Why Laser Products FDA Registration?
Radiation emission products FDA certification:
The Radiation Control Regulations (originally promulgated in 1968 as the Health and Safety Radiation Control Act) are located in Articles 531 to 542 of the Act. They apply to any "electronic product," which is defined as any manufactured or assembled product (or component, part or accessory of such product) that, at runtime,
(I) contain or act as part of an electronic circuit,
(Ii) emit electronic product radiation (or in the absence of effective shielding or other controls).
What forms do I need to submit to the FDA Import Department to import my products into the United States?
Importers of radiant-emitting electronics that meet FDA performance standards must submit FDA 2877 "Radiation Control Standard Product Notices" and other written import declaration information to the appropriate FDA import office through CBP. Radiated electronic products that do not comply with applicable performance standards or with a certification label or label (21 CFR 1010.2) that is not affixed to each product shall be rejected. If your product meets performance standards, one way to indicate that you have reported your product to the FDA is to include the accession number on the FDA 2877 form.
Electronic Product Radiation is defined as:
(A) Any ionizing or non-ionizing electromagnetic or particulate radiation
(B) any sonic, infrasonic or ultrasonic sound emitted from the electronic product due to the operation of electronic circuitry in the product.
Examples of electronic products:
Medical: diagnostic X-ray or ultrasound imaging devices, microwave or ultrasound hyperthermia devices, microwave heaters or sterilizers, laser coagulators, phacoemulsifiers, X-ray or electron accelerators, fluorescent lamps,
Non-medical: Industrial RF Seals for Microwave Ovens, TV Receivers and Displays (Video Displays), Entertainment Lasers, Industrial X-Ray Systems, Cordless and Mobile Phones, Plastic and Laminate, Laser CD Players
Luminous product performance standards:
(1) The attainable emission level means the achievable laser or parallel radiation at a particular wavelength and emission duration of a particular wavelength as measured in accordance with paragraph (e) of this section. As described in (b) (12), (15) and (22) of this section, accessible laser or incidental radiation is radiation that is accessible to the human body.
(2) The achievable emission limits refer to the maximum achievable emission levels permitted by the particular ratings specified in paragraphs (c), (d) and (e) of this section.
(3) Aperture refers to any opening through which the laser or incident light passes through the protective enclosure or other enclosure through which the laser product is emitted, thereby allowing human access to such radiation.
(4) An aperture diaphragm means an opening that limits the size and determines the shape of the radiation measurement area.
(5) Class I laser products are laser radiation levels at which any laser product is not allowed to approach any attainable emission limit listed in Table I in paragraph (d) of this section during operation of any laser product. 1
(6) Class IIa laser products are any laser product that allows an operator to enter the level of visible laser radiation that exceeds the attainable emission limit specified in Table I, but does not allow personnel to approach laser radiation levels during operation. (D) in Table II-A. 2
(7) Class II laser products are any laser products that, during operation, allow persons to enter visible laser radiation levels above the achievable emission limits specified in Table II-A, but do not allow personnel to access the laser during operation Radiation levels exceed the emission limits listed in Table 2 of paragraph (d) of this section. 3
(8) Class IIIa laser products are any laser products that, during operation, allow personnel to enter visible laser radiation levels above the achievable emission limits listed in Table II, but do not allow personnel to approach laser radiation levels during operation of this section The achievable emission limits contained in Table III-A of paragraph d). 4
(9) Class IIIb laser products are any laser product that, during operation, allow personnel to enter the level of laser radiation that exceeds the achievable emission limits of Table III-A but does not allow personnel to approach laser radiation levels during operation. Section (d) Emission limits contained in Table III-B. Fives
(10) Class III laser products are any Class IIIa or Class IIIb laser products.
(11) Class IV laser products are any lasers that, during operation, allow persons to access laser radiation levels that exceed the radiation limits set forth in Table III-B of paragraph (d) of this section. 6
(12) Incidental radiation means any radiation (S) of the electronic product other than laser radiation emitted by the laser product due to any part of the laser product necessary for the operation of the laser or the operation of the laser.
(13) Demo Laser Products means any laser products manufactured, designed, used or promoted for demonstration, entertainment, advertising display or artwork. The term "demo laser product" does not apply to laser products that have not been manufactured, designed, scheduled or promoted for this purpose, even though these laser products may be used for these purposes or for demonstration of other applications.
(14) Emission duration refers to the duration of a pulse in seconds, a series of pulses, or continuous operations during which people are allowed access to the laser or to the laser radiation in parallel for operational, maintenance or service reasons .
(15) Human body access refers to the ability of any part of the body to intercept a laser or to radiate in parallel. For laser products containing IIIb or IV laser radiation, "human body access" also means that laser radiation can be used and laser radiation can be reflected directly to any open product of the protective housing of the laser radiation by any single introduced flat surface inside the product .
(16) An integrated radiation refers to the radiant energy per unit area per unit of solid emission angle of a radiating surface expressed in Joules per Joule (Jcm-2 sr-1) per cubic centimeter.
(17) Invisible radiation refers to laser or parallel radiation having a wavelength equal to or greater than 180 nm but less than or equal to 400 nm or more but less than or equal to 1.0 × 10 6 nm (1 mm).
(18) Irradiance is the time average radiant power incident on a surface element divided by the area of the element, expressed in watts per square centimeter (Wcm-2).
(19) Laser means any device capable of making or amplifying electromagnetic radiation having a wavelength greater than 250 nanometers but less than or equal to 13,000 nanometers, or a device equal to or greater than 180 nanometers but less than primarily controlled stimulated emission after 20 August 1986 Process, greater than or equal to 1.0 × 10 6 nm.
(20) Laser energy means any device intended for use with a laser to provide laser operating energy. General energy such as power or batteries should not be considered as constituting the laser energy.
(21) A laser product is any collection of components that make up or incorporate, or intend to incorporate, a laser or laser system. A laser or laser system intended for use as a component of an electronic product should itself be considered as a laser product.
(22) Laser radiation refers to all electromagnetic radiation emitted by a laser product in the spectral range specified in paragraph (b) (19) of this section resulting from controlled stimulated emission or through a suitable aperture stop, And within the appropriate acceptance angle specified in paragraph (e) of this section.
(23) A laser system refers to the combination of a laser with an appropriate laser energy source, with or without additional components. See section (c) (2) of this section for an explanation of "Removable Laser Systems".
(24) Maintenance refers to those adjustments or procedures specified in the user information provided by the manufacturer, which the user uses to ensure the intended performance of the product. It does not include the operations or services defined in (b) (27) and (38) of this section.
(25) The maximum output shall mean the maximum radiated power as determined in accordance with paragraph (e) of this Article and, where applicable, the maximum radiant energy of the laser radiation accessible to each pulse emitted by the laser product during operation.
(26) A medical laser product means a laser product of any medical device as defined in 21 USC 321 (h) for the purpose of making, designing, anticipating or promoting in vivo laser irradiation for use in any part of the human body: (i) diagnosis, Surgery or treatment; or (ii) the relative positioning of the human body.
(27) Operation means the performance of the laser product over the full functional range. It does not include the maintenance or service as defined in (b) (24) and (38) of this section.
(28) Protective enclosure means the portion of the laser product used to prevent exposure of the body to laser or satellite radiation in excess of the specified attainable emission limit under the conditions specified in this section and 1040.11.
(29) Pulse duration refers to the time increment measured between the half-peak power points at the leading and trailing edges of the pulse.
(30) Radiance refers to the time-averaged radiant power per unit area of the radiating surface per unit of solid emission angle in watts per square centimeter per square meter (W cm-2 sr-1).
(31) Radiation energy refers to the energy in the form of radiation emitted, transferred or received in joules (J).
(32) Radiation exposure refers to the amount of radiant energy incident on the area of an element divided by the area of the element, expressed in Joules per square centimeter (Jcm-2)
(33) Radiated power refers to the time average power in watts (W) that is emitted, transferred or received as radiation.
