FDA Reviewer Guidance for PreMarket Notification Submissions
Test Plan Details
(ATTACHMENT)
Performance Criteria
This section details the system’s performance, what parameters are to be monitored, how to measure
them and what limits are acceptable. It is the customer's responsibility to provide all equipment
necessary for verifying the system’s performance, unless prior arrangements have been made with your
TÜV America Representative.
Standards to be Applied



FDA Reviewer Guidance for PreMarket Notification Submissions (November 1993)
EN 60601-1-2:1993
EN 60601-2-x (list part 2 requirements):
FDA Reviewer Guidance Performance Criteria
Compliance requirements are described in section (h) PERFORMANCE REQUIREMENTS ELECTRICAL and all sub-sections. Sections (h)(1) through (h)(6) are tests that are normally performed
by the product safety group at TÜV PS. Sub-sections under section (h)(7) include the performance
requirements for each electromagnetic compatibility test. Section (h)(7) mandates that these
requirements are to be met under normal operating conditions, and when recharging batteries (if
applicable), and when operating with the third-wire ground connection disconnected (if applicable). For
the EMC tests in the sub-sections to sections (h)(7), the performance criteria are summarized as follows:
 Emissions tests: operate within specification without emitting interference in excess of specified
limits
 ESD immunity: operate within specification within 5 seconds of any ESD discharge
 Other immunity: operate within specification during and after the test
Describe intended function(s) as specified:
Mode 1 (e.g. Standby):
Mode 2 (e.g. Normal):
Mode 3 (e.g. Upload):
General Information And Recommendations
The FDA Reviewer Guidance for Pre-market Notification Submissions [11/93] evolved from earlier
documents that were specific to apnea monitors. Some of the particular requirements were not
generalized when the scope of the document was expanded (i.e. - 10 second dwell during radiated
immunity test). Additionally, the FDA has indicated that products being tested to European requirements
do not necessarily need to be fully tested strictly according to both test procedures. Furthermore, the
FDA has shown flexibility in accepting reasonable deviations in the test procedure even for products not
intended for Europe.
However, some FDA reviewers may reserve the right to insist that testing strictly follow the guidelines,
especially as the FDA moves to contract out the reviewing of some of the submittals. TÜV recommends
that before testing is performed, any deviations from the FDA Reviewer Guidance procedure be
submitted for approval from the FDA reviewer who works on the manufacturer’s 510k package.
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FDA Reviewer Guidance for PreMarket Notification Submissions
Test Plan Details
(ATTACHMENT)
Summary Table of Required Electrical Tests
Description
Basic
Document
Battery Power
FDA RG
Power Indicators
FDA RG
Overcurrent Protection
FDA RG
Dielectric Withstand
FDA RG
AC Power Grounding
FDA RG
and Polarity
Leakage Current
FDA RG
Radiated and
Conducted
CISPR 11
Electromagnetic
Energy Emissions
Magnetic Field
Mil-Std 461D
Emissions
