Iec 60825-1 Latest Version
Carin Mita
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Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
You may obtain additional copies by sending an e-mail request to CDRH-G...@fda.hhs.gov to receive an electronic copy of the guidance. Please use the document number (1346) to identify the guidance you are requesting.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
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.
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.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
We believe we should consider the least burdensome approach in all areas of medical device and electronic product regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet.
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 effectiveness of this guidance will end on the effective date(s) of any amendments to the Federal regulations applicable to laser products under Chapter 1, Subchapter J of Title 21 of the Code of Federal Regulations.
IEC 60825-1:2014 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. A laser product may consist of a single laser with or without a separate power supply or may incorporate one or more lasers in a complex optical, electrical, or mechanical system. Typically, laser products are used for demonstration of physical and optical phenomena, materials processing, data reading and storage, transmission and display of information, etc. Such systems have found use in industry, business, entertainment, research, education, medicine and consumer products. Laser products that are sold to other manufacturers for use as components of any system for subsequent sale are not subject to IEC 60825-1, since the final product will itself be subject to this standard. Laser products that are sold by or for manufacturers of end products for use as repair parts for the end products are also not subject to IEC 60825-1. However, if the laser system within the laser product is operable when removed from the end product, the requirements of this Part 1 apply to the removable laser system.
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IEC 60825-1 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm.
A laser product may consist of a single laser with or without a separate power supply or may incorporate one or more lasers in a complex optical, electrical, or mechanical system. Typically, laser products are used for demonstration of physical and optical phenomena, materials processing, data reading and storage, transmission and display of information, etc.
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Next week I have to assemble and demonstrate my project in my local school. My project includes the VL53L5CX-Satel. Does the VL53L5CX compliant with the DIN EN ? Can you provide me a compliance report wich include all the measured limits of the VL53L5CX to remain within the IEC 60825-1:2007 and IEC 60825-1:2014 norm?
I checked the chapter already. The VL53L5CX will measure some Human gesture, so the sensor is interacting with Humans. This project takes place in germany, so there is a DIN or EN norm which classify laser sensors. The problem is the VL53L5CX is IEC classified will this be a problem?
In the U.S., when you start mass production you will file a document with the FDA. In that document, you will reference ST's Accession number. Our Accession number is all the testing you need. (Keep in mind that it's invalid if you focus the optics in any way.)
Unfortunaly the local government of radiation safty has mentioned that the norm have to be compliant with the up to date technology, but the VL53L5CX-Satel-Sensor is only IEC 60825-1 of the year 2014 compliant, Also the Sensor has to be in compliant with the EN norm for the "Presumption of conformity". Otherwise I cant put into operation in the school.
As mentioned the local government of radiation safty is confused about the IEC 60825-1 of the year 2007 and 2014. They said there have to be only one up to date norm at the time where the VL53L5CX was developed. They have not told me the current standard. The problem is that the VL53L5CX has no EN certification for the european market.
IEC 60825-1 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm.A laser product may consist of a single laser with or without a separate power supply or may incorporate one or more lasers in a complex optical, electrical, or mechanical system. Typically, laser products are used for demonstration of physical and optical phenomena, materials processing, data reading and storage, transmission and display of information, etc. Such systems have found use in industry, business, entertainment, research, education, medicine and consumer products.Laser products that are sold to other manufacturers for use as components of any system for subsequent sale are not subject to IEC 60825-1, since the final product will itself be subject to this standard. However, if the laser system within the laser product is operable when removed from the equipment, the requirements of this Part 1 apply to the removable unit.Any laser product is exempt from all further requirements of this Part 1 if classification by the manufacturer of that product according to Clauses 3, 8 and 9 shows that the emission level does not exceed the AEL (accessible emission limit) of Class 1 under all conditions of operation, maintenance, service and failure.In addition to the hazards resulting from laser radiation, laser equipment may also give rise to other hazards such as fire and electric shock.This Part 1 describes the minimum requirements. Compliance with this Part 1 may not be sufficient to achieve the required level of product safety. Laser products must conform to the applicable performance and testing requirements of the applicable product safety standards.Where a laser system forms a part of equipment which is subject to another IEC product safety standard (e.g. for medical equipment (IEC 60601-2-22), IT equipment (IEC 60950), audio and video equipment (IEC 60065), equipment for use in hazardous atmospheres (IEC 60079), or electric toys (IEC 62115)), this Part 1 will apply in accordance with the provisions of IEC Guide 104 ) for hazards resulting from laser radiation. If no product safety standard is applicable, then IEC 61010-1 applies.In previous editions, LEDs were included in the scope of IEC 60825-1, and they may be still included in other parts of the IEC 60825 series. However, with the development of lamp safety standards, optical radiation safety of LEDs in general can be more appropriately addressed by lamp safety standards. The removal of LEDs from the scope of this Part 1 does not preclude other standards from including LEDs whenever they refer to lasers. CIE S009 may be applied to determine the risk group class of an LED or product incorporating one or more LEDs.The MPE (maximum permissible exposure) values of this Part 1 were developed for laser radiation and do not apply to collateral radiation. However, if a concern exists that accessible collateral radiation might be hazardous, the laser MPE values may be applied to conservatively evaluate this potential hazard.The MPE values are not applicable to intentional human exposure to laser radiation for the purpose of medical or cosmetic/aesthetic treatment.The objectives of this part of IEC 60825 are the following:- to introduce a system of classification of lasers and laser products according to their degree of optical radiation hazard in order to aid hazard evaluation and to aid the determination of user control measures;- to establish requirements for the manufacturer to supply information so that proper precautions can be adopted;- to ensure, through labels and instructions, adequate warning to individuals of hazards associated with accessible radiation from laser products;- to reduce the possibility of injury by minimizing unnecessary accessible radiation and to give improved control of the laser radiation hazards through protective features.This second edition of IEC 60825-1 cancels and replaces the first edition published in 1993, its Amendment 1 (1997) and its Amendment 2 (2001). It constitutes a technical revision. The user's guide has been removed from this part of the IEC 60825 series and is now a separate document (Part 14). Light emitting diodes (LEDs) have been removed from the scope of this part of IEC 60825, but may still be included in other parts.This part of IEC 60825 has the status of a Group Safety Publication, in accordance with IEC Guide 104, for aspects of laser radiation pertaining to human safety.The contents of the corrigendum of August 2008 and the interpretation sheet 1 of December 2009 have been included in this copy.
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