Quick facts
- United States: a colour vision tester has a named entry at 21 CFR 886.1170. The identification paragraph says the device "consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color)".
- United States: section 886.1170(b) places the device in Class I (general controls), exempts it from premarket notification subject to 886.9, and exempts it from the quality management system regulation in part 820 except for records and complaint files.
- United States: an anomaloscope is a separate named entry at 21 CFR 886.1070, also Class I, described as an AC-powered device that displays "mixed spectral lines to be matched by the patient".
- Canada: Schedule 1 to the Medical Devices Regulations, SOR/98-282 names no colour vision tester. A chart or plate set that does not touch the eye surface is a non-invasive device, and Rule 7(1) places all other non-invasive devices in Class I.
- Canada: the Canadian Aviation Regulations, SOR/96-433 state vision in metres and contain no colour perception clause, while the United States writes colour perception directly into 14 CFR 67.103(c) and 49 CFR 391.41.
- Canadian regulation text cited here is current to 2026-09-21; the American sections were last amended 90 FR 55989, December 4, 2025, and 90 FR 55992 for the eye shield entry referenced below.
A colour vision chart looks like a page of coloured dots, and a colour vision tester looks like a drawer of coloured yarn. Both sit in a vision testing lane beside the acuity chart, and both are regulated by general sentences rather than by anything written for them. The difference between the two countries is not the class of the device but where each writes the requirement the device is used to check.
Are colour vision testers Class I in both Canada and the United States?
Yes, and the two countries reach Class I from opposite directions: the United States has a named entry that states the class, while Canada reaches the same class through a general rule.
The American entry is unusually specific about what the device is. Section 886.1170(a) describes a device that "consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision". That sentence is the classification: a chart of plates and a box of yarns are the same device type because both are intended to evaluate colour vision. The class follows, and the entry adds two exemptions, one from premarket notification and one from the quality management system regulation, leaving the records and complaint file requirements in place.
Canada does not list colour vision testers, so the question is which rule catches them. The device does not touch the surface of the eye, so Rule 2(1), which places devices that contact the surface of the eye in Class II, does not apply to a chart. It is a non-invasive device that is not covered by the earlier rules, so Rule 7(1) applies and places all other non-invasive devices in Class I. An anomaloscope is mains-powered and displays light, but it is still not an invasive device, and it lands in the same place.
A Canadian practice can record Class I, but it should record which rule produced that class rather than the product name, because the rule does not read the product name.
| Item | Canada | United States |
|---|---|---|
| Named entry for a colour vision tester | None in Schedule 1 | 886.1170, colour vision tester |
| Named entry for an anomaloscope | None | 886.1070, anomaloscope |
| Route to the class | Rule 7(1), other non-invasive devices, Class I | The section states Class I directly |
| Premarket notification | Not a Class I obligation under these rules | Exempt, subject to 886.9 |
| Quality system carve-out | Not stated for this device | Exempt from part 820 except records and complaints |
| Anomaloscope power source | Does not change the class | Entry notes AC power in the identification |
Does Canada write colour vision requirements into federal law the way the United States does?
No, and this is the clearest difference between the two systems for anyone running occupational screening.
The United States writes the requirement into the same federal instrument that sets the vision standard. For aircrew, 14 CFR 67.103(c) requires the "ability to perceive those colors necessary for the safe performance of airman duties". For commercial drivers, 49 CFR 391.41 requires "the ability to recognize the colors of traffic signals and devices showing standard red, green, and amber". In both cases the colour requirement sits beside the acuity numbers, in the same list, on the same page.
Canada sets acuity in the aviation regulations but does not put a colour clause in the same text. The Canadian Aviation Regulations state distant visual acuity in metres: SOR/96-433, section 804.26, requires "distant visual acuity with or without correction of 6/12 (20/40) or better in each eye separately and binocular visual acuity of 6/9 (20/30) or better". A full-text search of that consolidation for "colour perception", "colour vision" and "colour-blind" returns no hits. The colour requirement exists, but it is carried by the medical examination process rather than by a sentence in the regulation, and the two countries therefore look different to someone reading only the statute.
For a clinic the difference is about where the requirement is documented, not whether one exists. A Canadian screening station should record the authority that asked for the test, the plates or charts used, the result in the notation the referring body accepts, and the date. Copying an American federal colour clause into a Canadian file describes a requirement that is not in the Canadian text.
| Question | Canada | United States |
|---|---|---|
| Colour clause in the federal aviation text | No clause found in SOR/96-433 | Written into 14 CFR 67.103(c) |
| Acuity notation in the same text | Metres, 6/12 and 6/9 | Feet, 20/20 and 20/40 |
| Colour clause for commercial drivers | Not in the federal aviation text | Written into 49 CFR 391.41 |
| Where the colour requirement sits | The medical examination process | The regulation itself |
| Common error | Quoting a US federal colour clause as a Canadian one | Assuming the US rule is North American |
Which plates and charts are used for colour vision testing?
Four families, and the standard that matters to a certification body is the one that specifies the optotype rather than the one that specifies the colours.
- Pseudo-isochromatic plate sets. Plates in which a figure is formed from dots of differing colour but similar luminance. The American identification paragraph at 886.1170 describes exactly this: "multicolored plates which patients with color vision deficiency would perceive as being of one color".
- Yarn and matching tests. Also captured by 886.1170, which names "colored yarns" first, because matching a yarn to a colour is a way to test colour naming without requiring the patient to read.
- Arrangement tests. The patient orders a sequence of colour caps, and the error pattern locates the deficiency. These are charts and caps rather than illuminated instruments.
- Anomaloscopes. The instrument route, reached in the United States through 886.1070, which displays "mixed spectral lines to be matched by the patient". This is the entry that separates a matching task from a naming task.
