What Laser Safety standards apply?
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.
There can be small differences between the different countries versions of EN 60825, and these are in part caused by the process of translating the standard into the native language of that country.
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 IEC 60825 Range of Laser Safety Standards.
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.
|Standard Number||Brief Description|
|60825-1||Safety of Laser Products – Part 1: Equipment classification, requirements and user guide.|
|60825-2||Safety of Laser Products – Part 2: Safety of optical fibre communication systems (OFCS).|
|60825-3||Safety of Laser Products – Part 3: Guidance for laser displays and shows.|
|60825-4||Safety of Laser Products – Part 4: Laser guards.|
|60825-5||Safety of Laser Products – Part 5: Manufacturer’s checklist for IEC 60825-1.|
|60825-6||Withdrawn. Safety of Laser Products – Part 6: Safety of products with optical sources , exclusively used for visible information transmission to the human eye.|
|60825-7||Withdrawn. Safety of Laser Products – Part 7: Safety of products emitting infrared optical radiation, exclusively used for wireless ‘free air’ data transmission and surveillance.|
|60825-8||Safety of Laser Products – Part 8: Guidelines for the safe use of medical laser equipment.|
|60825-9||Safety of Laser Products – Part 9: Compilation of maximum permissible exposure to incoherent optical radiation.|
|60825-10||Withdrawn. Safety of Laser Products – Part 10: Application guidelines and explanatory notes to IEC 60825-1.|
|60825-11||Deleted. Safety of Laser Products – Part 11: Safety of lasers and laser equipment used in an industrial materials processing
|60825-12||Safety of Laser Products – Part 12: Safety of free space optical communication systems used for transmission of information.|
|60825-13||Safety of Laser Products – Part 13: Measurements for classification of laser products.|
|60825-14||Safety of Laser Products – Part 14: A user’s guide.|
|60825-15||Guidance to IEC Technical Committees for product manufacturing requirements for non-laser optical radiation safety.|
|60825-16||Proposed work. Safety of intense light source equipment – Guidelines for the safe use of intense light source equipment on humans and animals.|
|60825-17||Safety of laser products – Part 17: Safety aspects for use of passive optical components and optical cables in high power optical fibre communication systems|
Laser Safety Standards for Eyewear
In addition to these IEC standards and their equivalent BS EN 60825 documents, there are currently two standards for laser safety protective eyewear:
- BS EN 207: Specification for filters and equipment used for personal eye-protection against laser radiation.
- BS EN 208: Specification for personal eye protectors used for adjustment work on lasers and laser systems.
For most users it will be EN 207 standard that will be applicable to their use of lasers, with the EN 208 standard being applicable to only a much smaller group of more specialist laser technicians and engineers.
Laser Safety PPE (Eyewear)
An area of debate currently exists around the subject of PPE (personal protective equipment) as defined in the documents above, and when, if ever, it should or needs to be specified. This has arisen because some laser safety experts suggest that the correct risk control hierarchical approach should ensure that any PPE is a last resort, and that therefore other methods should be used to manage the hazards posed by lasers.
Laser and IPL Safety Eyewear Standard
A new standard is currently in draft form, for the eyewear to be worn by people undergoing laser and IPL treatments in clinics and hospitals. This laser and IPL safety eyewear is distinct from other types of eyewear in that the treatment head is likely at times to be very close to the patients eyes, and whilst the treatment specialist will need laser and IPL safety eyewear that also allows them sufficient transmission of visible wavelengths in order to be able to seewhat they are doing, this is not a prerequisite for the patient.
The new draft standard is BS 8497. This draft standard is in two parts, BS 8497-1 is the specification for the eyewear, whilst BS 8497-2 is the ‘code of practice’ which will detail accepted best practice. The draft standard is entitled “eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications”.
US ANSI Z136 Laser safety Standards
The US ANSI Z136 laser safety standard is now (since 2007) much closer to a full harmonisation with the international IEC 608255 laser safety standard. This is a much improved situation for all laser manufacturers and laser safety professionals, and although the CDRH 21 CFR requirements are still in some ways at odds with both the international and the ANSI standards, there is a work-around discussed below.
The ANSI Z136 standards comprise six parts as listed below:
ANSI Standard :
|American National Standard for Safe Use of Lasers|
|American National Standard for Safe Use of Optical Fiber Communications Systems Utilizing Laser Diode and LED Sources|
|American National Standard for Safe Use of Lasers in Health Care Facilities|
|Recommended Practice for Laser Safety Measurement for Hazard Evaluation|
|American National Standard for Safe Use of Lasers in Educational Institutions|
|American National Standard for Safe Use of Lasers Outdoors|
Of these the main, or core, standard is clearly Z136-1, but perhaps the most interesting standard is the Z136-6 standard that discusses flight zones and flight safety in the possible presence of visible laser light. This Z136-6 standard is of particular interest because there is not yet an equivalent European or international standard, and consequently this standard can be a useful guide, and has been referred to in legal cases where aircraft have been exposed to potentially dazzling laser light.
CDRH 21 CFR “Manufacturer’s Laser Standards” for the USA
The Code of Federal Regulations (CFR) title 21 is reserved for the Food and Drug Administration (FDA), and under this title 21 section J deals with Radiological Health, with part 1040 being the “Performance Standards for Light Emitting Products”. The relevant parts of this part 1040 are:
|Specific purpose laser products.|
|Sunlamp products and ultraviolet lamps intended for use in sunlamp products.|
|High-intensity mercury vapor discharge lamps.|
The regulations are reviewed and updated once a year, and it is hoped that the classification will be updated to the latest styles and classes as defined in the ANSI Z136.1 standard, rather than the older roman numeral classes currently included in this part 1040 of 21CFR.
US 21CFR Laser Accession Number
Before a laser or laser based product can be imported into the USA it must obtain a laser accession number. Lucid can help with the work required for this and can register the product and apply for the laser accession number, on behalf of clients, if required.
The laser accession number is a requirement in addition to ensuring the product meets applicable safety standards or guidelines, and issuing of an accession number does not signify approval of the safety of the product.
Laser Safety Consultancy Services
Lucid offer a wide range of laser safety services to assist clients in whatever ways they require in order to certify, improve or assess the safety of their products, labelling and user guides or instructions. Please contact us for a no obligation chat about your requirements and how we can help.
Laser Safety Training Courses
Lucid offer training courses in most aspects of laser safety – please see our laser safety training course page, but please contact us if we can help with training in a particular standard or area of laser safety.