A purchasing officer at a multi-site dental group is comparing two mask submissions. Both spec sheets carry the same six words: blood splash resistant, ISO 22609. One quotes a pressure. The other does not. One names the edition. The other names only the standard number. On the page, the two products look equivalent; on a test bench, they may not be.
That gap is not a marketing trick so much as a category error. ISO 22609 is a method. It tells a laboratory how to splash synthetic blood at a complete mask and how to decide whether the mask failed. It deliberately does not tell anyone what a passing result is worth, at what pressure a result was obtained, or what else a mask must do. Those answers live in separate documents — ASTM F2100 for the North American specification, EN 14683 for the European one — and in the certificate that follows.
This guide reads the method clause by clause, then marks the boundary of what a certificate can honestly claim. The companion piece, How to Read an ISO 22609 Report Before You Buy, covers the report itself; this article is about the method behind it and the standards it sits between.
What does ISO 22609 actually measure?
The full title settles most of it. ISO 22609:2004 is Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected). It runs eleven pages, was published as a first edition on 1 December 2004, and was prepared by ISO technical committee TC 94 on personal safety, subcommittee SC 13 on protective clothing. The foreword states plainly that it is based on ASTM F1862-00a.
Two words in the scope carry most of the weight. The standard "primarily addresses the performance of materials or certain material constructions used in medical face masks." It then lists what it does not address:
- the mask's design, construction and interfaces, and any other factor affecting the overall protection offered;
- filtration efficiency and pressure drop;
- breathability of the mask materials, or any other property affecting the ease of breathing;
- contamination through airborne exposure pathways, or penetration of aerosolised body fluids deposited on the mask;
- performance as a respirator.
That is not boilerplate. A mask can carry a passing ISO 22609 result and still fit its wearer badly, breathe poorly, and filter little. The method was written for one hazard — a high-velocity stream of blood from a punctured vessel landing on a mask worn close to the wound — and it stays inside that boundary.
The current ISO catalogue entry and the public preview file both carry the scope wording in full for verification.
How does the test method work, clause by clause?
The principle is a single paragraph. A complete mask is fixed on a convex fixture, a pneumatic valve dispenses synthetic blood horizontally at the target area, and any evidence of synthetic blood on the side of the mask contacting the wearer's face constitutes failure. Results are reported as pass or fail. The clauses that follow fix the numbers.
| Clause | What it fixes | What it means on a specification sheet |
|---|---|---|
| 1 Scope | Applies to material and construction performance | A data sheet for a fabric is not a substitute for testing the finished mask |
| 4 Principle | 2 ml of synthetic blood projected horizontally; pass/fail judged on the wearer-facing side | The judgement is visual detection of penetration, not a measurement of volume passed |
| 5.1.1 Equipment | 12,7 mm canula with 0,84 mm internal diameter; specimen held 300 mm from the canula tip | Working distance and orifice size are fixed, so a custom rig needs to state its deviations |
| 6 Specimens | Complete masks; separate tests for differing materials or thicknesses and for claimed seams | Seam performance is not implied by base-material performance |
| 6 Specimens | Sampling to an acceptable quality limit of 4,0 %, per ISO 2859-1 | A single sampling plan at that AQL calls for 32 specimens |
| 6 Conditioning | Minimum 4 h at (21 ± 5) °C and (85 ± 5) % relative humidity | Masks are tested moist, approximating a wearer breathing through the mask |
| 7.2 Procedure | Testing at (21 ± 5) °C and (85 ± 10) % relative humidity | An uncontrolled bench environment is a deviation, not a rounding error |
| 7.2 Procedure | A 0,1 ml droplet of synthetic blood is placed on an extra mask to confirm the strike-through will be visible | Visibility of the test liquid is checked before the run, not assumed |
| 7.3 Targeting plate | Optional alternative set-up: a plate with a 0,5 cm hole about 1 cm in front of the mask | Blocks the high-pressure front edge of the stream and steadies the impact velocity |
| 8 Report | Enumerates the items a report must state | Pressure, specimen-level results and set-up details are required outputs, not extras |
| Annex B | Synthetic blood: amaranth dye, surfactant, thickening agent, inorganic salts, distilled water | Surface tension is adjusted to (0,042 ± 0,002) N/m |
The fluid deserves its own note. Blood and body fluids other than saliva span roughly 0,042 to 0,060 N/m in surface tension, and the standard sets the simulant at the low end of that range to simulate wetting behaviour. The synthetic blood does not model coagulation, cell content or polarity, and the standard says so directly. A result therefore speaks to liquid penetration under one defined challenge, not to a general property called "blood resistance".
Delivery is verified by mass as well as by volume: 2 ml of the standard fluid, specific gravity 1,005, weighs (2,010 ± 0,040) g, and the apparatus is re-verified after every 16 specimens. A canula left unused for an hour or more is replaced. These details matter when a laboratory is asked to defend a result years later.
Which pressures and velocities does the method use?
Specimens are challenged at three velocities chosen to correspond to human blood pressures. The standard notes that mean human blood pressure generally varies from about 10,6 kPa to 16,0 kPa (80 to 120 mmHg), which is why those two figures anchor the method and why 21,3 kPa sits above the range as an upper step.
| Pressure (kPa) | Equivalent (mmHg) | Stream velocity (cm/s) | Valve time (s) | Where this level is used |
|---|---|---|---|---|
| 10,6 | 80 | 450 | 0,80 | Low end of the adult range; ASTM F2100 Level 1 fluid resistance |
| 16,0 | 120 | 550 | 0,66 | ASTM F2100 Level 2; the minimum for EN 14683:2025 Type IIR, expressed in the standard as ≥ 16,0 kPa |
| 21,3 | 160 | 635 | 0,57 | Above the mean range; ASTM F2100 Level 3 fluid resistance |
The mask is rated at the highest corresponding blood pressure for which specimens demonstrate an acceptable quality limit of 4,0. That single sentence explains why a pressure-free claim is close to empty: the same mask may pass at 10,6 kPa and fail at 21,3 kPa, and only the rating pressure tells a buyer which of those it is.
Non-standard pressures, volumes and specimen orientations are permitted by the method — but then the report has to say so. That is a feature for research and a hazard for procurement.
What does a certificate prove, and what does it not prove?
This is where most of the confusion lives. A certificate is a composite document: a method was used, a specification threshold was applied, and a laboratory concluded something. Read as a whole, it can support a useful claim. Read as a slogan, it can imply far more than the evidence carries.
| What the paperwork says | What actually supports it | What it does not establish |
|---|---|---|
| "Resists blood splash" | A pass under ISO 22609 at a stated pressure | Any protection against aerosolised body fluids or airborne exposure pathways |
| "Tested to ISO 22609" | A method was applied to the item | The pressure applied, the specimen count, or the rating pressure — unless each is stated |
| "EN 14683 Type IIR" | Splash resistance at ≥ 16,0 kPa tested with the targeting plate, plus BFE ≥ 98 % and differential pressure ≤ 300 Pa | Filtration of sub-micron particles, seal to the face, or how long protection lasts |
| "ASTM F2100 Level 3" | Fluid resistance at 160 mmHg, plus BFE and PFE floors and a differential-pressure ceiling | That the mask fits a particular wearer, or that it performs as a respirator |
| "Pass" | No visually detectable synthetic blood on the wearer-facing side | Penetration below the threshold of the eye's detection |
Two boundary statements belong in any procurement file. The first is that the method evaluates a mask as an item of protective clothing, not as a respiratory protective device; if respiratory protection is needed, the standard says an approved respirator should be used. The second is that the standard itself flags a trade-off: increasing synthetic-blood penetration resistance generally increases pressure drop, which reduces breathability for a mask of the same design and fit.
How do ISO 22609, ASTM F1862, ASTM F2100 and EN 14683 fit together?
