EN 14683:2025 has replaced EN 14683:2019+AC:2019. Most manufacturers that ship medical face masks to the EU or the UK hold test reports issued against the 2019 edition, and they ask two questions: which clauses actually changed, and can the existing reports still be used? This guide covers only those two questions. It draws on the change list in the European foreword of EN 14683:2025, the clause text in the public preview pages of both editions, and the status of the standard published by the EU and the UK government, all checked on 22 October 2026. It does not explain the Type I, II and IIR classification or list test items for a full submission.
Key points
- The 2025 edition is a new edition, not a corrigendum. CEN approved it on 29 December 2024, and it is dated January 2025. Its foreword states that it supersedes EN 14683:2019+AC:2019 and lists 15 significant technical changes, a) to o).
- It is a harmonised standard under the EU MDR. Implementing Decision (EU) 2025/2078, published in the Official Journal and in force on 20 October 2025, adds EN 14683:2025 to the list in Implementing Decision (EU) 2021/1182. EN 14683:2019+AC:2019 was harmonised under Directive 93/42/EEC by Implementing Decision (EU) 2020/437 in 2020 and was never published as an MDR harmonised standard.
- The main changes concern microbial cleanliness, two test method annexes and documentation. Bioburden requirements are more detailed and Annex D has been completely revised. Annex B (BFE) further specifies use of the six-stage cascade impactor. Annex C adds an airflow formula for test areas other than the 25 mm diameter circle, and differential pressure is now expressed in Pa. Annexes B and C no longer allow sample numbers to be set by AQL. A new Clause 6, "Manufacturing and processing requirements and documentation", moves marking, labelling and packaging to Clause 7.
- Splash resistance is not singled out in the change list. ISO 22609:2004 is still the normative reference.
- Start with a gap assessment, then decide whether to retest. Method changes for microbial cleanliness, BFE and differential pressure could affect results; changes to terms, informative annexes and marking mostly affect documents and labels. Whether a gap assessment is accepted is for your notified body or customer to decide.
- SUNGO's Shanghai laboratory has seven EN 14683:2025 items and five BS EN 14683:2025 items in its CNAS scope. The BS EN items exclude BFE and microbial cleanliness. The IAS scope lists EN 14683 and BS EN 14683 as whole standards without a year. Neither is in the CMA scope.
The standard and its scope
The two editions at a glance
From the title pages and forewords of both editions (public previews) and official EU and UK documents:
| Item | EN 14683:2019+AC:2019 | EN 14683:2025 |
|---|---|---|
| Approved by CEN | 19 November 2018; Corrigendum 1 issued 7 August 2019, which the foreword says updates a requirement in B.7.4 | 29 December 2024 |
| Document date | August 2019 (consolidated text) | January 2025 |
| Supersedes | EN 14683:2019 | EN 14683:2019+AC:2019 |
| Latest national adoption and withdrawal of conflicting standards | September 2019 | July 2025 |
| Annex ZA | Essential requirements of Directive 93/42/EEC | General safety and performance requirements of Regulation (EU) 2017/745 |
| EU Official Journal | Implementing Decision (EU) 2020/437, under Directive 93/42/EEC | Implementing Decision (EU) 2025/2078, entry 35 in the Annex to (EU) 2021/1182 |
| UK (BSI) edition | BS EN 14683:2019 | BS EN 14683:2025, published 31 January 2025; supersedes BS EN 14683:2019, which is withdrawn |
What changed in the scope
Clause 1 opens with the same paragraph in both editions: construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and similar medical settings. After that:
- The 2019 edition excludes masks intended exclusively for the personal protection of staff, with notes pointing to respiratory PPE standards and to Annex A.
- The 2025 edition keeps the exclusion and adds that compliance with the standard does not demonstrate compliance with the relevant PPE regulations. The pointer to respiratory protection standards has moved to the Introduction.
- The 2025 Introduction adds that bypass leakage can affect particle attenuation, especially for smaller particles, and that CEN/TC 205 proposes to remove the Type I specification at the next revision (reasons in Annex E).
Status in the EU and the UK
EU: the Commission adopted Implementing Decision (EU) 2025/2078 on 17 October 2025; it was published and entered into force on 20 October 2025. Its recitals state that conformity with harmonised standards whose references are published in the Official Journal gives a presumption of conformity with the corresponding MDR requirements from the date of publication. Recital (4) notes that CEN revised EN 14683:2019+AC:2019 and describes its reference as "not published in the Official Journal"; read together with Decision (EU) 2020/437, this means it was not published as an MDR harmonised standard.
UK: BSI published BS EN 14683:2025, identical to EN 14683:2025, on 31 January 2025. The UK government's designated standards list, which applies to England, Scotland and Wales, is separate. When we checked on 22 October 2026, the gov.uk page "Designated standards: medical devices" showed a last-updated date of 17 January 2026, and row 155 of the complete list in notice 0129/26 still showed EN 14683:2019 and EN 14683:2019+AC:2019. For the Great Britain market, agree the edition with your UK Approved Body or customer.
Clause-by-clause comparison: 2019+AC:2019 vs 2025
Only differences that can be confirmed from the text are listed. "Source" means the clause in each edition's preview, or the item letter in the 2025 foreword. The 2025 preview does not include the text of the 5.2 subclauses, the details of Annexes B, C and D, or the text of Clauses 6 and 7, so for those only the changes named in the foreword are given; the full standard prevails.
| Clause | 2019+AC:2019 | 2025 | Source |
|---|---|---|---|
| 2 Normative references | EN ISO 10993-1:2009; EN ISO 11737-1:2018; ISO 22609:2004 | EN ISO 10993-1:2020; EN ISO 11737-1:2018 (footnote: as impacted by EN ISO 11737-1:2018/A1:2021); ISO 22609:2004 | Clause 2 of both; foreword o) |
| 3 Terms | 3.1 to 3.11, including cleanliness, microbial cleanliness and surgical procedure | 3.1 to 3.14; adds processor, reusable product, single-use product and transparent medical face mask (TMFM); "surgical mask" listed as a synonym of medical face mask; no entries for cleanliness or surgical procedure | Foreword a); Clause 3 of both |
| 4 Classification | Two types by BFE; Type II divided by splash resistance, "R" meaning splash resistant | Same, plus: this type is marked "IIR" | Clause 4 of both |
| 5.1.1 Materials and construction | Filter between layers of fabric; attention to cleanliness | "Fabric" becomes "material"; attention also to release of potentially hazardous substances or particulates; new: products shall meet all requirements throughout their useful life | 5.1.1 of both |
| 5.1.2 Design | Close fit over nose, mouth, chin and sides; face shield, nose bridge and similar features possible | Requirements for additional features are not specified in the document; TMFM function and performance requirements set out in Annex F; new note: masks are not expected to seal tightly, and without a quantitative bypass leakage assessment total leakage is not well defined | Foreword b); 5.1.2 of both |
| 5.2.2 BFE, Annex B | Six-stage cascade impactor method | Use of the impactor further specified; AQL option removed | Foreword g), i) |
| 5.2.3 Breathability (differential pressure), Annex C | Table 1 unit Pa/cm²; Annex C "Method for determination of breathability (differential pressure)" | Unit Pa; Annex C retitled "Breathability – Method for determination of the differential pressure"; C.4.5 adds an airflow formula for test areas other than the 25 mm diameter circle; AQL option removed | Foreword d), h), i); contents of both |
| 5.2.4 Splash resistance | ISO 22609:2004 | Not singled out in the change list; ISO 22609:2004 still cited | Foreword; 2025 Clause 2 |
| 5.2.5 Microbial cleanliness, Annex D | EN ISO 11737-1:2018; informative Annex D "Microbial cleanliness" (D.1 Sampling, D.2 Testing) | Requirements more detailed; informative Annex D retitled "Test procedure for microbial cleanliness" and completely revised | Foreword c), j); contents of both |
| 5.2.6 Biocompatibility | Evaluation to EN ISO 10993-1:2009 | Clause 2 now cites EN ISO 10993-1:2020; for the 5.2.6 text, see the full standard | Clause 2 of both; 2019 5.2.6 |
| Clause 6 | Marking, labelling and packaging | New: manufacturing and processing requirements and documentation | Foreword e); 2025 contents |
| Marking, labelling and packaging | Clause 6, citing Annex I §13 of Directive 93/42/EEC or Annex I §23 of the MDR | Clause 7; text not in the public preview, see the full standard (foreword item n) concerns overall alignment with Regulation (EU) 2017/745, including Annex ZA) | 2025 contents |
| Annex A | Information for users | Completely revised: A.1 Selection and use, A.2 Donning and doffing | Foreword f); 2025 contents |
| Annexes E, F, G | None | New informative Annex E "Rationales" (including shelf life determination, proposed withdrawal of Type I, removal of AQLs in Annexes B and C), Annex F "Transparent medical face masks", Annex G "Environmental impact" | Foreword k), l), m); 2025 contents |
| Annex ZA | Directive 93/42/EEC | Regulation (EU) 2017/745 general safety and performance requirements | Foreword n); contents of both |
Existing 2019 reports: gap assessment or retest?
A new edition does not change the results recorded in an old report, but that report shows conformity with 2019+AC:2019. To claim conformity with the 2025 edition, your technical documentation has to explain why the old results still hold. The changes fall into three groups.
Group A: method changes that could affect results
- Microbial cleanliness (5.2.5, Annex D). Requirements are specified in more detail (foreword item c) and informative Annex D has been completely revised (foreword item j). Whether the old result can be carried over needs a step-by-step comparison with the new procedure; if that comparison cannot be made, retesting is the safer option.
- BFE (5.2.2, Annex B). Check whether the impactor set-up and use in the old report meet the further requirements of 2025. If the old report set sample numbers by AQL, that basis no longer exists.
- Differential pressure (5.2.3, Annex C). Check whether the old test used the 25 mm diameter circular test area; if not, check the airflow against C.4.5 of 2025. How old Pa/cm² values relate to the new Pa values, and whether acceptance requirements changed, must be taken from 5.2.3, 5.2.7 (summary of performance requirements) and Annex C of the 2025 text. Do not convert values yourself.
Group B: changed requirement text to review
- 5.1.1 adds "throughout their useful life" and wording on hazardous substances or particulates; your technical documentation needs supporting evidence.
- 5.1.2 has been amended. Review transparent masks against Annex F; for face shields, nose bridges and similar features, note that the document does not specify their requirements.
- The new Clause 6 "Manufacturing and processing requirements and documentation" is not in the public preview; see the full standard.
- Marking, labelling and packaging is now Clause 7; its text is not in the public preview, so see the full standard. Recheck label and packaging artwork against the new clause.
Group C: documentation updates
- The new terms, Annex A, Annexes E, F and G, Annex ZA and the EN ISO 10993-1 edition cited in Clause 2 mainly affect your technical documentation, IFU and biological evaluation documents.
- Although splash resistance is not singled out, we suggest checking the old report's test conditions and acceptance approach against the 2025 text of 5.2.4.
Separately, if materials, suppliers, layer structure or processes have changed since the old report, retest under your change assessment; a version gap assessment alone is not enough. The final conclusion belongs in the manufacturer's technical documentation, and acceptance is for the notified body or customer to decide.
SUNGO accreditation scope
Relevant rows from the CNAS and IAS scopes of Shanghai SUNGO Medical Technology Co., Ltd. The CNAS rows are effective from 9 March 2026, and none carries a limitation.
| Item | Clause | Notes / limitations |
|---|---|---|
| Materials and construction | EN 14683:2025 5.1.1; BS EN 14683:2025 5.1.1 | CNAS; no limitation stated |
| Design | EN 14683:2025 5.1.2; BS EN 14683:2025 5.1.2 | CNAS; no limitation stated. Annex F items for transparent masks are not listed separately |
| Bacterial filtration efficiency (BFE) | EN 14683:2025 5.2.2, Annex B | CNAS, EN 14683:2025 only; not listed for BS EN 14683:2025 |
| Differential pressure | EN 14683:2025 5.2.3, Annex C; BS EN 14683:2025 5.2.3, Annex C | CNAS; no limitation stated |
| Splash resistance | EN 14683:2025 5.2.4; BS EN 14683:2025 5.2.4; ISO 22609:2004 (no clause given) | CNAS; no limitation stated |
| Microbial cleanliness | EN 14683:2025 5.2.5, Annex D | CNAS, EN 14683:2025 only; not listed for BS EN 14683:2025 |
| Marking, labelling and packaging | EN 14683:2025 6; BS EN 14683:2025 6 | CNAS; clause number as it appears in the scope; confirm the clause reference for the report with the laboratory before ordering |
| Whole standard | EN 14683; BS EN 14683; ISO 22609 | IAS (TL-1019); listed without a year; confirm the edition with the laboratory before an IAS report is issued against the 2025 edition; the biological tests for 5.2.6 biocompatibility are subcontracted |
None of these standards is in the Shanghai CMA scope.
Where the testing is done and under which accreditation
EN 14683 testing is done in Shanghai, at No. 958 Kangqiao East Road, Pudong New Area. The laboratory belongs to Shanghai SUNGO Medical Technology Co., Ltd., which issues the reports.
- CNAS accreditation, CNAS L22083. The seven EN 14683:2025 items, the five BS EN 14683:2025 items and ISO 22609:2004 are in scope. The certificate states that CNAS is a signatory to the ILAC and APAC mutual recognition arrangements.
- IAS accreditation, TL-1019. EN 14683, BS EN 14683 and ISO 22609 are listed as whole standards, without a year; the biological tests for 5.2.6 biocompatibility are subcontracted, as described below. The certificate carries the ilac-MRA mark.
- CMA qualification, 240015340087. EN 14683, BS EN 14683 and ISO 22609 are not in the Shanghai CMA scope, so they cannot be reported under CMA. The CMA mark applies only to items in its scope and is valid only within the People's Republic of China.
BFE or microbial cleanliness to BS EN 14683:2025. The CNAS rows for BS EN 14683:2025 cover materials and construction, design, differential pressure, splash resistance, and marking, labelling and packaging, but not BFE or microbial cleanliness. BSI lists BS EN 14683:2025 as identical to EN 14683:2025. If you need these two items, we can issue a CNAS report against EN 14683:2025, or an IAS report once the edition is confirmed with the laboratory. Whether your UK Approved Body or customer accepts a report against the EN edition is for them to decide.
The CNAS scope does not list 5.2.6 biocompatibility, and SUNGO does not perform the biological tests it involves. If the client requires them, SUNGO subcontracts them to an appropriately qualified laboratory; under accreditation rules, the client's agreement is obtained in advance, and the report identifies the subcontracted items and the subcontractor.
SUNGO's Hefei laboratory belongs to a separate legal entity, Hefei SUNGO Medical Technology Co., Ltd., whose scopes do not include medical face mask items.
Before you send samples: bring the old report and confirm what needs retesting
- The full old report: report number, standard and edition, test dates, sample information and test conditions.
- Product changes: whether materials, suppliers, layer structure, processes, sterility or reusability have changed since that report.
- Market and purpose: EU MDR technical file, UK market or customer acceptance; EN 14683:2025 or BS EN 14683:2025; CNAS or IAS mark.
- Label, packaging and IFU artwork, to review against the "marking, labelling and packaging" item listed in the scope. Annex A is informative and is not in the CNAS scope; the manufacturer checks against it.
- Special designs: for transparent masks or masks with a face shield, nose bridge or similar feature, describe the construction in advance so we can confirm which items can be reported under accreditation.
- Sample quantity: the 2025 edition removed the AQL option in Annexes B and C, so sample numbers follow the 2025 text and the test plan; confirm them with us before ordering.
FAQ
Is EN 14683:2025 a corrigendum or a new edition?
A new edition. CEN approved it on 29 December 2024; its foreword states that it supersedes EN 14683:2019+AC:2019 and lists 15 significant technical changes. The "AC" in 2019+AC:2019 is a corrigendum issued on 7 August 2019, which the foreword says updates a requirement in B.7.4.
Can a 2019 report go into a CE technical file?
EN 14683:2025 has been listed under the MDR since 20 October 2025, while 2019+AC:2019 was never published as an MDR harmonised standard. Whether an old report can still be used depends on the manufacturer's clause-by-clause gap assessment and agreement with the notified body; we cannot decide that on the notified body's behalf.
Can old Pa/cm² results simply be converted to Pa?
We do not recommend converting values yourself. Take the correspondence and acceptance requirements from 5.2.3, 5.2.7 (summary of performance requirements) and Annex C of the 2025 text; where the old test conditions differ from the new edition, retesting is the safer option.
Can SUNGO report BFE against BS EN 14683:2025?
The CNAS rows for BS EN 14683:2025 do not include BFE or microbial cleanliness. We can issue a CNAS report against EN 14683:2025, or an IAS report once the edition is confirmed (the IAS scope lists BS EN 14683 as a whole standard).
Can an EN 14683:2025 report carry the CMA mark?
No. EN 14683, BS EN 14683 and ISO 22609 are not in the Shanghai CMA scope, and the CMA mark is valid only within China.
Requesting a quote
If you hold EN 14683:2019+AC:2019 reports and want to know which clauses need retesting against the 2025 edition, or which items can be reported under CNAS or IAS, start with our medical face mask testing service. To request a quote, use the contact page to send the old report, a note on product changes, your target market and your report requirements. Checking against the 2025 clauses and our accreditation scopes, we will reply with the test items to be repeated or added and the accreditation (CNAS or IAS) under which each can be reported. That reply is a list of test items, not an accredited gap-assessment conclusion; the gap-assessment conclusion stays in the manufacturer's technical documentation.