SBS - The best value in QMS software

Radiated Immunity Device Test Orientations - IEC 61000-4-3

rothlis

Involved In Discussions
#1
It appears to be standard practice to test four 90° "side" device orientations during radiated immunity (61000-4-3) and then also the "top" and "bottom" if the device can be used as such. This is reflected in several guidances I've encountered, and is presumably the inference behind clause 8.2 of 61000-4-3, where it says that "all sides shall be exposed ... In other cases, as determined for example by the type and size of EUT or the frequencies of test, more than four azimuths may need to be exposed".

From an electrical perspective, it would make sense to test orientations for all six sides of a cube to ensure all possibly orthogonal fields are covered by at least a 45° angle of incidence, on the assumption that any one wire or circuit in the device could be oriented in any direction and could be vulnerable to interference. So why isn't it standard practice to test all six orientations for every device? Is it because large devices aren't easily tested in the "top" and "bottom" orientations in a typical EMC lab setup?

As I see it, to exclude the "top" and "bottom" orientations is to presume that the real-world interference is never going to originate from a vector above or below the device and, unless I'm missing something, that doesn't seem like a justifiable assumption.
 
Elsmar Forum Sponsor

phase90

Starting to get Involved
#2
What I understand is it relates to the feasibility of testing. If the DUT is a smaller hand-held type of device that can operate in any orientation, it can be tested on all six sides. If it is a unit that cannot be tipped onto its side and operate, then four sides is all you can do. I guess until someone configures a chamber to be 10 meters high and have the antenna above the DUT, that is the reality of what can be done.
 

rothlis

Involved In Discussions
#3
What I understand is it relates to the feasibility of testing. If the DUT is a smaller hand-held type of device that can operate in any orientation, it can be tested on all six sides. If it is a unit that cannot be tipped onto its side and operate, then four sides is all you can do. I guess until someone configures a chamber to be 10 meters high and have the antenna above the DUT, that is the reality of what can be done.
Thanks for the input. That's what I suspected, but I also perceive tradition has limited testing to four sides whenever top and bottom orientations aren't obviously possible during normal operation, regardless of whether testing is feasible with the device on its side. And it seems to me that 61000-4-3 contributes to this oversight by inferring that four sides is the expected set of orientations, when really that is only appropriate to a minority of devices.
 

phase90

Starting to get Involved
#4
I just pulled up edition 3.1 of 61000-4-3. In clause 8.2, it says the "test shall normally be performed with the generating antenna facing each side of the EUT. When the equipment can be used in different orientations (i.e. vertical or horizontal) all sides shall be exposed t the field during the test. When technically justified, some EUT's can be tested by exposing fewer faces to the generating antenna. In other cases, as determined for example by the type and size of EUT or the frequencies of test, more than four azimuths may need to be exposed."

So really, they are saying if it can operate in any orientation, it needs to be tested on all side, otherwise only the four sides as that is what is feasible.

Yes, technically, floor standing equipment may be exposed from above or below out in the field, but the typical exposure will come from a source horizontal to the equipment. A EMC test house engineer kind of told me years ago that was why they only test four sides. Nowadays, I guess one would have to look at it from a risk analysis perspective to determine if other faces are needed.
 

rothlis

Involved In Discussions
#5
I read that excerpt as follows:
The "four azimuths" in the last sentence are equivalent to "each side" in the first sentence, so that "normally be performed" = left, right, front, back. The second sentence is then saying that if the device can be used without the top and bottom facing the ceiling and floor then the top and bottom also need to be exposed, and the last sentence is essentially saying the same thing in more general terms that include other conditions. So exposure of the top and bottom is treated as the exception rather than the rule.

It may be true that the majority of interference sources would come from a horizontal plane, but there is no shortage of cases where devices which have a defined upright position during use (and thus not treated as operating horizontally) would easily be exposed from the top or bottom (e.g., any pole or wall mounted device could have sources mounted above or below it, and any cart or similar device could have sources sitting directly above it).

I'm inclined to think that there is a deficiency in the language of the standard that has led to an accepted practice which doesn't align with the intent of the test. But maybe I'm over-analyzing this.
 
Thread starter Similar threads Forum Replies Date
S IEC 60601-1-2 Radiated Immunity Test - Diagnostic ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Radiated Immunity Testing as per IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-1-2 Radiated E-Field Emission Testing - Diagnostic ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P AIM 7351731 RFID reader immunity Other US Medical Device Regulations 2
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S IEC 60601-1-2 immunity to proximity fields Test setup - Diagnostic ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-1-2 - RF Conducted Immunity Test Setup - Diagnostic ECG device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
W IEC 60601-1-2 Susceptibility/Immunity for device intended to be used in patient body IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D IEC 60601-2-44: 202.101 Immunity Testing of Essential Performance IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E Particular standards, essential performance in EMC Immunity Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Q Can a fail still be a pass? (Criteria Level B for 61000-4-6 Conducted Immunity) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Electrosurgery Immunity Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
N IEC 60601-1-2 ESD: Lower Compliance Level for ESD Immunity IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Impact using two different materials for product enclosure in radiation and immunity IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Y Is it weird for my conducted immunity (4-6) test result? Need help. CE Marking (Conformité Européene) / CB Scheme 1
J MD Directive vs EMC Directive - Totally excluded (for both emissions and immunity)? ISO 13485:2016 - Medical Device Quality Management Systems 1
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
V MDSAP Requirements for Device Designer Canada Medical Device Regulations 1
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
H EU CE marking for Medical Device Class I EU Medical Device Regulations 0
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
J US Device Listing when not the 510(k) owner Medical Device and FDA Regulations and Standards News 2
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
G Voluntary Class I Device Filing Other US Medical Device Regulations 4
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
D Can a diagnostic device be class I? EU Medical Device Regulations 1
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
S Pre-Submission for Breakthrough Device Designation - What's the threshold? US Food and Drug Administration (FDA) 8
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom