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Guidance for laser products

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About this guidance document

Health Canada's guidance documents give general information to regulated parties and stakeholders on how to comply with governing acts and regulations. They also outline compliance guidance to staff, to ensure that mandates are implemented fairly, consistently and effectively.

Health Canada's Consumer and Clinical Radiation Protection Bureau administers the Radiation Emitting Devices Act and its regulations. These govern the sale, lease or import of radiation emitting devices, including laser products, in Canada.

This guidance document gives general information about Schedule II, Part VII of the Radiation Emitting Devices Regulations, which govern laser products in Canada.

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Regulations governing the sale, lease and import of laser products in Canada

In this guidance document, when we refer to the regulations, we are referring to Schedule I, Item 7 and Schedule II, Part VII of the Radiation Emitting Devices Regulations. "IEC standard" refers to the International Electrotechnical Commission standard IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements, published in 2014.

Under the regulations, a laser product is any device that can be made to produce or amplify electromagnetic radiation in the wavelength range of 180 nm to 1 mm, primarily by the process of controlled stimulated emission.

Laser products may have:

Laser products must meet the requirements of the regulations when they come into force on October 9, 2025.

Laser products that are sold, leased or imported into Canada must:

These products must also have:

The requirements for laser hazard classification, engineering features, labelling and information are derived from specific parts of the IEC standard. The requirements for laser-based projectors are derived from the IEC 62471 series of standards.

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Laser hazard classes

The IEC laser hazard classification system was developed to apply appropriate control measures to protect people from health or safety risks to the eyes and skin. For example, the higher the laser hazard class, the more stringent the engineering, labelling and accompanying information measures must be.

As taken from the IEC standard, the regulations categorize laser products from the lowest to the highest hazard class as follows:

Scope of the regulations

Out of scope

The following products are out of scope, which means they are exempt from the regulations:

Health Canada recommends regulated parties highlight if any of the 5 regulatory exemptions apply in records related to the product's import, lease or sale (such as advertisements, packaging, customs documents or sale invoices). This is helpful for our inspectors to review when they conduct market surveillance and compliance verifications.

In scope

The regulations concern the sale, lease or import of a broad range of laser products in Canada. These include consumer, commercial, industrial, pest management, defence and research applications.

The following products are in scope, which means they are subject to the regulations:

Also in scope are laser products that:

Certain conditions apply to the following types of laser products:

Lasers that are designed to function as conventional lamps:

For these laser systems, regulated parties may evaluate emissions under the IEC 62471 series of standards, but only if the prescribed criteria are met (as outlined in subclause 4.4 of the IEC standard). Clarification on how to determine the radiance level and compare it to the radiance limit is provided in Interpretation Sheet Number 2, which accompanies the IEC standard.

A regulated party that evaluates emissions under the IEC 62471 series of standards must ensure the laser product:

If this option is not exercised or any of the prescribed criteria in section 4.4 of the IEC standard are not met, regulated parties must ensure the laser product:

Medical laser products that do not require a medical device licence or authorization:

Laser products with low accessible emission levels:

As set out in subsection 3(1) of the regulations, all laser products must be assessed according to the mandatory considerations, test methods and rules outlined in clauses 4 and 5 of the IEC standard.

If the emission level does not exceed the accessible emission limit (AEL) of Class 1 under all conditions of operation, maintenance, service and failure (as taken from clause 1, paragraph 5 of the IEC standard), the laser product is inherently safe and exempt from the following requirements:

However, a Class 1 laser product with a higher-class laser that's incorporated, embedded or enclosed within it is subject to the requirements (no exemption).

For such a product, laser radiation levels above the Class 1 AEL may be accessible, if:

Classification and engineering requirements

Sections 3 and 4 of the regulations require that a laser product sold, leased or imported into Canada must be designed, constructed and function in accordance with the applicable requirements of the IEC standard.

This means that the device must:

Conformance with requirements specified in other standards incorporated within the IEC standard is not mandatory.

The required test conditions consider a variety of reasonably foreseeable worst-case situations. Measurements during operation, maintenance, service and failure are needed to determine appropriate engineering safety features, labelling and accompanying information.

According to subclause 4.2 of the IEC standard, the manufacturer must classify a laser product correctly. A manufacturer is an individual or organization that manufactures or assembles laser products to any extent (also referred to as integrators).

Additional clarification on IEC subclause 4.3 is provided in Interpretation Sheet Number 1, which accompanies the IEC standard.

The regulations require that anyone who sells, leases or imports a laser product into Canada must ensure the product is classified appropriately. To meet this requirement, emissions and classification could be verified by independent testing or through an accredited test body. We recommend that regulated parties check that the personnel responsible for hazard classification are familiar with Canadian requirements and have a quality management system in place (including appropriate laser measurement equipment, testing methods and training).

Labelling requirements

Laser products sold, leased or imported into Canada must have a product identification and origins label, as well as applicable IEC standard labels.

Product identification and origins labelling

The requirements:

A laser product must bear labels to identify the product and its origins in English or French.

As set out in subsection 8(3) of the regulations, every laser product must have a label containing the:

Name and address abbreviations are acceptable. Do not use any text, cipher or code that cannot be read directly, or would require another source to access or interpret.

The principal place of business must lead to a physical location where the main business can be found. Although a physical location is required to be declared on labels, the regulations do not prescribe the level of detail necessary or state that a complete mailing address is required.

Regulated parties should provide a mailing address that is complete enough so that consumers and inspectors, who wish to communicate with the manufacturer or distributor in writing, can do so in a timely manner. A best practice is to include the civic address, city, province, postal code and country.

Information such as websites and 1-800 telephone numbers may be included on a label, along with a manufacturer's name and principal place of business.

The regulations do not prescribe a format for the date of manufacture. However, common and acceptable formats include:

Regulated parties may also use additional text to indicate what the numerals refer to.

If a serial number is used to identify the manufacturing date, it must be readily available and easily interpreted at the time of sale, lease or import. There should be no need to contact the manufacturer for a decipher key.

Quick response (QR) codes and barcodes alone are not acceptable. The labels required by the regulations must be readily available and easily interpreted at time of sale, lease or import (without having to go to another source).

Regulated parties may voluntarily add a QR code or barcode to a laser product in addition to the required product identification and origins labels.

IEC standard labelling

The requirements:

The required IEC labels must be provided in both English and French as set out in subsection 6(1) of the regulations.

The number of labels depends on the assigned laser hazard class, emission characteristics, protective housings and intended use. A convenient summary is provided in Table F.2 of the IEC standard.

Table 1 provides descriptions and examples of IEC standard labels. Consult the referenced IEC standard subclauses for more specifics, including instructions on where to place them.

Table 1: Examples of IEC standard labels
Description Example

Warning label (per subclause 7.1 of the IEC standard)

Mandatory for Class 1C, 2, 2M, 3R, 3B or 4.

Must use required colours.

Must be legible. For recommended dimension values (in millimeters), consult Figure 3 of the IEC standard.
The warning label has a triangular shape, with a yellow background and black border. A black laser starburst hazard symbol is in the centre.
Figure - Text description

The warning label has a triangular shape, with a yellow background and black border. A black laser starburst hazard symbol is in the centre.

Explanatory label (per subclauses 7.2 to 7.7 of the IEC standard).

Must bear wording appropriate for the assigned laser hazard class (see option 1) or alternate label (see option 2).

Must use required colours (only Class 1 can be white and black).

Must be legible. For recommended dimension values (in millimeters), consult Figure 4 in the IEC standard.

Examples of explanatory labels for a Class 4 laser product:

Option 1:

The English explanatory label has a rectangular shape, with a yellow background and black border. In the centre of the label is a warning, in black and uppercase: DANGER − LASER RADIATION. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT.
Figure - Text description

The English explanatory label has a rectangular shape, with a yellow background and black border. In the centre of the label is a warning, in black and uppercase: DANGER − LASER RADIATION. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION CLASS 4 LASER PRODUCT.


The French explanatory label has a rectangular shape, with a yellow background and black border. In the centre of the label is a warning, in black and uppercase: EXPOSITION DANGEREUSE DE L'OEIL OU DE LA PEAU AU RAYONNEMENT DIRECT OU DIFFUS.
Figure - Text description

The French explanatory label has a rectangular shape, with a yellow background and black border. In the centre of the label is a warning, in black and uppercase: EXPOSITION DANGEREUSE DE L'OEIL OU DE LA PEAU AU RAYONNEMENT DIRECT OU DIFFUS.


