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1 Electromagnetic Compatibility (EMC)

2 of Medical Devices
3 ______________________________________________________________________________

4 Draft Guidance for Industry and

5 Food and Drug Administration Staff
6
7 DRAFT GUIDANCE
8 This draft guidance document is being distributed for comment purposes
9 only.
10
11 Document issued on November 17, 2020.
12
13
14 You should submit comments and suggestions regarding this draft document within 60 days of
15 publication in the Federal Register of the notice announcing the availability of the draft
16 guidance. Submit electronic comments to https://www.regulations.gov. Submit written
17 comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
18 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with the docket number
19 listed in the notice of availability that publishes in the Federal Register.
20
21 For questions about this document, Division of Biomedical Physics, Office of Science and
22 Engineering Laboratories at (301) 796-2580 or Seth Seidman at (301) 796-2477 or by email at
23 [email protected].
24
25 When final, this guidance will supersede “Information to Support a Claim of
26 Electromagnetic Compatibility (EMC) of Electrically-Powered Medical
27 Devices,” issued July 11, 2016.
28
29
30 U.S. Department of Health and Human Services
31 Food and Drug Administration
32 Center for Devices and Radiological Health
33 Center for Biologics Evaluation and Research
34

35

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36 Preface
37
38
39 Additional Copies
40
41 CDRH
42 Additional copies are available from the Internet. You may also send an e-mail request to
43 [email protected] to receive a copy of the guidance. Please use the document
44 number 16040 and complete title of the guidance in the request.
45
46 CBER
47 Additional copies are available from the Center for Biologics Evaluation and Research (CBER),
48 Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,
49 Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-
50 8010, by email, [email protected] or from the Internet at https://www.fda.gov/vaccines-blood-
51 biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.
52

53

54

55

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56 Table of Contents
57
58 I. Introduction ............................................................................................................................. 4
59 II. Scope ....................................................................................................................................... 5
60 III. Overview .............................................................................................................................. 5
61 IV. EMC Information for Premarket Submissions .................................................................... 6
62 A. EMC-Related Device Characteristics and Intended Use Environments .......................... 6
63 B. Assessment of Medical Device Risks .............................................................................. 7
64 C. Consensus Standards ........................................................................................................ 8
65 (1) Non-implantable Medical Devices ............................................................................... 9
66 (2) Active Implantable Medical Devices (AIMDs).......................................................... 10
67 (3) Special Environments ................................................................................................. 10
68 D. Essential Performance and Immunity Pass/Fail Criteria ................................................ 10
69 (1) Essential Performance ................................................................................................ 11
70 (2) Immunity Pass/Fail Criteria ........................................................................................ 11
71 E. Medical Device Configuration and Functions Tested .................................................... 12
72 F. Results of EMC Testing ................................................................................................. 14
73 G. Allowances ..................................................................................................................... 15
74 H. Deviations....................................................................................................................... 15
75 I. Modifications ................................................................................................................. 15
76 J. Common EM Emitters ................................................................................................... 16
77 K. Labeling.......................................................................................................................... 17
78 V. EMC Information to Support an Investigational Device Exemption (IDE) Submission ...... 18
79
80
81

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82 Electromagnetic Compatibility (EMC)

83 of Medical Devices
84 ______________________________________________________________________________

85 Draft Guidance for Industry and

86 Food and Drug Administration Staff
87
88 This draft guidance, when finalized, will represent the current thinking of the Food and Drug
89 Administration (FDA or Agency) on this topic. It does not establish any rights for any person
90 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the
91 requirements of the applicable statutes and regulations. To discuss an alternative approach,
92 contact the FDA staff or Office responsible for this guidance as listed on the title page.
93

94 I. Introduction
95 The Food and Drug Administration (FDA) has developed this guidance document to recommend
96 information that should be provided in a premarket submission (i.e., premarket approval (PMA)
97 application, humanitarian device exemption (HDE), biologics license application (BLA),
98 premarket notification (510(k)) submission, investigational device exemption (IDE) and De
99 Novo request) to demonstrate electromagnetic compatibility (EMC) for electrically powered
100 medical devices and medical devices with electrical or electronic functions. Typically, the review
101 of EMC information in a submission is based on the risk associated with malfunction or
102 degradation of the medical device under consideration, where malfunction or degradation could
103 be caused by inadequate EMC. The review is also based on the use of appropriate consensus
104 standards. This draft guidance, when final, will replace the FDA guidance, “Information to
105 Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical
106 Devices” (hereafter referred to as the 2016 EMC guidance), published July 11, 2016. This draft
107 guidance is not intended to change current policy, but provides additional technical information
108 to address the recommendations in the 2016 EMC guidance.
109
110 For the current edition of the FDA-recognized consensus standard(s) referenced in this
111 document, see the FDA Recognized Consensus Standards Database.1 For more information
112 regarding use of consensus standards in regulatory submissions, please refer to the FDA
113 guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions
114 for Medical Devices.”2
115

1
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
2
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices

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116 FDA's guidance documents, including this draft guidance, do not establish legally enforceable
117 responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
118 be viewed only as recommendations, unless specific regulatory or statutory requirements are
119 cited. The use of the word should in Agency guidance means that something is suggested or
120 recommended, but not required.
121

122 II. Scope

123 This draft guidance applies to medical devices and accessories3 that:
124 · are electrically powered; or
125 · have functions or sensors that are implemented using electrical or electronic circuitry.
126

127 III. Overview

128 For the purpose of this document, EMC is defined as the ability of a medical device to function
129 safely and effectively in its intended electromagnetic (EM) environment, including immunity to
130 EM disturbances (i.e., interference)4, without introducing excessive EM disturbances (i.e.,
131 emissions) that might interfere with other equipment. Immunity is the ability to protect against
132 unacceptable degradation due to EM disturbances such as radio waves, power surges, radio-
133 frequency (RF) disturbances, and electrostatic discharge (ESD). Interference can cause medical
134 devices to not perform as intended and lead to hazardous situations, such as delays or errors in
135 diagnosis, treatment, or monitoring that can result in serious injury or death. Emissions limits are
136 established to protect radio services and minimize interference to other equipment, both medical
137 and non-medical.
138
139 The IEC 60601/806015 series of standards apply to devices used in patient care settings, while
140 the IEC 61010-1 series applies to devices used in laboratory settings. These standards are used in
141 the majority of premarket submissions for electrically powered medical devices to support device
142 safety. These standards take an ‘all-hazards approach’ to device safety, encompassing electrical,
143 mechanical, and radiation hazards, among others, in addition to hazards posed by the
144 environment of use. Besides addressing the wide range of generic safety requirements, the IEC
145 60601/80601 and IEC 61010 series include close to 100 “particular standards” with safety
146 requirements for specific types of devices, such as clinical thermometers, infusion pumps, infant
147 incubators, and laboratory centrifuges. There are also consensus standards for active implantable
148 medical devices that include information on EMC.
149
3
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
4
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.
5
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.

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150 For electrically powered medical devices and medical devices with electrical or electronic
151 functions, sponsors should provide evidence that the medical device is safe and performs as
152 intended in the environments of use. This evidence includes risk management with regard to EM
153 disturbances, testing, labeling, and other documentation, as recommended in this guidance. To
154 facilitate premarket submissions and reviews for EMC, we recommend sponsors include the
155 information listed in Section IV. Section V contains additional information specific to IDE
156 submissions.

157 IV. EMC Information for Premarket Submissions

158 To facilitate the review of EMC information in premarket submissions, we recommend sponsors
159 include the information listed in subsections A-K below in the EMC section of the submission,
160 labeled with the section headings in the same order as they are listed in this guidance. If test
161 reports or test report summaries (e.g., Accreditation Scheme for Conformity Assessment
162 Summary Test Report6) include any of the recommended information below, the specific
163 location within these documents should be noted in the EMC section of the submission.
164 A. EMC­Related Device Characteristics and Intended Use
165 Environments
166 We recommend that the sponsor provide a description of all EMC-related device
167 characteristics and intended use environments including:
168
169 · an overview of the device and its functions and modes, including block diagrams,
170 photographs, cables, accessories, and device interoperability;
171 · a description of the power supply (i.e., mains-powered only, battery-powered only,
172 mains and battery-powered) and if the medical device can be used while charging;
173 · a statement regarding the environments in which the medical device is intended to be
174 used (i.e., professional healthcare facility environment, home healthcare environment,
175 magnetic resonance environment, transport/ambulatory environment, other/special
176 environment);
177 · a description of any wireless technology (for additional considerations regarding
178 wirelessly-enabled medical devices, refer to FDA guidance, Radio Frequency
179 Wireless Technology in Medical Devices);7 and
180 · a description of any specific RF emitters in the medical device that could be sources
181 of EM disturbances.
182
6
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
7
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-
wireless-technology-medical-devices-guidance-industry-and-fda-staff.

