FDA Reviewer Guidancefor 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.

Summary Table of Required Electrical Tests

Description / Basic Document / Procedure / Parameter / FDA RG
Test Level / EN 60601-1-2
Test Level / EN 60601-2-X
Test Level
Battery Power / FDA RG / (m)(1) / Product Safety Test
Power Indicators / FDA RG / (m)(2) / Product Safety Test
Overcurrent Protection / FDA RG / (m)(3) / Product Safety Test
Dielectric Withstand / FDA RG / (m)(4) / Product Safety Test
AC Power Grounding
and Polarity / FDA RG / (m)(5) / Product Safety Test
Leakage Current / FDA RG / (m)(6) / Product Safety Test
Radiated and Conducted Electromagnetic
Energy Emissions /
CISPR 11 / (m)(7)(i)(a) /
Performed at an OATS /
A or B /
A or B
Magnetic Field
Emissions / Mil-Std 461D RE101 / (m)(7)(i)(b) / 0.03 - 100 kHz
6 sides (when practical) / Army Limit
ESD
Immunity / IEC 801-2 (91) / (m)(7)(ii)(a) / Contact (Direct & Indirect)
Air (Direct) / ±2, 4, 6 kV
±2, 4, 6, 8 kV / ±2, 3 kV
±2, 4, 8 kV
Radiated Electromagnetic
Energy Immunity / IEC 801-3 (84) with Uniform Field Fig. 2, page 34 of FDA RG /
(m)(7)(ii)(b) / 26-1000 MHz,
1 MHz steps, 10 sec dwell
0.5 Hz (or "passband")
AM @ 80% or Square wave
6 sides (when practical) /
3 V/m
/
3 V/m
Steady-State Voltage Immunity / FDA RG / (m)(7)(ii)(c)(1) / Overvoltage
Undervoltage
Battery Backup / 132 VAC
95 VAC
>95 VAC
Dropout Immunity / FDA RG / (m)(7)(ii)(c)(2) / Dropout 95-0-95 VAC / 10 mS
Slow Sags, & Slow Surges Immunity / FDA RG / (m)(7)(ii)(c)(3) / Slow Surge 120-150-120 VAC rms
Slow Sag 120-90-120 VAC rms / 500 mS
500 mS
EFT/Burst
Immunity / IEC 801-4 (88) / (m)(7)(ii)(c)(4) / Burst rep. freq. <30 per minute
Signal Port (Length  3 meters)
AC Input / ±0.25, 0.5, 1.0 kV
±0.5, 1.0, 2.0 kV / ±500 V
±1.0 or 2.0 kV
Surge
Immunity / FDA RG / (m)(7)(ii)(c)(5) / AC Mains, Line-to-ground
AC Mains, Line-to-line / ±2kV
±1kV / ±2kV
±1kV
Conducted
Immunity /
Mil-Std 461D CS114 / (m)(7)(ii)(d) / 0.01 - 100 MHz
0.5 Hz (or "passband")
AM @ 80% or Square wave
Signal Port (Length  3 meters)
AC Input / Curve 3 or 57 mA
Curve 3 or 57 mA
Magnetic Field
Immunity / Mil-Std 461D RS101 /
(m)(7)(ii)(e) / 0.03 - 100 kHz
0.5 Hz (or "passband")
AM @ 80% or Square wave
6 sides (when practical) / Army Limit
Quasi-Static Electric Field Immunity / FDA RG / (m)(7)(ii)(f) / Static field Varying @ 0.5 Hz / 2000 Volts
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
Performed by
Procedure Section / Description / Manufacturer or other / TÜV PS
Safety Group
(m)(1) / Battery Power /  / 
(m)(3) / Overcurrent Protection /  / 
(m)(4) / Dielectric Withstand /  / 
(m)(5) / AC Power and Grounding /  / 
(m)(6) / Leakage Current /  / 
(m)(2) / Electrical Power Indications:
Visual Status Indicators indicate that the device is energized / Y N
Visual Status Indicators distinguish between battery and AC source / Y N NA
Visual Status Indicators indicate charging mode / Y N NA
Additional Notes:
Radiated Electromagnetic Energy Emissions [Section (m)(7)(i)(a)]
Time Estimate: / 4 hours - first configuration/mode of operation
Performance Criteria: / Operate within its specification without emitting excessive EM energy.
Test Standard: / CISPR 11 (EN 55011)
Test Levels: / Class A / Class B / Other:
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Conducted Electromagnetic Energy Emissions [Section (m)(7)(i)(a)]
Time Estimate: / 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:
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Magnetic Fields Emissions [Section (m)(7)(i)(b)]
Time Estimate: / 2 hours - first configuration/mode of operation
Performance Criteria: / Operate within its specification without emitting excessive EM energy.
Test Standard: / MIL-STD-461D/462D
Test Levels: / RE101, Army 7 cm limit / Other:
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
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: / 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.
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Diagram Of EUT With ESD Test Points Called Out(May be finalized a time of test.):
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 / Other:
List all Clocks and Oscillators within the Frequency Range: / None
 _____ MHz /  _____ MHz
 _____ MHz /  _____ MHz
 _____ MHz /  _____ MHz
 _____ MHz
*Modulation: / 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 / Other:
*Number of sides: / 4 (stationary)
6 (portable)
Other:
Cables provided for all ports: / 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.
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
*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
Steady-State Voltage Immunity [Section (m)(7)(ii)(c)(1)]
Time Estimate: / 0.5 hour - first configuration/mode of operation
Test not applicable - No AC connection
Performance Criteria: / Operate within its specification during and after test
Test Standard: / FDA Reviewer Guidance Procedure
Test Levels: / 132 Vac and 95 Vac / Duration:
Determine 95 Vac to 0 Vac - battery switch-over level
Determine 0 Vac to 95 Vac- battery switch-over level
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Dropout Immunity [Section (m)(7)(ii)(c)(2)]
Time Estimate: / 0.5 hours - first configuration/mode of operation
Test not applicable - No AC connection
Performance Criteria: / Operate within its specification during and after test
Test Standard: / FDA Reviewer Guidance Procedure
Test Levels: / 95 Vac to 0 Vac to 95 Vac - 10 events at 10 mS
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Slow Sags And Surges Immunity [Section (m)(7)(ii)(c)(3)]
Time Estimate: / 0.5 hours - first configuration/mode of operation
Test not applicable - No AC connection
Performance Criteria: / Operate within its specification during and after test
Test Standard: / FDA Reviewer Guidance Procedure
Test Levels: / 120 Vac to 150 Vac to 120 Vac - 10 events at 500 mS
120 Vac to 90 Vac to 120 Vac - 10 events at 500 mS
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
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
Performance Criteria: / Operate within its specification during and after test
Test Standard: / IEC 801-4:1988 (IEC 1000-4-4: 1995)
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 / Other:
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? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Fast Surges Immunity [Section (m)(7)(ii)(c)(5)]
Time Estimate: / 4 hours - first configuration/mode of operation
Test not applicable - No AC connection
Performance Criteria: / Operate within its specification during and after test
Test Standard: / FDA Reviewer Guidance Procedure
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:
Surge Protection Components: / Installed - Clamping Voltage:
Not installed
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (adds to time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Conducted Electromagnetic Energy Immunity [Section (m)(7)(ii)(d)]
*Time Estimate: / 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
*Test Standard: / MIL-STD-461D/462D
Substitute IEC 1000-4-6:1995
Test Levels: / CS114, Curve 3 / Other:
*Frequency Range: / 0.01 - 100 MHz / Other:
List all Clocks and Oscillators within the Frequency Range: / None
 _____ MHz /  _____ kHz
 _____ MHz /  _____ kHz
 _____ MHz /  _____ kHz
 _____ MHz
*Modulation: / 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 / Other:
*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
AC Power Leads excluding returns







Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
*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).
Magnetic Fields Immunity [Section (m)(7)(ii)(e)]
Time Estimate: / 1 hour per frequency sweep - first configuration/mode of operation
Performance Criteria: / Operate within its specification during and after test
Test Standard: / MIL-STD-461D/462D
Test Levels: / RS101 Army limit / Other:
*Frequency Range: / 30 Hz - 100 kHz / Other:
List all Clocks and Oscillators within the Frequency Range: / None
 _____ kHz /  _____ kHz
 _____ kHz /  _____ kHz
 _____ kHz /  _____ kHz
 _____ kHz
*Modulation: / 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 / Other:
*Number of location: / ___ (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)
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:
Quasi-Static Electric Fields Immunity [Section (m)(7)(ii)(f)]
Time Estimate: / 0.5 hours - first configuration/mode of operation
Performance Criteria: / Operate within its specification during and after test
Test Standard: / FDA Reviewer Guidance Procedure
Test Levels: / 500 to 2000 V/m with 0.5 Hz variation / Other:
Number of axes: / 1 (stationary)
3 (portable)
Modes of operation tested: / Mode 1:
Mode 2:
Mode 3:
Repeat with ground wire disconnected? / Yes (doubles time estimate) / No (Explanation found in the section describing Treatment Of Third-Wire Ground Connection - Page 3)
Additional Notes:

UEMC0921.DOC, Revision 2.0

Author: D.Swanson

Draft: 10 March 2003

Page 1 of 10

File: UEMC0921.doc. Revision 2.0