Does a 12V DC device need EMC (IEC 60601-1-2) Testing?

[SteveK]

We have an accessory for a non-electrical medical device (the accessory has a circuit board, LEDs and solenoids etc) and is intended to be fitted in an ambulance and powered by the vehicle’s 12V DC supply. Is there a requirement for such a device to be tested to IEC 60601-1-2 (EMC), or is this standard intended for mains driven devices? I get a serious pain in the brain trying to understand/interpret the 60601-1 series standards.

Steve

 

[Stijloor]

Can someone help our friend Steve?

Thank you!!

Stijloor.

 

[George Weiss]

IEC 60601-1-2 is a base standard referring to other standards for EMC testing. The Standard mainly is referencing medical devices, specifically ones which could impact the patient and other equipment. Assuming your device is clearly classed as a non-medical device, then IEC 60601-1-2 testing is not required, but only maybe desired. 3.201.4 Non-medical equipment of 60601-1-2, suggests your device does not require EMC compliance.
For other discussion, I reference an article by a respected EMC lab. @
http://www.elliottlabs.com/documents/IEC%2060601%20for%20Conformity%20DEC%202005.pdf
A reference document I have suggests that a permanently affixed device in a vehicle/ambulance could qualify it as medical.

 

[SteveK]

Hi George,

Do not think you read my post correctly. The 12V device is an accessory to a medical device (non-electrical). It does not have to be fiitted in an ambulance, but it is an option. Under MDD 93/42/EEC accessories are themselves classed as medical devices, thus my concern about EMC testing or non-testing requirements.

Steve

 

[Sjoerd]

We have an accessory for a non-electrical medical device (the accessory has a circuit board, LEDs and solenoids etc) and is intended to be fitted in an ambulance and powered by the vehicle’s 12V DC supply. Is there a requirement for such a device to be tested to IEC 60601-1-2 (EMC), or is this standard intended for mains driven devices? I get a serious pain in the brain trying to understand/interpret the 60601-1 series standards.

Steve

From the rationale A of 60601-1-2:2007

"This collateral standard is applicable to ME EQUIPMENT and ME SYSTEMS. For the purposes of this collateral standard, an ME SYSTEM includes those ACCESSORIES that are needed for operating the ME SYSTEM as specified by the MANUFACTURER. The reader is reminded that an ME SYSTEM can consist of ME EQUIPMENT used in combination with other ME EQUIPMENT or with other electrical equipment that is not ME EQUIPMENT."

If a device is mains driven is not relevant, immunity, ESD and radiated-emmision can be of intrest for battery driven devices, however some tests can be skipped (for instance surge immunity).

Apart from this, if your accessory would not be medical, it is possibly no longer excluded in 2004-108-EEC, and you can end up still doing EMC tests.