How to Read an ISO 22609 Report Before You Buy: Resistance of Masks to Blood Splash
Quick summary: ISO 22609 is the test behind a blood splash resistant claim on a medical face mask. It projects 2 mL of synthetic blood at a complete mask, checks whether any liquid reaches the wearer-facing side, and rates the mask at the highest of three blood pressures where it meets an acceptable quality limit of 4.0 %. Supplier one-pagers usually omit the pressure, the specimen count and the report items the standard requires.
A dental hygienist finishes scaling a lower molar. The ultrasonic scaler has run for twenty minutes and the assistant has stood inside the working area the whole time. Nothing dramatic happened, but the instrument threw a fine spray of water, saliva and a little blood across the operatory, and some of it landed on the assistant's mask.
That is the scenario ISO 22609 was written to model, and it is the test behind the words blood splash resistant when they appear on a mask box. What the box does not say is the pressure the mask passed at, how many masks were tested, or which items of the report the laboratory filled in. Those three details separate a verified claim from a sentence on a carton.
What does ISO 22609 actually test?
ISO 22609:2004 carries the title Clothing for protection against infectious agents — Medical face masks — Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected). It was prepared by ISO technical committee TC 94 on personal safety, subcommittee SC 13 on protective clothing, and it is based on ASTM F1862-00a.
The principle is direct. A complete mask is clamped onto a convex holding fixture, and a pneumatic valve dispenses 2 mL of synthetic blood through a small canula, projected horizontally at the target area from roughly 300 mm away. A technician then inspects the inside surface for any sign that liquid reached it.
- The whole mask is the specimen. Where a mask uses different materials or thicknesses in different areas, each area is tested separately, and seams claimed to match the base material are tested separately too. A material data sheet cannot stand in for the finished item.
- The inside surface decides. Any evidence of synthetic blood or wetness on the side that contacts the wearer's face is a failure, and results are reported as pass or fail. Where visibility is in doubt, the method allows a light daub with a cotton swab to confirm what the eye sees.
Synthetic blood is not a stand-in for every property of blood. The standard describes it as a mix of amaranth dye, surfactant, thickening agent, inorganic salts and distilled water, adjusted to a surface tension of 0.042 ± 0.002 N/m, at the low end of the 0.042 to 0.060 N/m range given for blood and body fluids. It does not model coagulation, cell content or polarity.
At which blood pressure was the mask rated?
This question decides whether a claim means anything. Specimens are tested at three velocities chosen to correspond to human blood pressures, and the mask is rated at the highest pressure for which it meets an acceptable quality limit of 4.0 %.
| Test pressure (kPa) | Equivalent (mmHg) | Stream velocity (cm/s) | Valve time (s) | What a rating at this level indicates |
|---|---|---|---|---|
| 10.6 | 80 | 450 | 0.80 | Low-pressure stream, such as a small puncture at the low end of normal blood pressure |
| 16.0 | 120 | 550 | 0.66 | Upper end of the mean human range; the pressure behind the EN 14683 Type IIR classification |
| 21.3 | 160 | 635 | 0.57 | Highest velocity in the method, above the normal mean range |
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 a result stated without a pressure is incomplete. Other pressures and velocities are permitted, but the report then has to say so.
Two apparatus details are worth knowing when comparing reports. The valve uses a 12.7 mm canula with an internal diameter of 0.84 mm, and the 2 mL delivery is verified by weight at 2.010 ± 0.040 g for a fluid of specific gravity 1.005, with re-verification after every 16 specimens. A laboratory that has followed the method will also tell you whether the alternative targeting-plate set-up was used, because the report has to state it.
What must an ISO 22609 report contain?
Clause 8 lists the items a report has to include. Suppliers rarely hand over all of them at once, and most gaps close with one email.
| Report item required by ISO 22609 | What it tells a buyer | What to do when it is missing |
|---|---|---|
| A statement that testing followed ISO 22609 | The method was applied, not only the standard number | Ask for the edition, ISO 22609:2004 |
| Identification of the mask and material tested | The report belongs to the item you are buying | Match the model code to the carton |
| Pressures, volumes and velocities, where they differ | Whether this is a standard rating or a custom set-up | Ask for the pressure that produced the pass |
| Description of the target area tested | Whether that is the area your staff face into a splatter | Ask whether seams were included |
| Distance from the canula and valve angle | Whether the 300 mm working distance was respected | Request the set-up page |
| Any technique used to make penetration visible | Whether a faint strike-through could have been missed | Ask about the inside surface check |
| Conditioning and testing humidity, and any pre-treatment | Whether specimens were conditioned, aged or wetted | Ask for the conditioning record |
| Pass or fail for each specimen at each pressure | The raw result rather than the summary | Ask for the specimen-level table |
| Highest pressure meeting an AQL of 4.0 % | The rating to quote in your records | Ask which pressure is claimed |
| Whether the targeting-plate method was used | Whether velocity control was applied | Ask the laboratory directly |
Conditioning belongs to the same method: at least four hours at 21 ± 5 °C and 85 ± 5 % relative humidity, then testing at 85 ± 10 %, with the challenge delivered within 60 seconds and the inside surface inspected 10 ± 1 seconds later.
