Non-sterile medical masks in China are moving to a new microbial test method. YY/T 0969-2023 took effect on 1 December 2025, and YY 0469-2023 takes effect on 1 December 2026. Neither new edition cites Annex B of GB 15979-2002 any more. Both now call for membrane filtration under General Chapter 1105 of the Chinese Pharmacopoeia (ChP), 2020 Edition, Volume IV, and the pass/fail rule changes from "total bacterial colony count plus five organisms not detected" to "aerobic count and yeast-and-mould count added together". Below we compare the two methods, cover release testing and old reports, and show where each sits in SUNGO Shanghai's scopes.
Key points first
- The method has changed. The old editions, YY 0469-2011 clause 5.9 and YY/T 0969-2013 clause 5.7, test non-sterile masks to GB 15979-2002 Annex B. The new editions, YY 0469-2023 clause 5.9.1 and YY/T 0969-2023 clause 5.7.1, use the membrane filtration method of ChP 2020 Volume IV General Chapter 1105.
- The acceptance rule has changed. Table 1 in both old editions requires a total bacterial colony count of no more than 100 CFU/g, with coliforms, Pseudomonas aeruginosa, Staphylococcus aureus, haemolytic streptococci and fungi not detected. The new editions only require that, for masks supplied non-sterile, the total microbial count shall be no more than 30 CFU/g, where the total is the aerobic count plus the yeast-and-mould count.
- No specified-organism tests in the new clauses. The microbial limit clauses of both new editions cite only General Chapter 1105 (enumeration), not General Chapter 1106 (tests for specified microorganisms).
- Method suitability now comes first. Chapter 1105 requires the counting method to be confirmed by a suitability test, and re-confirmed after relevant changes. GB 15979-2002 Annex B has no such step.
- Check the report mark separately for each method. Microbial limits tested to Chapter 1105 are within SUNGO Shanghai's CNAS and CMA scopes (2020 Edition only where cited by YY 0469-2023 or YY/T 0969-2023; 2025 Edition listed under medical devices). The IAS scope's only pharmacopoeia entry is Chapter 1101; confirm with the laboratory whether the new mask microbial limits can be reported under IAS. GB 15979 Annex B is within the Shanghai CNAS, CMA and IAS scopes.
- Sterile masks are not tested for this. Masks supplied sterile must be sterile: the old editions cite the sterility test of GB/T 14233.2-2005, and the new editions cite ChP General Chapter 1101. Sterility testing is covered in a separate article.
Standards and scope
The two mask product standards
YY 0469-2023 "Surgical mask" is a mandatory pharmaceutical industry standard, published on 22 November 2023 and effective from 1 December 2026, replacing YY 0469-2011 in full. It applies to single-use medical masks worn by healthcare workers where there is potential contamination by blood, body fluids or secretions, and during invasive procedures, but not to respirators.
YY/T 0969-2023 "Single-use medical face mask" is a recommended pharmaceutical industry standard, published on 22 November 2023 and effective from 1 December 2025, replacing YY/T 0969-2013 in full. It applies to single-use masks covering the mouth, nose and lower jaw, worn in general clinical settings to block contaminants exhaled or expelled from the mouth and nose, and not to medical protective masks or surgical masks.
The forewords of both new editions list changes to the microbial indicator requirement and test method. Each edition splits the microbial indicators into two clauses: microbial limits for products supplied non-sterile (YY 0469-2023 clause 4.9.1, YY/T 0969-2023 clause 4.7.1), and sterility for products supplied sterile (clauses 4.9.2 and 4.7.2). This article covers the first.
The two method documents
GB 15979-2002 "Hygienic standard for disposable sanitary products" is a mandatory national standard, published on 5 March 2002 and effective from 1 September 2002. According to the national standards information platform, it was withdrawn on 1 July 2025 and fully replaced by GB 15979-2024 (hygienic requirements for disposable sanitary products). The old mask editions cite the dated reference "GB 15979-2002 Annex B", so testing to YY 0469-2011 or YY/T 0969-2013 still uses the 2002 Annex B. GB 15979-2024 itself is covered in a separate article.
