Quick facts
- An eye colour chart is a reference chart of iris shades, used to name or illustrate eye colour; it is not a vision test.
- A colour-vision test is a different article: it measures how the eye perceives colour, and in the United States it is a named Class I device at 21 CFR 886.1170, product code HIT.
- A colour-vision plate illuminator is separately named at 21 CFR 886.1160.
- In Canada a printed chart that does not touch the eye is a non-invasive device; under Rule 7(1) of the Medical Devices Regulations it falls to Class I, and Rule 7(2) lifts a tester or quality-control support device to Class II.
- The claim decides: a chart sold to describe eye colour is a general supply; the same chart sold to test colour perception is a device.
- The entries and rule text below were checked against the current eCFR text and the Regulations on 2026-10-07.
An eye colour chart is the printed sheet of iris shades used to name eye colour — pale blue through hazel and dark brown — in education, in eyewear and cosmetic catalogues, and in some clinical notes. It is easily confused with a colour-vision test chart, which does something different: it checks whether the eye can tell colours apart. The two look similar on a wall and sit in very different places in the rulebooks, and the line between them is the intended use recorded for the product.
What is an eye colour chart used for?
The chart exists to standardise a description. Instead of writing "light greenish", a form can name the shade on a reference card so that two observers record the same word. The uses are mostly non-clinical: teaching, illustration, fitting tinted or coloured lenses, and matching cosmetic products. A clinician may note eye colour as an observation, but the colour of an iris is not a measurement of how the eye performs.
Because the chart makes no claim about seeing, it usually stays outside the device rules. What changes that is a claim. A chart that says it helps detect colour-vision deficiency, or screens for colour blindness, is describing a diagnostic function, and a diagnostic function is what turns a printed sheet into a device.
What is the difference between an eye colour chart and a colour-vision test?
The difference is what the result means. One names a shade, the other measures perception.
| Item | Eye colour chart | Colour-vision test |
|---|---|---|
| What it records | The shade of an iris | Whether the eye distinguishes colours |
| Typical article | Printed card or booklet | Ishihara plates, HRR or similar |
| Claim made | Description and education | Screening or testing of colour vision |
| Device status in the US | General supply, unless a colour-vision claim is made | 21 CFR 886.1170, Class I |
| Device status in Canada | General supply, or Class I non-invasive device | Class I as a non-invasive device; Class II if it is a tester or QC support to another device |
| Standard it follows | None for the device rules; colour reference is descriptive | Ishihara and related plate sets, read under controlled light |
The practical test is a sentence on the box. "Describes and illustrates eye colour" keeps a chart a supply. "Screens for colour vision deficiency" makes it a device, and in the United States that device has a name and a class.
How do Canada and the United States treat an eye colour chart?
Neither country names an eye colour chart. The two rulebooks then diverge in how they classify a colour-vision article.
| Point | Canada | United States |
|---|---|---|
| Named entry | None | 21 CFR 886.1170, color vision tester, Class I |
| Plate illuminator | Not named; a non-invasive device where a device | 21 CFR 886.1160, Class I |
| Plain colour chart | General supply | General supply |
| Chart with a colour-vision claim | Non-invasive device, Class I; Class II if a tester or QC support to another device | Class I under 886.1170 |
| Basis of the class | Intended use recorded for the device | The named entry it is filed under |
| Records expected | Establishment licence and device records where a device | Listing and general controls for a Class I device |
In Canada the regulating idea is the intended use. A non-invasive device that is not caught by an earlier rule falls to Class I under Rule 7(1), and only moves to Class II under Rule 7(2) where it is meant to act as a calibrator, tester or quality-control support to another device, or to be connected to an active device. A colour-vision plate set used to test a patient can therefore sit at Class II, because it is a tester, while a plain eye colour card stays outside the device path entirely.
In the United States the files are name-based. The openFDA device classification API lists a color vision tester under 21 CFR 886.1170 at Class I, product code HIT, and a colour vision plate illuminator under 21 CFR 886.1160. A product that does not fit either entry does not reach the device path at all.
Which standard applies to a colour-vision plate set?
