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U.S. Department of Health and Human Services

Medical Devices

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Labeling Requirements for Radiation Emitting Devices and Products

Please note: If you are unsure if your product emits radiation, please refer to "Does Your Product Emit Radiation?"

Introduction

Labeling of radiation-emitting products applies to all products which emit sonic, infrasonic, or ultrasonic radiation as the result of operation of an electronic circuit. It thus applies to medical devices which emit sonic, infrasonic, or ultrasonic radiation as the result of operation of an electronic circuit in addition to the general labeling requirements for medical devices. Radiation-emitting devices include electronic products that emit radiation either by design (e.g., X-ray equipment) or as a consequence of operation (e.g., television set), but exclude products that emit radiation as a result of the decay of a radioactive element or isotope (e.g., an ionization type smoke detector). Section 358 of the Radiation Control for Health and Safety Act (RCHSA) of 1968 authorizes the development of Federal standards for these types of radiation producing products. These standards are contained within the regulations listed under 21 CFR Part 1000. The corresponding regulations are listed by product type in subsequent headings of this section. This booklet will cover only those portions of these standards related to product labeling and will not attempt to address technical specifications contained in the standards. Thus, the nature and placement of labeling may vary from those discussed under GENERAL DEVICE LABELING REQUIREMENTS; however, the concepts of "label" and "labeling" remain the same, e.g., the "label" of a device might consist of a warning label on the console of an X-ray system, as well as a red indicator light on the panel; the "label" of a television receiver might consist not only of the name of the manufacturer, date of manufacture, and user caution statements, but also of labels inside the receiver to high voltages and X-ray shielding.

At the present time, as a matter of choice and practicality, FDA does not choose to actively regulate some common household products such as radios and incandescent light bulbs; however, if such products were found to pose a consumer hazard, the FDA could choose to regulate them. A good example of a hazard to consumers is the cordless telephone. As a result of consumer complaints, and confirmed injuries due to the placement, volume, and frequencies of ringers in certain brands of telephones, FDA set and enforced guidelines to prevent hearing injuries.

This section will cover labeling of radiation-emitting medical and other electronic devices. Due to the amount of technical data contained in the corresponding sections of the CFR, reprints of the CFR sections pertaining to laser labeling will be used where appropriate to demonstrate format requirements. Numbers appearing in parentheses next to subject headings are the corresponding sections of 21 CFR.

General Labeling Requirements for Electronic Products

Manufacturers of electronic products covered under a radiation performance standard shall provide the following information on a tag or label permanently affixed or inscribed on the product. The following information should be accessible to view when the product is fully assembled:

  • A statement that the product complies with the applicable preformance standard.
  • The full name and address of the manufacturer of the product.
    • Alternately, the product contain the full name and address of a company or individual other than the manufacturer, provided that the full name and address of the actual manufacturer has been previously identified to the Director of the Center for Devices and Radiological Health (CDRH). (This alternative is necessary so that CDRH can identify manufacturers of particular models of devices in those instances where the listed distributor uses different manufacturers for each model.)
       
    • Abbreviations such as Co., Inc., or their foreign equivalents, and the initial of the first and middle names of individuals may be used.
       
  • The place and month and year of manufacture.
    • The place of manufacture may be expressed in a code if the code has been previously supplied to the Director of CDRH.
    • The month and year of manufacture cannot be coded or abbreviated. The month and a four digit number for the year must appear as follows:

"MANUFACTURED: (Insert Month and Year of Manufacture)"

In a case where it is not feasible to affix identification labeling in accordance with the above, the Director of CDRH may approve an application for an alternate means of identification.

The manufacturer of an EPRC product subject to a standard must furnish the Director of CDRH with a complete listing of all brand names and the names and addresses of the individuals or companies for which electronic products are manufactured under a standard.

Electronic products intended for United States Government use may be exempted from any performance standard upon application to the Director of CDRH by manufacturer, assembler, or a U.S. department or agency.

All products intended solely for export shall be labeled or tagged to show that they are intended for export.

The manufacturer of any electronic product covered by an exemption from performance standards (i.e., standards, other than labeling, which are not covered in this chapter) must permanently attach a tag or label stating:

"This electronic product has been exempted from the Food and Drug Administration radiation safety performance standards prescribed in the Code of Federal Regulations, Title 21, Chapter I, Subchapter J, pursuant to Exemption No.      , Granted on    /   /   ."

Ionizing Radiation Emitting Products

Television Receivers 21 CFR 1020.10

A television receiver is an electronic product designed to receive and display a television picture through broadcast, cable, or closed circuit television. Computer monitors which can display any graphical image are included in the standard; monitors limited by design to display only alpha-numeric characters are excluded.

  • Any receiver capable of producing radiation in excess of the standard through component failure or improper adjustment shall have a permanently affixed or inscribed warning label listing the high voltage specification and instructions for adjusting the high voltage to the specified value.

Cold-cathode Gas Discharge Tubes 21 CFR 1020.20

Cold-cathode discharge tubes are devices designed to demonstrate the effects of a flow of electrons or the production of X-rays.

  • Manufacturers shall provide applicable safety instructions, instructions for use, and power source specifications for each tube.
    • Each enclosure or tube shall have permanently affixed polarity identification of the terminals.
       
    • Tubes designed for heat, fluorescence, or magnetic effect must have a warning indicating that excess power application may result in x-radiation.
    • Tubes designed for x-radiation must bear a warning that the device produces X-rays when energized.
       
  • The required tags or labels must be visible when the device is fully assembled for use.

Diagnostic X-ray Systems 21 CFR 1020.30

Diagnostic X-ray systems incorporate one or more certified components. The components of a diagnostic X-ray system which require certification are listed in 21 CFR 1020.30(a). Both diagnostic X-ray systems and computed tomography (CT) X-ray systems manufactured before November 29, 1984 [prior to this date the CT requirements were general, but the components still had to be certified. After this date, there were specific CT performance requirements], are subject to the following requirements:

  • The control panel containing the main power switch shall have a statement reading:

    "WARNING: This X-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."

  • Temporarily installed compatible components must bear the following labeling:

    "Temporarily Installed Compatible Component. This certified component has been assembled, installed, adjusted, and tested by me according to the instructions provided by the manufacturer. Signature; Company Name; Street Address, City, State, Zip Code, and Date of Installation."

  • Temporarily installed noncompatible components must bear the following labeling: "Temporarily Installed Noncompatible Component. This certified component has been assembled or installed by me, but could not be assembled, installed, adjusted, and tested by me according to the instructions provided by the manufacturer because other already existing components of the system do not meet the compatibility specifications of the certified component being installed, and there are no commercially available certified components of a similar type that are compatible with the system. Signature, Company Name, Street Address, City, State, Zip Code, and Date of Installation." The noncompatibility only applies if the component was manufactured before August 1974. Otherwise, there should be combatible components on the market.

Radiographic Equipment 21 CFR 1020.31

  • When more than one X-ray tube is operated from a control, the indication of which tube is selected shall be on the control and at or near the THA prior to exposure.
  • If the device has the capability of overriding the positive beam limitation (PBL) in case of system failure, the override key or switch shall be labeled: FOR X-RAY FIELD LIMITATION SYSTEM FAILURE."
  • Prior to exposure the technique factors shall be indicated.
  • For fixed aperture, beam limiting devices, each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed, and when applicable which aperture is in position for use.
  • If the spot-film device has the capability of overriding the automatic X-ray field size adjustment in case of system failure, the override switch shall be labeled: "FOR X-RAY FIELD LIMITATION SYSTEM FAILURE."
  • Stationary general purpose systems shall have indication of field size dimensions and SID's of operation.
  • SGF systems shall indicate when the X-ray beam axis is perpendicular to the IR.

Fluoroscopic Equipment 21 CFR 1020.32

  • X-ray tube potential and current shall be continuously indicated.
  • If the device has the capability of overriding the automatic X-ray field size adjustment in case of system failure the override switch shall be labeled "FOR X-RAY FIELD LIMITATION SYSTEM FAILURE."

Cabinet X-ray Systems 21 CFR 1020.40

  • At least one indicator shall be visible from each door, access panel and port, and labeled: "X-RAY ON."
  • If a cabinet X-ray system is designed to admit humans, it must bear the following additional labeling:

     

    • Any controls which can be used to initiate X-ray generation must be labeled:

      'CAUTION: X-RAYS PRODUCED WHEN ENERGIZED'

    • Each port shall have a clearly visible label stating:

      "CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED - X-RAY HAZARD."

Microwave and Radio Frequency(RF)Emitting Products

Microwave and Radio Frequency(RF)Emitting Products 21 CFR 1030.10

A microwave oven is a device designed to heat, cook, or dry food thoroughly through the application of electromagnetic energy in the normal ISM heating bands ranging from 890 megahertz to 6,000 megahertz. The definition in the standard is limited to those manufactured for use in homes, restaurants, food vending, or service establishments, on interstate carriers, and in similar facilities.

Light Emitting Products

Lasers 21 CFR 1040.10

Lasers are devices capable of producing intense radiation at a specific wavelength both for medical and industrial purposes. In addition to the general labeling requirements for firm name, street address, state, and zip code, lasers require labeling specific to their type, class, wavelength, and power output. Due to the numerous combinations of labeling types dictated by class, wavelength, and power output, it would not be practical to cover each in specific detail in this booklet. Instead, use the following sample label types in conjunction with the following reprints of CFR sections to demonstrate specific labeling requirements.

Sunlamp Products and Ultraviolet Lamps 21 CFR 1040.20

An ultraviolet lamp is any lamp that produces ultraviolet radiation in the wavelength interval of 200 to 400 nanometers in air that is intended for use in any sunlamp product.

All labels are to be affixed or inscribed on an exterior surface that can be easily seen by the person being exposed immediately before use of the product.

Sunlamp Products

A sunlamp product is any electronic product designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning.

  • Each sunlamp product shall have label(s) with the warning statement: "DANGER-Ultraviolet radiation. Avoid overexposure. As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR; FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG TERM INJURY TO THE EYES. Medications or cosmetic may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from use of this product."

    In addition the label must also contain:

    • Recommended exposure positions;
       
    • Directions for achieving the recommended exposure positions;
       
    • A recommended exposure schedule;
    • A statement of the amount of time it may take for the expected results to appear;
       
    • A designation of the ultraviolet lamp type to be used in the product; and
       
    • Reproduction of the required labeling are to be prominently displayed at the beginning of the product instruction manual.
       

Ultraviolet Lamps

Labels for ultraviolent lamps require the following:

  • The words: "Sunlamp - DANGER - Ultraviolet radiation. Follow instructions;"
  • The model identification; and
  • The words: "Use ONLY in fixtures equipped with a timer."
Ultrasonic Radiation Emitting Products

Ultrasonic Therapy Products 21 CFR 1050.10

In addition to the general labeling requirements, ultrasonic therapy products are subject to the following additional labeling requirements:

  • Operation controls--identification of operator control functions;
  • Service controls--identification of the service control functions plus the statement "For Service adjustment only;"
  • Generators--generator labels shall state the brand name, model designation, and serial number or other unique identification; the generator for which the applicator is intended; and the ultrasonic frequency, effective radiating area, maximum beam non uniformity ratio, and type of applicator.
  • Manuals--user instruction or operator manuals shall contain:
    • assembly, operation, safe use, safety procedures and precautions, and a maintenance schedule;
       
    • description of the spatial distribution of the ultrasonic radiation field and the orientation of the field with respect to the applicator;
       
    • description of the uncertainties in magnitude of various parameters relative to the ultrasonic energy; and
       
    • a listing of controls, adjustments, and procedures for operation and maintenance including a warning: "Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy.

 

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