Guidance for Industry and FDA 
Staff  
Radiation Safety Considerations 
for X-Ray Equipment Designed 
for Hand-Held Use  
 
 
Document issued on December 24, 2008  
 
 
For questions regarding this document contact CDR Sean Boyd at 301-796-5895.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug 
Administration 
Center for Devices and Radiological Health 
 Diagnostic Devices Branch 
Division of Mammography Quality and Radiation Programs 
Office of Communication, Education, and Radiation Programs  Contains Nonbinding Recommendations 
 
Preface 
 
 
Public Comment 
 
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.   
 
Additional Copies 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/ocer/guidance/1680.pdf.  You may also send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 
301-847-8149 to receive a hard copy.  Please use the document number (1680) to identify the 
guidance you are requesting. 
 
  Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff  
 
Radiation Safety Considerations for X-Ray 
Equipment Designed for Hand-Held Use  
 
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.  
 
 
Introduction 
 
The intent of this guidance is to advise manufacturers and FDA staff about safety procedures 
and recommendations that should be provided to the end user to promote safe use of hand-
held x-ray equipment.  In general, there are a number of regulations, consensus safety 
standards, and radiation protection guidelines governing the performance and use of 
diagnostic x-ray equipment. Diagnostic x-ray equipment manufactured for the US market 
must meet the performance requirements described in Title 21 of the Code of Federal 
Regulations, sections 1020.30 through 1020.33, which require manufacturers to provide 
users with operational and safety information as well as to meet standards for equipment 
performance.(1)  
 
Internationally, radiation safety standards are provided by the International Electrotechnical 
Commission (IEC) in its collateral standard 60601-1-3.(2)  Voluntary guidelines, particularly 
relevant to handheld equipment, have been provided by the National Council on Radiation 
Protection and Measurement (NCRP) for radiation protection in dentistry.(3) Many states 
regulate the use of x-ray equipment under their own regulations based on the Suggested State 
Regulations for the Control of Radiation, published by the Conference of Radiation Control 
Program Directors (CRCPD).(4)   
 
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 
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requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
The Least Burdensome Approach 
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 at http://www.fda.gov/cdrh/ombudsman/.  
 
1.  Issue 
There are two basic sources of potential x-ray exposure to operators that should be addressed 
during the use of hand-held diagnostic x-ray equipment: 
 
  Leakage radiation transmitted through the equipment housing and shielding that 
surrounds the source assembly 
  Backscatter radiation from the patient and nearby structures. 
 
2.  Guidance 
 
A primary consideration in any radiographic procedure is to reduce the dose to the patient as 
well as to the operator as much as possible while still achieving the diagnostic goals. This 
guidance briefly discusses the hazards unique to hand-held medical x-ray equipment, 
clarifies applicable requirements, and makes recommendations for safe use of the equipment. 
 
What are the exposure concerns with handheld x-ray systems? 
 
The federal performance standard for diagnostic x-ray systems and their major components 
did not anticipate hand-held x-ray systems at the time it was written. It therefore does not 
address system performance attributes or protective measures in light of the operators 
proximity to the source assembly and the patient. Because of such proximity, hand-held x-ray 
systems pose increased operator exposure concerns due to leakage radiation and backscatter 
radiation. The radiation exposure to the operator will be the sum of any radiation leaking 
from the x-ray tube source assembly (leakage radiation) and any radiation that scatters from 
the patient or any objects in the room that are in the x-ray field (backscattered radiation.) 
 
 
What limits are placed on leakage and backscatter radiation? 
 
  2 Contains Nonbinding Recommendations 
 
The applicable performance standard for a diagnostic source assembly, under 21 CFR 
1020.30(k), limits radiation leakage from the x-ray source assembly to an air kerma of 
0.88 mGy (corresponding to an exposure of 100 mR) in one hour at a distance of one meter 
from the x-ray source when measured as specified in the standard. 
 
How can leakage and backscatter radiation to the operator be 
reduced? 
 
  Shield the unit housing as required by the federal standard. 
Leakage radiation is of particular concern because the operator may be holding the x-ray 
source assembly.  Increasing the distance from the source may not be possible. Hand-held 
x-ray equipment must incorporate into its design physical means to protect the operator 
from leakage radiation with sufficient shielding surrounding the source assembly to 
ensure compliance with 21 CFR 1020.30(k). 
 