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183 Specifying the intended use environments provides important information to determine
184 the appropriate testing for expected EM disturbances. For the purposes of this guidance
185 and EMC evaluation, we categorize the intended use environments into one (or more) of
186 the following environments:
187
188 · Professional Healthcare Facility Environment: any environment where personnel with
189 medical training are continually available to oversee or administer the use of medical
190 devices. This includes, but is not limited to, hospitals, long-term care facilities,
191 nursing homes, emergency medical services, clinics, physicians’ offices, outpatient
192 treatment facilities, and clinical laboratories.
193 · Home Healthcare Environment: any environment where personnel with medical
194 training are not continually available to oversee or administer the use of medical
195 devices. This includes, but is not limited to, outdoor environments, office
196 environments, schools, vehicles, emergency shelters, and independent living
197 retirement homes.
198 · Special Environment: any environment with EM characteristics different from those
199 specified in EMC consensus standards. This includes, but is not limited to, aircraft,
200 military areas, heavy industrial areas, medical treatment areas with high-powered
201 medical devices such as magnetic resonance imaging (MRI).
202
203 See Appendix A for examples of typical medical device locations for each of the three
204 intended use environments mentioned above.
205
206 When considering the intended use environments, we recommend addressing common
207 EM emitters and unique medical emitters. These emitters are listed and discussed in
208 detail in subsection J below.
209 B. Assessment of Medical Device Risks
210 We recommend that sponsors provide a summary description of the risks associated with
211 malfunction, disruption, or degradation of the performance of the subject medical device
212 due to EM disturbances. This should include each potential malfunction, disruption, or
213 degradation due to electromagnetic interference (EMI) that could cause harm to the
214 patient, user or operator. This summary should categorize the severity of each harm into
215 the following three levels based upon FDA guidance, “Factors to Consider Regarding
216 Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement
217 Decisions Guidance for Industry and FDA Staff”8:
218
219 · Medical device-related deaths and serious injuries9 include events (including
220 procedure-related complications) in the use of the medical device that have caused or
221 could cause or contribute to a death or injury or illness that is life-threatening, results

8
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-regarding-benefit-
risk-medical-device-product-availability-compliance-and
9
See 21 CFR 803.3(w)

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

223 intervention to prevent permanent harm to the body.
224 · Medical device-related non-serious adverse events include events (including
225 procedure-related complications) in the use of the medical device that have caused or
226 could cause or contribute to minor, temporary or medically reversible injuries that do
227 not meet the criteria for classification as a medical device-related serious injury.
228 · Medical device-related events without reported or potential harm include medical
229 device nonconformities that have no related harm, medical device malfunctions that
230 have no related harm, and procedure-related complications with no related harm.
231
232 These considerations should be used in determining the immunity pass/fail criteria (see
233 Section IV(D)) and in addressing EMI caused by common EM emitters (see Section
234 IV(J)). For the 60601 series of standards, a risk analysis is used to determine the Essential
235 Performance,10 upon which the immunity pass/fail criteria are based, as well as other
236 aspects of EMC testing (e.g., additional modulation frequencies).
237 C. Consensus Standards
238 We recommend that the sponsor provide a summary describing all voluntary consensus
239 standards used to evaluate EMC. We recommend that EMC tests be performed using
240 methods described in FDA-recognized consensus standards that are appropriate for the
241 medical device. If a sponsor choses to declare conformity to a standard, we recommend
242 providing the supporting information described in this guidance and consistent with the
243 FDA guidance “Appropriate Use of Voluntary Consensus Standards in Premarket
244 Submissions for Medical Devices.”11 The extent of FDA recognition of a consensus
245 standard is included in the supplemental information sheet (SIS) published in the FDA
246 Recognized Consensus Standards Database.12 The “Extent of Recognition” section of the
247 SIS can specify an acceptable deviation or non-recognized clauses from the published
248 standard. The “Transition” section of the SIS can specify the date at which recognition of
249 one edition of a standard is superseded by the next edition. A cleared or approved device
250 does not need to be assessed or submitted again as a result of any changes to a recognized
251 EMC consensus standard.13
252
253 If the consensus standard(s) referenced in the submission are not recognized by FDA,14
254 sufficient justification should be provided regarding how the EMC testing performed
255 adequately addresses EMC, based on the medical device’s functions, modes, indications
10
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 subsection D below for more details.
11
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices
12
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
13
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” guidance available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices.
14
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” guidance.

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256 for use, intended use, and intended use environments. If no consensus standard exists for
257 a certain medical device type, we recommend specific EMC testing be performed based
258 on foreseeable EM disturbances in the intended use environments. We recommend
259 referencing an existing recognized consensus standard for a similar medical device type
260 and environment, and modifying the test specifications in the standard to address the
261 subject medical device. Each change in test specification should be documented and
262 accompanied by justification.
263
264 When using consensus standards, we recommend verifying that the intended use
265 environments are adequately addressed by the standards. Many consensus standards only
266 address and specify test levels for the home healthcare environment and the professional
267 healthcare facility environment.
268
269 The medical device configuration and intended use environments can determine the
270 applicability of FDA-recognized consensus standards for EMC. These can be generalized
271 into one or more of the following three categories:

272 (1) Non-implantable Medical Devices

273 The ANSI/AAMI/IEC 60601-1-2 Medical electrical equipment – Part 1-2: General
274 requirements for basic safety and essential performance – Collateral Standard:
275 Electromagnetic disturbances – Requirements and tests is a collateral standard to the
276 ANSI/AAMI ES 60601-1 Medical electrical equipment - Part 1: General requirements
277 for basic safety and essential performance standard and is recognized by FDA for testing
278 of non-implantable medical devices that are within its scope. The 60601-1-2 consensus
279 standard provides details about testing medical devices for safety with regard to EM
280 disturbances based on the Basic Safety15 and Essential Performance of the medical
281 device, the medical device design, and the intended use environments.
282
283 When using any consensus standard, careful consideration to the scope is critical. For
284 example, the scope of 60601 standards is limited to medical device safety. Evaluation of
285 medical device effectiveness is generally not within the scope of 60601 standards. This is
286 discussed in detail in subsection D(2) below.
287
288 There are over 80 particular consensus standards (e.g., IEC 60601-2-X, ISO 80601-2-X)
289 that cover a wide variety of medical devices. These particular consensus standards
290 augment or supersede the specifications in 60601-1-2 and can provide more detailed or
291 alternative EM test specifications. However, not all particular consensus standards are
292 FDA recognized at the time of this guidance publication, and the EMC specifications in
293 these particular standards should be assessed to ensure that they are appropriate for the
294 medical device’s functions, modes, indications for use, intended use, and intended use
295 environments.