Option 2:

The English alternate explanatory label has a rectangular shape, with 5 panels bordered in black. The 4 panels on the top have a white background. Panel 1 shows the warning label. Panel 2 has an exclamation mark in a yellow triangle, the word DANGER on a red background, and the words LASER 4. Panel 3 has a red cross-out symbol and an eye that is exposed to a laser beam. Panel 4 has a red cross-out symbol and a hand that is exposed to a laser beam. Panel 5 has a yellow background and a black legend in the centre. The following words are in uppercase: AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.
Figure - Text description

The English alternate explanatory label has a rectangular shape, with 5 panels bordered in black. The 4 panels on the top have a white background. Panel 1 shows the warning label. Panel 2 has an exclamation mark in a yellow triangle, the word DANGER on a red background, and the words LASER 4. Panel 3 has a red cross-out symbol and an eye that is exposed to a laser beam. Panel 4 has a red cross-out symbol and a hand that is exposed to a laser beam. Panel 5 has a yellow background and a black legend in the centre. The following words are in uppercase: AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION.


The French alternate explanatory label has a rectangular shape, with 5 panels bordered in black. The 4 panels on the top have a white background. Panel 1 shows the warning label. Panel 2 has an exclamation mark in a yellow triangle, the word DANGER on a red background, and the words LASER 4. Panel 3 has a red cross-out symbol and an eye that is exposed to a laser beam. Panel 4 has a red cross-out symbol and a hand that is exposed to a laser beam. Panel 5 has a yellow background and a black legend in the centre. The following words are in uppercase: EXPOSITION DANGEREUSE DE L'OEIL OU DE LA PEAU AU RAYONNEMENT DIRECT OU DIFFUS.

Figure - Text description

The French alternate explanatory label has a rectangular shape, with 5 panels bordered in black. The 4 panels on the top have a white background. Panel 1 shows the warning label. Panel 2 has an exclamation mark in a yellow triangle, the word DANGER on a red background, and the words LASER 4. Panel 3 has a red cross-out symbol and an eye that is exposed to a laser beam. Panel 4 has a red cross-out symbol and a hand that is exposed to a laser beam. Panel 5 has a yellow background and a black legend in the centre. The following words are in uppercase: EXPOSITION DANGEREUSE DE L'OEIL OU DE LA PEAU AU RAYONNEMENT DIRECT OU DIFFUS.

Aperture label (per IEC subclause 7.8)

Mandatory for Classes 3R, 3B and 4.

Must include 1 of 3 wording phrases or the alternate aperture label.

Examples of aperture labels for a laser product:

Option 1:

LASER APERTURE

OUVERTURE LASER

Option 2:

APERTURE FOR LASER RADIATION

OUVERTURE POUR RAYONNEMENT LASER

Option 3:

AVOID EXPOSURE – LASER RADIATION IS
EMITTED FROM THIS APERTURE

EXPOSITION DANGEREUSE – UN RAYONNEMENT LASER EST ÉMIS PAR CETTE OUVERTURE

Option 4:

The alternate aperture label has a rectangular shape, with a yellow background and black border. Inside this border, a rounded corner rectangular shape is outlined in black and a black laser starburst hazard symbol is in the centre of the triangle. A black arrow points right, from the triangle through the rectangular shape.
Figure - Text description

The alternate aperture label has a rectangular shape, with a yellow background and black border. Inside this border, a rounded corner rectangular shape is outlined in black and a black laser starburst hazard symbol is in the centre of the triangle. A black arrow points right, from the triangle through the rectangular shape.

Radiation output and standard information (per IEC subclause 7.9)

Mandatory for all laser products except Class 1.

Must include a statement of the maximum output of laser radiation, the pulse duration (if appropriate) and the emitted wavelength.

Must include the name and publication date of the standard used for classification. An example of an acceptable format is title and year of publication.

Must be included on the explanatory label, on the alternate label or in close proximity to either of these labels on the laser product.

Example for a Class 3R diode-pumped solid-state continuous wave laser:

Maximum power: 5 mW
Wavelength: 532 nm
IEC 60825-1:2014

Puissance maximale: 5 mW
Longueurs d'onde: 532 nm
IEC 60825-1:2014

Example for a Class 4 holmium: yttrium-aluminum-garnet crystal pulsed laser:

Peak energy: 3.5 J
Pulse duration: 600 μs
Wavelength: 2.1 μm
IEC 60825-1:2014

Énergie maximale: 3.5 J
Durée de l'impulsion: 600 μs
Longueurs d'ondes émises: 2.1 μm
IEC 60825-1:2014

Access panel or safety interlock label (per IEC subclause 7.10)

Mandatory, depending on accessible emissions if protective housing panels can be removed or displaced.

Mandatory additional wording for safety interlocked panels.

Example for a laser product with a safety interlock panel that can be defeated and where the accessible emissions do not exceed the AEL for Class 3B:

WARNING – CLASS 3B LASER RADIATION WHEN OPEN AND INTERLOCKS DEFEATED
AVOID EXPOSURE TO THE BEAM

AVERTISSEMENT – RAYONNEMENT LASER DE CLASSE 3B – EN CAS D'OUVERTURE OU LORSQUE LA SÉCURITÉ EST NEUTRALISÉE EXPOSITION AU FAISCEAU DANGEREUSE

Wording modifications (per IEC subclauses 7.11 and 7.12)

Mandatory, depending on the wavelength emitted.

Example for a laser product that emits green and infrared wavelengths:

VISIBLE AND INVISIBLE LASER RADIATION

RAYONNEMENT LASER VISIBLE ET INVISIBLE

Additional warnings (per IEC subclause 7.13)

Mandatory, depending on testing results.

Example for a laser product with an accessible emission that exceeds the AEL of Class 3B, as determined with a 3.5-mm diameter aperture placed at the closest point of human access:

LASER ENERGY - EXPOSURE NEAR APERTURE MAY CAUSE BURNS

LASER – L'EXPOSITION PRÈS DE L'OUVERTURE PEUT PROVOQUER DES BRÛLURES

Legibility and location of labelling

The requirements:

All required labelling must be:

Flexibility provisions

Direct printing or engraving:

Equivalent labels may be printed or engraved on the laser product or panels. For example, engraving is suitable for devices intended for use in harsh environments or where sterility cannot be compromised. "Equivalent" means that the content, durability, permanence, legibility, visibility, location and colour requirements are met.

Alternate ways to label (for example, a printed label that wraps around the device or folds like an accordion) may be acceptable if:

Wording substitutions:

The wording of labels shown in clause 7 of the IEC standard is recommended but not mandatory. You may use other wording if it conveys the same meaning.

Alternate means of labelling:

If the size or design of the laser product makes labelling impractical, the IEC standard labels and product identification and origins label must be included with the user information or on the package. Situations where it may not be feasible for laser products to bear labels include:

If labelling is impractical because the final laser product is encased in plastic film, place the required information on the outermost layer of the packaging intended for the end-user. This is only acceptable if the regulated party is not the manufacturer.

It is not acceptable to have a label in 1 language on the device and the second official language in the user information or packaging. Both languages must be treated equally.

We recommend that regulated parties document and keep important details (for example, an explanation or justification) on file in Canada for labels that aren't directly affixed to the laser product. This is helpful for our inspectors to review when they perform a compliance check.

Information requirements

The requirements:

Subsection 6(1) and section 7 of the regulations require that accompanying information for laser products sold, leased or imported into Canada must:

Table 2 summarizes required user information for each paragraph in subclause 8.1. Refer to the IEC standard for details.

Table 2: Required user information
IEC 60825-1 subclause 8.1 Information requirement
a) Instructions and warnings for proper assembly, maintenance and safe use
b) Warning of hazards when viewing with telescopic optical instruments
c) Description of laser radiation patterns and emissions
d) Description of incorporated laser and warning
e) Values for the maximum permissible exposure (MPE), nominal ocular hazard distance (NOHD) and extended nominal ocular hazard distance (ENOHD), as appropriate
f) Information for selecting eye protection
g) Legible reproductions of all required product labels and hazard warnings
h) Indication of laser aperture locations
i) List controls, adjustments and procedures for operation and maintenance, including a warning
j) Statement of laser energy source compatibility requirements
k) Warning that exposure near the aperture may cause burns to skin or anterior parts of the eye (refer to subclause 7.13 of the IEC standard)
l) Warnings to use according to instructions, not use the device on eye lids and repeated applications may pose a risk

Table 3 summarizes mandatory information requirements, according to hazard class and other criteria.