RE101
ESD
IEC 801-2 (91)
Immunity
Procedure
Parameter
(m)(1)
(m)(2)
(m)(3)
(m)(4)
Product Safety Test
Product Safety Test
Product Safety Test
Product Safety Test
(m)(5)
Product Safety Test
(m)(6)
Product Safety Test
(m)(7)(i)(a)
Performed at an OATS
(m)(7)(i)(b)
0.03 - 100 kHz
6 sides (when practical)
Contact (Direct & Indirect)
Air (Direct)
26-1000 MHz,
1 MHz steps, 10 sec dwell
0.5 Hz (or "passband")
AM @ 80% or Square wave
6 sides (when practical)
Overvoltage
Undervoltage
Battery Backup
Dropout 95-0-95 VAC
Slow Surge 120-150-120 VAC
rms
Slow Sag 120-90-120 VAC rms
Burst rep. freq. <30 per minute
Signal Port (Length  3 meters)
AC Input
AC Mains, Line-to-ground
AC Mains, Line-to-line
0.01 - 100 MHz
0.5 Hz (or "passband")
AM @ 80% or Square wave
Signal Port (Length  3 meters)
AC Input
0.03 - 100 kHz
0.5 Hz (or "passband")
AM @ 80% or Square wave
6 sides (when practical)
(m)(7)(ii)(a)
Radiated
Electromagnetic
Energy Immunity
IEC 801-3 (84)
with Uniform
Field Fig. 2,
page 34 of
FDA RG
(m)(7)(ii)(b)
Steady-State Voltage
Immunity
FDA RG
(m)(7)(ii)(c)(1)
Dropout Immunity
Slow Sags, & Slow
Surges Immunity
FDA RG
(m)(7)(ii)(c)(2)
FDA RG
(m)(7)(ii)(c)(3)
EFT/Burst
Immunity
IEC 801-4 (88) (m)(7)(ii)(c)(4)
Surge
Immunity
FDA RG
(m)(7)(ii)(c)(5)
Conducted
Immunity
Mil-Std 461D
CS114
(m)(7)(ii)(d)
Magnetic Field
Immunity
Mil-Std 461D
RS101
(m)(7)(ii)(e)
Quasi-Static Electric
Field Immunity
FDA RG
(m)(7)(ii)(f)
Static field Varying @ 0.5 Hz
FDA RG
Test Level
A or B
EN 60601-1-2 EN 60601-2-X
Test Level
Test Level
A or B
Army Limit
±2, 4, 6 kV
±2, 4, 6, 8 kV
±2, 3 kV
±2, 4, 8 kV
3 V/m
3 V/m
132 VAC
95 VAC
>95 VAC
10 mS
500 mS
500 mS
±0.25, 0.5, 1.0 kV
±500 V
±0.5, 1.0, 2.0 kV ±1.0 or 2.0 kV
±2 kV
±1 kV
±2 kV
±1 kV
Curve 3 or 57 mA
Curve 3 or 57 mA
Army Limit
2000 Volts
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FDA Reviewer Guidance for PreMarket Notification Submissions
Test Plan Details
(ATTACHMENT)
Cable Requirements
It is the responsibility of the customer to provide adequate cables for the test. Interface cables shall be
connected to ALL interface ports of the EUT, even though the cable is not sold with the EUT.
Recomended minimum length is 3 meters. Cables which exit a test area should be 6 to 8 meters.
Treatment Of Third-Wire Ground Connection (all EMC tests)
Per section (h)(7) and section (m)(7), devices intended for home use should comply with ALL electrical
tests with the third-wire ground connected and with it disconnected (includes while charging batteries).
How does the manufacturer choose to show compliance with this requirement?
 N/A - Battery-powered, no AC connection
 N/A -Two-wire AC connection only
 N/A -System is not for home use.
 Testing shall fully comply (DOUBLES all estimated times)
 Other (manufacturer assumes responsibility for any re-test required by the FDA).
Please describe:
Bandpass Frequencies
Several immunity tests require frequency modulation, with a modulating frequency related to any
physiological pass band that is monitored by the EUT. Identify all frequency pass bands used by the EUT
according to the intended function:
 None
 Breath rate (cutoff frequency of the lowpass band):
 Heart rate (cutoff frequency of the lowpass band):

Nerve stimulus rate (cutoff frequency of the lowpass band):

Other (pass band - low/high cutoff frequencies):
General Electrical Test Procedures
Procedure
Section
(m)(1)
(m)(3)
(m)(4)
(m)(5)
(m)(6)
(m)(2)
Performed by
Manufacturer
TÜV PS
or other
Safety Group










Description
Battery Power
Overcurrent Protection
Dielectric Withstand
AC Power and Grounding
Leakage Current
Electrical Power Indications:
Visual Status Indicators indicate that the device is energized
Visual Status Indicators distinguish between battery and AC source
Visual Status Indicators indicate charging mode
Additional Notes:
Y N
Y N NA
Y N NA
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FDA Reviewer Guidance for PreMarket Notification Submissions
Test Plan Details
(ATTACHMENT)
Radiated Electromagnetic Energy Emissions [Section (m)(7)(i)(a)]
Time Estimate:
Performance Criteria:
Test Standard:
Test Levels:
4 hours - first configuration/mode of operation
Operate within its specification without emitting excessive EM energy.
CISPR 11 (EN 55011)
 Class A
 Class B
 Other:
Modes of operation
tested:




Repeat with ground
wire disconnected?
Additional Notes:
Mode 1:
Mode 2:
Mode 3:
Yes (doubles
time estimate)
 No (Explanation found in the section describing
Treatment Of Third-Wire Ground Connection - Page 3)
Conducted Electromagnetic Energy Emissions [Section (m)(7)(i)(a)]
 2 hours - first configuration/mode of operation
 Test not applicable - battery-powered EUT
Performance Criteria: Operate within its specification without emitting excessive EM energy.
Test Standard:
CISPR 11 (EN 55011)
Test Levels:
 Class A
 Class B
 Other:
Time Estimate:
Modes of operation
tested:
Repeat with ground
wire disconnected?
Additional Notes:




Mode 1:
Mode 2:
Mode 3:
Yes (doubles
time estimate)
 No (Explanation found in the section describing
Treatment Of Third-Wire Ground Connection - Page 3)
Magnetic Fields Emissions [Section (m)(7)(i)(b)]
Time Estimate:
Performance Criteria:
Test Standard:
Test Levels:
2 hours - first configuration/mode of operation
Operate within its specification without emitting excessive EM energy.
MIL-STD-461D/462D
 RE101, Army 7 cm limit
 Other:
Modes of operation
tested:




Repeat with ground
wire disconnected?
Additional Notes:
Mode 1:
Mode 2:
Mode 3:
Yes (doubles
time estimate)
 No (Explanation found in the section describing
Treatment Of Third-Wire Ground Connection - Page 3)
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Test Plan Details
(ATTACHMENT)
Electrostatic Discharge Immunity [Section (m)(7)(ii)(a)]
Time Estimate:
2 hours - first configuration/mode of operation
Performance Criteria:  Operate within its specification within 5 seconds of an ESD event
 Operate within its specification during and after test
Test Standard:
IEC 801-2:1991(IEC 1000-4-2:1995)
Test Levels:
 ±2,4,6 kV Contact discharge: conductive surfaces & coupling planes
 ±2,4,6,8 kV Air discharge:
insulating surfaces
 Other:
Consideration of
exposed ports:
Modes of operation
tested:
Repeat with ground
wire disconnected?
Additional Notes:







Ports are NOT exposed, per manufacturer’s specifications.
Ports are exposed: Pins are to be avoided.
Ports are exposed: Pins are part of the ‘enclosure’ and subject to ESD.
Mode 1:
Mode 2:
Mode 3:
Yes (doubles
 No (Explanation found in the section describing
time estimate)
Treatment Of Third-Wire Ground Connection - Page 3)
Diagram Of EUT With ESD Test Points Called Out (May be finalized a time of test.):
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FDA Reviewer Guidance for PreMarket Notification Submissions
Test Plan Details
(ATTACHMENT)
Radiated Electromagnetic Fields Immunity [Section (m)(7)(ii)(b)]
*Time Estimate:
32 hours - first configuration/mode of operation/per modulation type
Performance Criteria: Operate within its specification during and after test
*Test Standard:
 FDA Reviewer Guidance Procedure
 Substitute IEC 1000-4-3:1995
Test Levels:
 3 V/m
 Other:
Frequency Range:
 26 - 1000 MHz
List all Clocks and
Oscillators within the
Frequency Range:
*Modulation:

 Other:
None
 _____ MHz
 _____ MHz
 _____ MHz
 _____ MHz
 _____ MHz
 _____ MHz
 _____ MHz




80% AM (sine) at 0.5 Hz
80% AM (sine) at a passband frequency:
100% pulse mod at 0.5 Hz
100% pulse mod at a passband frequency:
 Other:
*Sweep Rate:
 1 MHz steps
 Other:
*Dwell time per step:
 10 seconds
*Number of sides:
 4 (stationary)
 6 (portable)
 Other:
Cables provided for
all ports:






Modes of operation
tested:
Repeat with ground
wire disconnected?
Additional Notes:
 Other:
Cables provided for test are identical to cables supplied with EUT to end user.
Minimum length 3 meters for any cable NOT EXITING the test area.
Minimum length >6 meters for any cable which EXITS the test area.
Mode 1:
Mode 2:
Mode 3:
 Yes (doubles
time estimate)
 No (Explanation found in the section describing
Treatment Of Third-Wire Ground Connection - Page 3)
*Time Estimate Considerations:
FDA guidelines specify testing with 1 MHz steps from 26 - 1000 MHz, at 10 second dwell time per step,
which calculates out to about 2.7 hours per sweep. To sweep all 6 sides twice (for 2 antenna polarities)
requires 32.5 hours. It may be reasonable to adjust certain parameters, with consideration of the
information found in the GENERAL INFORMATION AND RECOMMENDATIONS section of this
attachment (Page 1).
Sample deviations #1:
5 MHz steps at 6 V/m
Dwell times <10 seconds
Sample deviations #2:
Test per IEC 1000-4-3
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FDA Reviewer Guidance for PreMarket Notification Submissions
Test Plan Details
(ATTACHMENT)
Steady-State Voltage Immunity [Section (m)(7)(ii)(c)(1)]
 0.5 hour - first configuration/mode of operation
 Test not applicable - No AC connection
Performance Criteria: Operate within its specification during and after test
FDA Reviewer Guidance Procedure
Test Standard:
 132 Vac and 95 Vac
Test Levels:
 Duration:
 Determine 95 Vac to 0 Vac - battery switch-over level
 Determine 0 Vac to 95 Vac- battery switch-over level
Modes of operation
 Mode 1:
tested:
 Mode 2:
 Mode 3:
Repeat with ground
 Yes (doubles
 No (Explanation found in the section describing
wire disconnected?
time estimate)
Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Time Estimate:
Dropout Immunity [Section (m)(7)(ii)(c)(2)]
 0.5 hours - first configuration/mode of operation
 Test not applicable - No AC connection
Performance Criteria: Operate within its specification during and after test
FDA Reviewer Guidance Procedure
Test Standard:
 95 Vac to 0 Vac to 95 Vac - 10 events at 10 mS
Test Levels:
Modes of operation
 Mode 1:
tested:
 Mode 2:
 Mode 3:
Repeat with ground
 Yes (doubles
 No (Explanation found in the section describing
wire disconnected?
time estimate)
Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Time Estimate:
Slow Sags And Surges Immunity [Section (m)(7)(ii)(c)(3)]
 0.5 hours - first configuration/mode of operation
 Test not applicable - No AC connection
Performance Criteria: Operate within its specification during and after test
FDA Reviewer Guidance Procedure
Test Standard:
 120 Vac to 150 Vac to 120 Vac - 10 events at 500 mS
Test Levels:
 120 Vac to 90 Vac to 120 Vac - 10 events at 500 mS
Modes of operation
 Mode 1:
tested:
 Mode 2:
 Mode 3:
Repeat with ground
 Yes (doubles
 No (Explanation found in the section describing
wire disconnected?
time estimate)
Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Time Estimate:
Fast Transient Burst Immunity [Section (m)(7)(ii)(c)(4)]
Time Estimate:
 1 hour - first configuration/mode of operation
 Test not applicable - No AC connection & no signal leads
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FDA Reviewer Guidance for PreMarket Notification Submissions
Test Plan Details
(ATTACHMENT)
Performance Criteria: Operate within its specification during and after test
IEC 801-4:1988 (IEC 1000-4-4: 1995)
Test Standard:
Test Levels:
 Mains supply leads: 0.5, 1 and 2 kV
 Signal leads: 0.25, 0.5 and 1 kV
 Other:
Burst Rep Rate:
 30/min
Cables Tested:
(Test is applicable
to ALL I/O cable
regardless of
length. A minimum
length of 3 meters
is recommended.)
 AC Power Leads







Modes of operation
tested:
 Mode 1:
 Mode 2:
 Mode 3:
Repeat with ground
wire disconnected?
Additional Notes:
 Yes (doubles
time estimate)
 Other:
 No (Explanation found in the section describing
Treatment Of Third-Wire Ground Connection - Page 3)
Fast Surges Immunity [Section (m)(7)(ii)(c)(5)]
 4 hours - first configuration/mode of operation
 Test not applicable - No AC connection
Performance Criteria: Operate within its specification during and after test
 FDA Reviewer Guidance Procedure
Test Standard:
 Substitute IEC 1000-4-5:1995
Test Levels:
 LN:
±1 kV @ 0, 90, 180, 270 degrees - 10 events
 LG & NG: ±2 kV @ 0, 90, 180, 270 degrees - 10 events
 Other:
Time Estimate:
Surge Protection
Components:
Modes of operation
tested:
Repeat with ground
wire disconnected?
Additional Notes:






Installed - Clamping Voltage:
Not installed
Mode 1:
Mode 2:
Mode 3:
Yes (adds to
 No (Explanation found in the section describing
time estimate)
Treatment Of Third-Wire Ground Connection - Page 3)
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FDA Reviewer Guidance for PreMarket Notification Submissions
Test Plan Details
(ATTACHMENT)
Conducted Electromagnetic Energy Immunity [Section (m)(7)(ii)(d)]
 1 hour per frequency sweep - first configuration/mode of operation
 Test not applicable - No AC connection & no signal leads
Performance Criteria: Operate within its specification during and after test
 MIL-STD-461D/462D
*Test Standard:
 Substitute IEC 1000-4-6:1995
Test Levels:
 CS114, Curve 3
 Other:
*Time Estimate:
*Frequency Range:
 0.01 - 100 MHz
List all Clocks and
Oscillators within the
Frequency Range:
*Modulation:

 Other:
None
 _____ kHz
 _____ kHz
 _____ kHz
 _____ MHz
 _____ MHz
 _____ MHz
 _____ MHz




80% AM (sine) at 0.5 Hz
80% AM (sine) at a passband frequency:
100% pulse mod at 0.5 Hz
100% pulse mod at a passband frequency:
 Other:
*Sweep Rate:
 1 x 10-3 decades/second [300 seconds per octave]
 1 Percent steps
 Other:
*Dwell time per step:
 10 seconds
*Cables Tested:
(Test is applicable
to ALL I/O cable
regardless of
length. Lengths of
=1 meter are
recommended.)
 AC Power Leads including high and returns
Modes of operation
tested:
 Mode 1:
 Mode 2:
 Mode 3:
Repeat with ground
wire disconnected?
Additional Notes:
 Yes (doubles
time estimate)
 Other:
 AC Power Leads excluding returns







 No (Explanation found in the section describing
Treatment Of Third-Wire Ground Connection - Page 3)
*Time Estimate Considerations:
The time required to perform this test is highly dependent upon the number of cables to be tested. It may
be reasonable to adjust certain parameters, with consideration of the information found in the GENERAL
INFORMATION AND RECOMMENDATIONS section of this attachment (Page 1).
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Test Plan Details
(ATTACHMENT)
Magnetic Fields Immunity [Section (m)(7)(ii)(e)]
Time Estimate:
Performance Criteria:
Test Standard:
Test Levels:
1 hour per frequency sweep - first configuration/mode of operation
Operate within its specification during and after test
MIL-STD-461D/462D
 RS101 Army limit
 Other:
*Frequency Range:
 30 Hz - 100 kHz
List all Clocks and
Oscillators within the
Frequency Range:
*Modulation:

 Other:
None
 _____ kHz
 _____ kHz
 _____ kHz
 _____ kHz
 _____ kHz
 _____ kHz
 _____ kHz




80% AM (sine) at 0.5 Hz
80% AM (sine) at a passband frequency:
100% pulse mod at 0.5 Hz
100% pulse mod at a passband frequency:
 Other:
*Sweep Rate:
 1 x 10-3 decades/second [300 seconds per octave]
 1 Percent steps
 Other:
*Dwell time per step:
 10 seconds
*Number of location:






Modes of operation
tested:
Repeat with ground
wire disconnected?
Additional Notes:
 Other:
___ (Small EUT:
Suggest 1 to 3 locations. e.g. - 1 per axis )
___ (Medium EUT: Suggest 5 to 6 locations. e.g. - 1 each side/top/bottom)
___ (Large EUT:
Many locations per side. Please provide diagram)
Mode 1:
Mode 2:
Mode 3:
 Yes (doubles
time estimate)
 No (Explanation found in the section describing
Treatment Of Third-Wire Ground Connection - Page 3)
Quasi-Static Electric Fields Immunity [Section (m)(7)(ii)(f)]
Time Estimate:
Performance Criteria:
Test Standard:
Test Levels:
0.5 hours - first configuration/mode of operation
Operate within its specification during and after test
FDA Reviewer Guidance Procedure
 500 to 2000 V/m with 0.5 Hz variation
 Other:
Number of axes:






Modes of operation
tested:
Repeat with ground
wire disconnected?
Additional Notes:
1 (stationary)
3 (portable)
Mode 1:
Mode 2:
Mode 3:
Yes (doubles
time estimate)
 No (Explanation found in the section describing
Treatment Of Third-Wire Ground Connection - Page 3)
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