Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Medical X-Ray Imaging Devices
Conformance with IEC Standards
Guidance for Industry and Food and
Drug Administration Staff
Document issued on February 21, 2023.
Document originally issued on May 8, 2019
For questions regarding this document contact Office of Health Technology 8 (OHT8): Office of
Radiological Health at RadHealth@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2016-D-2049. 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. You may also send an e-mail request to
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document
number GUI01400014 and complete title of the guidance in the request.

Contains Nonbinding Recommendations
Table of Contents
I. Introduction .............................................................................................................................. 1
II. Background .............................................................................................................................. 2
A. Device Regulations ............................................................................................................. 2
B. EPRC Regulations .............................................................................................................. 3
C. Avoidance of Duplication ................................................................................................... 4
III. Scope ........................................................................................................................................ 4
A. Devices Addressed in the Guidance ................................................................................... 4
B. Standards Addressed in the Guidance................................................................................. 6
IV. Policy........................................................................................................................................ 6
A. Electronic Products - Performance Standards..................................................................... 7
B. Medical Devices – 510(k) Clearance .................................................................................. 8
V. Submission of Declarations of Conformity.............................................................................. 9
VI. Certification .............................................................................................................................. 9
VII. Information to be Provided to Assemblers and Others .......................................................... 10
VIII. Compliance and Enforcement ........................................................................................... 11
Appendix A: Applicability of IEC Standards to Specific Device Types ...................................... 13

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Medical X-Ray Imaging Devices
Conformance with IEC Standards
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA
or Agency) on this topic. It does not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it satisfies the requirements
of the applicable statutes and regulations. To discuss an alternative approach, contact the
FDA staff responsible for this guidance as listed on the title page.
I. Introduction
This guidance describes FDA’s policy regarding the regulation of medical x-ray imaging
equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA’s
regulations that apply to medical devices and electronic products. In this guidance, FDA is
seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C
(Electronic Product Radiation Control (EPRC)) of the FD&C Act with International
Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure more
efficient and consistent regulatory review of submissions for these products. The guidance also
provides recommendations to industry on how to comply with the applicable requirements. FDA
has determined that industry conformance to certain IEC standards would provide, at a
minimum, the same level of protection of the public health and safety from electronic radiation
as certain EPRC regulatory standards.
Manufacturers and importers of medical x-ray imaging equipment must follow the current EPRC
regulations and procedures or provide a declaration of conformity to equivalent IEC standards, as
outlined in this guidance, to fulfill the requirements of the EPRC regulation. Using a declaration
of conformity to equivalent IEC standards reduces duplication of efforts by manufacturers and
allows FDA to provide more efficient and consistent regulatory reviews of submissions relating
to medical x-ray imaging devices.
For the current edition of the FDA-recognized consensus standard(s) referenced in this
document, see the FDA Recognized Consensus Standards Database.1 For more information
regarding use of consensus standards in regulatory submissions, please refer to FDA guidance
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

2
titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for
Medical Devices.”2
In general, FDA's guidance documents 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 guidance means that something is suggested or recommended, but
not required.
II. Background
Medical x-ray imaging equipment may fall under the definition of both a medical device, under
section 201(h) of the FD&C Act, and an electronic product, under section 531(2) of the FD&C
Act. As such, these devices may be subject to the provisions of the FD&C Act and FDA’s
regulations3 that apply to medical devices4 and electronic products.5
While the legal authorities relating to medical devices and electronic products focus primarily on
safety/effectiveness and radiation safety, respectively, there is some overlap in the requirements
established by these authorities. FDA is issuing this guidance to clarify the relevant applicable
standards and to help to ensure an efficient and consistent regulatory review of submissions for
these devices. This guidance describes current Agency thinking in the following areas:
1) Product conformance to IEC standards; and
2) Compliance with EPRC performance standards.
A. Device Regulations
FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their
risks and the regulatory controls necessary to provide a reasonable assurance of safety and
effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class
III devices pose the highest risk.
· For Class I devices, manufacturers generally must comply with general controls
authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration),
516 (banned devices), 518 (notification and other remedies), 519 (records and reports),
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices
3 The regulations specific to medical devices and electronic products are found in 21 CFR Chapter I Subchapter H
and Subchapter J, respectively.
4 For additional information regarding medical device regulation, see https://www.fda.gov/medical-devices/device-
advice-comprehensive-regulatory-assistance/overview-device-regulation
5 For additional information regarding electronic product regulation, see https://www.fda.gov/radiation-emitting-
products/electronic-product-radiation-control-program/getting-radiation-emitting-product-market-frequently-asked-
questions

