The situation for LED products is different in the United States. In the United States, product safety is governed by Federal Regulations, which are enforced by the Food and Drug Administration (FDA).

LED products are not subject to any Federal Regulation (for example, 21 CFR 1040.10) and are not required to be registered.

As a result, we strongly advise manufacturers to carefully consider their drive electronics to ensure that the reasonably foreseeable single fault failure requirement is met. Otherwise, serious issues are likely to arise during the testing stage, when manufacturers are under pressure to get the product on the market.

The standard for photobiological safety of lamps and lamp systems is BS EN 62471. It is used to evaluate the risk posed by LEDs, LED arrays, lamps, and general lighting sources.

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The product would be assigned to risk groups 1-3 or exempt depending on how the radiance / irradiance compares to the limits. The length of time a light source can be safely viewed depends on both the risk group and the wavelength.

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If some of the information/items requested above are not supplied, it may take a long time to analyze the circuit, resulting in additional test costs. In some cases, classifying the equipment may be impossible without all of the relevant samples/information listed above.

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LEDs were incorporated into IEC 62471-1:2005 “Photobiological safety of lamps and lamp systems” in 2005. This standard’s measurement conditions were set at 200 mm with varying fields of view based on risk group. IEC 60825-1 was revised again in 2007, including the removal of most LEDs from being tested under the same standard as lasers.

You work for two years on a product that uses LEDs (or another non-laser light source). Your focus will be on producing an excellent product, and only when you are close to production will you submit your product for LED safety testing, only to discover that changes are required to meet the standard. Changes in the late stages of development can be costly and cause production and sales to be delayed. Significant design changes can be costly both financially and in terms of time.

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We will issue a classification conditional on making the listed changes (such as labeling, user information, and minor engineering changes) if a product fails to meet the desired classification due to minor failures. When a retest is required, it is usually done at a reduced cost.

Since 60825-1(2001) was the last standard to implicitly apply to LEDs, it is often still used to evaluate LEDs because it is the most restrictive due to the possibility of a short measuring distance. Furthermore, other standards and directives, most notably the Electric Toys Standard, still refer to this version of the standard.

As a result, to avoid having to make changes to your product in order to meet the safety requirements of BS EN 62471, we recommend that you involve us early in the design process.

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The irradiance and radiance are measured in accordance with the standard, weighted according to the spectral distribution, and compared to the risk group limits of the following hazards:

We will test and certify your prototype or completed product to the appropriate standard or standards and provide a full test report including details of:

IManufacturers achieve product conformity in European countries by certifying products to the applicable standards. It is the manufacturer’s responsibility to identify the relevant standards, design the product appropriately, and include a declaration of conformity in the user manual. Non-conformances are detected and addressed by various national enforcement organizations, such as The Trading Standards Organisation in the United Kingdom. The standards are set by expert committees and are constantly reviewed and amended. This places responsibility on manufacturers while also allowing standards to be kept up to date with changing technology, new information, and changes in current practice.

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