Iec 60825 1 Ed 3 Free Pdf !FREE!

UPDATE: This document will be withdrawn on December 31, 2024. Please use Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56), which will supersede this document on January 1, 2025. See Getting a Radiation Emitting Product to Market: Frequently Asked Questions for more information.

This guidance describes the conditions under which laser product manufacturers may introduce into United States commerce laser products that comply with the IEC standards 60825-1, as amended, and 60601-2-22. This guidance also describes additional requirements of the CDRH standard and alternate certification statements to be used with such products.

Iec 60825 1 Ed 3 Free Pdf

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CDRH will not object to conformance with many sections of IEC 60825-1, as amended, and IEC 60601-2-22 as alternatives to comparable sections of 21 CFR 1040.10 and 1040.11. CDRH plans to amend federal regulations for laser products to reflect those sections of the IEC standards. CDRH is also listing sections of its standard that contain requirements to which manufacturers must conform. This action is appropriate because of the Center's intent to harmonize its requirements with many of those of the IEC standards.

Effective immediately, and until the effective date(s) of any amendments of the Federal regulations affecting laser products, CDRH will not object to conformance with the comparable sections of IEC 60825-1, Editions 1.2 or 2 or 60601-2-22 in lieu of conformance with the following sections of 21 CFR 1040:

The EN 60825-1 laser product safety standard has historically not differed from the base IEC 60825-1 laser product safety standard. Therefore, compliance with IEC 60825-1 could help cover any EN 60825-1 requirements. However, with Amendment 11 (A11) of EN 60825-1 issued in February 2021, additional requirements have been introduced that are not in IEC 60825-1. (Note: Amendment 11 is a reserved Amendment number that applies to the EN version of a standard but not the IEC version.) As a result, laser product manufacturers will need to make sure they meet those additional EN requirements to confirm compliance with both IEC 60825-1 and the latest EN 60825-1. The additional requirements to consider for EN 60825-1:2014/A11:2021 include:

In December 2021, the amendment EN 60825-1:2014/A11:2021 was listed as a harmonized standard under the Low Voltage Directive (LVD) in the Official Journal (OJ) of the European Union. The date of withdrawal of EN 60825-1:2014 without A11 in the OJ is June 21, 2023. Therefore, laser product manufacturers should consider June 21, 2023, as the date by which EN compliance relies on the new EN 60825-1:2014/A11:2021 requirements to grant presumption of conformity with the essential requirements to the LVD.

A second EN laser product safety standard issued in November 2021 is EN 50689, a brand-new standard that provides additional requirements for laser products defined as consumer laser products. Based on the definitions in EN 50689, a consumer laser product is defined as one intended for consumers or that is likely to be used by consumers under reasonably foreseeable conditions, even when it may not be intended for them. Therefore, manufacturers of laser products that meet this definition shall also consider EN 50689 in addition to IEC/EN 60825-1.

As a result, manufacturers should consider complying with EN 50689 to help eliminate any potential questions about compliance with applicable requirements. Manufacturers should also keep in mind that EN 60825-1:2014/A11:2021 requires the use of EN 50689, and EN 60825-1 with A11 is required as of June 21, 2023. Hence, manufacturers can infer that they will need to comply with EN 50689 by June 21, 2023.

Manufacturers can self certify their equipment to EN 60825-1, but the standard is highly complex and difficult to interpret and in many cases an expert is required to obtain the correct laser Class for the product. In any case many manufacturers prefer to have independent verification of their compliance with the classification requirements.

IEC 60825-1, IEC 60825-2 and IEC 60825-12 are currently identical to the corresponding EN standards (although the EU standards agencies reserve the right to vary from them if considered necessary for safety reasons). These standards are applicable in Japan, Australia, Canada and pretty much every other country not already covered.

This is just an indication of some of the methods which may be employed to comply with the single fault requirement in IEC/EN60825-1. Lasermet will act as consultants if required, providing advice on specific applications, applicability of a given design and particular information concerning the likely problems with each system.

This standard is challenging to comply with, namely because so few labs in the United States provide support for compliance to EN 60825-1 or the IEC version: IEC 60825-1. Keep in mind that if your laser pointer had a way to connect to AC mains power (say, for instance to an AC/DC adapter) then it would be considered as an AC-powered product, likely over the AC power threshhold of 50 VAC for inclusion in the scope of the LVD, and therefore you would have to comply with EN 60825-1 in order to place a CE marking on the laser.

