sampled packs must be intact and unopened before testing. Retained samples are used for retesting. Ethylene oxide residue is sampled separately under Annex D, which also calls for retest samples. Confirm the quantity to send with the laboratory.
• Edition and clauses: write GB 15979-2024 and the clauses you need from 7.2.1, 7.2.2, 7.2.5 and 7.2.9 on the application.

Frequently asked questions

Can SUNGO issue a full GB 15979-2024 report?

No. For GB 15979-2024, our Shanghai CNAS scope covers four items only: appearance, pH value, ethylene oxide residue and microbiological testing; the report can carry the CNAS mark but not the CMA mark. The other physicochemical, antibacterial/bacteriostatic and production-process items are outside our scope and need to be commissioned elsewhere; the toxicology tests are subcontracted by SUNGO to a suitably qualified laboratory, with the client's prior consent and with the subcontracted items and subcontractor identified in the report.

Are reports issued against the 2002 edition before 1 July 2025 still usable?

Chapter 10 only states that products manufactured or imported before the implementation date and complying with the 2002 edition may be sold until their shelf life ends. Whether an older report is still accepted is up to the party relying on it; products manufactured or imported on or after 1 July 2025 should be assessed against the 2024 edition.

Which organisms does the microbiological testing cover?

Under 7.2.9 and Annex B: total bacterial count, coliforms, Pseudomonas aeruginosa, Staphylococcus aureus, haemolytic streptococci and fungi. Initial contamination (7.1.2) is not among the listed clauses.

Do medical masks follow the 2024 edition for microbial indicators?

That depends on which edition the mask product standard or product technical requirements cite. SUNGO's scope lists GB 15979-2002 Annex B under masks. Mask microbial testing is covered in a separate article.

Requesting a quote

When you ask for a quote, please give the product name and category (menstrual, excreta-related, wipes or other), ordinary or disinfected grade, whether a pH value is labelled, whether ethylene oxide is used, any antibacterial or bacteriostatic ingredients, and the items and clauses you need (7.2.1, 7.2.2, 7.2.5, 7.2.9). Please also list any out-of-scope items; we will first tell you which are within our accreditation, which would be subcontracted and which need to be commissioned elsewhere, and then confirm the report format. Send your request through our contact page.