Table 3: Mandatory information requirements
Laser class Mandatory user information requirements (IEC 60825-1 standard reference and criteria)
1
  • 8.1a), c), f) and i) if the accessible emission during maintenance or service is greater than that of a Class 3R laser product
  • 8.1d) if embedded
  • 8.1g) and h)
  • 8.1j) if the necessary laser energy source is not incorporated
  • 8.1k) if the accessible emission exceeds the AEL of Class 3B, as determined with a 3.5 mm diameter aperture placed at the closest point of human access
1C
  • 8.1a), c), f) and i) if the accessible emission during maintenance or service is greater than that of a Class 3R laser product
  • 8.1g), h) and l)
  • 8.1j) if the necessary laser energy source is not incorporated
1M
  • 8.1a), c), f) and i) if the accessible emission during maintenance or service is greater than that of a Class 3R laser product
  • 8.1d) if embedded
  • 8.1b) e), g) and h)
  • 8.1j) if the necessary laser energy source is not incorporated
  • 8.1k) if the accessible emission exceeds the AEL of Class 3B, as determined with a 3.5 mm diameter aperture placed at the closest point of human access
2
  • 8.1a), c), f) and i) if the accessible emission during maintenance or service is greater than that of a Class 3R laser product
  • 8.1d) if embedded
  • 8.1g) and h)
  • 8.1j) if the necessary laser energy source is not incorporated
  • 8.1k) if the accessible emission exceeds the AEL of a Class 3B laser product, as determined with a 3.5 mm diameter aperture placed at the closest point of human access
2M
  • 8.1a), c), f) and i) if the accessible emission during maintenance or service is greater than that of a Class 3R laser product
  • 8.1b), e), g) and h)
  • 8.1d) if embedded
  • 8.1j) if the necessary laser energy source is not incorporated
  • 8.1k) if the accessible emission exceeds the AEL of a Class 3B laser product, as determined with a 3.5 mm diameter aperture placed at the closest point of human access
3R
  • 8.1a), c), f) and i) if the accessible emission during maintenance or service is greater than that of a Class 3R laser product
  • 8.1g) and h)
  • 8.1j) if the necessary laser energy source is not incorporated
  • 8.1k) if the accessible emission exceeds the AEL of a Class 3B laser product, as determined with a 3.5 mm diameter aperture placed at the closest point of human access
3B
  • 8.1a), c), e), f), g), h) and i)
  • 8.1j) if the necessary laser energy source is not incorporated
4
  • 8.1a), c), e), f), g), h) and i)
  • 8.1j) if the necessary laser energy source is not incorporated
Laser-based image projectors
  • 6.6 of the IEC 62471-5 standard, if the emissions are evaluated under the IEC 62471 standard
  • 6.7 of the IEC 62471-5 standard, if the emissions are evaluated under the IEC 62471 standard and the system includes interchangeable lenses that affect the risk group

There is no obligation under the regulations to supply the purchasing and servicing information described in subclause 8.2 of the IEC standard.

Certification and record-keeping

There is no certification, registration, licensing or pre-market approval process for laser products under the Radiation Emitting Devices Act or its regulations.

There are no record-keeping requirements for laser products under the Radiation Emitting Devices Act and regulations. However, we recommend that regulated parties prepare and maintain records in Canada to help demonstrate compliance and be able to trace them throughout the supply chain. For example, Health Canada inspectors may request and examine records related to:

Other requirements for specific laser products or situations

A laser product may be subject to other requirements (such as certification and record-keeping) under other Health Canada legislative frameworks, such as the:

Other authorities (federal, provincial, territorial, municipal, institutions, professional associations) may have additional requirements or restrictions for public or workplace health and safety, depending on the type of laser or situation. For example:

There is no obligation under the regulations to comply with additional requirements for specific laser products described in clause 9 of the IEC standard.

Conformance with other standards or regulations of other jurisdictions

The IEC standard is recognized internationally, and industry is familiar with it. Other jurisdictions, such as the United States (US) and European Union (EU), are either moving towards incorporating this standard or already have.

Laser products that meet the US requirements (for example, 21 CFR 1040.10 and 1040.11) or EU requirements do not automatically meet the requirements of Canada's regulations. This is because of differences in classification nomenclature and our official language requirements.

The Canadian Standards Association standard CAN/CSA E60825-1:15 is identical to the IEC 60825-1 (2014) standard but includes additional electrical code-based requirements that are not within the scope of the regulations.

Contact us

For questions, comments or concerns on the Radiation Emitting Devices Act or its regulations, email Health Canada's Consumer and Clinical Radiation Protection Bureau at ccrpb-pcrpcc@hc-sc.gc.ca.

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