Four documents are routinely cited in the same paragraph of a supplier email, and they do different jobs. ISO 22609 and ASTM F1862 are methods. ASTM F2100 and EN 14683 are specifications that borrow a method and set a threshold. Confusing the two categories is the single most common error in mask documentation.
| Document | Category | Fluid or splash requirement | Notes for a buyer |
|---|---|---|---|
| ISO 22609:2004 | Test method | None — it defines pass/fail at three pressures | Prepared by ISO/TC 94/SC 13; based on ASTM F1862-00a; rating pressure must be stated |
| ASTM F1862/F1862M-24 | Test method | Evaluates resistance to a small volume (~2 ml) of a high-velocity stream of synthetic blood | The standard states it does not define acceptable levels of penetration resistance; that determination is left to each responsible user |
| ASTM F2100-19e01 | Specification | Level 1 at 80 mmHg, Level 2 at 120 mmHg, Level 3 at 160 mmHg | Combines fluid resistance with BFE, PFE, differential pressure and flame spread |
| EN 14683:2025 | Specification | Type IIR at ≥ 16,0 kPa; all splash tests to be undertaken with the targeting plate | Combines splash resistance with BFE ≥ 98 %, differential pressure ≤ 300 Pa and bioburden ≤ 30 CFU/g |
The EN 14683 detail is the one most often quoted from memory and least often quoted correctly. The 2025 revision states the Type IIR splash minimum as ≥ 16,0 kPa in Table 1 — numerically the same challenge as 120 mmHg, but expressed in the standard's own units. The same revision moved differential pressure into pascals (≤ 200 Pa for Types I and II, ≤ 300 Pa for Type IIR) and set the pass rule for splash resistance at a minimum of 29 specimens out of 32. Standard summaries that still say "120 mmHg" and "mm H₂O" are describing the previous edition, EN 14683:2019+AC:2019.
One further direction of travel is worth flagging for anyone writing a specification this year. The foreword to EN 14683:2025 states that CEN/TC 205 "proposes to remove the specification for Type I medical face masks at the next revision," with the reasoning documented in Annex E, and encourages healthcare organisations to consider the impact on their guidance. Type I masks are already not intended for use by healthcare professionals in an operating room or comparable setting.
Why does the claim go wrong so often?
Almost every over-reading of "ISO 22609" traces to one of four compressions.
Dropping the pressure. The method's output is pressure-specific. A claim without a pressure removes the only number that makes it comparable.
Reading a method as a pass mark. ISO 22609 has no pass mark of its own. ASTM F1862 says as much in its own scope: it offers a procedure for establishing and ranking claims but does not define acceptable levels of penetration resistance. The threshold comes from the specification the buyer's jurisdiction or customer recognises.
Assuming the mask was the specimen. The method tests complete masks and requires separate testing of differing areas and of claimed seams. A laminate certificate does not describe a finished mask.
Extending the result past its scope. A splash result says nothing about aerosol, fit, filtration or duration of wear — four of the five statements a clinical team actually needs.
For a Canadian buyer, the practical response is a two-line check. Ask for the report's rating pressure and specimen count. Then ask which specification that rating satisfies — ASTM F2100 level, EN 14683 type, or a customer-specific threshold. The mask stock we supply for Canadian clinics is documented this way; the face mask and procedural mask range carries the applicable standard per product, and wholesale and multi-site ordering can supply the underlying documentation for a tender file.
Related Reading
- How to Read an ISO 22609 Report Before You Buy: Resistance of Masks to Blood Splash
- ASTM F1862 Explained: Blood Penetration Resistance for Face Masks
- BFE Testing for Face Masks: What ASTM F2101 Measures
- ASTM mask levels explained: which face mask does your clinic actually need?
- Face masks and procedural mask stock for Canadian clinics
- Sterilization monitoring range for clinics, labs and care homes
- Learning hub — standards, records and procurement
- Five-pack biological indicator trial pack
- Aurelia Level 2 medical face mask — ASTM F2100, made in Canada, 50-count
- Wholesale and multi-site ordering desk
Sources
- ISO 22609:2004 — Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected), ISO, first edition, 1 December 2004.