The optotype standard that certification bodies name is ISO 8596:2017, which specifies "a range of Landolt ring optotypes and describes a method for measuring distance visual acuity under photopic conditions for the purposes of certification or licensing". The same Scope states that the standard is "neither intended as a standard for clinical measurements nor for the certification of blindness". That sentence matters when a practice is asked to supply a number for a licensing body: the standard behind the chart is a licensing standard, and a clinical record is a different document.
How does a colour vision chart differ from a Snellen acuity chart?
The two charts sit in the same lane but measure different things, and the American entries keep them apart by name.
An acuity chart is reached through 21 CFR 886.1150, which describes "a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity". A colour vision tester is reached through 886.1170, and the difference in the identification paragraphs is the point: acuity is about size at a distance, and colour vision is about the perception of coloured material.
That separation is why a practice cannot answer a colour question with an acuity result. A patient can read the 6/6 line and still misname the plates, and a patient who cannot read the small line can still match colours correctly. Recording the two results in the same field loses the distinction the two entries preserve.
For a Canadian file, the same separation applies through the general rules rather than through named entries. Both devices are non-invasive, both are Class I, and both are described by their intended use, which is why the intended use is the sentence worth writing down.
What does a clinic record when it runs colour vision testing?
Six records, and the two that usually go missing are the notation and the authority.
- The intended use. Screening, pre-employment certification, or a clinical assessment, stated on the file rather than inferred from the chart used.
- The chart or instrument. The plate set, the arrangement test, or the anomaloscope, recorded by the name the manufacturer gives it.
- The illumination. Arrangement and plate tests are read under a stated light source, and the source belongs in the record with the result.
- The notation. Metres or feet, and the exact form the referring body asked for, since the same result is written differently by an aviation examiner and a clinic.
- The authority. The regulation, employer policy or college requirement that prompted the test, recorded by name.
- The date of the device reference. The class of the device comes from a rule, and the rule text carries a currency date that belongs in the file.
A station that keeps these six fields can answer a certification question without re-testing, with the acuity standard and the colour plate set named on separate lines.
Which consumables does a vision testing lane restock?
A testing lane consumes paper and contact items on the same cycle as the instruments. For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. The exam table paper covers the lane surface, the cotton swabs cover preparation and cleaning, and practices that also run a steriliser can pair the monitoring collection with the biological indicator 5-pack trial.
Sources
- 21 CFR 886.1170, colour vision tester
- 21 CFR 886.1070, anomaloscope
- 21 CFR 886.1150, visual acuity chart
- 21 CFR 886.4750, ophthalmic eye shield
- 14 CFR 67.103, medical standards for airmen
- 49 CFR 391.41, physical qualifications for drivers
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- Canadian Aviation Regulations, SOR/96-433, full text
- ISO 8596:2017, optotypes for visual acuity testing
- ISO 15004-1:2020, ophthalmic instruments, general requirements
- ISO 14971:2019, risk management of medical devices
- ISO 13485:2016, medical device quality management systems
- Health Canada, medical devices
- Health Canada, drug and health product portal
- openFDA device classification API
- CCOHS, OSH answers
- World Health Organization, blindness and visual impairment resources
- College of Medical Laboratory Technologists of Ontario
- Public Health Ontario, laboratory services test index
- Royal College of Dental Surgeons of Ontario
A colour result is only useful if the lane that produced it can be documented. The printable lane log is a free sheet with a column for the chart or plate set and a column for the notation used, so metres and feet never share a line. The generator built for single-lane vision practices assembles the sheet from the number of patients a lane sees and the device it holds, which keeps a two-room optometry practice from being handed a hospital form. No account and no sign-up are needed to open either one.
Where the class of a device and the rule behind it need to be explained for an inspection file, the written answer is the one worth having. Ask a compliance specialist and a written answer comes back specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Snellen Chart and Eye Test Charts in Canada vs the US: Which Scale Applies
- Amblyopia Eye Patches in Canada vs the US: Which Patching Rules Apply
- Eye Masks in Canada vs the US: Warm Compress and Dry Eye
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, occupational health and procurement professionals and is not safety or regulatory guidance; the acceptance of a device, its use in a screening programme and its documentation belong to the practice's quality system and to the requirements that apply to it.
Frequently Asked Questions
Are colour vision testers Class I in Canada?
Yes. Canada does not list a colour vision tester in Schedule 1, so the device is reached by the general rules. A chart or plate set that does not touch the eye surface is a non-invasive device, and Rule 7(1) places all other non-invasive devices in Class I.
Does Canada require colour vision testing in federal law?
The Canadian Aviation Regulations set visual acuity in metres at section 804.26 but a full-text search of that consolidation for colour perception, colour vision and colour-blind returns no hits. A colour requirement may be applied through the medical examination process, but it is not written into that regulation the way 14 CFR 67.103(c) writes it into the American one.
What is the difference between a colour vision tester and an anomaloscope?
In the United States they are two named entries. Section 886.1170 covers charts, plates and coloured yarns used to evaluate colour vision, and section 886.1070 covers an AC-powered instrument that displays mixed spectral lines to be matched by the patient.
Is a colour vision chart the same device as a Snellen chart?
No. A Snellen chart is reached through 21 CFR 886.1150 as a visual acuity chart, while a colour vision tester is reached through 886.1170. Acuity is about the size of an optotype at a distance, and colour vision is about the perception of coloured material.
Does the illumination matter for a colour vision test?
Yes, for plate and arrangement tests. The light source under which the charts are read belongs in the record with the result, because the reading and the lighting are one measurement.
Which notation should a Canadian clinic use?
Use the notation the referring body accepts and record it explicitly, because the Canadian aviation text uses metres while the American federal texts use feet. Keeping both notations in separate fields prevents the same result from being written two incompatible ways.
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