15
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.”

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296
297 Most in vitro diagnostic devices (IVDs) are outside the scope of 60601-1-2. In the
298 absence of a recognized EMC standard for IVDs16 at the time of this guidance
299 publication, we recommend using the test methods in IEC 61326:2-6, using acceptance
300 criteria specific to the device’s functions and intended use, and using the test levels
301 specified by 60601-1-2 for the device’s intended use environment.

302 (2) Active Implantable Medical Devices (AIMDs)

303 AIMDs are outside the scope of 60601-1-2. However, for AIMD systems, we recommend
304 that the non-implantable subsystems (e.g., pacemaker programmer) be tested to
305 consensus standards appropriate for non-implantable devices (e.g., 60601-1-2).
306 Consensus standards such as ISO 14117 Active implantable medical devices --
307 Electromagnetic compatibility -- EMC test protocols for implantable cardiac
308 pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization
309 devices and the ISO 14708 series are often referenced to address EMC for AIMDs.
310
311 EMC consensus standards for AIMDs focus on specific EM phenomena to address the
312 immunity of the medical device in consideration of the types of EM disturbances that the
313 medical device is likely to encounter. For example, cardiac implantable electronic device
314 consensus standards (e.g., ISO 14117) include immunity testing for exposure to
315 defibrillation devices, which inject high-energy electrical signals into the heart for life-
316 saving functions.

317 (3) Special Environments

318 It is important to understand the scope and limitations of each standard. For example,
319 60601-1-2 is generally applicable to both the home healthcare environment and the
320 professional healthcare facility environment. However, if a medical device is intended to
321 be used in a special environment, we recommend that you provide additional EMC
322 information and perform testing for that environment. This could be achieved by
323 referencing appropriate standards for each special environment. For example, we
324 recommend testing to RTCA DO-160 Environmental Conditions and Test Procedures for
325 Airborne Equipment for non-implantable medical devices that are intended or expected to
326 be used in an aircraft environment. Similarly, the ISO 14708 series of consensus
327 standards does not adequately address AIMD use in a magnetic resonance environment
328 (e.g., exposure within the bore of an MRI system). Therefore, we recommend test
329 methods specific to this potentially high-risk environment, such as those described in
330 ISO/TS 10974 Assessment of the safety of magnetic resonance imaging for patients with
331 an active implantable medical device.
332
333 D. Essential Performance and Immunity Pass/Fail Criteria

16
IEC 61326-2-6:2012 is non-recognized by FDA (see
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/nr_results.cfm)

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334 We recommend that the sponsor provide clear immunity pass/fail criteria, and, if
335 applicable, a clear statement of the device’s Essential Performance. The Essential
336 Performance and immunity pass/fail criteria are fundamental to performing and assessing
337 the adequacy of EMC testing to demonstrate that the medical device is safe and performs
338 as intended.

339 (1) Essential Performance

340 Essential Performance is defined in ANSI/AAMI/ES 60601-1:2005 as “performance of a
341 clinical function, other than that related to Basic Safety, where loss or degradation
342 beyond the limits specified by the manufacturer results in an unacceptable risk. Note:
343 Essential Performance is most easily understood by considering whether its absence or
344 degradation would result in an unacceptable risk.” If a sponsor references 60601-1-2,
345 60601-2-X, or 80601-2-X, the sponsor should specify the Essential Performance of the
346 medical device. Essential Performance should be specific to each medical device and be
347 determined by the sponsor by assessing the risk to the patient. The Essential Performance
348 should be determined by:
349
350 · identifying the performance of the clinical functions,
351 · specifying performance limits for fully functional performance versus loss or
352 degradation of the identified performance, and
353 · evaluating the risk from the loss, disruption, deviation, degradation, or over-delivery
354 of the identified performance.
355
356 If the resulting risk is determined to be unacceptable, then the identified performance is
357 Essential Performance.
358
359 It is also possible for a medical device to have no Essential Performance. A determination
360 of no Essential Performance should be accompanied by scientific justification and risk
361 analysis. Even for medical devices that have no Essential Performance, appropriate
362 immunity pass/fail criteria should be used to demonstrate that the device is safe and
363 performs as intended.
364
365 See informative annex “General guidance and rationale” of ANSI/AAMI ES 60601-1 and
366 AAMI CR500:2019 Basic Introduction to the IEC 60601 Series for additional
367 information regarding Essential Performance.

