Electromagnetic Compatibility (EMC) of Medical Devices

Contains Nonbinding Recommendations

Electromagnetic Compatibility (EMC)

of Medical Devices

Guidance for Industry and

Food and Drug Administration Staff

Document issued on June 6, 2022.

The draft of this document was issued on November 17, 2020.

This document will supersede “Information to Support a Claim of

Electromagnetic Compatibility (EMC) of Electrically-Powered Medical

Devices,” issued July 11, 2016, 1 year after the publication of this guidance

for

in vitro diagnostics and 60 days after the publication of this guidance for other

device types within the scope of this guidance.

For questions about this document, contact the Office of Science and Engineering Laboratories

(OSEL) at [email protected] or (301) 796-2530; the Division of Biomedical Physics,

OSEL at (301) 796-2580; or Seth Seidman at (301) 796-2477 or by email at

[email protected]. For questions about this document regarding CBER-regulated

devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-

835-4709 or 240-402-8010, or by email at [email protected].

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

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-2015-D-3787. Comments may not be acted

upon by the Agency until the document is next revised or updated.

Additional Copies

CDRH

Additional copies are available from the Internet. You may also send an e-mail request to

CDRH[email protected] to receive a copy of the guidance. Please use the document

number 1400057 and complete title of the guidance in the request.

CBER

Additional copies are available from the Center for Biologics Evaluation and Research (CBER),

Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,

Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-

8010, by email, [email protected] or from the Internet at https://www.fda.gov/vaccine

s-blood-

biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

Contains Nonbinding Recommendations

Table of Contents

I. Introduction ............................................................................................................................. 4

II. Scope ....................................................................................................................................... 5

III. Overview .............................................................................................................................. 5

IV. EMC Information for Premarket Submissions .................................................................... 6

EMC-Related Device Characteristics and Intended Use Environments .......................... 7

Assessment of Medical Device Risks .............................................................................. 8

Consensus Standards ........................................................................................................ 8

(1) Non-implantable Medical Devices ............................................................................... 9

(2) Active Implantable Medical Devices (AIMDs) .......................................................... 10

(3) Special Environments ................................................................................................. 11

Essential Performance and Immunity Pass/Fail Criteria ................................................ 11

(1) Essential Performance ................................................................................................ 11

(2) Immunity Pass/Fail Criteria ........................................................................................ 12

Medical Device Configuration and Functions Tested .................................................... 13

Results of EMC Testing ................................................................................................. 15

Allowances ..................................................................................................................... 15

Deviations ....................................................................................................................... 15

Modifications ................................................................................................................. 16

Common Electromagnetic (EM) Emitters ...................................................................... 16

Labeling .......................................................................................................................... 17

V. EMC Information to Support Investigational Device Exemption (IDE) or Investigational

New Drug (IND) Submissions ...................................................................................................... 19

Appendix A – Examples of Typical Medical Device Locations within Intended Use

Environments ................................................................................................................................ 20

Contains Nonbinding Recommendations

Electromagnetic Compatibility (EMC)

of Medical Devices

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

or Office responsible for this guidance as listed on the title page.

I. Introduction

The Food and Drug Administration (FDA) has developed this guidance document to recommend

information that should be provided in a premarket submission (i.e., premarket approval (PMA)

application, humanitarian device exemption (HDE), premarket notification (510(k)) submission,

investigational device exemption (IDE), De Novo request, and certain biologics license

application (BLA) and investigational new drug (IND)

) to demonstrate electromagnetic

compatibility (EMC) for electrically-powered medical devices and medical devices with

electrical or electronic functions. Typically, the review of EMC information in a submission is

based on the risk associated with malfunction or degradation of the medical device under

consideration, where malfunction or degradation could be caused by inadequate EMC. The

review is also based on the use of appropriate consensus standards. This guidance, when final,

will replace the FDA guidance, “Information to Support a Claim of Electromagnetic

Compatibility (EMC) of Electrically-Powered Medical Devices” (hereafter referred to as the

2016 EMC guidance), published July 11, 2016. This guidance provides additional technical

information to address the recommendations in the 2016 EMC guidance. Throughout this

guidance, the terms “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug

Administration and the terms “you” and “yours” refer to medical device manufacturers.

For the current edition of the FDA-recognized consensus standard(s) referenced in this

document, see the FDA Recognized Consensus Standards Database.

For more information

INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health

Service (PHS) Act.

Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Contains Nonbinding Recommendations

regarding use of consensus standards in regulatory submissions, please refer to the FDA

guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

for Medical Devices.”

The contents of this document do not have the force and effect of law and are not meant to bind

the public in any way, unless specifically incorporated into a contract. This document is intended

only to provide clarity to the public regarding existing requirements under the law. FDA

guidance documents, including this guidance, 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. Scope

This guidance applies to medical devices, including in vitro diagnostic products,

and

accessories

that:

• are electrically-powered; or

• have functions or sensors that are implemented using electrical or electronic circuitry.

FDA recognizes and anticipates that the Agency and industry may need up to 1 year to perform

activities to operationalize the policies within the guidance, only for in vitro diagnostic products.

Since this guidance generally reflects current practice for the assessment of EMC for other

device types, but some activities to fully operationalize the policies are needed (e.g., updates to

eSTAR

), FDA intends to implement this guidance 60 days after issuance for device types within

the scope of this guidance, excluding in vitro diagnostic products. If new information regarding

electromagnetic compatibility as outlined in this guidance is not included in a premarket

submission for an in vitro diagnostic received by FDA before or up to 1 year after the publication

of this guidance or for other device types within the scope of this guidance before or up to 60

days after the publication of this guidance, FDA does not generally intend to request such

information during the review of the submission. FDA does, however, intend to review any such

information if submitted.

III. Overview

For the purpose of this document, EMC is defined as the ability of a medical device to function

safely and effectively in its intended electromagnetic (EM) environment, including immunity to

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-

standards-premarket-submissions-medical-devices

See 21 CFR 809.3(a)

For more information, see “Medical Device Accessories - Describing Accessories and Classification Pathways:

Guidance for Industry and FDA Staff” at https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/medical-device-accessories-describing-accessories-and-classification-pathways and “Medical Device

Accessories” at https://www.fda.gov/medical-devices/classify-your-medical-device/medical-device-accessories

Available at https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program

Contains Nonbinding Recommendations

EM disturbances (i.e., interference)

, without introducing excessive EM disturbances (i.e.,

emissions) that might interfere with other equipment. Immunity is the ability to protect against

unacceptable degradation due to EM disturbances such as radio waves, power surges,

radiofrequency (RF) disturbances, and electrostatic discharge (ESD). Interference can cause

medical devices to not perform as intended and lead to hazardous situations, such as delays or

errors in diagnosis, treatment, or monitoring that can result in serious injury or death. Emissions

limits are established to protect radio services and minimize interference to other equipment,

both medical and non-medical.

The IEC 60601/80601

series of standards applies to medical devices and systems that directly

apply or transfer energy to the patient, and the IEC 61010-1 standard applies to electrical

laboratory equipment. These standards are used in the majority of premarket submissions for

electrically-powered medical devices to support device safety. These standards attempt to

address all hazards (e.g., mechanical, electrical, radiation). Besides addressing the wide range of

generic safety requirements, the IEC 60601/80601 and IEC 61010 series include close to 100

“particular standards” with safety requirements for specific types of devices, such as clinical

thermometers, infusion pumps, infant incubators, laboratory centrifuges, medical device

sterilizers and reprocessors, and medical washer-disinfectors. There are also consensus

standards for active implantable medical devices that include information on EMC.

For electrically-powered medical devices and medical devices with electrical or electronic

functions, you should provide evidence that the medical device is safe and performs as intended

in the environments of use. This evidence includes risk management with regard to EM

disturbances, testing, and labeling, as recommended in this guidance. To facilitate premarket

submissions and reviews for EMC, we recommend you include the information listed in Section

IV. Section V contains additional information specific to IDE or IND submissions.

IV. EMC Information for Premarket Submissions

To facilitate the review of EMC information in premarket submissions, we recommend you

include the information listed in subsections A-K below in the EMC section of the submission,

labeled with the section headings in the same order as they are listed in this guidance. If test

reports or test report summaries (e.g., Accreditation Scheme for Conformity Assessment

Summary Test Report

) or other sections of the premarket submission include any of the

To harmonize with international definitions, this document will use the word “disturbance” as the cause (per IEC

60601-1-2) and “interference” as the effect (per IEC 60050). In the US, “interference” is often used interchangeably

for both cause and effect.

In this document, the reference to the IEC 60601/80601 series of standards includes the ANSI/AAMI ES 60601-1,

the IEC and US adopted collaterals [60601-1-xx], the IEC 60601-2-xx, and the IEC or ISO 80601-2-xx particulars.

For more information, see the FDA guidance: “The Accreditation Scheme for Conformity Assessment (ASCA)

Pilot Program” available at

https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/accreditation-scheme-conformity-assessment-asca-pilot-program and “Basic Safety and Essential

Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment -

Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program”

available at

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-and-essential-

performance-medical-electrical-equipment-medical-electrical-systems-and

Contains Nonbinding Recommendations

recommended information below, the specific location within these documents should be noted

in the EMC section of the submission.

EMC-Related Device Characteristics and Intended Use

Environments

We recommend that you provide a description of all EMC-related device characteristics

and intended use environments including:

• an overview of the device and its functions and modes, including block diagrams,

photographs, cables, relevant accessories, and device interoperability;

• a description of the power supply (i.e., mains-powered only, internally-powered only,

mains and internally-powered) including if the internally-powered medical device can

be used while charging;

• a statement regarding the environments in which the medical device is intended to be

used (see Appendix A);

• a description of any wireless technology (for additional considerations regarding

wirelessly-enabled medical devices, refer to FDA guidance, Radio Frequency

Wireless Technology in Medical Devices

); and

• a description of any intentional RF emitters in the medical device that could be

sources of EM disturbances.

Specifying the intended use environments provides important information to determine

the appropriate testing for expected EM disturbances. For the purposes of this guidance

and EMC evaluation, we categorize the intended use environments into one (or more) of

the following environments:

• Professional Healthcare Facility Environment: any environment where personnel with

medical training are continually available to oversee or administer the use of medical

devices. This includes, but is not limited to, hospitals, long-term care facilities,

nursing homes, limited care facilities, emergency medical services, clinics,

physicians’ offices, outpatient treatment facilities, and clinical laboratories.

• Home Healthcare Environment: any environment where personnel with medical

training are not continually available to oversee or administer the use of medical

devices. This includes, but is not limited to, outdoor environments, office

environments, schools, vehicles, emergency shelters, and independent living

retirement homes.

• Special Environment: any environment with EM characteristics different from those

specified in EMC consensus standards. This includes, but is not limited to, aircraft,

military areas, heavy industrial areas, medical treatment areas with high-powered

medical devices such as magnetic resonance imaging (MRI).

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-

wireless-technology-medical-devices-guidance-industry-and-fda-staff.

Contains Nonbinding Recommendations

See Appendix A for examples of typical medical device locations for each of the three

intended use environments mentioned above.

When considering the intended use environments, we recommend addressing common

EM emitters and unique medical emitters. These emitters are listed and discussed in

detail in Section IV.J below.

Assessment of Medical Device Risks

We recommend that you provide a summary description of the risks associated with

malfunction, disruption, or degradation of the performance of the subject medical device

due to EM disturbances. This should include each potential malfunction, disruption, or

degradation due to electromagnetic interference (EMI) that could cause harm to the

patient, user or operator. This summary should categorize the severity of each harm into

the following three levels based upon the FDA guidance, “Factors to Consider Regarding

Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement

Decisions Guidance for Industry and FDA Staff”

• Medical device-related deaths and serious injuries

include events (including

procedure-related complications) in the use of the medical device that have caused or

could cause or contribute to a death or injury or illness that is life-threatening, results

in permanent impairment or damage to the body, or requires medical or surgical

intervention to prevent permanent harm to the body.

• Medical device-related non-serious adverse events include events (including

procedure-related complications) in the use of the medical device that have caused or

could cause or contribute to minor, temporary or medically reversible injuries that do

not meet the criteria for classification as a medical device-related serious injury.

• Medical device-related events without reported or potential harm include medical

device nonconformities that have no related harm, medical device malfunctions that

have no related harm, and procedure-related complications with no related harm.

These considerations should be used in determining the immunity pass/fail criteria (see

Section IV.D) and in addressing EMI caused by common EM emitters (see Section IV.J).

For the 60601 series of standards, a risk analysis is used to determine the Essential

Performance,

upon which the immunity pass/fail criteria are based, as well as other

aspects of EMC testing (e.g., additional modulation frequencies).

Consensus Standards

We recommend that you provide a summary describing all voluntary consensus standards

used to evaluate EMC. When applicable, we recommend that EMC tests be performed

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-regarding-benefit-

risk-medical-device-product-availability-compliance-and

See 21 CFR 803.3(w)

Essential Performance is a defined term from ANSI/AAMI/ES 60601-1:2005 Medical electrical equipment - Part

1: General requirements for basic safety and essential performance. See Section IV.D below for more details.

Contains Nonbinding Recommendations

using methods described in FDA-recognized consensus standards that are appropriate for

the medical device. If you chose to declare conformity to a standard, we recommend

providing the supporting information described in this guidance and consistent with the

FDA guidance “Appropriate Use of Voluntary Consensus Standards in Premarket

Submissions for Medical Devices.”

The extent of FDA recognition of a consensus

standard is included in the Supplemental Information Sheet (SIS) published in the FDA

Recognized Consensus Standards Database.

The “Extent of Recognition” section of the

SIS can specify an acceptable deviation or non-recognized clauses from the published

standard. The “Transition” section of the SIS can specify the date when recognition of

one edition of a standard is superseded by the next edition. A cleared or approved device

does not need to be assessed or submitted again as a result of any changes to an FDA-

recognized EMC consensus standard.

If the consensus standard(s) referenced in the submission are not recognized by FDA,

sufficient justification should be provided regarding how the EMC testing performed

adequately addresses EMC, based on the medical device’s functions, modes, indications

for use, intended use, and intended use environments. If no consensus standard exists for

a certain medical device type, we recommend specific EMC testing be performed based

on foreseeable EM disturbances in the intended use environments. We recommend

referencing an existing FDA-recognized consensus standard for a similar medical device

type and environment and modifying the test specifications in the standard to address the

subject medical device. Each change in test specification should be documented and

accompanied by justification.

When using consensus standards, we recommend verifying that the intended use

environments are adequately addressed by the standards. Many consensus standards only

address and specify test levels for the home healthcare environment and the professional

healthcare facility environment.

The medical device configuration and intended use environments can determine the

applicability of FDA-recognized consensus standards for EMC. These can be generalized

into one or more of the following three categories:

(1) Non-implantable Medical Devices

The ANSI/AAMI/IEC 60601-1-2 Medical electrical equipment – Part 1-2: General

requirements for basic safety and essential performance – Collateral Standard:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-

consensus-standards-premarket-submissions-medical-devices

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

For more information, refer to Section VIII of the FDA guidance, When Devices or Standards Change After

Marketing Authorization, of the “

Appropriate Use of Voluntary Consensus Standards in Premarket

Submissions for Medical Devices” guidance available at

https://www.fda.gov/regulatory-information/search-fda-

guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.