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and 520 (general provisions) of the FD&C Act (see 21 CFR 860.3(c)(1)). The following
regulations set forth requirements related to these general controls:
o 21 CFR 801: Labeling;
o 21 CFR 803: Medical Device Reporting;
o 21 CFR 807: Establishment Registration and Device Listing for Manufacturers and
Initial Importers of Devices; and
o 21 CFR 820: Quality System Regulation.
Most Class I devices can be legally marketed without FDA clearance of a 510(k)
submission.
· For Class II devices, manufacturers must comply with general controls and applicable
special controls and are subject to premarket notification (510(k)) requirements prior to
marketing, unless otherwise exempted (21 CFR 860.3(c)(2)).6
· For Class III devices, manufacturers must comply with general controls and generally
must receive FDA approval of a premarket approval application (PMA) that demonstrates
the safety and effectiveness of the device prior to marketing (21 CFR 860.3(c)(3)).
B. EPRC Regulations
The EPRC regulations are aimed at protecting the public from hazardous and unnecessary
exposure to radiation from electronic products. By regulation, FDA identified types of electronic
products,7 including diagnostic x-ray systems and their major components, and established
product performance standards for those products to control radiation.
Manufacturers and importers of x-ray imaging devices must comply with applicable
requirements, including, but not limited to:
· 21 CFR 1002.20: Reporting of accidental radiation occurrences
· 21 CFR 1002.30: Records to be maintained by manufacturers
· 21 CFR 1002.40: Records to be obtained by dealers and distributors
· 21 CFR Part 1003: Notification of defects or failure to comply
· 21 CFR Part 1004: Repurchase, repairs, or replacement of electronic products
· 21 CFR 1010.2: Certification
· 21 CFR 1020.30: Diagnostic x-ray systems and their major components
· 21 CFR 1020.31: Radiographic equipment
6 Certain radiologic devices were exempt from 510(k) submissions under section 510(m)(1)(A) of the FD&C Act in
82 FR 31976, subject to the limitations in 21 CFR 892.9.
7 These types include: Television receivers (21 CFR 1020.10); Cold-cathode gas discharge tubes (21 CFR 1020.20);
Diagnostic x-ray systems and their major components (21 CFR 1020.30); Cabinet x-ray systems (21 CFR 1020.40);
Microwave ovens (21 CFR 1030); Laser products (21 CFR 1040.10); Sunlamp products and ultraviolet lamps
intended for use in sunlamp products (21 CFR 1040.20); High-intensity mercury vapor discharge lamps (21 CFR
1040.30).