Where a product is presented as a colour-vision test, the standard follows the claim. Plate sets are read under a defined light source, because colour perception changes with the colour temperature of the room. The general requirements for ophthalmic instruments in ISO 15004-1:2020 cover the instrument side, and the older plate designs carry their own reading rules. ISO 8596:2017 covers acuity optotypes and is the standard that a vision chart, rather than a colour plate, is measured against.
| Element | Colour reference chart | Colour-vision test |
|---|---|---|
| Illumination | Any stable light | Defined source; plates are light-sensitive |
| Reference | Iris shades | Plates designed to be misread by a deficient eye |
| Records | Descriptive note | Screening result kept in the file |
| Control | None | Plate set kept intact and in date |
A clinic that keeps an eye colour chart on the wall and a colour-vision test in a drawer has two objects that look alike and behave differently. The colour chart can be replaced without a record; the test plates are part of the clinical file and are read under the conditions the library was designed for.
Which consumables sit on the same lane as the charts?
A vision lane restocks as a set. The smooth white exam table paper keeps the headrest clean between patients, and the double-tipped cotton swabs handle lid-margin prep when a test needs a clean surface. Where a clinic also takes a bench sample, the sterile graduated 90 mL specimen cups carry it away. Clinics that monitor their own steriliser pair the sterilization monitoring collection with the 24-hour monitoring five-pack trial. Multi-site groups ordering at case level use the wholesale ordering page, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
How is a colour chart kept in a clinical file?
The chart itself is not a record; the test result is. Where a colour-vision test is run, the plate set, the light used and the outcome belong in the file, because a result read under the wrong light is not comparable with the same result read under the right one. An eye colour note is descriptive and is recorded the way height or an allergy is recorded. The distinction is simple: one line describes the patient, the other records a measurement, and only the measurement needs the conditions and the date attached.
Sources
- 21 CFR 886.1170, Color vision tester
- 21 CFR 886.1160, Illuminator, color vision plate
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- Health Canada, medical devices
- ISO 8596:2017, ophthalmic optics, visual acuity testing
- ISO 15004-1:2020, ophthalmic instruments, general requirements
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management of medical devices
- Standards Council of Canada
- CSA Group
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- American Academy of Ophthalmology, eye health
- Public Health Ontario, infection prevention and control
- CCOHS, OSH answers
- US FDA, medical devices
- World Health Organization, blindness and visual impairment
Where a colour-vision result is written down
A colour-vision result that is not written down cannot be compared with a repeat test. The printable colour-vision screening log is a blank sheet with columns for the patient, the eye tested, the plate set and light used, and the outcome, so a recheck follows the same conditions rather than a different room. The screening record generator on the same page sizes the sheet to the number of lanes a clinic runs. No account and no sign-up are needed to open either one.
Every lane and every plate set is different. Ask a compliance specialist and you will get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Colour vision test charts in Canada vs the US: which rules apply
- Ishihara vision test in Canada vs the US: which colour rules
- Eye chart in Canada vs the US: which optotype standard applies
CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the class of a device and the records kept by a clinic belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
Is an eye colour chart a medical device?
Usually not. A chart that describes and illustrates iris colour makes no claim about seeing, so it is a general supply. It becomes a device only where it is sold to test or screen colour vision.
What is the difference between an eye colour chart and an Ishihara test?
An eye colour chart names a shade; an Ishihara or similar plate set measures colour perception. The plate set is a diagnostic article and is classified as a device, while a colour reference chart is not.
How is a colour-vision tester classified in the United States?
A colour-vision tester is a named Class I device at 21 CFR 886.1170, product code HIT. A colour-vision plate illuminator is separately named at 21 CFR 886.1160.
How does Canada classify the same articles?
A non-invasive device falls to Class I under Rule 7(1) of the Medical Devices Regulations, and rises to Class II under Rule 7(2) where it is intended to act as a calibrator, tester or quality-control support to another device, or to be connected to an active device.
Does a chart need a licence in Canada?
A Class I device has no device licence of its own; the manufacturer holds an establishment licence and keeps the records the Regulations require. A Class II device needs a licence under section 32 supported by a CAN/CSA-ISO 13485 quality management certificate.
Which standard covers a colour-vision plate set?
Plate sets are read under a defined light source, and the general ophthalmic instrument requirements in ISO 15004-1:2020 cover the instrument side. ISO 8596:2017 covers acuity optotypes rather than colour plates.
Can the same card be a supply and a device?
Yes. The material can be identical while the claim differs, and the claim decides the class. A card sold to describe eye colour and a card sold to screen colour vision are described differently.
Where should a colour-vision result be recorded?
The printable colour-vision screening log at the compliance log centre has columns for the patient, eye, plate set, light used and outcome, and the screening record generator on the same page sizes the sheet to the number of lanes a clinic runs.
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