EMI/EMC Test differences for Radiography Equipment

J

jayanthi

Dear All,
We are designing a mobile Computed radiography(CR) equipment Which will have X ray generator, CPU ,monitor and CR casette reader and with UPS backup. All these modules in a mechanical housing.
As per IEC 60601-1-2, this device comes under CISPR 11- Group 2 -Class A device.

Earlier, we have done EMC testing for products of Group I category.I would like to know difference in tests and their limits for Group 1 and Group 2 (shielding and without shielding).

Thanks in advance.
Jaya
 
P

Pads38

Moderator
Re: EMI/EMC for radiography equipment?

Hi Jaya,

Thanks for providing some extra details - bit easier to jump in.

As for the grouping -
Are you sure your device is Group 2?
If you check Annex D (2007 edition) diagnostic X-ray and CT systems are both clearly identified as Group 1.

When it comes to the difference - it only affects the emissions tests where Group 2 have higher allowed emissions.

But remember that even for Group 1 equipment you can have an "exclusion band" if your device includes an (intentional) RF transmitter.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Is a 3V torch classified as medical electrical equipment needing EMI/EMC testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Airborne Medical Equipment EMI/EMC IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
V What are EMC and EMI Tests for PCBs? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
S EMI/EMC Failure Cause Analysis per IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
O Can unit be categorized as EMI class A when it has EMI class B power supply in it? CE Marking (Conformité Européene) / CB Scheme 2
H EMC & Safety Testing of the product with the same Sr. No. for EC Declaration CE Marking (Conformité Européene) / CB Scheme 3
C IEC60601-1-2 :2020 EMC Reliability Analysis - Predictions, Testing and Standards 2
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
H Regarding the validity of EMC & Safety test reports without NABL & ILAC-MRA mark. CE Marking (Conformité Européene) / CB Scheme 2
H Regarding EMC & Safety retesting requirements of the product CE Marking (Conformité Européene) / CB Scheme 2
S What EMC 60601-1-2 version to use with 60601-2-47 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M IEC 60601-1-2 EMC Tables IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L IEC60601-1-11 Home Healthcare + IEC60601-1-2 EMC (Functional Earth allowed?) IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M EMC Directive and product safety standards CE Marking (Conformité Européene) / CB Scheme 1
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Does EMC Directive 2014/30/EU cease to apply when the Machine Directive 2006/42/EC is applicable? CE Marking (Conformité Européene) / CB Scheme 4
H External power supply - requirements in safety/EMC test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
F EMC testing for a system that is provided with a computer IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
O EMC - EFT (Electrical Fast Transients) on SIP couples erroneously with other cable CE Marking (Conformité Européene) / CB Scheme 1
M Arguing with the test lab about failing in an EMC test IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
S Portugal ISO 13485 Certification and EMC Test Houses Other Medical Device and Orthopedic Related Topics 3
T Question: Do we consider 60601-1-2 (4th ed) EMC testing a mode for a diagnostic port? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
O Medical Device EMC Risk Management CE Marking (Conformité Européene) / CB Scheme 4
O Guide on EMC for Functional Safety CE Marking (Conformité Européene) / CB Scheme 3
T CE Marking & Compliance to MDD, EMC, RoHS, and GPSD REACH and RoHS Conversations 4
J IEC 60601-2-2 - EMC Requirements - Surgical instrument manufacturer IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
O EMC testing per IEC 60601-1-2 for considering new cables CE Marking (Conformité Européene) / CB Scheme 1
O EMC testing under RED and IEC 60601-1-2 CE Marking (Conformité Européene) / CB Scheme 1
D EMC Testing for a Production Fixture CE Marking (Conformité Européene) / CB Scheme 0
Q IVD vs EMC OJ (Official Journal of the European Union) Harmonised Standard Conflicts EU Medical Device Regulations 1
A EMC Emission Issues - Communication between PC and Monitor IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F Is EMC + Radio Re-Test Required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Particular standards, essential performance in EMC Immunity Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F EMC (Electromagnetic Compatibility) Conformity Charts - IFU Requirements Misc. Quality Assurance and Business Systems Related Topics 3
G CE Marking - Low Voltage Directive and EMC Directive CE Marking (Conformité Européene) / CB Scheme 4
T Firmware version in EMC report / DoC CE Marking (Conformité Européene) / CB Scheme 1
W EMC, ESD for battery operated apparatus Other Medical Device and Orthopedic Related Topics 1
N New EMC IEC60601-1-2 4.0 Ed. Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
B What is our requirement for maintaining the EMC series of standards? IEC 61000 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P EMC requirements for an accessory to a medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T EMC for Medical Devices in Home Environment Other US Medical Device Regulations 4
M EMC Testing for a US-only, Home-Based Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B Safety & EMC certificate updated when MCU (MIcro-Controller) is changed? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T EMC Tests - While certified power supply is part of device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B EMC Repeat Justification - Reducing NRTL testing required after modification of ME IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
C EMC Test Report Requirements to IEC 60601-1-2:2009 ISO 13485:2016 - Medical Device Quality Management Systems 4
O CE TCF (Technical Construction File) Template for LVD/EMC/Pressure Directive CE Marking (Conformité Européene) / CB Scheme 5
P New EMC standard IEC 60601-1-2:2014 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
T IEC 60601-1-2 EMC and WiFi IEC 60601 - Medical Electrical Equipment Safety Standards Series 8

Similar threads

Top Bottom