draft for public - rain rfid · electrical equipment and systems electromagnetic to emissions from...

RFID Experts Group HCI WG

AIM, Inc: 1 – 2015 Version 1.0, 2015

DRAFT FOR PUBLIC REVIEW

MEDICAL ELECTRICAL EQUIPMENT AND SYSTEM ELECTROMAGNETIC IMMUNITY TEST FOR EXPOSURE TO RADIO FREQUENCY IDENTIFICATION READERS DRAFT AIM Standard

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DRAFT FOR PUBLIC REVIEW DRAFT AIM STANDARD MEDICAL ELECTRICAL EQUIPMENT AND SYSTEM ELECTROMAGNETIC IMMUNITY TEST FOR EXPOSURE TO RADIO FREQUENCY IDENTIFICATION READERS

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DRAFT FOR PUBLIC REVIEW DRAFT AIM STANDARD MEDICAL ELECTRICAL EQUIPMENT AND SYSTEM ELECTROMAGNETIC IMMUNITY TEST FOR EXPOSURE TO RADIO FREQUENCY IDENTIFICATION READERS


TABLE OF CONTENTS Page

1. SCOPE ................................................................................................................................................. 1

2. BACKGROUND ................................................................................................................................. 1

3. NORMATIVE REFERENCES ......................................................................................................... 2

4. RECORDS AND DOCUMENTATION ........................................................................................... 2 5. COMPLIANCE CRITERIA.............................................................................................................. 6

6. CALIBRATION OF THE FIELD ...................................................................................................... 6

6.1 Calibration Method for tests below 100 MHz: .................................................................... 6

6.2 Calibration Method for tests above 100 MHz: .................................................................... 6

7. TEST LEVELS .................................................................................................................................... 7 8. TEST METHODS ............................................................................................................................... 7

ANNEX A - TEST SETUP AND PROCEDURE FOR 134.2 KHZ RFID FIELDS (ISO 14223) ...................................... 9

ANNEX B - TEST SETUP AND PROCEDURE FOR 13.56 MHZ RFID FIELDS (ISO/IEC 14443 -3 (TYPE A) .............10 ANNEX C - TEST SETUP AND PROCEDURE FOR 13.56 MHZ RFID FIELDS (ISO/IEC 14443-4 (TYPE B) ..............11

ANNEX D – TEST SETUP AND PROCEDURE FOR 13.56 MHZ RFID FIELDS (ISO/IEC 15693 OR ISO/IEC 18000-3 MODE 1) .........................................................................................................................................................11

ANNEX E - TEST SETUP AND PROCEDURE FOR 433.92 MHZ RFID FIELDS (ISO/IEC 18000-7) ..........................13

ANNEX F – TEST SETUP AND PROCEDURES FOR 860-960 MHZ RFID FIELDS (ISO/IEC 18000-63, FORMERLY ISO 18000-6 TYPE C) .........................................................................................................................................14 ANNEX G - TEST SETUP AND PROCEDURE FOR 2.4 GHZ RFID FIELDS (ISO/IEC 18000-4 MODE 1) .................16

ANNEX H - REPRESENTATIVE HARDWARE FOR TESTING ..........................................................................17

ANNEX I – SELECTION OF RFID FREQUENCIES AND TYPES .......................................................................17

ANNEX J - RATIONALE FOR TEST LEVELS ..................................................................................................17

ANNEX K – OPTIONAL TESTS .....................................................................................................................18

ANNEX L – BIBLIOGRAPHY ............................................................................................................ 23

1. SCOPE The purpose of this draft AIM Standard document is to provide test methods and test levels for the evaluation of the electromagnetic immunity of (non-implantable) medical electrical equipment and systems to electromagnetic emissions from radio-frequency-identification (RFID) readers.

For the purposes of this draft AIM Standard, other technologies such as Wi-Fi and ultra-wideband (UWB) are not considered. It focuses on the most common RFID technologies currently deployed in healthcare environments.

2. BACKGROUND Electromagnetic Interference (EMI) in electrical equipment is usually caused by electromagnetic disturbances in the vicinity. This can occur when common-mode noise couples to cables or printed circuit board (PCB) traces and then causes junction rectification (demodulation) in transistors on the PCB. Often interference occurs when the cabling or circuitry is in resonance at the fundamental or harmonic frequencies of the disturbance signal. In this way, fast rise time pulses transmitted wirelessly by RFID readers can cause EMI in medical electrical equipment

The IEC 60601-1-2 electromagnetic compatibility (EMC) standard for medical electrical equipment and systems specifies that radiated and conducted RF immunity testing of medical electrical equipment and systems be performed according to IEC 61000-4-3 (radiated RF immunity) and IEC 61000-4-6 (conducted RF immunity). These standards specify disturbance test signals comprising an amplitude modulated carrier with 80 % amplitude deviation and usually a 1 kHz envelope. IEC 61000-4-6 specifies that a carrier is swept from 150 kHz to 80 MHz and injected into power and I/O ports of the medical electrical equipment or system, and the amplitude is specified by IEC 60601-1-2 to be a maximum of 6 Vrms. IEC 60601-1-2:2014 specifies that the method of IEC 61000-4-3 is used with a carrier swept from 80 MHz through 2.7 GHz and the signal radiated through an antenna pointed at the medical electrical equipment or system, at a maximum of 10 V/m, and also at spot communications frequencies up to 5.8 GHz and 28 V/m. AM was chosen because it has been found to produce the most EMI in electronic products as compared with GSM cellular phone RF signals and emissions from RS-232 serial port cables. Studies published in the late 2000s showed the potential for RFID to interfere with medical devices that claimed conformance to IEC 60601-1-2. In response, the Healthcare Initiative (HCI) Work Group of AIM’s RFID Experts Group developed this draft AIM Standard to assist in assessing the possible effects. A preliminary test method and test levels for the immunity of medical electrical equipment and systems to RFID readers were drafted by the members of the working group. Medical device manufacturers were then invited to

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support this project by submitting their devices for testing and by providing equipment and technical expertise. Although the HCI Working Group had hoped for broad participation by medical device manufacturers, in fact only a limited number of devices were received. However, the working group believed that the results were sufficient to demonstrate the feasibility and adequacy of this draft AIM Standard.

3. NORMATIVE REFERENCES IEC 60601-1-2, Edition 4, 2014 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests

IEC 61000-4-3:2010 – Electromagnetic compatibility (EMC) - Testing and measurement techniques-Radiated, radio-frequency, electromagnetic field immunity test

ISO/IEC 15693-3:2009 Second edition,– Identification cards - Contactless integrated circuit cards – Vicinity cards. Part 3: Anticollision and transmission protocol

ISO/IEC 14443-3:2011 Second edition,– Identification cards - Contactless integrated circuit cards – Proximity cards. Part 3: Initialization and anticollision

ISO/IEC 14443-4:2008 Second edition– Identification cards - Contactless integrated circuit cards – Proximity cards. Part 4: Transmission protocol

ISO/IEC 18000-7:2009 Third edition,– Information technology - Radio frequency identification for item management. Part7: Parameters for active air interface communications at 433 MHz

ISO/IEC 18000-63:2013 – Information technology-Radio frequency identification for item management. Part 63: Parameters for air interface communications at 860 MHz to 960 MHz – Type C

ISO/IEC 18000-4:2008 Second edition, – Information technology-Radio frequency identification for item management. Part4: Parameters for air interface communications at 2,45 GHz

4. RECORDS AND DOCUMENTATION A test plan shall be documented before testing begins and a test report shall be documented after testing is completed. They shall record at least the following information:

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Test plan a) The purpose for performing the test b) The testing to be done. c) The type and model number of the medical electrical equipment or system to be

tested (equipment under test (EUT)) d) EUT functions and intended use. e) Method to be used to monitor the EUT. f) Exposure and field generation method g) The specific RFID standards. h) EUT-specific compliance (pass/fail) criteria.

Test report a) The purpose for performing the test b) Date and time of testing, c) Testing performed. d) Type, manufacturer, model number, serial number and photograph of the EUT. e) EUT functions and intended use. f) Method of monitoring the EUT. This shall be checked to assure minimal perturbation

of the exposure fields and interference with the readings. g) Test equipment used, along with calibration information. h) Exposure and field generation method i) The specific RFID standards. j) EUT-specific compliance (pass/fail) criteria. k) Findings for each EUT exposure. This should include observations of any effects on the

EUT and a determination whether the EUT passed or failed the test, based on the criteria in j).

l) For each determination of test failure, the RFID parameters that caused it and the effects observed on EUT performance.

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Table 1 shows an example of a blank test data sheet.

Table 1 – Blank test data sheet

Test parameters Side/surface of EUT

Dwell time (s) Pass/fail, anomalies

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Table 2 shows an example of a completed test data sheet for vertical antenna orientation.

Table 2 – Example of Table 1 with test data entered

Test parameters Side/surface of EUT

Dwell time (s) Pass/fail, anomalies

• Standard: ISO/IEC 18000-63

• Frequency sweep: 860 – 960 MHz

• Frequency

step: 1 MHz

• Modulation: DSB-ASK

• Tari: 6.25 µs • Pulse width:

3.281 µs • Modulation

depth: 100% • 255 bit Mask:

all zeroes • Mandatory

command: Inventory (i.e., Select, Query)

• Field

strength: 54 V/m RMS

• Antenna

polarity: vertical

Right 3 Pass

Left 3 Fail: blood pressure out of tolerance

Front 3 Pass

Back 3 Pass

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5. COMPLIANCE CRITERIA Compliance criteria are used to determine if the medical electrical equipment or system passed or failed the immunity testing. The medical electrical equipment or system manufacturer is responsible for specifying these criteria as well as providing or specifying monitoring methods to determine if the compliance criteria are met during and after testing. The compliance criteria shall be in accordance with 8.1 of IEC 60601-1-2:2014, tailored to the specific medical electrical equipment or system under test using the guidance in Annex I of that standard.

6. CALIBRATION OF THE FIELD 6.1 Calibration Method for tests below 100 MHz: When feasible, a Helmholtz coil large enough to surround the medical electrical equipment or system should be used. If the medical electrical equipment or system is too large to be placed inside a Helmholtz coil, best engineering practices should be used to generate a uniform field plane to expose each face of the medical electrical equipment or system. For large medical electrical equipment or systems, it may be necessary to move the equipment through the field to cover the full equipment or system. Field calibration measurements shall be made with the medical electrical equipment or system removed from the field.

6.2 Calibration Method for tests above 100 MHz: The test lab shall perform a field calibration inside a test chamber to assure that a uniform field can be generated at the required electric field strengths over the required uniform field area. The calibration shall be performed as specified in IEC 61000-4-3, with the following deviations:

1. Use any commercially available signal generator to perform a calibration per the IEC 61000-4-3 constant field strength method, using an unmodulated signal for each frequency and corresponding field strength listed in Table 3.

2. Next, remove the commercially available generator and replace it with the proprietary RFID signal generator and perform a calibration at a single test point with an unmodulated carrier. This test point is to be chosen so that it is one of the outer boundaries of the grid. Record the drive levels required to produce the required field strength as specified in Table 2. These recorded drive levels shall then be used to perform the actual testing. The generator shall be checked to ensure that it is not in saturation. One way to accomplish this is to vary the input and check to see that the output varies accordingly.

Justification for deviations:

Generally, calibration and testing to IEC 61000-4-3 is performed with specialized immunity test software. The software interfaces with the signal generator and field probe to generate the correct drive levels when performing the calibration and also plays back the calibration file when performing testing. For testing medical electrical equipment 6

and systems for immunity to RFID fields, a signal generator capable of producing the RFID signals and commands is required. At present, no such generator is commercially available. The test lab must rely on proprietary hardware to produce these signals. This proprietary equipment does not interface with the immunity test software at this time. Performing the calibration manually is time consuming. Therefore, these alternate procedures are specified to ease the burden on test labs and also improve repeatability,

Rationale for deviations from the calibration method specified in IEC 61000-4-3 appears in Annex J.

The test lab shall use suitable equipment (i.e. antennas, amplifiers, signal generators etc.) for the frequencies being tested.

7. TEST LEVELS The test levels for each frequency are shown in Table 3. Rationale for the test levels and the assumed separation distances used to derive them appears in Annex J.

Table 3 – Test levels

RFID SPECIFICATION FREQUENCY TEST LEVEL (RMS)

ISO 14223 134.2 kHz 65 A/m

ISO/IEC 14443-3 (Type A) 13.56 MHz 7.5 A/m

ISO/IEC 14443-4 (Type B) 13.56 MHz 7.5 A/m

ISO/IEC 15693 (ISO 18000-3 Mode 1) 13.56 MHz 5 A/m

ISO 18000-3 Mode 3 13.56 MHz 12 A/m

ISO/IEC 18000-7 433 MHz 3 V/m

ISO/IEC 18000-63 Type C 860-960 MHz

54 V/m

ISO/IEC 18000-4 Mode 1 2.45 GHz 54 V/m

8. TEST METHODS The manufacturer of the medical electrical equipment or system shall provide or specify methods to monitor the performance of the medical electrical equipment or system and determine if the compliance criteria are met during and after testing (see Clause 5). If the medical electrical equipment or system in its normal operation is inactive for long periods of time, a special mode of operation for testing could be used (e.g., standby).

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The test equipment shall be configured to generate the RFID signals and appropriate field strengths as specified in Annex A through Annex G of this standard. An appropriate field probe for each test shall be used during testing. The field strength read by the probe during testing is not important because the placement of the medical electrical equipment or system will disturb the field and thus the readings from the probe could be lower or higher than the actual required field. However, use of the probe is essential in verifying that the test equipment is functioning properly and that a field is being generated.

Each side (right, left, front, back) of the medical electrical equipment or system shall be tested to the following RFID standards:

a) ISO 14223 (Annex A)

b) ISO/IEC 14443-3 (Type A) (Annex B)

c) ISO/IEC 14443-4 (Type B) (Annex C)

d) ISO/IEC 15693 (ISO/IEC 18000-3 Mode 1) (Annex D)

e) ISO/IEC 18000-7 (Annex E)

f) ISO/IEC 18000-63 Type C (Annex F)

g) ISO/IEC 18000-4 Mode 1 (Annex G)

The medical electrical equipment or system shall be monitored during and after testing to verify that the compliance criteria have been met.

If any unintentional behavior of the medical electrical equipment or system occurs, all corresponding test information associated with the anomaly shall be recorded, including frequency and test parameters. The testing shall be repeated with the same test parameters to determine if the anomaly is reproducible.

As stated in IEC 60601-1-2, the exposure time (dwell time) at any frequency to which the medical electrical equipment or system is exposed is a function of the slowest responding function of the medical electrical equipment or system plus the settling time of the radiated RF immunity test system. The test lab shall use the information from the medical electrical equipment or system manufacturer and good engineering judgment to determine the dwell time. For medical electrical equipment and systems for which faster-responding signals can be used to determine the effect of the test signal on the medical electrical equipment or system, the dwell time may be reduced if the faster responding signals are monitored.

Recommended test setups, including equipment used, are specified in Annex A through Annex G. However, other setups are acceptable as long as good engineering practices are followed and documented.

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ANNEX A - TEST SETUP AND PROCEDURE FOR 134.2 KHZ RFID FIELDS (ISO 14223) A1 Configure the field strength meter and monitor, signal generator, amplifier and

antenna as shown in Figure A.1 using a Helmholtz or other appropriate radiating antenna to achieve the required field. (Testing for magnetic field immunity does not have to be performed in a chamber.)

A2 Program the signal generator to output a waveform of maximum occupied bandwidth:

a) Standard: ISO 14223 Type A

b) Frequency: 134.2 kHz

c) Modulation Depth: 100 %

d) ETU: 3 µs

e) Mandatory Command: Activation_FDX

f) Field strength: 65 A/m RMS

Figure A.1 – Possible laboratory test setup for 134.2 kHz exposures

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ANNEX B - TEST SETUP AND PROCEDURE FOR 13.56 MHZ RFID FIELDS (ISO/IEC 14443-3 (TYPE A) B1 Configure the field strength meter and monitor, signal generator, amplifier and

antenna as shown in Figure B.1 or use a Helmholtz or other appropriate radiating device to achieve the required field. (Testing for magnetic field immunity does not necessarily have to be performed in a chamber.)

B2 Program the signal generator to output a waveform of maximum occupied bandwidth:


b) Frequency: 13.56 MHz

c) Pulse width: 3 µs

d) Transition edge: 1 ns

e) Command data rate: 848 kbps

f) Mandatory command: Select (ISO/IEC 14443-3:2011, 6.4)

g) Field strength: 7.5 A/m RMS

Figure B.1 – Laboratory test setup for 13.56 MHz exposures

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ANNEX C - TEST SETUP AND PROCEDURE FOR 13.56 MHZ RFID FIELDS (ISO/IEC 14443-4 (TYPE B) C1 Configure the field strength meter and monitor, signal generator, amplifier and


C2 Program the signal generator to output a waveform of maximum occupied bandwidth:

a) Standard: ISO 14443 Type B


c) Modulation Depth: 25%

d) Transition Edge: 0.001µs

e) Command Data Rate: 424 kbps

f) SOF low: 11 etu

g) SOF high: 2.5 etu

h) EOF low: 10.5 etu

i) Mandatory Command: I-Block (ISO/IEC 14443-4:2008, Clause 7)

j) Antenna Polarity: vertical and horizontal

k) Field Strength: 7.5 A/m RMS

ANNEX D – TEST SETUP AND PROCEDURE FOR 13.56 MHZ RFID FIELDS (ISO/IEC 15693 OR ISO/IEC 18000-3 MODE 1) D1 Configure the field strength meter and monitor, signal generator, amplifier and


D2 Program the signal generator to output a waveform of maximum occupied bandwidth:

a) Standard: ISO 15693-3

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d) Pulse width: 9.44 µs

e) Command coding: 1/4

f) Transition time: 1 ns

g) Mandatory command: Stay Quiet (ISO/IEC 15693-3:2009, 10.3.2)

h) Field strength: 5 A/m RMS

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ANNEX E - TEST SETUP AND PROCEDURE FOR 433.92 MHZ RFID FIELDS (ISO/IEC 18000-7) E1 Configure the field strength meter and monitor, signal generator, amplifier and

antenna as shown in Figure E.1.

E2 Program the signal generator to output a waveform (only one set of parameters are defined for this document because a change of parameters does not affect the bandwidth):

a) Frequency: 433.92 MHz

b) Dwell time: 60 s

c) Modulation: FSK

d) Mandatory command: collection with UDB (window size=0001h, max packet length=1fh, Udb type =00h) (ISO/IEC 18000-7:2009, 6.3.1)

e) Field strength: 3 V/m RMS

f) Antenna: Bilog

g) Antenna polarity: vertical and horizontal

Figure E.1 – Laboratory test setup for 433.93MHz and 860-960 MHz exposures

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ANNEX F – TEST SETUP AND PROCEDURES FOR 860-960 MHZ RFID FIELDS (ISO/IEC 18000-63, FORMERLY ISO 18000-6 TYPE C) F1 Configure the field strength meter and monitor, signal generator, amplifier and

antenna as shown in Figure E.1. Two modulations are tested, hence the four configurations for this annex.

F2 Testing will be performed first with the test equipment configured to output the maximum bandwidth per the following parameters:

a) Frequency sweep: 860 – 960 MHz

b) Frequency step: 1 MHz

c) Modulation: DSB-ASK

d) Tari: 6.25 µs

e) Pulse width: 3.281 µs

f) Modulation depth: 100%

g) 255 bit Mask: all zeros

h) Mandatory command: Inventory (i.e., Select, Query)

i) Field strength: 54 V/m RMS

j) Antenna polarity: vertical and horizontal

F3 Repeat testing with the following parameters:

a) Frequency sweep: 860 – 960 MHz


c) Modulation: PR-ASK

d) Tari: 6.25 µs

e) Pulse width: 1.656 µs

f) Modulation depth: 100%

g) 255 bit Mask: All zeros

h) Mandatory command: Inventory (i.e., Select, Query)

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j) Test distance (d): 3 m

k) Antenna polarity: vertical and horizontal

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ANNEX G - TEST SETUP AND PROCEDURE FOR 2.4 GHZ RFID FIELDS (ISO/IEC 18000-4 MODE 1) G1 Configure the field strength meter and monitor, signal generator, amplifier and

antenna as shown in Figure G.1.

G2 Program the signal generator to output a waveform of maximum occupied bandwidth:


b) Frequency: 2.45 GHz


d) Transition Time: 1 ns

e) TRLB: 25 µs

f) Mandatory Command: Group_Unselect_GT (or LT or NE) (ISO/IEC 18000-4:2008, 5.2.3.6.2.3.9)

g) Field strength: 54 V/m RMS

h) Antenna Polarity: vertical and horizontal

Figure G.1 – Laboratory test setup for 2.4 GHz frequency exposures 16

ANNEX H - REPRESENTATIVE HARDWARE FOR TESTING The testing shall be performed using appropriate equipment. Example equipment appropriate for this testing includes:

• Semi-anechoic chambers

• Software Defined Radio or equivalent RFID Conformance Test System

• Amplifiers

• Antennas

NOTE: Testing of large medical electrical equipment and systems –may require special equipment or setup (e.g. hospital bed).

NOTE: A Nexgen Conformance Analyzer was used in the development of this standard.

ANNEX I – SELECTION OF RFID FREQUENCIES AND TYPES The RFID frequencies and standards shown in Table 3 were chosen by the AIM REG HCI Working Group as being representative of the types of RFID in use in healthcare environments at the time of writing this draft AIM Standard.

Other frequencies and standards could be applicable in certain circumstances and if so, the tester should discuss the applicability of these with the manufacturer of the equipment under test.

Actual RFID signals were chosen over a generic AM signal to more accurately represent RFID readers.

ANNEX J - RATIONALE FOR TEST LEVELS The test levels in Table 1 are based on the expected normal use distance between the medical electrical equipment or system under test and the RFID reader.

The test levels at 134.2 kHz are based on measured values at 2.5 cm from a radiating reader antenna.

Because the typical read range distances of 13.56 MHz systems can be as small as 1 mm, the test levels used are the maximum permissible values from each representative standard:

• For ISO/IEC 14443-3 (Type A), the test level is taken from the tag testing values specified in ISO/IEC 10373-6, ISO/IEC 10373-7 and ISO/IEC 18046-3.

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• For ISO/IEC 14443-4 (Type B), the test level is taken from ISO 14443-2:2001, 6.2 and is at least as stringent as those listed in the tag testing subclauses of ISO/IEC 10373-6, ISO/IEC 10373-7 and ISO/IEC 18046-3.

• For ISO/IEC 15693 (ISO 18000-3 Mode 1), the values from the ISO 15693 standard

are used because ISO 15693 is the authoritative document for the physical layer and air interface (ISO 15693-1 and ISO 15693-2, respectively) in the ISO 18000-3 Mode 1 standard (SC31 controls ISO 18000-3 but another group within ISO is responsible for ISO 15693). ISO 18000-3 Mode 1 references ISO 15693 as the applicable document for the physical layer and air interface. The value of 5 A/m RMS is taken from ISO 15693-2:2000, 6.2 (maximum value). While ISO 18000-3:2010, 6.3.3.1 specifies a maximum value of 12 A/m, 5 A/m RMS is used for this test because it is the maximum value specified in the authoritative standards for the physical layer and air interface (ISO 15693-1 and ISO 15693-2). This test level is at least as stringent as those listed in the tag testing subclauses of ISO/IEC 10373-6, ISO/IEC 10373-7 and ISO/IEC 18046-3.

• For ISO 18000-3 Mode 3, the test level of 12 A/m was taken from ISO 18000-3:2010,

6.3.3.1. This test level is at least as stringent as those listed in the tag testing subclauses of ISO/IEC 10373-6, ISO/IEC 10373-7 and ISO/IEC 18046-3.

The test levels at 433 MHz, 915 MHz, and 2.4 GHz are based on the maximum allowed power under FCC Part 15 and a typical use distance of 20 cm.

Note: The 54 V/m level is higher than the immunity test levels (e.g. 3 V/m, 10 V/m) that are specified for medical electrical equipment and systems by IEC 60601-1-2:2007. Edition 4 (2014) also specifies immunity test levels up to 28 V/m for portable RF communications equipment.

ANNEX K – OPTIONAL TESTS The following information lists the specifications for testing at the minimum occupied bandwidth.

Preliminary test results indicate that these tests might or might not provide addition information related to potential interference with medical electrical equipment and systems.

Test procedure for 134.2 kHz RFID fields (ISO 14223)

A3 Change the parameters to the following to output a waveform of minimum occupied bandwidth:


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b) Frequency: 134.2 kHz

c) Modulation Depth: 90 %

d) ETU: 12 µs

e) Mandatory Command: Inventory ISO 11785

f) Field strength: 65 A/m RMS

Test procedure for 13.56 MHz RFID fields (ISO/IEC 14443-3 (Type A)

B3 Change the parameters to output a waveform of minimum occupied bandwidth:

a) Standard: ISO 14443-3 (Type A)


c) Pulse width: 2 µs

d) Transition edge: 2.98 µs


f) Mandatory command: WUPA (ISO/IEC 14443-3:2011, 6.4.1)

g) Field strength: 7.5 A/m RMS

Test procedure for 13.56 MHz RFID fields (ISO/IEC 14443-4 (Type B)

C3 Change the parameters to output a waveform of minimum occupied bandwidth:

a) Standard: ISO 14443-4 ( Type B)


c) Modulation depth: 15%

d) Transition edge: 1.17 µs


f) SOF low: 10 etu

g) SOF high: 2 etu

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h) EOF low: 10 etu

i) Mandatory command: ATTRIB (ISO/IEC 14443-3:2011, 7.10.1)

j) Field strength: 7.5 A/m RMS

Test procedure for 13.56 MHz RFID fields (ISO/IEC 15693 or ISO/IEC 18000-3 Mode 1)

D3 Change the parameters to output a waveform of minimum occupied bandwidth:

a) Standard: ISO 15693


c) Modulation depth: 10%

d) Pulse width: 7.5 µs

e) Command coding: 1/256

f) Transition time: 800 ns

g) Mandatory command: Inventory (ISO/IEC 15693-3:2009, 10.3.1)

h) Field strength: 5 A/m RMS

Test procedures for 860-960 MHz RFID fields (ISO/IEC 18000-63 Type C, formerly ISO/IEC 18000-6 Type C)

F4 Testing is repeated with the test equipment configured to output the minimum bandwidth per the following parameters:

a) Frequency sweep: 860 -960 MHz


c) Modulation: DSB-ASK

d) Tari: 25 µs

e) Command coding: 0.5 PIE

f) Pulse width: 0.265 Tari

g) Modulation depth: 80%

h) 255 bit mask: empty

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i) Mandatory command: Inventory Multiple Tags (i.e., Select, Query)

j) Field strength: 54 V/m RMS

k) Antenna polarity: vertical and horizontal

F5 Repeat testing with the following parameters:

a) Frequency sweep: 860-960 MHz


c) Modulation: PR-ASK

d) Tari: 25 µs

e) Command coding: 0.005 PIE

f) Pulse width: 0.525 Tari

g) 255 bit mask: empty

h) Mandatory command: Inventory Single Tag (i.e., Select, Query)


j) Antenna polarity: vertical and horizontal

Test procedure for 2.4 GHz RFID fields (ISO/IEC 18000-4 Mode 1)

G3 Change the parameters to output a waveform of minimum occupied bandwidth:


b) Frequency: 2.45 GHz


d) Transition Time: 400 ns

e) TRLB: 33 µsec

f) Mandatory Command: Initialize (ISO/IEC 18000-4:2008, 5.2.3.6.2.4.4)

g) Field strength: 54 V/m RMS

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h) Antenna Polarity: vertical and horizontal

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ANNEX L – BIBLIOGRAPHY

Agilent Technologies: 11941A

Augello,A., Chiara,G.D.,Primiani,V.,M., and Moglie,F.: Immunity tests of implantable cardiac pacemaker against CW and pulsed ELF fields: experimental and numerical results, IEEE Transactions on Electromagnetic Compatibility, vol. 48, no. 3, pp. 502-515, August 2006

Barbaro V., Bartolini P., Calcagnini G., Censi F., Beard B., Ruggera P., and Writters D.: On the Mechanisms of Interference Between Mobile Phones and Pacemakers: Parasitic Demodulation of GSM Signal by the Sensing Amplifier, Phys. Med. Biol., vol. 48, no. 11, pp. 1661-1671, June 2003

Barbaro V., Bartolini P., Donato A., and Militello C.: Electromagnetic Interference of Analog Cellular Telephone with Pacemakers, J. Pacing and Clinical Electrophysiology, vol. 19, no. 10, pp. 1410-1418, October 1996

Buriette E.C., Cain F.L., and Seals J.: In vivo probe measurement technique for determining dielectric properties at VHF through microwave frequencies, IEEE Trans. Microwave Theory Tech., vol. 28, no. 4, pp. 414-427, 1980

Censi, F., E. Mattei, et al. (2012). "Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part I: medical devices." Expert Rev Med Devices 9(3): 283-288.

Christe, B., E. Cooney, et al. (2008). "Testing potential interference with RFID usage in the patient care environment." Biomed Instrum Technol 42(6): 479-484.

Ellenbogen K.,A.,Kay G.,N.,Lau C.,P., and Wilkoff B.,L.: Clinical cardiac pacing, defibrillation, and resynchronization therapy, Figure7-6, 3rd edition, Pennsylvania: Saunders, 2007

F. Censi, G. C., E. Mattei, M. Triventi, P. Bartolini (2011). Electromagnetic Compatibility of Portable RF Emitters in Uniquos Health Environment: Regulatory Issues. Progress in Electromagnetics Research Symposium, Marrakesh, Morocco.

Finkenzeller, K. (2010). RFID Handbook, John Wiley & Sons, Ltd.

Guidelines on the use of radio communication equipment such as cellular telephones – Safeguards for electric medical equipment –, presented at the EMC Conf. Japan, Electromagnetic Medical Equipment Study Group, 1997

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Gwechenberger,M., Rauscha,F., Stix,G., Schmid,G., and Strametz-J,S.: Interference of programmed electromagnetic stimulation with pacemakers and automatic implantable cardioverter defibrillators, Bioelectromagnetics, vol. 27, no. 5, pp. 365-377, 2005

Houliston, B., D. Parry, et al. (2009). "Interference with the operation of medical devices resulting from the use of radio frequency identification technology." N Z Med J 122(1297): 9-16.

Jamali, B. and B. D. Bates (2009). EMC considerations in deployment of RFID systems. Electromagnetic Compatibility Symposium Adelaide, 2009.

Mattei, E., F. Censi, et al. (2012). "Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part II: active implantable medical devices." Expert Rev Med Devices 9(3): 289-297.

Rahbek J.: Comparison of the RF immunity of operational amplifiers, in Proc. Zurich 12th Int. EMC Symp., 8B3, pp. 43-46, 1997

Remko T., Erik J.L., Reinout H., Beinat E., Binnekade J. M., and Bakker P. J. M.: Electromagnetic Interference From Radio Frequency Identification Inducing Potentially Hazardous Incidents in Critical Care Medical Equipment, Journal of the American Medical Association (JAMA), Vol 299, No. 24, pp. 2884-2890, June 25, 2008

SEMCAD X: Schmid & Partner Engineering AG, Zurich, Switzerland http://www.speag.com/products/semcad/

Stevenson R.A.: EMI filters for cardiac pacemakers and implantable defibrillators, Proceedings of the 19th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, October 30-November 2, 1997, Chicago

Stogryn A.: Equations for calculating the dielectric constant of saline water, IEEE Trans. Microwave Theory Tech., vol.19, no.8, pp.733-736, 1971

van der Togt, R., E. J. van Lieshout, et al. (2008). "Electromagnetic interference from radio frequency identification inducing potentially hazardous incidents in critical care medical equipment." Jama-Journal of the American Medical Association 299(24): 2884-2890.

Ying, Y. (2009). Electromagnetic interference with RFID readers in hospitals. IFMBE.

Seidman, S. J., P. S. Ruggera, et al. (2007). "Electromagnetic compatibility of pacemakers and implantable cardiac defibrillators exposed to RFID readers." International Journal of Radio Frequency Identification Technology and Applications 1(3): 10.

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van der Togt, R., E. J. van Lieshout, et al. (2008). "Electromagnetic interference from radio frequency identification inducing potentially hazardous incidents in critical care medical equipment." Jama-Journal of the American Medical Association 299(24): 2884-2890.

Seidman, S. J., R. Brockman, et al. (2010). "In vitro tests reveal sample radiofrequency identification readers inducing clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators." Heart Rhythm 7(1): 99-107.

Pantchenko, O. S., S. J. Seidman, et al. (2011). "Electromagnetic compatibility of implantable neurostimulators to RFID emitters." Biomedical Engineering Online 10.

AAMI TIR18:2010, Guidance on electromagnetic compatibility of medical devices in healthcare facilities

ANSI/AAMI/IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests

ANSI/IEEE C95.1-1999: IEEE Standard Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz

EN50371: Generic standard to demonstrate the compliance of low power electronic and electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields (10 MHz - 300 GHz).

EN50392: Generic standard to demonstrate the compliance of electronic and electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields (0 Hz - 300 GHz)

EN62311: Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz - 300 GHz)

ICNIRP Guidelines:1998, GUIDELINES FOR LIMITING EXPOSURE TO TIME-VARYING ELECTRIC, MAGNETIC, AND ELECTROMAGNETIC FIELDS (UP TO 300 GHz)

ISO/IEC 29160, Information technology – Radio frequency identification for item management –RFID Emblem

ARIB STD-T82, ver.1.1:2005, CONTACTLESS IC CARD SYSTEMS

ARIB STD-T89, ver.3.0:2008, 950MHz-BAND RFID EQUIPMENT FOR PREMISES RADIO STATION

EPCTM Radio-frequency identity protocols Class-1 Generation-2 2.4 GHz RFID protocol for communications at 860 MHz-960 MHz Version 1.2.0

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http://www.fda.gov/cdrh

http://www.gsmworld.com/health/index.shtml

Ministry of Internal Affairs and Communications, Japan: Regulations for Enforcement of the Radio Law, Article 44-1-1-2(1), April, 2010

U.S. Code of Federal Regulations, Title 47, Telecommunication, Chapter 1, Part 15.247



U.S. Code of Federal Regulations, Title 47, Telecommunication, Chapter 1, Part 95.601-95.673 Subpart E

Ministry of Internal Affairs and Communications, Japan: Results of a study on the effects of electromagnetic waves on medical equipment, MIC Communications News, vol.18, no.4, June 8, 2007

FCC OET Bulletin 65 Supplement C:2001, Evaluating Compliance with FCC Guidelines for Human Exposure to Radiofrequency Electromagnetic FieldsFCC OET Bulletin 65:1997, Evaluating compliance with FCC guidelines for human exposure to radiofrequency electromagnetic fields

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