Guidance for laser products: Labelling and information requirements

On this page

• Labelling requirements
  • Product identification and origins labelling
  • IEC standard labelling
  • Legibility and location of labelling
  • Flexibility provisions for labelling
• Information that must accompany a laser product

Labelling requirements

Product identification and origins labelling

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

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

1. manufacturer's name and civic address of its principal place of business
2. model number of the product
3. date of manufacture of the product; and
4. if the product is imported for sale or lease, the distributor's name and civic address of its principal place of business in Canada

In cases where the laser product is imported for sale or lease, only the importing distributor’s name and address is required.  A distributor who does not import the laser product into Canada is not required to include their name and civic address on the product identification/origins label. For example, an individual Canadian retail store that bought the laser product from a Canadian importer is not required to include this information.

Name and civic 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.  An image of a company logo, for instance, would not be considered compliant.

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

If a serial or lot number is used to identify the manufacturing date, it must be readily available and easily interpreted at the time of sale, lease or import (for example, the accompanying laser product instruction manual states how to interpret the manufacturing date from the serial number or lot number). There should be no need to contact the manufacturer for a decipher key or search online.

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.

When identifying each required product identification and origins element, it is acceptable to use graphical symbols.

IEC standard labelling

IEC standard labelling enables users to better understand the hazard levels and  safe operation of laser products.

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.

Legibility and location of labelling

All required labelling must be:

• durable
  • indelible under the conditions in which the device may be reasonably used
• permanently affixed to the laser product
  • printed and remain applied or attached to the external surface over the expected lifetime of the device
• legible
  • the wording, lettering, legend, text, words and symbols must be of a size and quality that makes them easy to read
    • refer to Figures 3 and 4 of the IEC standard for recommendations on label dimensions
  • content must not be blurred, faded, defaced or distorted, have low contrast from the background, or have inadequate space between letters or lines of text
  • handwriting is not recommended
• visible during operation, maintenance or service, according to their purpose
  • for example, it is not acceptable if the label cannot be read when laser eye protection is worn
• positioned so they can be read without the need to expose someone to laser radiation exceeding the AEL for Class 1
• in the prescribed colours
  • depends on the laser hazard class and whether alternate warning and explanatory labels are used
• accurate
  • labels, packaging and advertising related to radiation emissions from a device must not be false, misleading or deceptive or create a wrong impression related to its design, construction, performance, intended use, character, value, composition, merit or safety
  • refer to section 5 of the Radiation Emitting Devices Act

Flexibility provisions for labelling

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:

• all the requirements previously mentioned are met
• the label doesn't interfere with the user or service provider reading other required labels (such as access panel warnings) and
• the label doesn't interfere with the engineering safety features

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

It is acceptable to have the required IEC standard labels and the manufacturer’s product identification and origins label affixed to the laser product, and the importing distributor’s name/address included on the outermost layer of packaging intended for the end-user.

If the size or design of the laser product makes labelling impractical, the required IEC standard labels and product identification and origins label must be included with the accompanying user information or on the package.

Situations where it may not be physically feasible for laser products to bear labels include:

• limited surface area
• sterile environment applications

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.

Cost is not a reason that makes labelling impractical.

It is not acceptable to have a label in one language on the device and the second language in the user information or packaging. English and French must be treated equally.

As detailed in IEC 7.9 for Class 1 or Class 1M laser products only, it is acceptable for the laser radiation maximum output, pulse duration, emitted wavelength(s), classification standard name and date to be included in the accompanying information for the user (instead of labels on the product).

Information that must accompany a laser product

Certain information required by the IEC standard must accompany products to help people who purchase, operate and service laser products make more informed decisions and take appropriate safety precautions.

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

• be in both English and French
• accompany the laser product (must be physically present at the time of sale, resale, lease or import)
• include content described in subclause 8.1 of the IEC standard or, if applicable, subclauses 6.6 and 6.7 of IEC 62471-5 standard and
• include items 8.1a), c), f) and i) of the IEC 60825-1:2014 standard if the accessible emission during operation, maintenance or service is greater than that of a Class 3R laser product

The accompanying information must be consistent with the product labelling and be based on accessible emissions during operation, maintenance and service. Recognizing some laser products are shipped wholly or partly (for example, as a kit to be assembled by the end-user), Health Canada recommends placing the required information in whichever package contains the output aperture(s) (the opening through which laser radiation can be emitted).

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.