For more information on use of consensus standards that are not FDA-recognized, refer to Section IV B. General

Use of the “Appropriate Use of Voluntary Consensus Standards

in Premarket Submissions for Medical Devices”

guidance.

Contains Nonbinding Recommendations

Electromagnetic disturbances – Requirements and tests is a collateral standard to the

ANSI/AAMI ES 60601-1 Medical electrical equipment - Part 1: General requirements

for basic safety and essential performance standard and is recognized by FDA for testing

of non-implantable medical devices that are within its scope. The 60601-1-2 consensus

standard provides details about testing medical devices for safety with regard to EM

disturbances based on the Basic Safety

and Essential Performance of the medical

device, the medical device design, and the intended use environments.

When using any consensus standard, careful consideration to the scope is critical. For

example, the scope of 60601 standards is limited to medical device safety. Evaluation of

medical device effectiveness is generally not within the scope of 60601 standards. This is

discussed in detail in subsection D(2) below.

There are over 80 particular consensus standards (e.g., IEC 60601-2-X, ISO 80601-2-X)

that cover a wide variety of medical devices. These particular consensus standards

augment or supersede the specifications in 60601-1-2 and can provide more detailed or

alternative EM test specifications. However, not all particular consensus standards are

FDA recognized at the time of this guidance publication, and the EMC specifications in

these particular standards should be assessed to ensure that they are appropriate for the

medical device’s functions, modes, indications for use, intended use, and intended use

environments.

Most laboratory equipment and in vitro diagnostic devices (IVDs) are outside the scope

of 60601-1-2. At the time of the issuance of this guidance, we partially recognize IEC

61326-1:2020 and IEC 61326-2-6:2020 and recommend using the test methods from

these standards. However, we recommend using acceptance criteria specific to the

device’s functions and intended use. Additionally, we recommend using test levels

specified by 60601-1-2 or, alternatively, determining the reasonably foreseeable

maximum levels of the electromagnetic phenomena in the device intended use

environments (e.g., through study of published literature or environmental

measurements).

(2) Active Implantable Medical Devices (AIMDs)

AIMDs are outside the scope of 60601-1-2. However, for AIMD systems, we recommend

that the non-implantable subsystems (e.g., pacemaker programmer) be tested to

consensus standards appropriate for non-implantable devices (e.g., 60601-1-2).

Consensus standards such as ISO 14117 Active implantable medical devices --

Electromagnetic compatibility -- EMC test protocols for implantable cardiac

pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization

devices and the ISO 14708 series are often referenced to address EMC for AIMDs.

EMC consensus standards for AIMDs focus on EM phenomena to address the immunity

of the medical device. The ISO 14708 Series and ISO 14117 standards assess AIMD

Basic Safety is defined in ANSI/AAMI/ES 60601-1:2005 as “freedom from unacceptable RISK directly caused by

physical

HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION.”

Contains Nonbinding Recommendations

performance when exposed to commonly encountered EM sources as well as particular

sources that an implantable device is likely to encounter. For example, cardiac

implantable electronic device consensus standards (e.g., ISO 14117) include immunity

testing for exposure to defibrillation devices, which inject high-energy electrical signals

into the heart for life-saving functions.

(3) Special Environments

It is important to understand the scope and limitations of each standard. For example,

60601-1-2 is generally applicable to both the home healthcare environment and the

professional healthcare facility environment. However, if a medical device is intended to

be used in a special environment, we recommend that you provide additional EMC

information and perform testing for the given special environment. This could be

achieved by referencing appropriate standards for each special environment. For

example, we recommend immunity testing to RTCA DO-160 Environmental Conditions

and Test Procedures for Airborne Equipment for non-implantable medical devices that

are intended or expected to be used in an aircraft environment. Note that some AIMD

consensus standards do not specify EMC test parameters for use in a magnetic resonance

imaging (MRI) environment (e.g., exposure within the bore of an MRI system). Where an

applicable AIMD standard does not specify such requirements, we recommend test

methods specific to this potentially high-risk environment, such as those described in

ISO/TS 10974 Assessment of the safety of magnetic resonance imaging for patients with

an active implantable medical device.

Essential Performance and Immunity Pass/Fail Criteria

We recommend that you provide clear immunity pass/fail criteria, and, if applicable, a

clear statement of the device’s Essential Performance. The Essential Performance and

immunity pass/fail criteria are fundamental to performing and assessing the adequacy of

EMC testing to demonstrate that the medical device is safe and performs as intended.

(1) Essential Performance

Essential Performance is defined in ANSI/AAMI/ES 60601-1:2005 as “performance of a

clinical function, other than that related to Basic Safety, where loss or degradation

beyond the limits specified by the manufacturer results in an unacceptable risk. Note:

Essential Performance is most easily understood by considering whether its absence or

degradation would result in an unacceptable risk.” If you reference 60601-1-2, 60601-2-

X, or 80601-2-X, you should specify the Essential Performance of the medical device.

Essential Performance should be specific to each medical device and be determined by

you by assessing the risk to the patient. The Essential Performance should be determined

by:

• identifying the performance of the clinical functions,

• specifying performance limits for fully functional performance versus loss or

degradation of the identified performance, and

Contains Nonbinding Recommendations

• evaluating the risk from the loss, disruption, deviation, degradation, or over-delivery

of the identified performance.

If the resulting risk is determined to be unacceptable, then the identified performance is

Essential Performance.

It is also possible for a medical device to have no Essential Performance. A determination

of no Essential Performance should be accompanied by scientific justification and risk

analysis. Even for medical devices that have no Essential Performance, appropriate

immunity pass/fail criteria should be used to demonstrate that the device is safe and

performs as intended.

See informative annex “General guidance and rationale” of ANSI/AAMI ES 60601-1 and

Clause 2.3.4 of AAMI CR500:2019 Basic Introduction to the IEC 60601 Series for

additional information regarding Essential Performance.

(2) Immunity Pass/Fail Criteria

Immunity pass/fail criteria should address the degradation of the medical device’s

functions caused by the test disturbance. Your EMC test plan should specify which

degradations are considered acceptable. Acceptance criteria should be documented in the

EMC test plan prior to testing. We recommend that you specify detailed immunity

pass/fail criteria that are (1) quantitative, (2) specific to the medical device and functions,

and (3) observable. These criteria should be determined based on the medical device’s

functions, modes, indications for use, intended use, and Essential Performance (if

applicable). If a medical device has multiple medical device subsystems (e.g., an AIMD

with active external parts) or more than one function (e.g., a ventilator with physiological

monitoring), then each medical device subsystem or function can have specific immunity

pass/fail criteria. We recommend that you specify how the immunity pass/fail criteria

were derived, quantified, and monitored, and justify how they demonstrate that the

medical device remains safe and performs as intended.

Immunity pass/fail criteria can be different for transient EM phenomena and for

continuous EM phenomena. Transient phenomena include ESD, electrical fast

transients/bursts, surges, and voltage dips and interruptions. Continuous phenomena

include conducted and radiated RF disturbances and power-frequency magnetic fields.

For transient phenomena, it might be acceptable that the medical device provides the

specified performance after application of the test disturbance. A recovery time can be

acceptable and should be specified based on the risk analysis. For continuous phenomena,

the medical device should provide the specified performance during and after application

of the test disturbance.

Some EMC test standards list general examples of immunity pass/fail criteria for a

medical device or general descriptions of immunity pass/fail criteria (e.g., Performance

Criterion A, Operates as Intended). However, these general immunity pass/fail criteria are

not sufficiently specific to the medical device’s functions, modes, indications for use,

intended use, and Essential Performance (if applicable). Even devices with the same

Contains Nonbinding Recommendations

hardware could have different immunity pass/fail criteria. For example, immunity

pass/fail criteria for a ventilator for adult patients would be expected to be different from

that for neonatal patients because of the different physiological characteristics of the

intended use populations.

If a submission references a standard in the 60601 family of standards, then the immunity

pass/fail criteria should address both Basic Safety and Essential Performance. Many

particular standards (e.g., 60601-2-X) specify the Essential Performance and some

specify immunity pass/fail criteria. As noted in subsection C(1) above, the scope of

60601 standards is limited to safety (i.e., Basic Safety and Essential Performance).

Therefore, we recommend that the immunity pass/fail criteria include considerations to

demonstrate that the device performs as intended. We recommend conforming to IEC TR

60601-4-2 Medical electrical equipment - Part 4-2: Guidance and interpretation -

Electromagnetic immunity: performance of medical electrical equipment and medical

electrical systems to assess the immunity of the performance associated with the intended

use because the test methods are similar to 60601-1-2 and can be tested at the same time.

See IEC 60601-1-2 informative annex “Identification of IMMUNITY pass/fail criteria”

for additional information and examples on determination of specific immunity pass/fail

criteria.

Medical Device Configuration and Functions Tested

We recommend that you provide a detailed description of the medical device under test,

including the configuration, functions, modes, and settings that were tested. We

recommend testing functions and modes that include a feature or control such that the

failure or malfunction would most likely result in an unacceptable risk or to not achieve

its intended use. The description of the device under test should include the medical

device name, model number, manufacturer, and an indication of whether the device is the

final production-ready medical device currently under review.

We recommend you perform testing on the final finished device. If the device tested is

not the final finished device, the description of the device under test should include an

explanation and a scientific justification of how test results are applicable to the final

finished device. When leveraging EMC test results from a prior or different medical

device model/version to another model/version, we recommend that you:

• identify and summarize all modifications or changes from the previously tested

medical device and include any changes in the medical device’s indications, intended

use, and intended use environments,

• provide an analysis of whether each modification could affect EMC of the medical

device, and

• assess whether the consensus standard used for the prior EMC testing has been

superseded/replaced by a revised version.

New EMC testing should be performed if any of the analyses of the device differences

indicate that the prior testing might not support the EMC of the updated medical device

Contains Nonbinding Recommendations

model/version. We also recommend applying these considerations when you perform

EMC testing on only a subset of models within a product family.

We recommend that you consider the following to help determine the appropriate device

configuration(s) for testing:

• The device should be tested as a system with all medical device accessories,

components, and subsystems connected and functioning as intended. If non-medical

equipment is used in a medical system and could affect the ability of the medical

device to meet the immunity pass/fail criteria, the non-medical equipment should also

be tested as part of the medical device system. Examples of non-medical equipment

include mobile phones, tablets, and computers. Any non-medical equipment, medical

device accessories, or subsystems not included in the EMC test should be listed with

a rationale for why they were not tested. You should provide a scientific justification

for how the test configuration demonstrates EMC of the entire medical device system.

• If a medical device has multiple subsystems or accessories (e.g., a left ventricular

assist device (LVAD) that includes an implantable blood pump and external

controller), or more than one function (e.g., a ventilator with physiological

monitoring), then the medical device system test specifications should consider all

EMC-related consensus standards applicable to those subsystems, accessories, and

functions. This can be used to formulate an appropriate superset of test

specifications.

• If EMC testing is performed on a subsystem basis, each subsystem not included in the

testing should be simulated, including any potential third-party medical devices or

connections.

• Medical device and test or ancillary equipment should be configured in the modes

and with settings considered to be representative of the medical device’s intended

use. For example, a medical device that can operate in battery power mode and in

mains power mode should be tested in both modes. Additionally, batteries with

embedded electronic circuitry (i.e., smart batteries) that are intended to be handled by

the user should be removed from the medical device and tested separately for

immunity to ESD due to the potential of ESD damaging the circuitry of the battery.

• Patient simulators should be used where specified by the referenced EMC consensus

standards or as appropriate for the medical device. For example, certain EMC test

methods for AIMDs specify that the medical device be submerged in a saline

phantom with specific conductivity. Other consensus standards such as 60601-1-2

specify that patient coupled medical devices be electrically loaded in a way that

simulates a patient and be provided with electrical or mechanical signals that simulate

a patient.

• If wireless technology is used in the medical device to achieve its intended use, the

wireless technology should be “on” and communicating with other medical device

subsystems or ancillary equipment during EMC testing. This is important because

having active connections at each antenna could affect whether the subject medical

device operates as intended when exposed to EM disturbances.

Contains Nonbinding Recommendations

You should also include a description of how the medical device was monitored during

EMC testing. Monitoring methods should include a means to quantitatively observe

performance associated with the immunity pass/fail criteria without significant

perturbation or effect on the test being performed or to the device under test.

Results of EMC Testing

We recommend that you provide a summary of EMC testing. This information should

summarize the medical device emissions and the immunity to EM disturbances at test

levels appropriate for the medical device’s intended use environments. If neither the test

methods nor the acceptance criteria are well-defined in the EMC consensus standard(s),

we recommend that information requested in this guidance be supported by the inclusion

of EMC test reports.

We recommend that the summary of EMC testing include the

following:

• Name and location of the test facility, the date of the testing.

• Results for each emissions test. Pass/Fail criteria should be expressed in terms of

limits, against which the medical device’s measured emissions are compared and

should not exceed.

• Results for each immunity test performed (e.g., ESD, voltage dips, radiated

immunity). This should include any degradations that were observed during and after

each immunity test for continuous phenomena and after each immunity test for

transient phenomena. For all degradations, you should detail how the medical device

continued to meet the immunity pass/fail criteria and if any additional mitigations will

be implemented.

Allowances

Allowances are specifications within a consensus standard that permit well-defined or

conditional variations of, or exemptions from, certain requirements of the standard. In

general, an allowance of a standard can include the test setup, test methodology,

immunity test levels, or immunity test modulations. For example, a consensus standard

might provide an exemption from certain immunity and emissions tests that are

applicable for permanently installed large medical electrical equipment or medical

electrical systems with a rated input current more than 16 A per phase. We recommend

that you provide a description of all allowances used, with a justification to support the

use of each allowance. The allowance should only be used if all the specified conditions

of the allowance are satisfied. The use of allowances should not increase risks to patients

or operators. If the conditions for use of an allowance cannot be justified, then the

allowance should not be used.

Deviations

A deviation from a consensus standard is when a requirement of the consensus standard

is intentionally not satisfied, or testing is performed in an alternative way other than that

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-

consensus-standards-premarket-submissions-medical-devices

Contains Nonbinding Recommendations

specified and allowed in the standard. The difference between a deviation and an

allowance is that an allowance is specified in a standard, whereas a deviation is not. We

recommend that you provide a description of all deviations used along with a justification

to support the use of each deviation. Deviations from a referenced consensus standard

should be supported with a justification that explains how the deviation would not

adversely impact the safety or performance of the medical device.

Modifications

If the device was modified or altered to pass the EMC testing, such as after initial EMC

test failure, then we recommend that you include a description and analysis of those

medical device modifications. Many types of modifications can alter medical device

EMC, including hardware, software, firmware, and even cosmetic changes (e.g., use of a

metallic material for labeling where the prior labeling was non-conductive). Some

common device modifications made to pass EMC testing include incorporating ferrite

beads, adding filters or EMC shielding materials, and changes or updates to firmware or

software. When a medical device is modified to pass EMC testing, we recommend the

following information be provided:

• A description of all changes or modifications that were made to the medical device in

order to pass EMC testing.

• A statement whether the provided EMC test results occurred before or after the

modifications were incorporated into the medical device. If EMC testing was not

performed after the modifications were made to the medical device, a risk analysis

and scientific justification should be provided that the modified medical device does

not adversely impact the safety or performance of the medical device.

• A statement indicating that the changes will be incorporated into the final finished

medical device prior to marketing; the changes must be documented in the design

history file in accordance with design controls.

• An analysis as to whether these modifications might impact other aspects of the

medical device safety or performance, such as whether they increase risks to patients

or operators, alter the biocompatibility or sterility, affect electrical safety, or introduce

software anomalies/defects.

Common Electromagnetic (EM) Emitters

Certain emitters commonly found in some use environments might not be adequately

addressed by FDA-recognized consensus standards. This could be because a consensus

standard specifies a range of frequencies that omits some bands, such as emitters in the

kHz range, or it could be because a technology is adopted so quickly that consensus

standards cannot keep up with the rapidly changing EM environment. You should be

familiar with their intended use environments and reasonably foresee the potential for

interference from emitters commonly found in those environments.

At the time of publication of this guidance, some examples of common EM emitters not

adequately addressed by FDA-recognized consensus standards are radiofrequency

21 CFR 820.30

Contains Nonbinding Recommendations

identification (RFID) readers, electronic security systems (e.g., metal detectors, electronic

article surveillance), near-field communications (NFC) systems, wireless power transfer

(WPT), Cellular 5G, and unique medical emitters such as electrocautery, MRI,

electrosurgical units, and diathermy equipment. The EM disturbances caused by these

emitters should be taken into account during the risk management process.

We recommend mitigating the risks associated with these common EM emitters and

unique medical emitters based on the intended use environments and the potential

severity of harm the medical device could cause (see Section IV.B above). For medical

devices in the risk category “Medical device-related events without reported or potential

harm,” we recommend that the medical device labeling (e.g., user manual, instructions

for use) mention the potential for EMI from emitters expected to be nearby. If you make

specific claims or specify a specific intended use regarding any particular emitter, we

recommend that those claims be supported with additional testing, engineering analysis,

or computer modeling. For medical devices in the risk category “Medical device-related

deaths and serious injuries” or “Medical device-related non-serious adverse events” we

recommend that:

• testing be performed according to FDA-recognized consensus standards (e.g., FDA-

recognized AIM 7351731 Medical Electrical Equipment and System Electromagnetic

Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM

Standard or IEC 60601-1-2:2020 Clause 8.11 for RFID emitters), or equivalent EMC

test methods, with justification. If no consensus standards exist, specific immunity

testing should be performed to demonstrate that the medical device is safe with regard

to each identified emitter that is foreseeable in the intended use environment; and

• labeling be specific to the risks to patients and operators and include any mitigations

and warnings needed, based on the test results.

Labeling

It is important to include EMC-related information in the labeling because EMC testing

alone may be insufficient to mitigate the risk associated with use in all environments. For

example, EMC specifications in the labeling can help end users select equipment with

electromagnetic immunity that is compatible with the environments in which the device

is intended to be used, or to compare EMC characteristics of candidate equipment prior to

purchase. Providing EMC information in the labeling (e.g., instructions for use) can help

make users aware of the degradations that can be caused by EMI and to understand the

circumstances to avoid. We recommend that the submission include EMC information to

be included in the labeling to enable safe and effective installation and use of the medical

device in the intended EM environments over the expected service life. EMC-related

information can be presented as physical markings on the medical device related to EMC,

or in accompanying documents, such as instructions for use, user manual, and/or

technical and service manuals. The EMC-information included in the labeling should

meet the specifications of the referenced medical device consensus standards (e.g.,

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60601-1-2, 60601-4-2).

We recommend that the medical device labeling include the

following information related to EMC:

• The environments of use for which the medical device is suitable to be used/exposed.

• Accessories and other equipment with which the device has been determined to be

compatible.

• The medical device’s functions/performance and a description of what the operator

can expect if the functions/performance are lost or degraded due to EM disturbances.

For 60601-4-2, these are the functions/performance needed to demonstrate the

medical device performs as intended, and for all other 60601 standards this is Basic

Safety and Essential Performance.

• The compliance level for each emissions and immunity test.

• The use of any deviations from, or allowances specified by, the referenced standards.

• Precautions regarding sources of EM energy that:

• emit levels of EM energy that exceed the immunity test levels of the referenced

EMC standards used, or

• have other emission characteristics to which the medical device has not been

tested for immunity.

• Specifications of the wireless communication for medical devices with RF wireless

functions.

• Any maintenance instructions needed to ensure that the medical device remains safe

and performs as intended with regard to EM disturbances throughout the expected

service life.

• Markings affixed to the medical device and warnings for certain types of known EM

environments, such as in or near an MRI scanner. Medical devices intended for use in

the MR environment that have not been shown to be MR Safe or MR Conditional

should be marked with the ASTM F2503 symbol for MR Unsafe. (See ASTM F2503-

13 Standard Practice for Marking Medical Devices and Other Items for Safety in the

Magnetic Resonance Environment.)