How many specimens does an ISO 22609 test require?
The method ties the result to a statistical plan. Specimens are taken at random for each type, design or lot, and enough are tested to reach an acceptable quality limit of 4.0 % as defined in ISO 2859-1 at each selected pressure. The standard's own note is the most useful sentence for a procurement file: a single sampling plan providing an AQL of 4.0 % requires 32 specimens, and the limit is met when 29 or more of those 32 pass.
That note separates a test from a demonstration. A report showing three masks passing at 160 mmHg has shown you three masks passing, not a rated product. When a supplier quotes a pressure figure, the specimen count is the natural follow-up, and a laboratory that ran the method answers it without hesitation.
The standard also warns that testing without any degradation from physical, chemical or thermal stress could give a false sense of security, and suggests considering storage and shelf life effects for disposable masks. If those conditions matter in your setting, the right request is a test run after a pre-treatment representative of use.
What does ISO 22609 not tell you about a mask?
The scope is unusually explicit about its own limits, and those limits keep a buyer from over-claiming.
- Filtration is out of scope. ISO 22609 does not address filtration efficiency or pressure drop, which are measured by ASTM F2101 for bacteria and ASTM F2299 for particles.
- Breathability, design and interfaces are out of scope. Nothing in a splash result describes how hard the mask is to breathe through, which is measured as differential pressure, and the method evaluates materials and material construction rather than how a nose wire, fold or cheek gap behaves on a real face.
- Airborne exposure is out of scope. A splash test says nothing about aerosolised body fluids or inhalation routes, which belong to respirator standards and fit testing.
For a clinic the list is practical. A mask that passes ISO 22609 at 120 mmHg has a documented answer to exactly one question: whether a stream of blood or body fluid at that pressure passes through the item. Everything else on the specification has to come from another test, and the guide to BFE, PFE and ASTM F2100 testing covers the filtration half.
How is ISO 22609 different from ASTM F1862 and ISO 16603?
Three standards come up in the same conversation and they are not interchangeable. Each scope describes a different threat.
| Standard | What it tests | Specimen | Challenge | Where a buyer meets it |
|---|---|---|---|---|
| ISO 22609:2004 | Synthetic blood penetration resistance of medical face masks | Complete face mask | 2 mL projected horizontally at 80, 120 and 160 mmHg | ISO markets, EN 14683 Type IIR, international tenders |
| ASTM F1862/F1862M | The same style of test under the ASTM designation, on which ISO 22609 is based | Complete face mask | Synthetic blood at a known velocity, mapped to ASTM F2100 levels | North American mask specifications and level claims |
| ISO 16603:2004 | Blood and body fluid penetration resistance of protective clothing | Clothing material specimen | Continuous contact at 13.8 kPa for one minute | Gowns and other clothing worn where contact is prolonged |
The difference is one of threat model. ISO 22609 delivers a short, high-velocity stream at a complete mask, because that is what a punctured vessel during a procedure looks like. ISO 16603 holds a material specimen under sustained hydrostatic pressure, which suits clothing in contact with fluid for minutes rather than milliseconds. Both ISO 16603 and ISO 16604, which adds a bacteriophage challenge, are aimed at garments rather than masks.
How do I verify a blood splash claim before a bulk order?
The verification path is short enough to run before a purchase order rather than after one. The face mask range stocked for clinics names the level each product was tested to, and the other steps are paperwork.
- Ask for the report, not the claim. Four fields turn a marketing line into evidence: standard and edition, pressure passed, specimen count, laboratory name.
- Cross-check the model code. The mask identified in the report has to match the carton you receive, since a sibling SKU with a different layer structure is a different test article.
- Match the mask to the task. Splatter-generating procedures and ultrasonic scaling belong with a fluid-resistant mask such as a 3-ply ASTM Level 3 mask; a reception desk does not.
- Keep the report with the purchase record. If a staff member reports a splash incident, the answer should be a document rather than a memory.
Does a Canadian clinic need ISO 22609, or is ASTM F2100 enough?
Canada regulates medical devices federally through Health Canada, while day-to-day infection control expectations are set by provincial public health authorities and professional colleges. There is no single national table assigning a mask type to each task, which is why most facilities anchor selection in a recognised performance specification and keep the test documentation with the purchase record. Public health checklists for clinic settings, such as the ones Ontario publishes for dental practice, concentrate on process and documentation rather than on one mask standard number, and the dental compliance hub collects the record-keeping side of that work.
The ISO designation surfaces in three situations: products made for the European market, where the EN 14683 Type IIR classification depends on a splash resistance result recorded to ISO 22609 at 16.0 kPa; tenders that list international standards; and cross-border supply arrangements, where a distributor needs one report to satisfy buyers in several jurisdictions. Where masks are specified under ASTM F2100 levels, the test behind the fluid resistance level is ASTM F1862, the standard ISO 22609 was derived from, so the underlying evidence is comparable even when the document header is not.
