60601-1-2 ME Equipment sub system definition

blazin912

Starting to get Involved
#1
6.1.1.2 Tests

CISPR test methods shall be used, with the clarifications and exceptions specified in a), b), and c) below.

b) * Subsystems

Compliance with the requirements of CISPR 11 may be demonstrated by testing each subsystem of an ME SYSTEM, provided that normal operating conditions are simulated.

When ME EQUIPMENT is being evaluated that interacts with other equipment to form an ME SYSTEM, then the evaluation may be carried out using either additional equipment to represent the total ME SYSTEM or with the use of simulators.
In regards to this test, we have a ME system that has external ports. Usb, Ethernet, VGA. The external video port allows the final location to attach an external monitor to the ME System to display the video on an ADDITIONAL display other than the display associated with the ME System we provide.

The problem is, we do not provide a second monitor. So, do we need to attach a monitor to this VGA port to perform EMC?

In my experience this would mean any monitor other than the one utilized would fall into the category of IFU statements saying, "Any use of this equipment in ways other than those described in this document/testing configuration may result in EMC compliance issues."

How does one handle this situation? Wouldn't this be similar to having a USB port that allows the user to attach/supply their own USB Hub, Thumbdrive, Keyboard, Mouse.. whatever. You can show you have a port but you can't show what's attached in every possible configuration.
 
Elsmar Forum Sponsor

Pads38

Trusted Information Resource
#2
I might suggest that you could have different set-ups for the emissions tests and the immunity tests.

For the emissions use a "dummy monitor" - connect using your specified length of video lead to 75 ohm terminations of the video lines.

For immunity connect a monitor to ensure that the signal continues to be usable. For the RF radiated immunity test the monitor would be outside the anechoic chamber with, probably, lots of ferrites on the video lead so as to restrict the exposure to just your equipment under test.

But, hopefully, you can discuss this with your test house. They are usually able to provide some ideas, ideally well in advance of "test day". If they cannot / will not offer advise then perhaps you are using the wrong test house!
 
Thread starter Similar threads Forum Replies Date
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D The necessity of a SECONDARY CIRCUITS in ME EQUIPMENT (IEC 60601-1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
R IEC 60601-2-57 - Subclause 201.7.101.2 - Explanatory Label - LS Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
O Difference in 60601-1-2 3rd and 4th ed separation RF portable equipment CE Marking (Conformité Européene) / CB Scheme 1
F Test Equipment for IEC 60601-2-27 related to the picture 201.105 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E ME (Medical Equipment) Systems - IEC 60601-1 Clause 16.1 Interpretation IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R IEC 60601-2-18 Endoscopic Medical Electronic Equipment question IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
K Definition of ME Equipment/Applied part according to IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
I IEC 60601-1 Least Favourable Working Conditions for Medical Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Amendment 1 to 60601-1, 3rd Edition Medical Electrical Equipment Standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
I Dielectric Test for HF Surgical Equipment (IEC 60601-2-2 clause 201.8.5.1.2) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Marking (Labeling) Requirements on Medical Equipment per IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
D IEC 60601-2-18 (IEC 601-2-18) Particular Requirements for Endoscopic Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
J Medical Equipment (AC Adapter) Classification as per IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
N CB Scheme and Conformity of Medical Equipment to IEC/EN 60601 EU Medical Device Regulations 2
M IEC 60601 Medical electrical equipment - Send declaration and guidance to customers? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M IEC 60601-2-6, Microwave Therapy Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F Medical Electrical Equipment / System Peripherals - IEC 60601-1-3 IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
D Training for IEC 60601-1-8:2006 Alarm Systems in Medical equipment. IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 0
R IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M What to Expect from Next IEC 60601-1 and IEC 60601-1-2 Amendments? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
R Hand transmitted vibration 9.6.3 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Different methods of achievement of the isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Unused SIP/SOPs - IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4

Similar threads

Top Bottom