- ISO 22609:2004 public preview file — full front matter, contents and clauses 1–7 as published.
- ISO 22609:2004 catalogue record, iTeh Standards.
- ASTM F1862/F1862M-24 — Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood, ASTM International, 2024.
- ASTM F1862/F1862M-24 standard scope summary, CDC PPE-Info.
- ASTM F2100-19e01 — Standard Specification for Performance of Materials Used in Medical Face Masks, ASTM International.
- EN 14683:2025 — Medical face masks — Requirements and test methods, CEN, with the Table 1 performance requirements and clause 5.2.4 splash-resistance provision reproduced in the public record.
Each link above was checked on 26 September 2026.
Frequently Asked Questions
Is ISO 22609 a standard a mask can pass?
No. ISO 22609 is a test method. It defines how a laboratory challenges a complete mask with a fixed volume of synthetic blood projected horizontally, and how a pass or fail is decided at each of three pressures. What counts as acceptable is set elsewhere — by ASTM F2100 levels in North America, by EN 14683 types in Europe, or by a customer specification. A claim that says only "ISO 22609" has named the method and withheld the threshold.
At what blood pressure is a medical mask tested under ISO 22609?
The method uses three pressures corresponding to human blood pressure: 10,6 kPa (80 mmHg) at 450 cm/s, 16,0 kPa (120 mmHg) at 550 cm/s and 21,3 kPa (160 mmHg) at 635 cm/s. Specimens are tested at all three, and the mask is rated at the highest pressure at which it meets an acceptable quality limit of 4,0 %. A result without a stated pressure cannot be compared with any other result.
How many masks have to be tested?
A single sampling plan delivering an acceptable quality limit of 4,0 % calls for 32 specimens. EN 14683:2025 applies the same arithmetic from the specification side: at least 29 of 32 specimens must pass the splash-resistance test. A supplier submitting three passing specimens has carried out a demonstration, not a compliant sampling plan.
Does a passing ISO 22609 result mean the mask blocks viruses?
It does not. The standard excludes contamination via airborne exposure pathways and the penetration of aerosolised body fluids deposited on the mask, and it does not evaluate filtration efficiency, pressure drop or breathability. The synthetic blood is also a partial simulant: it does not model coagulation, cell content or polarity. A splash pass describes one hazard — a directed liquid stream — and nothing about airborne transmission.
What is the difference between ISO 22609 and ASTM F1862?
They are closely related methods. ISO 22609's foreword records that it is based on ASTM F1862-00a, and both project a small volume of synthetic blood at a complete mask and judge penetration visually. ASTM F1862's own scope notes that it establishes and ranks penetration-resistance claims but does not define acceptable levels, which is why the specification documents are layered over it. The current ASTM edition is F1862/F1862M-24.
Why do some documents say EN 14683 Type IIR is 120 mmHg and others say 16.0 kPa?
Both describe the same challenge in different units. Table 1 of EN 14683:2025 states the Type IIR splash-resistance minimum as ≥ 16,0 kPa, and the same revision expresses differential pressure in pascals rather than millimetres of water. Summaries written against the 2019 edition still quote 120 mmHg and mm H₂O. Two further changes in the current edition are easy to miss: splash testing must be undertaken with the targeting plate, and CEN/TC 205 has signalled that the Type I category is proposed for removal at the next revision.
Does the targeting plate change the result?
It can. The targeting plate is an optional alternative set-up in ISO 22609 that blocks the high-pressure front edge of the fluid stream so only the steady-state stream reaches the mask, which the standard says increases the accuracy and repeatability of impact velocity. EN 14683:2025 removes the choice for its own purposes: all splash-resistance tests under that specification must use the targeting plate. When comparing two reports, whether the plate was used is a fair question.
Last updated: 26 September 2026. CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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