368 (2) Immunity Pass/Fail Criteria

369 Immunity pass/fail criteria should address degradation of the medical device’s functions
370 caused by a test disturbance that are considered acceptable, and should be developed and
371 documented in the EMC test plan prior to testing. We recommend that the sponsor
372 specify detailed immunity pass/fail criteria that are (1) quantitative, (2) specific to the
373 medical device and functions, and (3) observable. These criteria should be determined
374 based on the medical device’s functions, modes, indications for use, intended use, and
375 Essential Performance (if applicable). If a medical device has multiple medical device

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376 subsystems (e.g., an AIMD with active external parts) or more than one function (e.g., a
377 ventilator with physiological monitoring), then each medical device subsystem or
378 function can have specific immunity pass/fail criteria. We recommend that the sponsor
379 specify how the immunity pass/fail criteria were derived, quantified, and monitored, and
380 justify how they demonstrate that the medical device remains safe and performs as
381 intended.
382
383 Immunity pass/fail criteria can be different for transient EM phenomena and for
384 continuous EM phenomena. Transient phenomena include ESD, electrical fast
385 transients/bursts, surges, and voltage dips and interruptions. Continuous phenomena
386 include conducted and radiated RF disturbances and power-frequency magnetic fields.
387 For transient phenomena, it might be acceptable that the medical device provides the
388 specified performance after application of the test disturbance. A recovery time can be
389 acceptable and should be specified based on the risk analysis. For continuous phenomena,
390 the medical device should provide the specified performance during and after application
391 of the test disturbance.
392
393 Some EMC test standards list general examples of immunity pass/fail criteria for a
394 medical device or general descriptions of immunity pass/fail criteria (e.g., Performance
395 Criterion A, Operates as Intended). However, these general immunity pass/fail criteria are
396 not sufficiently specific to the medical device’s functions, modes, indications for use,
397 intended use, and Essential Performance (if applicable). Even devices with the same
398 hardware could have different immunity pass/fail criteria. For example, immunity
399 pass/fail criteria for a ventilator for adult patients would be expected to be different from
400 that for neonatal patients because of the different physiological characteristics of the
401 intended use populations.
402
403 If a submission references a standard in the 60601 family of standards, then the immunity
404 pass/fail criteria should address both Basic Safety and Essential Performance. Many
405 particular standards (e.g., 60601-2-X) specify the Essential Performance and some
406 specify immunity pass/fail criteria. As noted in subsection C(1) above, the scope of
407 60601 standards is limited to safety. Therefore, we recommend that the immunity
408 pass/fail criteria include considerations to demonstrate that the device performs as
409 intended. We recommend conforming to IEC TR 60601-4-2 Medical electrical
410 equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity:
411 performance of medical electrical equipment and medical electrical systems to assess the
412 immunity of the performance associated with the intended use because the test methods
413 are similar to 60601-1-2 and can be tested at the same time.
414
415 See IEC 60601-1-2 informative annex “Identification of IMMUNITY pass/fail criteria”
416 for additional information and examples on determination of specific immunity pass/fail
417 criteria.
418 E. Medical Device Configuration and Functions Tested

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419 We recommend that the sponsor provide a detailed description of the medical device
420 under test, including the configuration, functions, modes, and settings that were tested.
421 We recommend testing all functions and modes that include a feature or control such that
422 the failure or malfunction could cause the medical device to present an unacceptable risk
423 or to not achieve its intended use. The description of the device under test should include
424 the medical device name, model number, manufacturer, and an indication of whether the
425 device is the final production-ready medical device currently under review.
426
427 We recommend that the sponsor perform EMC testing for each new device, as well as
428 devices with significant changes or added functions or features that might alter the EMC
429 of the medical device. If the device tested is not the final finished device, the description
430 of the device under test should include an explanation and scientific justification of how
431 test results are applicable to the final finished device. When leveraging EMC test results
432 from a prior or different medical device model/version to another model/version, we
433 recommend that sponsors:
434
435 · identify and summarize all modifications or changes from the previously tested
436 medical device and include any changes in the medical device’s indications, intended
437 use, and intended use environments,
438 · provide an analysis of whether each modification could affect EMC of the medical
439 device, and
440 · assess whether the consensus standard used for the prior EMC testing has been
441 superseded/replaced by a revised version.
442
443 New EMC testing should be performed if any of the analyses of the device differences
444 indicate that the prior testing might not support the EMC of the updated medical device
445 model/version. We also recommend applying these considerations when sponsors
446 perform EMC testing on only a subset of models within a product family.
447
448 We recommend that the sponsor consider the following to help determine the appropriate
449 device configuration(s) for testing:
450
451 · The device should be tested as a system with all medical device accessories,
452 components, and subsystems connected and functioning as intended. If non-medical
453 equipment is used in a medical system and could affect the ability of the medical
454 device to meet the immunity pass/fail criteria, the non-medical equipment should also
455 be tested as part of the medical device system. Examples of non-medical equipment
456 include mobile phones, tablets, and computers. Any non-medical equipment, medical
457 device accessories, or subsystems not included in the EMC test should be listed with
458 a rationale for why they were not tested. You should provide a scientific justifications
459 for how the test configuration demonstrates EMC of the entire medical device system.
460 · If a medical device has multiple subsystems or accessories (e.g., a left ventricular
461 assist device (LVAD) that includes an implantable blood pump and external
462 controller), or more than one function (e.g., a ventilator with physiological
463 monitoring), then the medical device system test specifications should consider all