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· 21 CFR 1020.32: Fluoroscopic equipment8
· 21 CFR 1020.33: Computed tomography (CT) equipment
C. Avoidance of Duplication
Industry has previously raised concerns about overlapping requirements in the medical device
and EPRC regulations for products that are both medical devices and electronic products. The
Agency has addressed this overlap through guidance and amendments to the EPRC regulations:
1. Laser Products (see “Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-
22; Laser Notice No. 50,”9 and “Laser Products - Conformance with IEC 60825-1 Ed. 3
and IEC 60601-2-22 Ed. 3.1; Laser Notice No. 56”10), and
2. Radiological Health Regulations; Amendments to Records and Reports for Radiation
Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-
ray, Laser and Ultrasonic Products.11
III. Scope
A. Devices Addressed in the Guidance
This guidance addresses diagnostic x-ray imaging systems and their major components (see 21
CFR 1002.1 and 21 CFR 1020.30(a)(1)). Most diagnostic x-ray imaging systems and their major
components are classified as Class I or II devices. Tables 1 and 2 include the regulations and
product codes for these devices.
8 For additional information on complying with EPRC performance standards for fluoroscopic equipment, see the
guidance titled “Policy Clarification for Certain Fluoroscopic Equipment Requirements” at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-clarification-certain-
fluoroscopic-equipment-requirements
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laser-products-
conformance-iec-60825-1-and-iec-60601-2-22-laser-notice-no-50
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laser-products-
conformance-iec-60825-1-ed-3-and-iec-60601-2-22-ed-31-laser-notice-no-56
11 88 FR 3638 available at https://www.federalregister.gov/documents/2023/01/20/2023-00922/radiological-health-
regulations-amendments-to-records-and-reports-for-radiation-emitting-electronic

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Table 1 – Class II devices that are covered by this guidance
Regulation
Number
Regulation Description Associated Applicable
Product Codes
21 CFR 872.1800 Extraoral source x-ray system EHD, MUH
21 CFR 872.1810 Intraoral source x-ray system EAP
21 CFR 892.1170 Bone densitometer KGI
21 CFR 892.1600 Angiographic x-ray system IZI
21 CFR 892.1610 Diagnostic x-ray beam limiting-device KPW, IZW, IZX
21 CFR 892.1630 Electrostatic x-ray imaging system IXK
21 CFR 892.1650 Image-intensified fluoroscopic x-ray system JAA, OWB, OXO, RCC
21 CFR 892.1660 Non-image-intensified fluoroscopic x-ray system JAB
21 CFR 892.1670 Spot-film device IXL
21 CFR 892.1680 Stationary x-ray system KPR, MQB, MWP
21 CFR 892.1710 Mammographic x-ray system IZH
21 CFR 892.1715 Full-field digital mammography system MUE
21 CFR 892.1720 Mobile x-ray system IZL
21 CFR 892.1730 Photofluorographic x-ray system IZG
21 CFR 892.1740 Tomographic x-ray system IZF
21 CFR 892.1750 Computed tomography x-ray system JAK, OAS
21 CFR 892.1860 Radiographic film/cassette changer KPX
21 CFR 892.1980 Radiologic table KXJ, IXQ, IXR, IZZ
Table 2 – Class I devices that are covered by this guidance
Regulation Number Regulation Description Associated Product
Codes
21 CFR 892.1700 Diagnostic x-ray high voltage generator IZO
21 CFR 892.1760 Diagnostic x-ray tube housing assembly ITY
21 CFR 892.1830 Radiologic patient cradle KXH
21 CFR 892.1880 Wall-mounted radiographic cassette holder IXY
Some imaging devices are hybrids; that is, they are combinations of more than one imaging
component (e.g., Positron Emission Tomography (PET) and Computed Tomography (CT)). In
the situation where one of the components has an applicable EPRC standard, the policy
described in this guidance applies to that component.
This guidance does not address radiation therapy products because there are no EPRC
performance standards promulgated for these products. These devices are cleared for market
through the 510(k) process.12
12 For a list of recognized consensus standards applicable to radiation therapy products, see FDA’s product
classification database at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
Classification regulations for radiologic therapeutic devices can be found in 21 CFR 892 subpart F.