What stays constant across both designations is the arithmetic. A pass exists at a pressure, at a specimen count, in a laboratory report. A clinic that asks for those three things gets a usable answer whatever the standard number on the front page.
Ordering for a clinic, lab or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers.
References and standards cited
- 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) (link checked 23 September 2026)
- ISO 22609:2004 online browsing platform entry (scope, principle and report clause) (link checked 23 September 2026)
- ISO 16603:2004, Protective clothing — Test method for penetration by blood and body fluids using synthetic blood (link checked 23 September 2026)
- ASTM F1862/F1862M, Resistance of Medical Face Masks to Penetration by Synthetic Blood (link checked 23 September 2026)
- ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks (link checked 23 September 2026)
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials (link checked 23 September 2026)
- ASTM F2299, Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates (link checked 23 September 2026)
- European Commission MDCG guidance on regulatory requirements for medical face masks (link checked 23 September 2026)
- EN 14683 medical face mask types and measured properties (Type I, Type II, Type IIR) (link checked 23 September 2026)
- Measurlabs, EN 14683 face mask testing — splash resistance performed to ISO 22609 (link checked 23 September 2026)
- Health Canada, Medical devices (federal device framework) (link checked 23 September 2026)
- Medical Devices Regulations, SOR/98-282, Consolidation of Regulations (link checked 23 September 2026)
- Public Health Ontario, IPAC checklist for dental practice — core elements (PDF) (link checked 23 September 2026)
- OSHA, Bloodborne Pathogens standard, 29 CFR 1910.1030 (link checked 23 September 2026)
- Canadian Centre for Occupational Health and Safety, Biological hazards (link checked 23 September 2026)
- Cochrane review, PPE against exposure to contaminated body fluids in healthcare staff (link checked 23 September 2026)
- Droplet and aerosol generation in dentistry: a systematic review, Journal of Dentistry, 2021 (link checked 23 September 2026)
- Splatter, droplet and aerosol contamination in dental periodontal procedures, BDJ Open, 2021 (link checked 23 September 2026)
Related Reading
- ASTM F1862 Explained: Blood Penetration Resistance for Face Masks
- BFE Testing for Face Masks: What ASTM F2101 Measures
- Surgical Mask Filtration Explained: BFE, PFE and ASTM F2100 Testing
- Face masks and procedural mask stock for Canadian clinics
- Dental practice infection control hub
- Clinic learning hub — standards, records and procurement
- Medical face mask — 3-ply ASTM Level 1, procedural mask
- Medical face mask — 3-ply ASTM Level 3, 50-pack
- Medical face mask — 3-ply, bulk clinic pack
- Wholesale and multi-site ordering desk
Frequently Asked Questions
What is ISO 22609?
ISO 22609:2004 is a laboratory test method for measuring how well a medical face mask resists penetration by a splash of synthetic blood. A fixed volume is projected horizontally at a complete mask, and any liquid reaching the wearer-facing side counts as a failure. It is a method, not a specification, so it returns a pass or fail at a stated pressure.
At what blood pressure is a mask tested under ISO 22609?
The method uses three pressures that mirror human blood pressure: 10.6 kPa (80 mmHg), 16.0 kPa (120 mmHg) and 21.3 kPa (160 mmHg). Each set of specimens is challenged at a matched velocity, and the mask is rated at the highest pressure where it meets an acceptable quality limit of 4.0 %.
How many masks are tested for an ISO 22609 result?
A single sampling plan delivering an acceptable quality limit of 4.0 % calls for 32 specimens, and the standard notes that the limit is met when 29 or more of those 32 pass. A report showing three masks passing at one pressure has not demonstrated a rating.
Does an ISO 22609 pass mean a mask filters viruses?
No. The scope covers liquid penetration only and states that the method does not address filtration efficiency, pressure drop, breathability, or the design and interfaces of the mask. Filtration is measured by separate methods such as ASTM F2101 for bacteria and ASTM F2299 for particles.
Can a supplier claim a mask is ISO 22609 certified?
Not in that wording. ISO 22609 is a test method, so a mask is tested to it rather than certified to it, and the result is a pass or fail at a stated pressure. A claim becomes checkable when it names the pressure, the specimen count and the laboratory; a claim that names none of those cannot be verified.
Is ISO 22609 the same as ASTM F1862?
They describe the same style of test. ISO 22609 was prepared by ISO technical committee TC 94 subcommittee SC 13 and is based on ASTM F1862-00a, so the two share the synthetic blood challenge, the pressure points and the visual reading. What differs is the paperwork: the number the report cites and the specification the result is mapped onto.
Do Canadian clinics need ISO 22609, or is ASTM F2100 enough?
Canada regulates masks as medical devices under the federal framework, while day-to-day infection control expectations come from provincial public health authorities and professional colleges. There is no single national table assigning a mask type to each task, so facilities anchor selection in a recognised performance specification and keep the test report with the purchase record.
What should I ask a supplier for before ordering masks in bulk?
The standard and edition tested to, the pressure that produced the pass, the specimen count, and the testing laboratory. A supplier working with a real report can supply all four in one message.
Last updated: September 2026. CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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