  Provide external shielding or a means to increase distance between the operator and 
the unit. 
To reduce operator exposure to backscatter radiation, manufacturers of hand-held x-ray 
equipment should incorporate physical means to provide operator shielding or allow 
operation of the unit at a distance. For example, an external, physical shield may be 
supplied with the equipment to be placed between the operator and the patient to 
attenuate backscatter radiation. Additionally, you may provide a means to initiate x-ray 
exposure using an equipment stand and remote switch from a distance to increase 
distance between the operator and the unit during exposure. 
 
Any product features designed into the equipment to protect the operator from radiation 
exposure should be described in user information with instructions for their proper use. 
 
  Measure typical exposures near and around the unit. 
Because operators will typically be closer than 1 m to the unit, exposure measurements at 
distances closer than those required by the Federal standard become important. 
Manufacturers of hand-held x-ray units should make and report exposure measurements 
at distances near the unit, especially representative of positioning where the operator will 
actually be in contact with or in close proximity to the unit during use. For example, 
exposures at the location of handgrips and control devices are of particular interest to the 
operator of the unit. 
 
These data may be used to estimate an operators whole-body or partial-body radiation 
dose for a single exposure or over an extended period of typical use. The data may be 
compared to occupational exposure limits to ensure limits are not exceeded and allow 
users to implement appropriate control measures based on an actual exposure assessment. 
 
  Identify necessary safety precautions as required by the Federal standard. 
Under 21 CFR 1020.30(h)(1)(i) manufacturers must provide adequate instructions 
concerning radiological safety procedures and precautions which may be necessary 
  3 Contains Nonbinding Recommendations 
 
because of unique features of the equipment. A unit that is hand-held constitutes a 
unique feature that requires manufacturers to describe any safety procedures and 
precautions necessary to reduce operator exposure. Safety precautions may include 
designating a significant zone of occupancy and providing exposure information near the 
unit as described in the IEC standard.(2) 
  
Information on exposure levels near and around a hand-held unit should be included with 
operator instructions to identify the unique exposure hazards posed by the equipment. 
Providing exposure information will support any manufacturers precautions and allow 
the operator to develop additional safe working practices to limit unnecessary exposure 
during equipment use. Precautions may include wearing appropriate personnel 
monitoring and protective equipment, such as a personnel exposure monitoring device or 
lead-lined gloves and gowns. Procedural controls may be recommended to limit the 
number of exposures initiated by a single operator over a period or time, or to limit use of 
the hand-held unit without an equipment stand or remote switch in such circumstances 
only as necessary. 
 
Manufacturers may also include information describing exposure hazards and radiation 
safety precautions appropriate for patients and other individuals present in the area 
during examination (e.g., a person holding a child or other personnel assisting with 
procedures). 
 
3.  Getting More Information 
 
For additional information on state requirements applicable to hand-held x-ray systems, refer 
to your states radiation control program regulations.  The CRCPD website has a list of 
contacts for each state (http://www.crcpd.org/links.asp).  Please contact your state officials 
on this subject.  Another resource to consider is the Suggested State Regulations for the 
Control of Radiation.  Some state programs do not allow the use of hand-held x-ray 
equipment.  
 
If you have any questions about this guidance, contact CDR Sean Boyd in the Division of 
Mammography Quality and Radiation Programs, Office of Communication, Education and 
Radiation Programs, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993 at 301-796-5895 or 
sean.boyd@fda.hhs.gov. 
 
 
 
 
4.  References 
 
1.  Code of Federal Regulations, Title 21 (Food and Drugs), Part 1020 (Performance 
Standards for Ionizing Radiation Emitting Products), Sections 1020.30-1020.33. 
  4 Contains Nonbinding Recommendations 
 
2.  International Standard IEC 60601-1-3, Medical electrical equipment  Part 1-3: 
General requirements for basic safety and essential performance  Collateral 
Standard: Radiation protection in diagnostic X-ray equipment, Edition 2.0, 
(International Electrotechnical Commission, Geneva, 2008). 
3.  Radiation Protection in Dentistry, NCRP Report no. 145, (National Council on 
Radiation Protection and Measurements, Bethesda, MD, 2003). 
4.  Suggested State Regulations for the Control of Radiation, 
http://www.crcpd.org/publications.asp#ssrcr,(Conference of Radiation Control 
Program Directors, 2008). 
 
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