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B. Standards Addressed in the Guidance
To avoid duplication and provide an efficient and consistent regulatory review of submissions
relating to medical x-ray imaging devices, this guidance clarifies the relevant applicable
voluntary consensus standards for medical x-ray systems and components. FDA has recognized
the following IEC standards that apply to one or more of the devices covered by this guidance
(see Appendix A):
· 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;
· IEC 60601-2-28 Medical electrical equipment - Part 2-28: Particular requirements for
the basic safety and essential performance of X-ray tube assemblies for medical
diagnosis;
· IEC 60601-2-43 Medical electrical equipment – Part 2-43: Particular requirements for
the safety and essential performance of X-ray equipment for interventional procedures;
· IEC 60601-2-44 Medical electrical equipment – Part 2-44: Particular requirements for
the basic safety and essential performance of X-ray equipment for computed tomography;
· IEC 60601-2-45 Medical electrical equipment – Part 2-45: Particular requirements for
the basic safety and essential performance of mammographic X-ray equipment and
mammographic stereotactic devices;
· IEC 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for
the basic safety and essential performance of X-ray equipment for radiography and
radioscopy;
· IEC 60601-2-63 Medical electrical equipment – Part 2-63: Particular requirements for
the basic safety and essential performance of dental extra-oral X-ray equipment; and
· IEC 60601-2-65 Medical electrical equipment – Part 2-65: Particular requirements for
the basic safety and essential performance of dental intra-oral X-ray equipment.
IV. Policy
FDA has determined that conformance to certain IEC standards would provide, at a minimum,
the same level of protection of the public health and safety from electronic radiation as certain
EPRC performance standards. FDA recommends that manufacturers elect to conform to a
recognized and applicable IEC standard to meet certain requirements of the performance
standards outlined in Table 3, below. Conformance must be to a version, including corrigenda
and amendments, of the applicable IEC standards that is recognized by FDA at the time

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conformance is declared.13 For more information regarding transition periods associated with the
recognition of newer versions of consensus standards, see “Appropriate Use of Voluntary
Consensus Standards in Premarket Submissions for Medical Devices.”14
A. Electronic Products - Performance Standards
The IEC standards described in section 3b of this guidance (see Appendix A for additional
details) are applicable to many parts of the performance standards for diagnostic x-ray systems
(see Table 3) established under section 534 of the FD&C Act.
FDA has determined that conformance to the identified IEC standards would provide, at a
minimum, the same level of protection of the public health and safety from electronic product
radiation as the requirements in 21 CFR 1020.30 (in part), 1020.31, 1020.32 (in part), and
1020.33 (in part) (see Table 3). Therefore, a manufacturer or importer that has submitted a
declaration of conformity to the applicable IEC standards through the process discussed in
sections 5 and 6 of this guidance would be deemed to have met certain performance standard
requirements in 21 CFR 1020.30, 1020.31, 1020.32, and 1020.33, assuming the criteria in
section 514(c) of the FD&C Act are satisfied.
Table 3 – EPRC requirements deemed to be met based on conformity to applicable IEC
standard(s)
21 CFR 1020.30(c),
(h), (k), (l), (m), (n),
(o)
Diagnostic x-ray systems and their major components
21 CFR 1020.31 Radiographic equipment
21 CFR 1020.32(a),
(b), (c), (d)(1), (d)(2),
(d)(3)(i) – (iv), (d)(4),
(f), (h), (i), (j), (k)
Fluoroscopic equipment
21 CFR 1020.33(a),
(b). (c), (f), (g), (h), (i),
(j)
Computed tomography (CT) equipment
Some sections of the electronic product regulations are not adequately addressed or are outside
the scope of the IEC standards identified in section 3b of this guidance (see Appendix A). For
these parts of the electronic product regulations, FDA has determined that there is no applicable
portion of the IEC standards that can be used to meet the requirements. Consequently,
manufacturers, importers, and their devices would not be deemed to have met the requirements
identified in Table 4 below solely based on conformance with the identified IEC standards.
13 Section 514(c)(1)(B) of the FD&C Act.
14 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices

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Table 4 – EPRC requirements that would not be deemed to be met based solely on
conformity to IEC standards
21 CFR 1002 Subparts
A, C, D, E, F
Records and Reports
21 CFR 1010.3 Identification
21 CFR 1010.4 Variances (from EPRC requirements only)
21 CFR 1020.30(a) Applicability
21 CFR 1020.30(b) Definitions (see note immediately below this table)
21 CFR 1020.30(d) Assemblers’ responsibility
21 CFR 1020.30(e) Identification of x-ray components
21 CFR 1020.30(g) Information provided to assemblers
21 CFR 1020.30(j) Warning label
21 CFR 1020.30(q) Modification of certified components
21 CFR 1020.32(d)(3)(v) Lateral plane patient entrance point
21 CFR 1020.32(g) Source-skin distance
21 CFR 1020.33(d) Quality assurance
Note: The FDA medical device regulations and IEC use different definitions of extra-oral and
intra-oral x-ray systems. IEC standards 60601-2-63 and 60601-2-65 use the location of the image
receptor to determine whether the device is an extra-oral device or an intra-oral device. FDA
uses the location of the x-ray source to make the distinction (21 CFR 872.1800 and 21 CFR
872.1810). This difference in definitions means that some devices classified as an “Extra-oral
source x-ray system” under 21 CFR 872.1800 will be defined as an intra-oral x-ray system by the
IEC. In these cases, the applicable IEC standard is 60601-2-65 (for intraoral x-ray systems), and
manufacturers who choose to conform to IEC standards should submit a declaration of
conformity to IEC 60601-2-65.
B. Medical Devices – 510(k) Clearance
To obtain 510(k) clearance, manufacturers must establish the substantial equivalence of their
new device to a legally marketed predicate that does not require a premarket approval application
(PMA). This is done by showing their new device has the same intended use, and technological
characteristics that either: are the same, or; are different, but the differences do not raise different
questions of safety and effectiveness than the predicate (see section 513(i) of the FD&C Act).
Conformance with recognized consensus standards may in some situations support a substantial
equivalence determination (see guidance entitled “Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices”).15 Moreover, declaration(s) of
conformity to recognized consensus standard(s) could be sufficient to eliminate the need for
manufacturers to submit in their 510(k) (and for FDA to review) the complete testing reports for
those aspects of the device addressed by the standards. While there are few mandatory FDA
standards that apply to medical devices, there are numerous national and international voluntary
15 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices

9
consensus standards that the Agency has reviewed and recognized.16 A discussion of the
substantial equivalence review process is found in the guidance entitled “The 510(k) Program:
Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”17
V. Submission of Declarations of Conformity
If manufacturers and importers elect to conform to a recognized and applicable IEC standard to
meet the applicable requirements of an EPRC performance standard, they must complete a
declaration of conformity that certifies that the device is in conformity with the standard (see
section 514(c)(1)(B) of the FD&C Act) and include the declaration as part of a premarket
submission, as applicable to the device type. If a premarket submission is not required for that
device type, then the declaration should be kept as part of the manufacturer’s records.
Information on such declarations is available in the guidance entitled “Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”18
VI. Certification
Manufacturers of diagnostic x-ray systems, and their major components, for which an applicable
EPRC performance standard is in effect, including those that conform to applicable IEC
standards to meet EPRC performance standards, must provide certifications for their products
(see 21 CFR 1010.2(a)). To properly certify their product, manufacturers must furnish product
certifications to dealers or distributors, at the time of delivery, that the product conforms to the
IEC standards that are declared in the associated declaration of conformity and any other
standards in Chapter J (Radiological Health) of Title 21 of the CFR (such as parts of 21 CFR
1020.30) (see 21 CFR 1010.2(a)).
The certification must be provided on a label or tag permanently affixed to or inscribed on a
product, including major components for which there is an applicable EPRC performance, so as
to be legible, readily accessible to view when the product is fully assembled for use, and in the
English language (see 21 CFR 1010.2(b)).
The certification label or tag should include a modified statement of compliance, such as:
“Complies with 21 CFR Subchapter J including section [insert FDA performance
standard CFR number(s)], partially by conforming with IEC [insert IEC Standard number
and edition number], dated [Insert publication date of the FDA-recognized IEC standard],
[add, as appropriate] including corrigenda dated [insert publication dates of the FDA-
recognized corrigenda] and amendments dated [insert publication dates of the FDA-
recognized amendments], in accordance with section 514(c)(1)(A) of the FD&C Act as
16 For more information, see the FDA Recognized Standards Database, available at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
17 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-
evaluating-substantial-equivalence-premarket-notifications-510k
18 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices

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outlined in "Medical X-Ray Imaging Devices: Conformance with IEC Standards,” dated
[Insert date of final guidance issuance].”
For example, for a CT device:
Complies with 21 CFR Subchapter J including sections 21 CFR 1020.30 and 1020.33,
partially by conforming with IEC 60601-2-44 ed1.0 (2009), including Amendment 1
(2012), in accordance with section 514(c)(1)(A) of the FD&C Act as outlined in
"Medical X-Ray Imaging Devices: Conformance with IEC Standards,” dated [date of
issuance of final guidance].
Under 21 CFR 1010.2(c), this certification must be “based upon a test, in accordance with the
standard, of the individual article to which it is attached or upon a testing program which is in
accordance with good manufacturing practice.” The manufacturer’s quality system should
address various aspects of radiation safety and conformity to standards through design controls.
Testing results should be documented and placed in the firm’s records.
VII. Information to be Provided to Assemblers and Others
Manufacturers of diagnostic x-ray equipment components listed in 21 CFR 1020.30(a)(1) are
required by 21 CFR 1020.30(g) to provide instructions for assembly, installation, adjustment,
and testing, (AIAT) to assure that the product will comply with applicable performance standard
provisions. This requirement in the performance standard helps to ensure that diagnostic x-ray
equipment, the characteristics of which may require adjustment upon assembly, installation, and
thereafter, will continue to comply with radiation safety requirements and thus protect the public
from unnecessary exposure to radiation. As outlined in Table 4, section 1020.30(g) is not met
through conformance to applicable IEC standards.
To comply with the instructions for the AIAT requirement of 21 CFR 1020.30(g), a
manufacturer who elects to declare conformity to IEC standards to satisfy other sections of the
EPRC performance standards outlined in Table 3 should include in their AIAT documentation a
Radiation Safety Specification and Testing Comparison Document.19 The Radiation Safety
Specification and Testing Comparison Document (the “Document”) should provide information
that enables, for example, an assembler, qualified medical physicist, or state radiation control
program inspector, to test the device and determine whether it conforms to the applicable IEC
radiation safety specifications, and not the EPRC performance standards. Although the
Document may be limited to only those specifications and would not indicate full compliance
with the relevant EPRC performance standards, FDA recommends that manufacturers format
their AIAT documentation so that all radiation safety specifications and test methods, including
acceptance and constancy testing, are available in a format that is practical for users testing the
equipment.
19 An example Radiation Safety Specification and Testing Comparison Document can be found at
https://www.nema.org/standards/view/radiation-safety-specification-and-testing-comparison-document-for-medical-
x-ray-imaging-devices-general-radiography-and-fl