(34) Remote Interlock Connectors are electrical connectors that allow external remote interlocking.
(35) Safety interlock means a device associated with the protective enclosure of a laser product to prevent human exposure to excessive radiation as defined in paragraph (f) (2) of this section.
(36) Sampling interval is the time interval over which a sample of accessible laser or incidental radiation is sampled by the measurement process. The size of the sampling interval in seconds is indicated by the symbol (t).
Laser radiation scanned by (37) refers to laser radiation having a time-varying direction, origin or propagation mode relative to a stationary frame of reference.
(38) Service is the execution of procedures or adjustments described in the manufacturer's service manual that could affect any aspect of the performance of this section and the applicable requirements of 1040.11. It does not include the maintenance or operation as defined in (b) (24) and (27) of this section.
(39) Measuring, Leveling or Calibrating a Laser Product means a laser product that is manufactured, designed, used or promoted for one or more of the following uses:
(I) Determine and characterize the form, extent, or location of a point, body, or area through angle measurements.
(B) parts that locate or adjust the proper relationship with each other.
(Iii) determine the plane, level, elevation or straight line.
(40) Visible radiation refers to a laser or parallel radiation having a wavelength greater than 400 nm but less than or equal to 710 nm.
(41) Warning signs refer to the signs shown in Figure 1 or Figure 2 of paragraph (g) of this section.
(42) Wavelength is the propagation wavelength of electromagnetic radiation in the air.
Highly concentrated laser beams can cause damage to the human body, such as the eyes or skin. Therefore, the International Electrotechnical Commission IEC (International Electrotechnical Commission) and the Food and Drug Administration FDA (Food and Drug Administration) on the safety of laser equipment, according to the size of the laser output value has been classified.
Regular production of laser equipment, the safety level should be marked according to FDA or IEC standards.
IEC standard laser equipment is divided into five levels, respectively, called Class1, Class2, Class3A, Class3B, Class4. Class 1 laser equipment, for example, is a safety device under "foreseeable working conditions," while Class 4 laser equipment is a device that can produce harmful, diffuse reflections that can cause skin burns or even fire Be especially careful.
Laser safety level is generally divided into 4 levels.
Class Ⅰ: low output laser (power less than 0.4mW). The basic will not be harmful to the eyes, you can ensure the design of the safety, without special management.
Class II: Low-output visible laser (power 0.4mW-1mW), usually less than 1mW laser can cause dizziness can not think, with closed eyes to protect the general to eliminate the symptoms. Do not observe directly in the beam, do not use less than 1mw laser direct exposure to other people's eyes, to avoid the use of Yuan Yuan equipment observed Class Ⅱ laser.
Class Ⅲ Ⅲ A and Ⅲ B level:
ClassⅢA level of continuous laser for visible light, the output of 1-5mW laser beam, to avoid the use of Yuan Yuan equipment I laser, which may increase the risk, as Class Ⅱ, do not directly
Observation in the beam, do not use Class Ⅲ A laser direct exposure to other people's eyes.
ClassⅢB level 5-500mW continuous laser, directly in the beam observation is dangerous, do not use Class Ⅲ B laser direct exposure to other people's eyes, so the danger will be even greater. Class Ⅳ level for the high output continuous laser (greater than 500mW), higher than the third level, there is a danger of fire, diffuse reflection is also dangerous, of particular note. Children should avoid direct viewing of such lasers.
Summary: Class Ⅱ, Class Ⅲ A, Class Ⅲ B, Class Ⅳ level of products have some harmful effects, please use under the guidance and supervision, children should pay more attention, please guardianship under the guardianship or other use.
Laser FDA certification need to provide the following information:
1. Application Form,
2. English manual,
3. Circuit diagram,
5 parts list,
6. Specifications or JAQ reports, including laser wavelength range,
7. Laser path map,
8. Tag electronic file,
Quality assurance aspects of the test flow chart; production, installation flow chart, never expected to warehousing the entire process,