General Chapter 1105 in ChP Volume IV covers microbial enumeration tests for non-sterile products, that is, counting mesophilic bacteria and fungi that grow under aerobic conditions. The 2025 Edition of the ChP was promulgated by Announcement No. 29 of 2025 of the National Medical Products Administration and the National Health Commission and has been in force since 1 October 2025. Its Volume IV table of contents titles 1105 "microbial limit tests for non-sterile products: microbial enumeration tests"; the next chapter, 1106, covers tests for specified microorganisms. Both new mask editions list the dated ChP 2020 Edition, Volume IV in their normative references, state that only the cited edition of a dated reference applies, and no longer list GB 15979.
How the two methods differ
| Aspect | GB 15979-2002 Annex B (cited by the old mask editions) | ChP General Chapter 1105 (cited by the new mask editions) |
|---|---|---|
| What is tested | Total bacterial colony count and total fungal colony count; separate methods for coliforms, P. aeruginosa, S. aureus and haemolytic streptococci; and a qualitative fungal test | Two counts: total aerobic microbial count (TAMC) and total yeast and mould count (TYMC) |
| Sample preparation | Weigh the sample, cut it up, add it to sterile physiological saline and mix well; count from the supernatant after natural settling (sample mass and diluent volume as stated in the standard) | Take not less than 10 g, cut it up and prepare a 1:50 (g/mL) test solution in a diluent containing 0.1% (mL/mL) polysorbate 80 or another non-inhibitory surfactant (as set by the product standard) |
| Counting | Pour plates: nutrient agar for the bacterial count and Sabouraud agar for the fungal count | Membrane filtration: membranes placed on soya-bean casein digest agar (TAMC) and Sabouraud dextrose agar (TYMC) |
| Method confirmation | No method suitability test in Annex B | Media suitability check and suitability test of the counting method |
| Acceptance for masks | Old Table 1: total bacterial colony count ≤ 100 CFU/g; coliforms, P. aeruginosa, S. aureus, haemolytic streptococci and fungi not detected | The two counts added together; total microbial count ≤ 30 CFU/g |
Different targets
GB 15979-2002 Annex B combines counting with qualitative detection. Total bacterial and total fungal colony counts are made on plates. Coliforms, P. aeruginosa, S. aureus and haemolytic streptococci each have their own enrichment, isolation and identification procedure, reported only as detected or not detected. Annex B gives both a fungal count (B.7) and a qualitative fungal test (B.8); as the old mask editions say fungi shall not be detected, agree with the laboratory which subclause the result is reported under.
Chapter 1105 only counts; it does not identify specified organisms. The definitions of the two counts and the reporting rules are as given in the chapter. The new mask editions require the two results to be added together before comparing with the limit.
Sample handling: cutting, extraction and dilution
Both methods cut and extract the sample, but with different diluents: Annex B uses sterile saline, while the new mask editions specify a surfactant-containing diluent such as pH 7.0 sterile sodium chloride-peptone buffer, pH 7.2 phosphate buffer or 0.9% sterile sodium chloride solution, mixed thoroughly. Chapter 1105 allows a surfactant to be added to the diluent for products that disperse poorly; cut mask nonwovens do not always disperse evenly, and the product standards write the surfactant straight into the diluent. Chapter 1105 also requires that, where a surfactant is used to prepare the test solution, it is shown to be non-toxic to microorganisms and compatible with any neutraliser or inactivator in use.
What method suitability means for masks
Chapter 1105 requires a suitability test to confirm that the counting method is appropriate for the product. Test organisms specified in the chapter (representative bacteria, a yeast and a mould) are added to the test solution, alongside a product control and an inoculum control, and recovery is compared. Acceptance criteria are as stated in the chapter.
Poor recovery suggests the product may be inhibitory. Chapter 1105's remedies are to increase the volume of diluent or medium, add a suitable neutraliser or inactivator, use membrane filtration, or combine these. If the mask material has an antimicrobial finish, contains inhibitory substances, or has additives that leach into the diluent, the preparation and rinsing steps may need to be adjusted at this stage. Membrane filtration, which the product standards specify, is itself one of these remedies.
Chapter 1105 also states that the counting method shall be re-tested for suitability when a change in the test procedure or the product could affect the result. A new meltblown or nonwoven supplier, an added antimicrobial finish, or a change in disinfection or other post-treatment should all be assessed.
Acceptance: the sum of two counts, no specified organisms
The new limit applies to the combined total. We suggest that the report shows TAMC, TYMC and their sum, for traceability.
Neither new microbial limit clause cites Chapter 1106, and neither says that pathogens shall not be detected. If your product technical requirements, a customer specification or another market still calls for specified-organism tests, raise this before ordering: SUNGO's certificates list Chapter 1105 enumeration, while Chapter 1106 is not listed as a separate item, so coverage has to be confirmed item by item.
Adjusting factory release testing
The mask standards set requirements and test methods; which items are tested at release, and how often, is for the manufacturer to decide under its product technical requirements and quality system. If release includes a microbial test, the changeover usually involves the following.
- Update the documents. Change the method reference in inspection procedures and product technical requirements from GB 15979-2002 Annex B to ChP Chapter 1105 membrane filtration, change the criterion to total microbial count ≤ 30 CFU/g, and state the pharmacopoeia edition.
- Build the capability. In-house testing needs membrane filtration equipment and media, plus media suitability checks and a method suitability test under Chapter 1105. If you outsource, confirm that the laboratory's accreditation or CMA scope covers the pharmacopoeia edition and chapter you cite.
- Start a new baseline. Historical data from the old method cannot be compared directly with the new method, because sample preparation, diluent, counting technique and acceptance basis have all changed. Trend data from the new method separately.
- Control changes. Bring changes to raw materials, additives and processes under change control, and assess whether method suitability needs to be repeated.
Reading old reports during the changeover
A report only shows conformity with the edition of the standard it was tested to. Results in an old GB 15979-2002 Annex B report cannot be re-judged against the new limit or treated as a Chapter 1105 test. Until YY 0469-2023 takes effect, YY 0469-2011 is the edition in force. Whether a report to a given edition can still support registration, renewal or change applications depends on the product technical requirements and the regulator, so check in advance.
SUNGO Shanghai's CNAS and CMA schedules list the microbial items of both old and new mask editions. State the edition when you order, so the report matches your submission.
Certificate scope table
Rows relevant to this article from the CNAS, CMA and IAS scopes of Shanghai SUNGO Medical Technology Co., Ltd. (Chinese entries translated).
| Item | Standard and clause | Notes / limitations |
|---|---|---|
| Surgical mask: microbial limits | YY 0469-2023 clause 5.9.1 | Shanghai CNAS and CMA (no clause number in the CMA schedule) |
| Surgical mask: microbial limits | ChP 2020 Edition, Volume IV, General Chapter 1105 | Shanghai CNAS and CMA; limitation: only where cited by YY 0469-2023 |
| Single-use medical face mask: microbial limits | YY/T 0969-2023 clause 5.7.1 | Shanghai CNAS and CMA (no clause number in the CMA schedule) |
| Single-use medical face mask: microbial limits | ChP 2020 Edition, Volume IV, General Chapter 1105 | Shanghai CNAS and CMA; limitation: only where cited by YY/T 0969-2023 |
| Medical devices: microbial limits | ChP 2025 Edition, Volume IV, General Chapter 1105 | Shanghai CNAS and CMA |
| Surgical mask: microbial indicators | YY 0469-2011 clause 5.9 | Shanghai CNAS and CMA (no clause number in the CMA schedule) |
| Single-use medical face mask: microbial indicators | YY/T 0969-2013 clause 5.7 | Shanghai CNAS and CMA (no clause number in the CMA schedule) |
| Surgical mask and single-use medical face mask: microbial indicators | GB 15979-2002 Annex B | Shanghai CNAS and CMA (no annex number in the CMA schedule) |
| (IAS lists the standard without a separate item name) | GB 15979 Annex B | Shanghai IAS; title as listed: Hygienic standard for disposable sanitary products – Annex B: Determination of a population of microorganisms on products; the scope does not state a year |
| (IAS lists the standard without a separate item name) | YY 0469 | Shanghai IAS; title as listed: Surgical mask; limitation: Except for 5.6.2, 5.11, 5.12, 5.13; the scope does not state a year |
| (IAS lists the standard without a separate item name) | YY/T 0969 | Shanghai IAS; title as listed: Single-use medical face mask; limitation: Except for 5.9; the scope does not state a year |
Besides the rows above, the certificates also list GB/T 14233.2-2005 Chapter 3 under the "microbial indicators" item of the old mask editions (the IAS scope also lists GB/T 14233.2 Chapter 3). That is the sterility test for sterile masks, not a microbial limit method.
Where the work is done at SUNGO, and under which accreditation
- Shanghai laboratory. All items in this article belong to Shanghai SUNGO Medical Technology Co., Ltd., whose laboratory is at No. 958 Kangqiao East Road, Pudong, Shanghai. Hefei SUNGO Medical Technology Co., Ltd. is a separate legal entity, and its accreditation and CMA scopes do not include mask microbial items.
- Chapter 1105 (new method): CNAS and CMA. CNAS registration No. L22083; CMA certificate No. 240015340087. The 2020 Edition of Chapter 1105 is listed under the two mask types and limited to citation by YY 0469-2023 and YY/T 0969-2023 respectively; the 2025 Edition of Chapter 1105 is listed under "medical devices".
- IAS reports for the new mask microbial limits: confirm first. The Shanghai IAS scope (TL-1019) lists only Volume 4, Section 1101 (sterility test) from the pharmacopoeia, limited to medical device testing, and not Chapter 1105. YY 0469 and YY/T 0969 are listed without a year, each with excluded clauses. Confirm with the laboratory whether, and to which edition, the new microbial limit clauses can be reported under IAS.
- GB 15979 Annex B (old method): CNAS, CMA and IAS. The IAS scope lists GB 15979 Annex B without a year; if you need an IAS report to a specific edition, confirm the edition with the laboratory first.
- Limits of the CMA. The CMA qualification covers only the items in its schedule, and the certificate states that it is valid within the People's Republic of China.
Preparing your submission
- State the product condition and the edition. Say whether the mask is supplied non-sterile or sterile, which edition you are testing to (YY 0469-2011/2023 or YY/T 0969-2013/2023), and the pharmacopoeia edition.
- Provide samples per the standard. The new editions require at least two smallest packages taken at random and a test portion of not less than 10 g. Method suitability testing and retained samples need additional product, so agree the total quantity with the laboratory. Annex B has its own sampling rules, dividing samples into test, retained and retest portions.
- Keep packages intact. Ship samples unopened in their smallest sales packages, not repacked; Annex B also forbids opening them before testing.
- Describe materials and treatments. Tell us about any antimicrobial finish, inhibitory additive or other post-treatment, and whether the product has been disinfected; this shapes the suitability test design.
- Flag changes. If this is your first submission to Chapter 1105, or raw materials or processes have changed, note it on the request form so we can judge whether method suitability needs to be repeated.
- State the report requirements. Specify whether you need the CNAS, CMA or IAS mark (see above on IAS coverage), and whether the report is for registration, outsourced release testing or customer acceptance.
FAQ
Which edition should surgical masks be tested to before YY 0469-2023 takes effect?
YY 0469-2023 takes effect on 1 December 2026; until then YY 0469-2011 is in force. Which edition to test to depends on your product technical requirements and the regulator's requirements.
Do the new editions still require tests for coliforms, S. aureus and other pathogens?
YY 0469-2023 clause 4.9.1 and YY/T 0969-2023 clause 4.7.1 only specify a total microbial count, tested to Chapter 1105, with no specified-organism items. If your product technical requirements keep tests for specified microorganisms, confirm before ordering, because the certificates do not list Chapter 1106 as a separate item.
An old report shows a very low bacterial count. Can it be judged as passing to the new edition?
No. Sample preparation, diluent, counting technique and acceptance basis all differ between the two methods, so old results cannot be converted into Chapter 1105 results.
Can microbial limits tested to Chapter 1105 be issued under IAS?
Confirm with the laboratory first. The Shanghai IAS scope lists only Section 1101 from the pharmacopoeia, not Chapter 1105; YY 0469 and YY/T 0969 are listed without a year, so IAS coverage of the new microbial limit clauses must be confirmed item by item. The item is within the Shanghai CNAS and CMA scopes.
Are microbial limits the same as bioburden?
No. Microbial limits decide whether a non-sterile product meets a limit. Bioburden determination follows ISO 11737-1, which covers enumerating and characterizing the viable microorganisms on or in a health care product, component, raw material or package; the purpose and method differ. For bioburden, see How to Determine Bioburden: Key Points of ISO 11737-1.
Quotes and submissions
If you need testing to the Chapter 1105 method of YY 0469-2023 or YY/T 0969-2023, or still need reports to GB 15979-2002 Annex B during the changeover, start with our medical mask testing service. To request a quote, use the contact page and send the product name and models, whether it is supplied sterile or non-sterile, the standard and edition, materials and post-treatments, and the report mark you need. We will check each item against our CNAS, CMA and IAS scopes.