• The FCC term “harmful interference” has a meaning that is different from that of the

term “harm” as used in medical device risk management and ANSI/AAMI/ISO 14971

Medical devices - Application of risk management to medical devices. To avoid

confusion and concern regarding the FCC term, we recommend adding the note

specified below after the FCC warning in the labeling:

• NOTE: “Harmful interference” is defined in 47 CFR §2.1

by the FCC as

follows: Interference which endangers the functioning of a radionavigation

service or of other safety services or seriously degrades, obstructs, or repeatedly

interrupts a radio communication service operating in accordance with the [ITU]

Radio Regulations.

The labeling specifications of IEC 60601-1-2:2020 and IEC TR 60601-4-2:2016 are in Clause 5 and summarized

in Annex B.

Available at https://www.govinfo.gov/content/pkg/CFR-2018-title47-vol1/xml/CFR-2018-title47-vol1-sec2-1.xml

Contains Nonbinding Recommendations

V. EMC Information to Support Investigational Device

Exemption (IDE) or Investigational New Drug (IND)

Submissions

When evaluating EMC of a medical device in an IDE or IND submission, we recommend that

you consider all applicable points detailed in Section IV of this guidance that are applicable to

patient and operator safety. We recognize that there are often iterations to the design of the

medical device during a clinical study, and thus comprehensive EMC testing to consensus

standards might not be the least burdensome approach to demonstrate EMC. Other appropriate

EMC mitigations can be used to support a favorable benefit/risk determination.

If immunity

testing has not been performed using appropriate consensus standards (see Section IV.C) for the

medical device under study, you should provide in the IDE or IND submission, a description of

alternative mitigations, such as ad-hoc testing and a list of labeling mitigations (e.g., continuous

oversight from medical professionals, procedures to prevent harm to operators, ESD mitigation

precautions) along with an explanation of how the mitigations protect the safety of patients and

operators. If emissions testing has not been performed for the medical device under study per

appropriate consensus standards, then you should provide in the IDE or IND submission a

description of potential risks to patients and operators in case the subject medical device

introduces excessive emissions that might interfere with other medical or non-medical

equipment. This should include a justification about how each risk will be mitigated.

For more information see the FDA guidance “Factors to Consider When Making Benefit-Risk Determinations for

Medical Device Investigational Device Exemptions” at

https://www.fda.gov/regulatory-information/search-fda-

guidance-documents/factors-consider-when-making-benefit-risk-determinations-medical-device-investigational-

device

Contains Nonbinding Recommendations

Appendix A – Examples of Typical Medical Device Locations within Intended Use

Environments

Professional Healthcare

Facility Environment

Home Healthcare Environment

Special Environment

• Physician offices

• Outpatient facilities

• Dental offices

• Clinics

• Nursing homes

• Hospital facilities including

emergency rooms, patient

rooms, intensive care,

surgery rooms, etc., (except

areas with high-powered

medical equipment)

• Limited care facilities

• Surgical centers

• Birthing centers

• Laboratories

• Personal residences

• Dormitories

• Independent living retirement

homes

• Restaurants and cafes

• Shops, stores, markets

• Cars, buses, trains, boats,

ambulances

• Office buildings

• Schools

• Churches

• Libraries

• Theaters and stadiums

• Outdoor environments (e.g.,

streets, sidewalks, parks)

• Medical treatment areas with high-

powered medical equipment

o (e.g., high-frequency surgical

equipment, short-wave therapy

equipment, inside the RF

shielded room of an MRI

system)

• Military areas (e.g., submarines,

radar installations, weapons

control systems)

• Heavy industrial areas (e.g., power

plants, steel and paper mills,

foundries, automotive and

appliance manufacturing, smelting

and mining operations, oil and gas

refineries)

• Aircraft environments (e.g.,

planes, helicopters)

a) Facilities where outpatient services, i.e., medical procedures or tests that can be performed without an overnight

stay, can be performed (e.g., medical center, rehabilitation center).

b) Refer to the SIS for the scope of FDA’s recognition of IEC 60601-1-11 Medical electrical equipment - Part 1-11:

General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical

electrical equipment and medical electrical systems used in the home healthcare environment. The FDA considers

nursing homes in the United States to be Professional Healthcare Facilities because professionals with medical

training are available when patients are present.

c) Laboratories have operators with medical training or operators without medical training. For the purpose of this

guidance, we include laboratories under the Professional Healthcare Facility Environment in either case. This is

because, in the latter case, there are generally no patients. According to IEC 60601-1-11, a patient is necessary to be

included in the Home Healthcare Environment.

d) Although healthcare professionals are present in an ambulance, the EM environment is similar to that of the

Home Healthcare Environment.

e) IEC 60601-1-2 includes aircraft in the Home Healthcare Environment while referencing RTCA DO-160G for

higher immunity test levels. Since the test levels are potentially different than the Home Healthcare Environment,

aircraft is included in the Special Environment (see Section IV.C(3)for more details).

Adapted from IEC 60601-1-2 with modification

See definitions from FDA Guidance, “Design Considerations for Devices Intended for Home Use,” available at

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-devices-

intended-home-use.