The radiation hazards of lasers are described in standard EN 60825-1. Originally EN 60825-1 (issue 1994) also covered LEDs, but after the introduction of EN 62471 in 2008, the 2007 issue of EN 60825-1 no longer included LEDs.

So since September 2011 the requirements for lasers are stated in EN 60825-1; and the safety requirements for LEDs in EN 62471.

The 2014 version of EN 60825-1 provides details of the labelling that is required for lasers. The label is dependent on the classification:

Class 1: this class is eye-safe under all operating conditions.

IEC 60825-1: 2007 is a standard issued by the European Union, applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. Its scope of application would be only applied to LASER products after September 2010, and LED lighting products are no longer covered by the latest version of IEC / EN 60825-1, but need to be assessed in accordance with IEC / EN 62471.

IEC / EN62471 is a test standard for laser products (including LED) issued by the European Union. It is applicable to all lamps and lamp systems, including LEDs, incandescent bulbs, fluorescent lamps, gas discharge lamps, and arc lamps and other lamps and lamps, to evaluate the related light radiation hazards of different lamps and lamp systems. And it fully replaces the IEC / EN60825 standards on the LED product energy level requirements, and increases light biological requirements, including radiation intensity, radiance, etc. Moreover, it classifies product hazard levels according to the test data, Including the exemption level, low-hazard, medium-hazard, high-hazard level. The EU part of the standard EN62471: 2008 has been implemented in 2009.09.01 and EN60825 part of the LED will be completely invalid since 2010.09.01. EU Directive 244/2009 on energy efficiency requirements for non-directional lamps for domestic use also specifies that tests on UV content shall be carried out in accordance with IEC / EN 62471 (including energy saving lamps and incandescent / halogen lamps).

In the past, there is no detailed measurement and evaluation method for the harm to human body caused by optical radiation. The traditional test method is to evaluate the content of ultraviolet or invisible light contained in the light wave. When the LED appears, we evaluate it with the same IEC / EN 60825 standard for laser product. But now, LED products are no longer covered by IEC / EN 60825-1: 2007, but according to IEC / EN 62471 for risk assessment. And IEC / EN 60825 is only suitable for laser products. IEC / EN 62471 is covered by the CE Low Voltage Directive (LVD directive 2006/95 / EC) and is also covered by the Artificial Light Radiation Directive (AORD 2006/25).

For most of the world the applicable laser safety standard is the international standard set by the International Electrotechnical Commission (IEC), and known as IEC 60825 (previously IEC 825). This standard has several parts that are detailed in the table below. The exception to this rule is the USA who have never adopted the international standard, but instead have their own CDRH (Center for Devices and Radiological Health) standard, adminstered under the auspices of the FDA (Food and Drug Administration). The US user standard is ANSI Z136.1 (more detail below), whilst the manufacturer's standard is CDRH 21 CFR parts 1040.10 and 1040.11.

If lasers or laser devices are being used or sold into any European country, and most other international countries outside the USA, then the appropriate standard for classification and labelling purposes is the international IEC 60825 standard. Within Europe this standard has been adopted as a European Normative standard known as EN 60825, and each European country will have its own version of this standard with, for example, the British Standards version known as BS EN 60825.

Luckily for some International laser product manufacturers the CDRH in the USA has decided to harmonise their requirements with 21 CFR 1040.10 and 1040.11 with the IEC 60825-1 and IEC 60601-2-22 standards. This process has not yet happened and in the interim, so as to reduce the regulatory burden on industry and the CDRH agency, they have released 'Laser Notice No.50' that explains what they require. This notice allows some IEC classification and labelling of lasers within the USA. Further information on CDRH requirements can be found at www.fda.gov/cdrh/radhlth.

The table below summarises the IEC 60825 range of laser safety standards. These all originate from the base laser safety standard, IEC 60825-1. The reader should note that work is in progress on some of these documents, and it is important to ensure that the latest version of the standard is used. This can be problematic when the standard is still referred to as, for example, the 1994 standard when there was a significant revision issued in 2001. Ironically, the latest version of the base IEC 60825-1 standard is arguably a less significant development, and yet it has had the year updated so it can be referred to as IEC 60825-1:2006, with the British Standards version being BS EN 60825-1:2007. be457b7860