Safety Considerations for Embedding RFID in Medical Devices
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This document discusses safety considerations for embedding RFID in medical devices. It begins with examples of how RFID is used in various medical applications like medical waste tracking, ventilator component identification, and patient tracking. It then covers pertinent facts about RFID technology, primary safety concerns regarding human and medical device exposure to electromagnetic radiation, and FDA actions to study RFID effects. Finally, it discusses applicable testing standards like IEC 60601 and publications by AIM to ensure RFID systems meet compliance requirements.
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Safety Considerations for Embedding RFID in Medical Devices
- 1. Safety Considerations for Embedding RFID in Medical Devices 1
- 2. © FEIG ELECTRONICS l PRESENTER AND AGENDA Introduction to FEIG Use cases for RFID in medical applications Safety considerations for RFID Testing standards for compliance requirements Q&A 2 Michael Hrabina Executive Vice President FEIG ELECTRONICS, INC
- 3. © FEIG ELECTRONICS l Upcoming events 3
- 4. © FEIG ELECTRONICS l A bit about FEIG ELECTRONIC German manufacturer and technology supplier since 1966 320 employees and approximately €50 million Euros in sales All development and production “Made in Germany“. Wide, international and recognizable customer base Four Operating Divisions: Passive RFID-Readers & Antennas Sensor-Products for moving & stationary traffic Intelligent control technology for gate & barrier systems Payment Terminals 4
- 5. © FEIG ELECTRONICS l FEIG ELECTRONICS in HEALTHCARE 5
- 6. Use cases for RFID in medical applications
- 7. © FEIG ELECTRONICS l Example 1: MEDICAL DEVICES • Medical Waste Management System for suctioned biohazards • Manifolds are equipped with ISO18000-3M3 transponders • Two, customized reader modules per device 7
- 8. © FEIG ELECTRONICS l Example 2: MEDICAL DEVICES • Identification of connecting components on medical ventilators • Connections identified with an ISO15693 transponders • Reader module with integrated, eight channel antenna multiplexer embedded into the system. 8
- 9. © FEIG ELECTRONICS l Example 3: Patient-ID / Document Tracking • Identification of patient documents • UHF-transponders affixed to the patient’s chart that travels everywhere the patient travels. • UHF Long Range Reader identifies the chart at multiple reading points throughout the Hospital 9
- 10. © FEIG ELECTRONICS l Example 4: Patient-ID • Patients receive a transponder at a printing machine / workstation and use this as a means to check in at each treatment point. Staff and loved ones will be up to date in which area the patient is. • Also very helpful in daycare for children and eldercare centers for alzheimer and dimentia patients, staff administration and many more with wristband or badges tags etc. • Reader terminals for IP-based Networks are installed on every printing machine / workstation / and treatment area 10
- 11. © FEIG ELECTRONICS l Example 5: Hospital Logistics / Garment Identification • Hospital staff return used clothing and receive new ones automatically. • UHF Mid-Range and Long Range Reader are installed in the return and dispensing panel 11
- 12. © FEIG ELECTRONICS l Example 6: Smart Shelf Medical Equipment Tracking and Visibility and FDA UDI Compliance • FIFO and automatic billing/replenishment • Intelligent shelf for real-time inventory management 12 • Shelf can have a Proximity Reader installed. Or possible to perform the application with other reader systems and modules, a multiplexer and customized antennas.
- 13. © FEIG ELECTRONICS l Example 7: Blood Tracking Blood Tracking with FDA Approved RFID Data Carrier help protect the safety of vital blood supplies while improving efficiency, reducing costs and increasing patient safety. • Intelligent refrigerator for stored blood • HF Long Range Reader with Multiplexer and special antennas are installed. • Workstation with Desktop Reader 13
- 14. © FEIG ELECTRONICS l Example 8: Smart Distribution System Automated delivery of devices, medication to maximize staff’s time for patient care and improve efficiency and response. • Intelligent inventory management on a robotic vehicle • RFID Equipment used is Long Range HF Reader 14
- 15. © FEIG ELECTRONICS l 15 Example 9: Smart Analytical Devices RFID for Medical Device Calibration • RFID provides wireless authentication and maintenance by checking for original consumable (Filter) • RFID Equipment: • Reads certain Machine Parameters from RFID Tag • HF OEM Reader Module
- 16. Safety Considerations for RFID in Healthcare
- 17. © FEIG ELECTRONICS l Pertinent facts concerning RFID 1. RFID technology is certainly not new and has widespread use in healthcare 2. Understand that Radio Frequency Identification by design is an intentional radiator 3. There are three primary RFID operating frequencies 4. Realize there are a variety of RFID protocols 5. Multiple beam antennas combined with Radio Signal Strength Indicator (RSSI) and phase of the return signal can be effective at determining approximate location and direction of tag movement. 6. Passive sensor tags for measuring moisture and temperature are available. 7. Dual-ported RFID EEPROM’s provide wireless configuration of device operating parameters 8. The data streams produced by passive RFID can be are truly transformative to processes 17
- 18. © FEIG ELECTRONICS l An abundance of EMI everywhere around us Primary RFID safety concerns 1. Human exposure to radiated emissions 2. Pharma exposure to radiated emissions 3. Immunity of medical devices, both implantable and non-implantable 18
- 19. © FEIG ELECTRONICS l What are the affects Risk of exposure should balance the medical benefits Short duration to high levels of radiation vs. long duration to low levels of radiation. Recommendation to limit exposure to both. RFID produces very low levels of radiated emission. Radiation of HF near field energy drops on a cube function of distance Radiation of UHF far field energy drops on a square function of distance Conclusion: if you are mainly concerned with limiting radiation exposure consider the distance as and important factor. Shielding and Absorption as methods to limit exposure Passive RFID Tags have much less radiation then cell phones 19
- 20. © FEIG ELECTRONICS l FDA Actions 20 The FDA has taken steps to study RFID and its potential effects on medical devices including: Working with manufacturers of potentially susceptible medical devices to test their products for any adverse effects from RFID and encouraging them to consider RFID interference when developing new devices. Working with the RFID industry to better understand, where RFID can be found, what power levels and frequencies are being used in different locations, and how to best mitigate potential EMI with pacemakers and ICDs. Participating in and reviewing the development of RFID standards to better understand RFID’s potential to affect medical devices and to mitigate potential EMI. Working with the Association for Automatic Identification and Mobility (AIM) to develop a way to test medical devices for their vulnerability to EMI from RFID systems,. Collaborating with other government agencies, such as the Federal Communications Commission (FCC), the National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) to better identify places where RFID readers are in use.
- 21. © FEIG ELECTRONICS l Electromagnetic Compatibility of Medical Devices 21 BioMedical Engineering Online https://biomedical-engineering-online.biomedcentral.com/articles/10.1186/1475-925X-10-50 Evaluated 6 implants to the affects of 22 RFID emitters, across six frequencies.
- 22. © FEIG ELECTRONICS l 22 Electromagnetic Compatibility of Medical Devices 3 syringe pumps, 3 infusion pumps, 4 AEDs and 1 ventilator exposed to 19 RFID emitters and one active RFID tag.
- 23. © FEIG ELECTRONICS l From the FDA site 23 Information for Health Care Professionals Because this technology continues to evolve and is more widely used, it is important to keep in mind its potential for interference with pacemakers, implantable cardioverter defibrillators (ICDs), and other electronic medical devices. Physicians should stay informed about the use of RFID systems. If a patient experiences a problem with a device, ask questions that will help determine if RFID might have been a factor, such as when and where the episode occurred, what the patient was doing at the time, and whether or not the problem resolved once the patient moved away from that environment. If you suspect that RFID was a factor, device interrogation might be helpful in correlating the episode to the exposure. Report any suspected medical device malfunctions to MedWatch, FDA’s voluntary adverse event reporting system.
- 24. Standards and Compliance for RFID in Healthcare
- 25. © FEIG ELECTRONICS l RFID is an intentional radiator and requires EMI Assessments An RFID interrogator by design emits electromagnetic signals necessarily used to: 1) power the passive transponder 2) perform duplex communications over a wireless interface Energy transfer methods Conductive and inductive coupling Communication Methods Modulated carrier side bands 25
- 26. © FEIG ELECTRONICS l Standards for Medical Equipment IEC 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance Part 2 - Collateral Standard regarding electromagnetic disturbances – requirements and tests IEC 60601 is the accepted benchmark for medical electrical equipment Compliance with IEC 60601-1 has become a requirement for the commercialization of electrical medical equipment in many countries and most markets Standard is for: Risk management Essential performance Humidity Documentation Marking and Labeling Electrical hazards Temperature testing Programmable Electrical Medical Systems Construction 26
- 27. © FEIG ELECTRONICS l IEC 62369-1:2008 Evaluation of human exposure to electromagnetic fields from short range devices (SRDs) in various applications over the frequency range 0 GHz to 300 GHz - Part 1: Fields produced by devices used for electronic article surveillance, radio frequency identification and similar systems IEC 62369-1:2008 presents procedures for the evaluation of human exposure to electromagnetic fields (EMFs) from devices used in electronic article surveillance (EAS), radio frequency identification (RFID) and similar applications. It adopts a staged approach to facilitate compliance assessment. https://www.vde-verlag.de/iec-normen/214881/iec-62369-1-2008.html 27 Applicable Testing Standards
- 28. © FEIG ELECTRONICS l 28 Publications by AIM
- 29. © FEIG ELECTRONICS l Take a common sense approach from a safety perspective It is generally unnecessary to continuously energize the field of an RFID reader Limit the on time. Most readers support RF On/RF Off and can use a sensor input to a GPIO to activate the On time. Some RFID systems such as for door access control go into a very low power state, automatically sense the presence of a transponder brought into the field, then power up briefly to read the transponder. This is done to extend battery life, but is also effectively limiting radiation. Use of RF absorption material and shielding material are useful in limiting EMF and the affects of EMI. Many readers on the market have adjustable RF output power. Only use the amount of power necessary to perform the application. 29
- 30. © FEIG ELECTRONICS l Contact FEIG for Help in RFID Safety in Healthcare FEIG ELECTRONICS provides FCC/CE Certified Readers in Low Frequency LF High Frequency HF Ultra High Frequency UHF We’re here to support manufacturers embedding RFID into their devices. We are available to help manufacturers ensure their systems meet regulations. 30
- 31. © FEIG ELECTRONICS l Contact: FEIG ELECTRONICS Mike Hrabina 2220 Northmont Pkwy Suite 250 Duluth, GA 30096 E-Mail: SALES@FEIG.US Phone: +1 770-491-8060 31 Questions & Answers Download Whitepaper http://rfidreadernews.com/webinar-safety-considerations-for-embedding- rfid-in-medical-devices/
Hinweis der Redaktion
- Hello everyone and welcome to “Safety Considerations for Embedding RFID in Medical Devices” I’m Mike Hrabina, Executive Vice President of FEIG ELECTRONICS. I’m speaking to you from FEIG’s U.S. office in Duluth, GA The topic of this webinar is aimed at design engineers and product managers tasked with incorporating RFID technology into a medical device. FEIG is an OEM manufacturer of RFID readers and antennas. The majority of which are designed in to RFID enabled products. Therefore, we can speak to the subject from direct experience. This webinar is being recorded and will be made available for future reference. So relax from the note taking. I’ll share a link with you shortly after the session is complete. In the meantime, please familiarize yourself with the Go-to-Webinar control panel on your screen. Due to the size of the group everyone is of course muted and cannot be heard, but you may post questions that will be collected and I will answer as many as possible in the time available. The agenda is brief and should last about forty minutes. It is intended to be informative and is not a commercial presentation. But, I do need to establish who FEIG is and explain our position in the industry and the experience we have on this subject. I will begin with a short introduction to FEIG. I’ll provide examples of current RFID deployments in medical application, then move onto the safety considerations and testing for compliance RFID. I’ll leave time for question and answers at the end.
- We purposely timed the webinar to occur just prior to the Medical Device and Manufacturing Show that is taking place in a few short weeks in Anaheim, CA And the HIMSS Show that follows in early March in Chicago. FEIG is exhibiting at both these events and hopefully we will have an opportunity to speak to you or a colleague that may attend these events. For those unable to attend either of these events, there is the MD&M East takes place in June in New York City.
- So, I bit about FEIG. FEIG Electronics is a privately held German manufacturer. We celebrated our 50th anniversary in business last year. We are a mid-size company with 320 employees with approximately 50 million Euro in turnover. It’s notable that all hardware and software development and production is performed in Weilburg, a small town north of Frankfurt. We have a remarkable, and recognizable international customer base, most under terms of strict non-disclosure in the manner that they use our products. The company derives revenue from four operating divisions. Identification is one of these divisions. The company got its start with inductive loop detector used in traffic control systems. Our Sensors division now includes microware motion sensors and light curtains along with loop detectors. Our Controller division offers intelligent control technology for gate, door and barriers used in perimeter access control such as parking and secure gated facilities. Payment is our newest division and combines an NFC contactless RFID reader, a secure cryptographic processor running an embedded Linux platform for unattended payment systems such as kiosks, ticketing and vending machines. But, we’re talking about embedded Medical Devices today, so allow me to describe a bit about our position in Healthcare.
- We are a supplier to system integrators that use contactless identification as an input to their information or control system. And we are a technology partner, an expert resource as it were, to OEM customers that design RFID as a component into their medical devices. The portfolio of products include handheld readers for mobile data collection, desktop workstations, fixed positioned antennas. We offer board level reader modules and housed units in rugged industrial rated enclosures. The products include vicinity, mid-range and long range products. 42% of our U.S. revenue in 2017 was derived in the Healthcare markets. You will find FEIG products in a variety of medical devices. Let me provide a few specific examples.
- Here in an example an RFID reader embedded into a medial waste management system where the manifolds are equipped with a 15.56MHz, ISO 18000-3 Mode 3 transponder. Two customize readers are installed in the device to insure the containers are authentic to the manufacturers part. If the container does not authenticate, the device will not operate.
- Here connected components on a ventilator are identified with an ISO 15693 transponder. There are number of connection points. Rather than placing a separate reader at of these locations, a module with eight, multiplexed antenna ports is embedded into the machine, effectively amortizing the cost of the reader hardware across multiple read points. All hoses connected to the correct port and also that it is authentic to the device manufacturer
- In this application, a UHF transponder is affixed to the patient’s medical chart. The chart travels everywhere the patient travels. By placing read points throughout the hospital the patient’ location and time in the area is identified. The system is used to gauge productivity, efficiency and staffing requirements.
- Here is another Patient identification application using a wrist band assigned at check in station and read at each point of treatment. Staff and loved one are up to date on where the patient is. The system is also helpful in daycare and elder care centers.
- Hospital garments are identified with a UHF transponder. Staff pick up and return garments specifically assigned to them. The transponder is read at the return and dispensing bins.
- RFID provides an excellent method to tracking inventory in real time using smart shelves and cabinets. Inventory is tagged with a transponder and each storage location has either a reader or multiplexed antenna. In one deployment, heart catheters are identified with a transponder which is then used to insure first-in-fist out inventory utilization. The catheter itself has an expiration date of the anti-coagulant medicine. The system reduces loss associated to expiry
- Here is another example of a smart shelf tracking a date sensitive product. Blood tracking using HF RFID is approved by the FDA after years of research and study.
- Have you seen robotic systems roaming hospital halls. The robot delivers pharmacuticals to the nursing stations on the med surge floors
- In this use case an RFID tag is used in the calibration of the device by providing authentication and maintenance of a consumable item, in this case a filter.
- So, with the many systems already deployed in healthcare, what are the safety considerations?
- First, let me share a few pertinent facts about RFID. Radio frequency identification in medical and healthcare applications is not new. There are many RFID of deployments in hospitals and by the examples just illustrated demonstrate the use of the technology in healthcare is widespread and growing. RFID may be new to you and that’s what brought you to this meeting, but there’s a lot of practical experience and knowledge existing in the market for embedded RFID applications. The take away… you have the advantage of others breaking ground. Next, I want you to understand that an RFID reader and antenna is an intentional radiator designed to emit radio waves. These emissions must be within regulatory limits and can pose potential for interference with other devices through inductive and capacitive coupling. It is essential that medical devices do not interfere with one another. Distance, shielding, absorption, and power levels are techniques often used to address this interference. Consider there are several frequencies used in passive RFID. Each frequency has characteristic operational features, some of those feature can be quite desirable in a specific use case, while other characteristics of a certain frequency may not so desirable. Realize within these frequencies there are a number of air protocols defined between the reader and the transponder. Some protocols have high levels of security to protect data, others have limited protection, some have no data security what-so-ever. There may be as much concern about data safety as human safety when it comes to RFID. Did you know multiple beam UHF antennas combined with RSSI and phase of the receiving signal can be effective at determining the approximate location and direction of travel of a tag? Are you aware of the passive RFID sensor tags used to measure temperature and moisture. These device have medical use to wirelessly monitor patient temperature. The moisute tag has a use case to monitor incontinence, a leading cause of skin breakdown and infection in the elderly. Dual ported RFID memory chips create a means to wirelessly configure a device through a smart phone or tablet using NFC. Perhaps more importantly, yet often overlooked is that data streams produced by passive RFID can truly transform a process and can be downright disruptive to an existing business model. the wide variety of successful deployments for patient safety both on the med-surge floor and in the OR. In the pharmacy for access to controlled substances, for asset tracking of critical medical devices and controlling inventory, especially date sensitive items to assure FIFO usage to prevent expiration losses. Consider the new applications that have been opened by passive moisture tags in nursing homes to reduce skin breakdown and infection caused by incontinence. Or passive sensor temperature tags to monitor patient without disturbing them from their sleep. Or how medical devices are incorporating dual port EEPROM memory chips that offer an RFID interface to wireless configure parameters of the device. It is easily understood why healthcare is one of the fastest growing RFID market segments.
- There is an abundance of EMF around us at any given time produced by a wide variety of sources. As it relates to RFID and medical devices you will find three primary safety concerns. 1. Human exposure to radiated emissions 2. Effect of radiated emission on pharmaceuticals 2. Medical device immunity bot to the affects of both conductive and radiating sources The affects on human exposure to long term, low level radiation in any form be it use of cell phones, proximity to cell towers, power lines, WiFi hotspots, airport screening systems is not fully understood. And the available research shows that medical devices can be affected by proximity to inductive, conductive and radiating sources.
- There affect of low level radiation are not completely known. Exposure to high levels of radiation is understood. X-ray and MRI are examples of short duration, high levels of radiation. The risk of exposure is balanced against the medical benefits. And the recommendation is to limit exposure. But, RFID is low level radiation. Increased power level at the antenna generally translates to greater reading distances. At any given power level, the near field HF energy drop is a cubic function of distance. The far field energy used in UHF RFID drops as a function to the square of distance. Near field energy drops off quite quickly versus far field energy and this is the technical reason HF NFC is short range by comparison to its UHF counterpart. If the concern is to limit exposure then perhaps the operating distance of the application should be an important consideration. And of course shielded enclosures and use of absorption materials are the methods used to limit radiation. I provide a few links on some materials use in this purpose.
- The FDA is supportive of the technology and active in helping to increase technologies deployed to increase patient safety, improve care and improve efficiency of healthcare’s delivery. They are very much involved and active with these actions. The FDA has approved a variety of implantable, and non-implantable RFID uses. Additionally, standards for testing procedures for immunity testing of RFID devices have been developed. So with the webinar title of Safety considerations for embedding RFID into medical devices. The question to answer, is RFID safe?
- To answer that, let’s take a moment to look at a few of the scientific, peer reviewed tests of RFID Biomedical Engineering Online provides an open access to articles made freely and permanently available to researchers throughout the world. It is a community of biomedical engineers linked together by their various research interests and their values in promoting benefits to all humanity Here’s one such article, “Electromagnetic compatibility of implantable neurostimulators to RFID emitters”. In this test six implantable neurostimulators with lead systems were tested for the susceptibility to electromagnetic fields generated by 22 different RFID emitters. The medical devices were previously approved for marketing in the U.S. for a number of intended uses that include epilepsy, depression and incontinence, Parkinsonian tremor and pain relief. Each RFID emitter had one of the following carrier frequencies: 125kHz, 134kHz, 13.56MHz 433MHz, 915Mhz and 2.45GHz The results showed the output of one of the implantable neurostimulators was inhibited by 134 kHz RFID emitter at separation distance of 10cm or less. The output of that same implantable neurostimulator was also inhibited by another 134 kHz RFID emitter at separation distance of 10cm or less, but also showed inconsistent pulsing rate at a separation distance of 15cm. Both effects occurred during and lasted though out the the duration of the exposure. The clinical significance of the effects was assessed by a clinician at the U.S. Food and Drug Administration. The effects were determined to be clinically significant only if they occurred for an extended period of time. There was no observed effects from the other five implantable neurostimulators or during exposures from other RFID emitters.
- Here is a second… Here Medical devices were exposed to 19 different RFID readers and one active RFID tag. The RFID systems that were used covered five different frequency bands. Three syringe pumps, three infusion pumps, four automatic external defibrillators (AEDs) and one ventilator were tested. The test procedure was modified from ANSI C63.18 which is a recommended practice for on-site, ad hoc test method for estimating radiated Electromagnetic Immunity for Medical Devices to specific Radio Frequency Transmitters. The results… EMI was observed in 13 of 60 experiments conducted with syringe pumps at a maximum distance of 59cm EMI was observed in 10 of 60 experiments conducted with infusion pumps at a maximum distance of 136cm EMI was observed in 18 of 75 experiments of AEDs at a maximum distance of 51cm The majority of EMI observed was classified as probably clinically significant. No EMI was observed for all medical devices tested during exposure to 433MHz (two readers and one active tag tested) No Emi was observed for all medical devices tested during exposure to 2.45GHz (two readers tested) The testing confirmed that RFID does have the ability to interfere with medical equipment. Therefore, hospital staff should be aware of the potential for medical device EMI and should be encouraged to perform on-site RF immunity tests prior to RFID system deployment or prior to placing new medical devices into an RFID environment. The conclusion of this test suggests the need for standard test methods for assessing the immunity of medical devices to RFID systems
- The FDA has posted this information to their website with regard to RFID.
- Remember, RFID readers are by design intentional radiators. The radio waves they produce are used to both power the passive (battery-less) transponder AND to perform a duplex communication protocol to command and control tag functions. You can not deploy RFID without radiating an EMF signal. These devices of course meet radio regulations in the region they are deployed. Here in the United States the Federal Communications Commission (FCC) EN in Europe, EN in Europe, IC in Canada and so on. Manufacturers such as FEIG obtain radio regulatory certifications for their products for use in countries across the globe. And you will find the approvals and test reports posted to the regulatory bodies website. However, when incorporating an RFID reader into a medical device, additional considerations exist.
- And AIM released a standard for electromagnetic immunity testing of Medical Devices.
- In regard to RFID deployments in healthcare take a common sense approach. It is generally unnecessary to continuously energize the field of an RFID interrogator when the transaction time is measured in fractons of a second Limit the ON time. Most readers support RF On/RFOFF commands in the API and can use a general purpose input from a sensor to activate the ON time. Some RFID readers such as door access control, go into a very low power sleep state, automatically sense the presence of a transponder brought into the field , briefly power up to read the transponder then return to a low power state. This is done to extend useful battery life, but is alos an effective way to limit EM radiation. Use of RF absorption and shielding materials are also useful in limiting A UHF reader operated at 200mW can capture a transponder at 6’. Most long range UHF readers have output power of 2-4 watts.
- High frequency RFID operates in a harmonized frequency band of 13.56 MHz. An HF reader will operate the same way and prvide the same performance in any region of the world Passive UHF RFID operates in an unlicensed ISM band crowded by actively powered UHF transmitters. It is not harmonized across the world and requires a reader to be configured to operate at a regionally defined frequency band. For instance here in the U.S. that band is 902MHz to 928MHz and the reader is required to hop over 50 channels within this band. Europe is operating a 865MHz - 868MHz and hops over four channels. This creates some potential for challenges for a medical device that may be intended for global distribution.
- Although dated, this graphic illustrates the UHF bands across the globe. The latest UHF regulations can be found at the GS1 website. The point here is to understand that for optimum performance, UHF transponders are tuned to match the operating frequency of the reader. A transponder tuned to operate in the U.S. for instance will perform quite differently when presented to a reader operating in the EU band. It is essential to understand the relationship between the reader, the transponder and the region the equipment is deployed.
- In regard to RFID deployments in healthcare take a common sense approach. A UHF reader operated at 200mW can capture a transponder at 6’. Most long range UHF readers have output power of 2-4 watts.
- So, where does RFID exist in the RF spectrum.
- In addition to the FCC guidance, there is an ISO/IEC technical report in regard to to ISO18000 interrogator emitters.