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

465 functions. This can be used to formulate an appropriate superset of test
466 specifications.
467 · If EMC testing is performed on a subsystem basis, each subsystem not included in the
468 testing should be simulated, including any potential third-party medical devices or
469 connections.
470 · Medical device and test or ancillary equipment should be configured in the modes
471 and with settings considered to be representative of the medical device’s intended
472 use. For example, a medical device that can operate in battery power mode and in
473 mains power mode should be tested in both modes. Additionally, batteries with
474 embedded electronic circuitry (i.e., smart batteries) that are intended to be handled by
475 the user should be removed from the medical device and tested separately for
476 immunity to ESD due to the potential of ESD damaging the circuitry of the battery.
477 · Patient simulators should be used where specified by the referenced EMC consensus
478 standards or as appropriate for the medical device. For example, certain EMC test
479 methods for AIMDs specify that the medical device be submerged in a saline
480 phantom with specific conductivity. Other consensus standards such as 60601-1-2
481 specify that patient coupled medical devices be electrically loaded in a way that
482 simulates a patient and be provided with electrical or mechanical signals that simulate
483 a patient.
484 · If wireless technology is used in the medical device to achieve its intended use, the
485 wireless technology should be “on” and communicating with other medical device
486 subsystems or ancillary equipment during EMC testing. This is important because
487 having active connections at each antenna could affect whether the subject medical
488 device operates as intended when exposed to EM disturbances.
489
490 The sponsor should also include a description of how the medical device was monitored
491 during EMC testing. Monitoring methods should include a means to quantitatively
492 observe performance associated with the immunity pass/fail criteria without significant
493 perturbation or effect on the test being performed or to the device under test.
494 F. Results of EMC Testing
495 We recommend that the sponsor provide a summary of EMC testing. This information
496 should summarize the medical device emissions and the immunity to EM disturbances at
497 test levels appropriate for the medical device’s intended use environments. If neither the
498 test methods nor the acceptance criteria are well-defined in the EMC consensus
499 standard(s), we recommend that information requested in this guidance be supported by
500 the inclusion of EMC test reports.17 We recommend that the summary of EMC testing
501 include the following:
502
503 · Name and location of the test facility, the date of the testing.

17
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices

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504 · Results for each emissions test. Pass/Fail criteria should be expressed in terms of
505 limits, against which the medical device’s measured emissions are compared and
506 should not exceed.
507 · Results for each immunity test performed (e.g., ESD, voltage dips, radiated
508 immunity). This should include any degradations that were observed during and after
509 each immunity test for continuous phenomena and after each immunity test for
510 transient phenomena. For all degradations, the sponsor should detail how the medical
511 device continued to meet the immunity pass/fail criteria and if any additional
512 mitigations will be implemented.
513 G. Allowances
514 Allowances are specifications within a standard that permit well-defined or conditional
515 variations of, or exemptions from, certain requirements of the standard. In general, an
516 allowance of a standard can include the test setup, test methodology, immunity test
517 levels, or immunity test modulations. For example, a consensus standard might provide
518 an exemption from certain immunity and emissions tests that are applicable for
519 permanently installed large medical electrical equipment or medical electrical systems
520 with a rated input current more than 16 A per phase. We recommend that the sponsor
521 provide a description of all allowances used, with justification to support the use of each
522 allowance. The allowance should only be used if all the specified conditions of the
523 allowance are satisfied. The use of allowances should not increase risks to patients or
524 operators. If the conditions for use of an allowance cannot be justified, then the allowance
525 should not be used.
526 H. Deviations
527 A deviation from a standard is when a requirement of the consensus standard is
528 intentionally not satisfied, or testing is performed in an alternative way other than that
529 specified and allowed in the standard. The difference between a deviation and an
530 allowance is that an allowance is specified in a standard, whereas a deviation is not. We
531 recommend that the sponsor provide a description of all deviations used along with
532 justification to support the use of each deviation. Deviations from a referenced consensus
533 standard should be supported with justification that explains how the deviation would not
534 adversely impact the safety or performance of the medical device.
535 I. Modifications
536 If the device was modified or altered to pass the EMC testing, such as after initial EMC
537 test failure, then we recommend that the sponsor include a description and analysis of
538 those medical device modifications. Many types of modifications can alter medical
539 device EMC, including hardware, software, firmware, and even cosmetic changes (e.g.,
540 use of a metallic material for labeling where the prior labeling was non-conductive).
541 Some common device modifications made to pass EMC testing include incorporating
542 ferrite beads, adding filters or EMC shielding materials, and changes or updates to
543 firmware or software. When a medical device is modified to pass EMC testing, we
544 recommend the following information be provided:

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545
546 · A description of all changes or modifications that were made to the medical device in
547 order to pass EMC testing.
548 · A statement whether the provided EMC test results occurred before or after the
549 modifications were incorporated into the medical device. If EMC testing was not
550 performed after the modifications were made to the medical device, a justification
551 should be provided that the modified medical device does not adversely impact the
552 safety or performance of the medical device.
553 · A statement indicating that the changes will be incorporated into the final finished
554 medical device prior to marketing; the changes must be documented in the design
555 history file in accordance with design controls18.
556 · An analysis as to whether these modifications might impact other aspects of the
557 medical device safety or performance, such as whether they increase risks to patients
558 or operators, alter the biocompatibility or sterility, affect electrical safety, or introduce
559 software anomalies/defects.
560 J. Common EM Emitters
561 Certain emitters commonly found in some use environments might not be adequately
562 addressed by FDA-recognized consensus standards. This could be because a consensus
563 standard specifies a range of frequencies that omits some bands, such as emitters in the
564 kHz range, or it could be because a technology is adopted so quickly that consensus
565 standards cannot keep up with the rapidly changing EM environment. Sponsors should be
566 familiar with their intended use environments and reasonably foresee the potential for
567 interference from emitters commonly found in those environments.
568
569 At the time of publication of this guidance, some examples of common EM emitters not
570 adequately addressed by FDA-recognized consensus standards are radio-frequency
571 identification (RFID) readers, electronic security systems (e.g., metal detectors, electronic
572 article surveillance), near-field communications (NFC) systems, wireless power transfer
573 (WPT) and unique medical emitters such as electrocautery, MRI, electrosurgical units,
574 and diathermy equipment. The EM disturbances caused by these emitters should be taken
575 into account during the risk management process.
576
577 We recommend mitigating these common EM emitters and unique medical emitters
578 based on the intended use environments and the potential severity of harm the medical
579 device could cause (see subsection B above). For medical devices in the risk category
580 “Medical device-related events without reported or potential harm,” we recommend that
581 the medical device labeling (e.g., user manual, instructions for use) mention the potential
582 for EMI from emitters expected to be nearby. If the sponsor makes specific claims or
583 specifies a specific intended use regarding any particular emitter, we recommend that
584 those claims be supported with additional testing. For medical devices in the risk
585 category “Medical device-related deaths and serious injuries” or “Medical device-related
586 non-serious adverse events” we recommend that:

18
21 CFR 820.30
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587
588 · testing be performed according to FDA-recognized consensus standards (e.g., FDA-
589 recognized AIM 7351731 Medical Electrical Equipment and System Electromagnetic
590 Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM
591 Standard for RFID emitters), or equivalent EMC test methods, with justification. If
592 no consensus standards exist, specific immunity testing should be performed to
593 demonstrate that the medical device is safe with regard to each identified emitter that
594 is foreseeable in the intended use environment; and
595
596 · labeling be specific to the risks to patients and operators and include any mitigations
597 and warnings needed, based on the test results.
598 K. Labeling
599 It is important to include EMC-related information in the labeling because EMC testing
600 alone may be insufficient to mitigate the risk associated with use in all environments. For
601 example, EMC specifications in the labeling can help end users select equipment with
602 electromagnetic immunity that is compatible with the environments in which the device
603 is intended to be used, or to compare EMC characteristics of candidate equipment prior to
604 purchase. Providing EMC information in the labeling (e.g., Instructions for Use) can help
605 make users aware of the degradations that can be caused by EMI and to understand the
606 circumstances to avoid. We recommend that the submission include EMC information to
607 be included in the labeling to enable safe and effective installation and use of the medical
608 device in the intended EM environments over the expected service life. EMC-related
609 information can be presented as physical markings on the medical device related to EMC,
610 or in accompanying documents, such as instructions for use, user manual, and/or
611 technical and service manuals. The EMC-information included in the labeling should
612 meet the specifications of the referenced medical device consensus standards to which the
613 sponsor claims conformity (e.g., 60601-1-2, 60601-4-2).19 We recommend that the
614 medical device labeling include the following information related to EMC, consistent
615 with 60601-1-2:
616
617 · The environments of use for which the medical device is suitable to be used/exposed.
618 · The medical device’s functions/performance and a description of what the operator
619 can expect if the functions/performance are lost or degraded due to EM disturbances.
620 For 60601-4-2, these are the functions/performance needed to demonstrate the
621 medical device performs as intended, and for all other 60601 standards this is the
622 Essential Performance.
623 · The compliance level for each emissions and immunity test.
624 · The use of any deviations from, or allowances specified by, the referenced standards.
625 · Precautions regarding sources of EM energy that:
626 o emit levels of EM energy that exceed the immunity test levels of the referenced
627 EMC standards used, or

19
The labeling specifications of IEC 60601-1-2:2014 and IEC TR 60601-4-2:2016 are in Clause 5 and summarized
in Annex B.

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628 o have other emission characteristics to which the medical device has not been
629 tested for immunity.
630 · Specifications of the wireless communication for medical devices with RF wireless
631 functions.
632 · Markings affixed to the medical device and warnings for certain types of known EM
633 environments, such as in or near an MRI scanner. Medical devices intended for use in
634 the MR environment that have not been shown to be MR Safe or MR Conditional
635 should be marked with the ASTM F2503 symbol for MR Unsafe. (See ASTM F2503-
636 13 Standard Practice for Marking Medical Devices and Other Items for Safety in the
637 Magnetic Resonance Environment.)
638 · The FCC term “harmful interference” has a meaning that is different from that of the
639 term “harm” as used in medical device risk management and ANSI/AAMI/ISO 14971
640 Medical devices - Application of risk management to medical devices. To avoid
641 confusion and concern regarding the FCC term, we recommend adding the note
642 specified below after the FCC warning in the labeling:
643 · NOTE: “Harmful interference” is defined in 47 CFR §2.120 by the FCC as
644 follows: Interference which endangers the functioning of a radionavigation
645 service or of other safety services or seriously degrades, obstructs, or repeatedly
646 interrupts a radio communication service operating in accordance with the [ITU]
647 Radio Regulations.

648 V. EMC Information to Support an Investigational Device

649 Exemption (IDE) Submission
650
651 When evaluating EMC of a medical device in an IDE submission, we recommend that the
652 sponsor consider all applicable points detailed in Section IV of this guidance that are applicable
653 to patient and operator safety. We recognize that there are often iterations to the design of the
654 medical device during a clinical study, and thus comprehensive EMC testing to consensus
655 standards might not be the least burdensome approach to demonstrate EMC. Other appropriate
656 EMC mitigations can be used to support a favorable benefit/risk determination. 21 If immunity
657 testing has not been performed using appropriate consensus standards (see Section IV(c)) for the
658 medical device under study, the sponsor should provide in the IDE, a description of alternative
659 mitigations, such as ad-hoc testing and a list of labeling mitigations (e.g., continuous oversight
660 from medical professionals, procedures to prevent harm to operators, ESD mitigation
661 precautions) along with an explanation of how the mitigations protect the safety of patients and
662 operators. If emissions testing has not been performed for the medical device under study per
663 appropriate consensus standards, then the sponsor should provide in the IDE a description of
664 potential risks to patients and operators in case the subject medical device introduces excessive

20
Available at https://www.govinfo.gov/content/pkg/CFR-2018-title47-vol1/xml/CFR-2018-title47-vol1-sec2-1.xml
21
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

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665 emissions that might interfere with other medical or non-medical equipment. This should
666 include a justification about how each risk will be mitigated.

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667 Appendix A – Examples of Typical Medical Device Locations within Intended Use
668 Environments22
669
Professional Healthcare Home Healthcare Environment Special Environment
Facility Environment
· Physician offices · Personal residences · Medical treatment areas with high-
· Outpatient facilities · Dormitories powered medical equipment
· Dental offices · Independent living retirement o (e.g., high-frequency surgical
· Clinics homes equipment, short-wave therapy
· Nursing homesa) · Restaurants and cafes equipment, inside the RF
· Hospital facilities including · Shops, stores, markets shielded room of an MRI
emergency rooms, patient · Cars, buses, trains, boats, system)
rooms, intensive care, ambulancesc) · Military areas (e.g., submarines,
surgery rooms, etc. (except · Office buildings radar installations, weapons
areas with high-powered · Schools control systems)
medical equipment) · Churches · Heavy industrial areas (e.g., power
· Surgical centers · Libraries plants, steel and paper mills,
· Birthing centers foundries, automotive and
· Theaters and stadiums
· Laboratories b) appliance manufacturing, smelting
· Outdoor environments (streets,
and mining operations, oil and gas
sidewalks, parks)
refineries)
· Aircraft environments (e.g.,
planes, helicopters)

670 a) Refer to the SIS for the scope of FDA’s recognition of ISO 60601-1-11 Medical electrical equipment - Part 1-11:
671 General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical
672 electrical equipment and medical electrical systems used in the home healthcare environment. The FDA considers
673 nursing homes in the United States to be professional healthcare facilities because professionals with medical
674 training are available when patients are present23.
675 b) Laboratories have operators with medical training or operators without medical training. For the purpose of this
676 guidance, we include laboratories under the Professional Healthcare Facility Environment in either case. This is
677 because, in the latter case, there are generally no patients. According to IEC 60601-1-11, a patient is necessary to be
678 included in the Home Healthcare Environment.
679 c) Although healthcare professionals are present in an ambulance, the EM environment is similar to that of the home
680 healthcare environment.
681
682

22
Adapted from IEC 60601-1-2
23
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.

20