11
At minimum, the Document should include:
a. The radiation safety specifications that apply to the device, where those specifications
would not otherwise meet the comparable EPRC performance standards;
b. The IEC document number, version, and specific clause(s) under which each such
specification may be found;
c. The EPRC performance standard requirement being replaced by the IEC standard; and
d. The test method and acceptance criterion.
Availability of Documents online enables easy access by assemblers and other personnel. Access
can be provided on an individual manufacturer’s website or in a centralized database.
Information on how to access the Document should be included with the device’s accompanying
documents. Additionally, if the device includes user documentation20 that is provided
electronically, inclusion of the Document as part of the electronic documentation may be helpful
for assemblers and other personnel.
VIII. Compliance and Enforcement
This guidance does not limit the Agency’s ability to pursue an enforcement action if
manufacturers do not comply with applicable laws and regulations.
If a manufacturer is using a declaration of conformity to comply with certain requirements, as
discussed in this guidance, the manufacturer or importer must declare conformance to certain
IEC standards, with that conformance being based on a testing program.21 The manufacturer’s
quality system must address various aspects of radiation safety and conformity to standards
through design verification and validation.22 Testing results must be documented and placed in
the firm’s records as part of the design history file23 for the device and are subject to inspection
in accordance with 21 CFR 820.180. FDA will consider a product to be in violation of the
electronic product performance standards if FDA finds that a manufacturer’s testing program
does not assure the adequacy of safeguards against hazardous electronic product radiation or that
it does not assure that electronic products comply with the appropriate standards (see 21 CFR
1010.2(c)).
By declaring conformance with the IEC standards, corrigenda, and amendments identified in this
guidance, manufacturers declare that they have established design specifications that relate to
radiation emission. When a diagnostic x-ray system fails to conform to design specifications
relating to the emission of electronic product radiation, the system has an electronic product
defect.24 Thus, failure to meet any of the requirements relating to the emission of electronic
20 This is the same as the IEC term “accompanying documents.”
21 See FDA’s guidance “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices, for more information about testing that
supports a declaration of conformity.
22 21 CFR 820.30.
23 21 CFR 820.30(j).
24 21 CFR 1003.2(b).

12
product radiation of an IEC standard, corrigenda, or amendment to which a manufacturer
declares conformance, is an electronic product defect and is cause for notification and
repurchase, repair, or replacement, as defined in 21 CFR parts 1003 and 1004.
This guidance does not change FDA’s policy towards enforcement of correction of such defects.
Manufacturers and importers must notify FDA upon discovery of a radiation safety defect, as
required by 21 CFR 1003.10. Also, as required by 21 CFR 1003.11, FDA will notify industry
when the Agency makes such discoveries. As required by 21 CFR part 1004, the manufacturer
must repurchase, repair, or replace defective products without charge, under a plan approved by
FDA. FDA will review and approve or reject all corrective action plans, as required by 21 CFR
1004.6.

13
Appendix A: Applicability of IEC Standards to Specific
Device Types
The IEC uses a tiered structure for its standards: general standards, collateral standards, and
particular standards. The base standard (e.g., IEC 60601-1 for medical electrical equipment) is
called the general standard. Collateral standards (e.g., IEC 60601-1-3 for radiation protection in
diagnostic x-ray equipment) provide general specifications for safety that are applicable to a
subgroup of devices covered by the general standard, or a specific characteristic of all equipment
covered by the general standard that is not fully addressed in the general standard (e.g., alarm
systems). Particular standards apply to specific types of equipment (e.g., IEC 60601-2-43 for
interventional fluoroscopy systems), and may replace, add to, amend, or remove conditions
contained in the general or collateral standards, as appropriate for the specific type of equipment
under consideration. Particular standards may also add other basic safety and essential
performance conditions.
In particular standards, the term “this standard” is used to make reference to the general standard,
any applicable collateral standards, and the particular standard, taken together. Therefore,
conformance to a particular standard includes conformance to any collateral standards and the
general standard in the same series (e.g., IEC 60601), as well as to any other particular standards
included as normative. However, a condition in a particular standard takes priority over any
conflicting conditions in collateral and general standards in the same series and normative
particular standards (e.g., conditions in IEC 60601-2-43 take precedence over any conflicting
conditions in IEC 60601-2-54, IEC 60601-1-3, and IEC 60601-1).
The chart below indicates the IEC standards that apply to different devices classified in the CFR
after taking into consideration the IEC’s tiered structure system. The far-left column lists the
classification regulation numbers for devices within the scope of this guidance. To determine
which IEC standard(s) applies to a device:
1. Find the row containing the classification regulation in the left column.
2. Trace the row across the rest of the table and note which columns are marked with an
‘X’.
3. The column headings for the columns marked with an ‘X’ provide the names of the IEC
standards that apply to that device.

1
Table 6 – Applicability of IEC Standards to Specific Medical Device Classifications
Classification
Regulation
IEC
60601-1-3
Diagnostic
X-ray
Equipment
IEC
60601-2-28
X-Ray Tube
IEC
60601-2-43
Interventional
X-ray
Equipment
IEC
60601-2-44
Computed
Tomography
IEC
60601-2-45
Mammography
IEC
60601-2-54
Radiography
and
Radioscopy
IEC
60601-2-63
Extra-Oral
Dental
Equipment
IEC
60601-2-65
Intra-Oral
Dental
Equipment
21 CFR
872.1800
EHD, MUH
X X X
21 CFR
872.1810
EAP
X X
21 CFR
892.1170
KGI
X X
21 CFR
892.1600
IZI
X X X
21 CFR
892.1610
KPW, IZW,
IZX
X X
21 CFR
892.1630
IXK
X X
21 CFR
892.1650
JAA, OWB,
OXO, RCC
X X‡ X‡
21 CFR
892.1660
JAB
X X
21 CFR
892.1670
IXL
X

2
Classification
Regulation
IEC
60601-1-3
Diagnostic
X-ray
Equipment
IEC
60601-2-28
X-Ray Tube
IEC
60601-2-43
Interventional
X-ray
Equipment
IEC
60601-2-44
Computed
Tomography
IEC
60601-2-45
Mammography
IEC
60601-2-54
Radiography
and
Radioscopy
IEC
60601-2-63
Extra-Oral
Dental
Equipment
IEC
60601-2-65
Intra-Oral
Dental
Equipment
21 CFR
892.1680
KPR, MQB,
MWP
X X
21 CFR
892.1700
IZO
X X
21 CFR
892.1710
IZH
X X
21 CFR
892.1715
MUE
X X
21 CFR
892.1720
IZL
X X
21 CFR
892.1730
IZG
X X
21 CFR
892.1740
IZF
X X
21 CFR
892.1750
JAK, OAS
X X
21 CFR
892.1760
ITY
X X
21 CFR
892.1830
KXH
X
21 CFR
892.1860 X

3
Classification
Regulation
IEC
60601-1-3
Diagnostic
X-ray
Equipment
IEC
60601-2-28
X-Ray Tube
IEC
60601-2-43
Interventional
X-ray
Equipment
IEC
60601-2-44
Computed
Tomography
IEC
60601-2-45
Mammography
IEC
60601-2-54
Radiography
and
Radioscopy
IEC
60601-2-63
Extra-Oral
Dental
Equipment
IEC
60601-2-65
Intra-Oral
Dental
Equipment
KPX
21 CFR
892.1880
IXY
X
21 CFR
892.1980
KXJ, IXQ,
IXR, IZZ
X
The FDA medical device regulations and IEC use different definitions of extra-oral and intra-oral x-ray systems. IEC standards
60601-2-63 and 60601-2-65 use the location of the image receptor to determine whether the device is an extra-oral device or an intra-
oral device. FDA uses the location of the x-ray source to make the distinction (21 CFR 872.1800 and 21 CFR 872.1810). This
difference in definitions means that some devices classified as an “Extra-oral source x-ray system” under 21 CFR 872.1800 will be
defined as an intra-oral x-ray system by the IEC. In these cases, the applicable IEC standard is 60601-2-65, for intraoral x-ray systems,
and manufacturers who choose to conform to IEC standards should submit a declaration of conformity to IEC 60601-2-65.
‡IEC 60601-2-43 applies to devices under 21 CFR 892.1650 that are intended to be used in interventional procedures. The applicable
standard for all other devices under 21 CFR 892.1650 is IEC 60601-2-54.
See the FDA Recognized Consensus Standards Database25 for a current list of FDA-recognized consensus standards.
25 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm