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

Involved In Discussions
#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

Involved In Discussions
#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
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P AIM 7351731 RFID reader immunity Other US Medical Device Regulations 4
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
I Calibrating the monitoring device but not the unit General Measurement Device and Calibration Topics 4
J Shoe Covers - medical device class I EU Medical Device Regulations 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
P Certification process for registered device China Medical Device Regulations 11
Nihls MSA after the device move Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
I How to determine "generic/me too" device? Japan Medical Device Regulations 0
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
shimonv Can you submit a traditional application for a class I device? Other US Medical Device Regulations 7
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
DanBOS Cloud Connected Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
M Changing Investigational Device from Non-Sterile to Sterile - what are the implications? Other Medical Device and Orthopedic Related Topics 3
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
D Add new device to current license Canada Medical Device Regulations 0
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 1
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
B Is labeling on the device itself required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Intended Purpose on device label EU Medical Device Regulations 7
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
T CE Marking - Bench mark Device from same manufacturer CE Marking (Conformité Européene) / CB Scheme 2
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2

Similar threads

Top Bottom