YY/T 0969-2023, Single-use medical face mask, was issued on 22 November 2023 and took effect on 1 December 2025, replacing YY/T 0969-2013 in full. After the change, regulatory and quality teams usually ask three things: which clauses changed, which tests apply to non-sterile and sterile masks, and where the testing is done and under which accreditation. This article compares the two editions clause by clause from the standard texts, checked on 22 October 2026. For every limit and requirement, the standard text governs.
Key points
- This is the first revision of YY/T 0969. The 2023 foreword lists 16 technical changes, a) to p), covering definitions, requirements, test methods and marking. The BFE requirement and Chapter 7 are not among them.
- BFE is unchanged; airflow resistance changed most. BFE must still be at least 95%, tested by the YY 0469 method. For airflow resistance, the limit, specimen number and number of test areas all changed; specimens changed from 3 taken at random to at least 5.
- Nose clip and strap requirements were rewritten. A structure replacing the nose clip is now allowed, and nose clip length is set relative to the marked length of its edge. Ear-loop and tie-on masks have separate strap requirements.
- Microbial testing moved to pharmacopoeia methods. Both editions treat sterile and non-sterile masks separately; under 2023, non-sterile masks are tested for microbial limits under General Chapter 1105 of the Chinese Pharmacopoeia (ChP) 2020 Edition, Volume IV; sterile masks for sterility under General Chapter 1101. GB 15979-2002 Annex B and GB/T 14233.2-2005 Clause 3 are no longer cited.
- Packaging clause 7.1 is not new. The 2013 edition already had it; only the wording changed. What is new is in SUNGO's appendices: "Packaging 7.1" is listed under YY/T 0969-2023 but not under the 2013 edition.
- SUNGO's Shanghai laboratory has both editions listed in its CNAS and CMA appendices; in the CNAS appendix, YY/T 0969-2013 5.1 (appearance) is marked "for specific clients only". Its IAS scope lists YY/T 0969 without a year, except 5.9. Biocompatibility (5.9) is outside SUNGO's accredited scope; SUNGO subcontracts it to a laboratory with the appropriate qualifications, with the client's prior consent, and the report identifies the subcontracted tests and the subcontractor.
The standard and its scope
Basic data
Sources: covers and forewords of both editions, and the National Public Service Platform for Standards Information.
| Item | YY/T 0969-2013 | YY/T 0969-2023 |
|---|---|---|
| Issued / effective | 2013-10-21 / 2014-10-01 | 2023-11-22 / 2025-12-01 |
| Issued by | China Food and Drug Administration | National Medical Products Administration |
| Status | Abolished 2025-12-01 | Current; replaces the 2013 edition in full |
| Type | Recommended industry standard | Recommended industry standard |
| Responsible committee | Beijing Medical Device Quality Supervision and Testing Center of the State Food and Drug Administration | National Medical Protective Equipment Standardization Working Group (SAC/SWG 30) |
| Normative references | GB/T 14233.1-2008, GB/T 14233.2-2005, GB 15979-2002, GB/T 16886.5, GB/T 16886.10, GB/T 16886.12, YY 0469 | GB/T 14233.1-2022, GB/T 16886.5, GB/T 16886.10, GB/T 16886.12, YY 0469, ChP 2020 Edition Volume IV |
Scope essentially unchanged
Both editions cover single-use masks that cover the mouth, nose and jaw, worn in general medical settings to block contaminants exhaled or expelled from the mouth and nose, and both exclude medical protective masks and surgical masks. The 2023 scope no longer mentions instructions for use, in line with the rewritten Chapter 6.
Two referencing rules that affect testing
- YY 0469 is undated. The BFE method cites YY 0469 without a year. Under Clause 2 of the 2023 edition, the latest edition of an undated reference, including amendments, applies. Which edition the report uses is covered in the FAQ.
- The Pharmacopoeia is dated. The 2023 edition cites the ChP 2020 Edition, Volume IV, and only the cited edition of a dated reference applies. The ChP 2025 Edition has been in force since 1 October 2025, but clause 5.7 still names General Chapters 1105 and 1101 of the 2020 Edition.
Clause-by-clause comparison
Taken from both texts, condensed in places.
| Clause | 2013 edition | 2023 edition | Change |
|---|---|---|---|
| 3.1 BFE | Percentage of bacteria-laden particles removed by the mask material at a specified flow | Ability of the mask to remove bacteria-laden particles under specified conditions, usually as a percentage | "Mask material" became "mask" |
| 3.2 Airflow resistance | Pressure difference, in Pa | Pressure difference per unit area | Aligned with 4.6 and 5.6 |
| 4.1/5.1 Appearance | Clean, intact, no damage or stains; 3 random specimens, visual | Adds sharp protrusions and other obvious defects; at least 3 specimens, visual | More specific |
| 4.2/5.2 Structure and dimensions | Design dimensions, maximum deviation ±5% | Manufacturer's marked dimensions and permitted deviation; inner and outer sides distinguishable | Tolerance set by manufacturer; inner/outer side added |
| 4.3/5.3 Nose clip | Malleable nose clip, at least 8.0 cm; material checked and bent by hand, clip removed and measured | Nose clip or replacing structure, holding the mask on the nose with good fit; length at least 50% of the marked edge length; visual, measured, worn | Alternative allowed; relative length; fit |
| 4.4/5.4 Straps | Easy to put on and remove; each strap-to-body connection at least 10 N; 10 N static load for 5 s | Ear-loop: each strap, and the combined breaking strength at the two strap-to-body connection points, at least 15 N; tie-on: each strap and each strap-to-body connection at least 10 N | Split by type; higher for ear loops |
| 4.5/5.5 BFE | At least 95%; 3 random specimens, YY 0469 method | At least 95%; at least 3 specimens, YY 0469 method, all must comply | Unchanged |
| 4.6/5.6 Airflow resistance | Not more than 49 Pa/cm²; 3 random specimens, mask centre | Less than 40 Pa; at least 5 specimens, 3 non-overlapping areas each, averaged | Limit, specimens and number of test areas changed |
| 4.7/5.7 Microbial | Non-sterile: total bacterial count not more than 100 CFU/g, five listed organisms or groups not detected, GB 15979-2002 Annex B; sterile: sterile, GB/T 14233.2-2005 Clause 3 | Supplied non-sterile: total microbial count not more than 30 CFU/g, ChP 1105; supplied sterile: validated sterilization process, product sterile, ChP 1101 | Pharmacopoeia methods; new acceptance basis |
| 4.8/5.8 EO residue | If EO-sterilized or disinfected, not more than 10 μg/g; GB/T 14233.1-2008, Clause 9 exhaustive-extraction GC as referee method | Heading adds "if applicable"; same limit; GB/T 14233.1-2022 sub-clause 9.4 | Method standard updated |
| 4.9/5.9 Biological | "Biological evaluation", three tests | "Biocompatibility", same three tests; cytotoxicity judged by relative cell proliferation (viability); new 5.9.1 sample preparation | Outside SUNGO's accredited scope |
| Chapter 6 Marking | 6.1 Smallest package marking (11 items); 6.2 Instructions for use (9 items) | Chinese marking on the smallest sales unit only (at least 12 items) | No separate instructions-for-use clause |
| Chapter 7 Packaging, transport, storage | 7.1 Packaging prevents damage and contamination before use, breathable if EO is used; 7.2 Transport; 7.3 Storage | 7.1 Packaging prevents mechanical damage and contamination before use, breathable requirement unchanged; 7.2 Transport and storage per contract or instructions | 7.1 wording only |
BFE and airflow resistance: specimens and conditions
BFE. Clause 5.5 calls for at least 3 specimens tested by the YY 0469 BFE method, each result meeting 4.5. YY/T 0969 sets no aerosol or flow parameters of its own; those come from YY 0469.
Airflow resistance. Under 5.6 of the 2023 edition: at least 5 specimens; 3 non-overlapping test areas at the mask centre (the mouth and nose area when worn); air flow (8.0±0.2) L/min; test area diameter 25 mm, area 4.9 cm²; ΔP = M/4.9, reported as pressure difference per square centimetre (Pa); a specimen passes when the average of its 3 areas meets 4.6. The 2013 edition used (8±0.2) L/min, the same 25 mm diameter and ΔP = M/A, in Pa/cm².
With at least 5 specimens, each judged on the average of its 3 areas, variation between masks is more likely to show in the result, and the limit moved from not more than 49 Pa/cm² to less than 40 Pa. Design verification should leave margin.
Nose clip and straps: know your mask type
Nose clip. A structure replacing the nose clip is accepted if it holds the mask firmly on the nose with good fit. The nose clip must be at least 50% of the marked length of its edge, so state that marked length when submitting samples.
Straps. Ear-loop: with the mask body fixed in its natural shape and both connection points level, a 15 N static load is applied at the middle of the strap for 5 s, then the other side; any break is recorded with its location. Tie-on: 10 N is applied to the strap end in the direction of Figure 1 b) for 5 s; a strap with no fixed connection is removed, one end fixed and the other loaded with 10 N. The 2013 requirement that straps be easy to put on and remove (4.4.1) and its wearing check are no longer included.
Non-sterile vs sterile masks: which tests apply
The 2023 clause headings name the product state:
| Clause | Supplied non-sterile | Supplied sterile |
|---|---|---|
| 5.1 to 5.6 Appearance, structure and dimensions, nose clip, straps, BFE, airflow resistance | Applies | Applies |
| 5.7.1 Microbial limits | Applies | Does not apply |
| 5.7.2 Sterility | Does not apply | Applies |
| 5.8 EO residue (if applicable) | Applies if EO-disinfected | Applies if EO-sterilized; not relevant to other methods |
| 5.9 Biocompatibility | Required; subcontracted by SUNGO to a laboratory with the appropriate qualifications (see below) | Required; subcontracted by SUNGO to a laboratory with the appropriate qualifications (see below) |
| Chapter 6 k) Sterile marking | Not relevant | Sterile symbol and sterilization method shown |
The tests for a given product are set by its product technical requirements.
Microbial indicators: pharmacopoeia methods
For non-sterile masks, 5.7.1 uses the membrane filtration method of ChP General Chapter 1105, summing the total aerobic microbial count and the total yeast and mould count; test solution preparation needs at least 2 smallest packages drawn at random and not less than 10 g of sample. For sterile masks, 5.7.2 follows ChP General Chapter 1101, handling and inoculating samples as specified for dressings under direct inoculation. How the old and new microbial methods differ, and how to read older reports, is covered in a separate article.
Marking: Chapter 6 rewritten
Compared with 2013 clause 6.1, the main changes in the 2023 Chapter 6 are:
- "Standard number" became "product technical requirements number";
- "Service life or expiry date" was added; 2013 required a sterilization expiry date for sterile products only;
- "Size" became "model, specification and information showing the dimensions";
- "Front and back identification and how to wear" became "inner and outer side identification and how to wear";
- "Intended use" became "scope of application"; manufacturer details dropped the address.
The 2013 clause 6.2, instructions for use, has no counterpart in 2023. Regulatory requirements for labels and instructions for use are set by the regulator.
Packaging 7.1: not new, but now a listed test item
In both editions, 7.1.1 requires packaging that prevents damage and contamination before use (2023 says "mechanical damage"), and 7.1.2 requires breathable packaging if EO is used for disinfection or sterilization. Chapter 5 has no test method dedicated to Chapter 7.
The change is in the accreditation scope: SUNGO Shanghai's CNAS and CMA appendices list "Packaging 7.1" under YY/T 0969-2023 but not under 2013, so a full 2023 programme can include packaging within the accredited scope. Before submitting:
- Send smallest sales units and outer cartons as supplied; do not open or repack them.
- Describe the packaging materials and construction; for EO-treated masks, include the packaging material specification so 7.1.2 can be checked.
- Quantitative evaluation of sterile mask packaging, such as seal strength or integrity, belongs to sterile packaging validation, outside Chapter 7 of YY/T 0969; see sterile medical device packaging validation.
Biocompatibility: outside SUNGO's accredited scope
Clause 4.9 keeps cytotoxicity, skin irritation and delayed-type hypersensitivity; foreword items i) and o) record changes to the cytotoxicity requirement and the test methods. Clause 5.9 is not in SUNGO's CNAS or CMA appendices, and the IAS scope excludes it explicitly. Where these tests are needed, SUNGO subcontracts them to a laboratory with the appropriate qualifications; under the accreditation rules, subcontracting requires the client's prior consent, and the report identifies the subcontracted tests and the subcontractor. Commissioning biological tests is covered in a separate article.
SUNGO accreditation scope
Rows reproduce the items, standards and clauses under "Single-use medical mask" in the CNAS appendix of SUNGO Shanghai (L22083). The CMA appendix (240015340087) lists the same items, mostly without clause numbers; differences are noted.
| Item | Standard and clause | Notes / limitations |
|---|---|---|
| Appearance | YY/T 0969-2023 5.1 | CNAS, CMA |
| Structure and dimensions | YY/T 0969-2023 5.2 | CNAS, CMA |
| Nose clip | YY/T 0969-2023 5.3 | CNAS, CMA |
| Mask straps | YY/T 0969-2023 5.4 | CNAS, CMA |
| Bacterial filtration efficiency (BFE) | YY/T 0969-2023 5.5 | CNAS, CMA |
| Airflow resistance | YY/T 0969-2023 5.6 | CNAS, CMA |
| Microbial limits | YY/T 0969-2023 5.7.1; ChP 2020 Edition Volume IV, General Chapter 1105 | CNAS, CMA; pharmacopoeia row limited to use as cited by YY/T 0969-2023 |
| Sterility | YY/T 0969-2023 5.7.2; ChP 2020 Edition Volume IV, General Chapter 1101 | CNAS, CMA; pharmacopoeia row limited to use as cited by YY/T 0969-2023 |
| Ethylene oxide residue | YY/T 0969-2023 5.8; GB/T 14233.1-2022 9.4 | CNAS, CMA |
| Marking | YY/T 0969-2023 Chapter 6 | CNAS, CMA |
| Packaging | YY/T 0969-2023 7.1 | CNAS, CMA |
| Appearance | YY/T 0969-2013 5.1 | CNAS appendix note: for specific clients only; no such note in the CMA appendix |
| Structure and dimensions | YY/T 0969-2013 5.2 | CNAS, CMA |
| Nose clip | YY/T 0969-2013 5.3 | CNAS, CMA |
| Mask straps | YY/T 0969-2013 5.4 | CNAS, CMA |
| Bacterial filtration efficiency (BFE) | YY/T 0969-2013 5.5 | CNAS, CMA |
| Airflow resistance | YY/T 0969-2013 5.6 | CNAS, CMA |
| Microbial indicators | YY/T 0969-2013 5.7; GB 15979-2002 Annex B; GB/T 14233.2-2005 Clause 3 | CNAS, CMA |
| Ethylene oxide residue | YY/T 0969-2013 5.8; GB/T 14233.1-2022 Clause 9 | CNAS, CMA |
| Gas chromatographic determination of EO | GB/T 16886.7-2015 Annex B | CNAS (listed under single-use medical mask) |
| Marking | YY/T 0969-2013 Chapter 6 | CNAS, CMA |
| Single-use medical face mask | YY/T 0969 (no year in IAS scope) | IAS TL-1019: except 5.9 |
Note: the 2013 text cites GB/T 14233.1-2008 in 5.8, while the certificate lists GB/T 14233.1-2022 Clause 9 under the 2013 edition; the method edition is confirmed at ordering.
Where the testing is done and under which accreditation
- Shanghai laboratory. All items above are performed by Shanghai SUNGO Medical Technology Co., Ltd., at 958 Kangqiao East Road, Pudong, Shanghai. Hefei SUNGO Medical Technology Co., Ltd. is a separate legal entity whose accreditation and CMA scopes do not include masks.
- CNAS (L22083) and CMA (240015340087): both editions listed. In the CNAS appendix, YY/T 0969-2013 5.1 (appearance) is marked "for specific clients only"; confirm with the laboratory before ordering a CNAS report to the 2013 edition. CMA covers only the items in its appendix, and the certificate states it is valid within the People's Republic of China.
- IAS (TL-1019): YY/T 0969, except 5.9. The IAS scope gives no year; confirm the edition with the laboratory before ordering an IAS report. The only pharmacopoeia method listed separately in the IAS scope is Volume IV Section 1101 (sterility test, medical device testing only); General Chapter 1105, cited in 5.7.1, is not listed separately, so confirm with the laboratory before ordering an IAS report for 5.7.1.
- Biocompatibility (5.9): subcontracted. SUNGO subcontracts these tests to a laboratory with the appropriate qualifications; under the accreditation rules, subcontracting requires the client's prior consent, and the report identifies the subcontracted tests and the subcontractor.
Full scopes for both sites: SUNGO Medical Device Testing Scope: CNAS, CMA and IAS in Shanghai and Hefei.
Preparing samples
- State the edition. 2013 or 2023, the clauses cited in your product technical requirements, and full or partial testing.
- State how the mask is supplied. Non-sterile or sterile, sterilization method, and any EO disinfection or sterilization. This decides 5.7.1 or 5.7.2, and whether 5.8 and 7.1.2 apply.
- State mask type and marked dimensions. Ear-loop or tie-on, fixed strap connections or not; nose clip or alternative; marked dimensions and permitted deviation, and the marked length of the nose clip edge. Clauses 4.2 and 4.3.2 are judged against these values.
- Prepare specimens and agree the total. Under the 2023 edition, 5.1 to 5.5 each need at least 3 specimens, 5.6 at least 5, and 5.7.1 at least 2 smallest packages with not less than 10 g of sample. Agree with the laboratory whether specimens can be shared and what is needed for method suitability and retention.
- Keep the final packaging. Chapter 6 marking and 7.1 packaging are checked on the original packaging.
- State report requirements. The accreditation mark, the purpose of the report, and whether subcontracted biocompatibility is needed.
FAQ
The 2013 edition is abolished. Can I still get a report to it?
The national standards platform shows YY/T 0969-2013 abolished on 1 December 2025. SUNGO's CNAS and CMA appendices still list it; in the CNAS appendix, YY/T 0969-2013 5.1 (appearance) is marked "for specific clients only", so confirm with the laboratory before ordering a CNAS report to the 2013 edition. Whether such a report can support registration, changes or renewal depends on your product technical requirements and the regulator.
Must BFE follow the YY 0469-2023 method?
Clause 5.5 cites YY 0469 without a date, so under Clause 2 its latest edition applies; YY 0469-2023 takes effect on 1 December 2026. The edition used is agreed at ordering and stated in the report.
The Pharmacopoeia is now the 2025 Edition. Why test to 2020?
YY/T 0969-2023 cites the ChP 2020 Edition, Volume IV, with a date, so only that edition applies. The 1105 and 1101 rows in SUNGO's CNAS and CMA appendices are also the 2020 Edition, limited to use as cited by YY/T 0969-2023.
Can old airflow resistance data be judged against the new limit?
Not directly. Specimen numbers, test areas, acceptance basis and limit all differ. Old data is a reference only; whether to retest is for the registrant to assess.
Requesting a quote
For full or partial testing to YY/T 0969-2023, or reports to the 2013 edition, see our medical mask testing service. To request a quote, use the contact page with the product model and the information listed under Preparing samples. We check each item against the CNAS, CMA and IAS scopes and flag anything outside the accredited scope in advance.