Is compliance to IEC 60601-1 Required for my Product?

[kmbird33]

I am trying to determine whether 60601-1 is a requirement for my product. Per the definition of ME equipment in the standard it is not ME equipment; however, it will be operating in the patient environment. In a nutshell, its a off-the-shelf desktop PC with touchscreen monitors and custom image generation software, and is classified as a PACS (product code LLZ) by the FDA. It will be used in an operating room.

 

[J0anne]

Does it fall within the definition of an ME system? 3.64

 

[kmbird33]

Good question. By itself it does not meet the definition of ME equipment; however, it can connect via network cable to a ME system manufactured and sold by another vendor which provides data.

 

[kmbird33]

Would our product be considered an accessory to the ME system (manufactured by someone else) that it interfaces to? It can function alone, but the ability to use the data provided by the ME system is a major feature.

Thanks in advance for any help.

 

[Marcelo]

PACS are not MEE. MEE need to touch the patient, or transfer energy, or monitor this transfer, etc.

 

[kmbird33]

Although its not MEE, does that fact that it is operating in the patient environment (specifically the operating room) require 60601-1 and 60601-1-2 testing? Would the FDA expect to be included in 510(k) submission?

Thanks again in advance for your help.

 

[Marcelo]

Although its not MEE, does that fact that it is operating in the patient environment (specifically the operating room) require 60601-1 and 60601-1-2 testing?

No, 60601- and 60601-1 are only applicable to MEE. The definition of patient environment was created to understand when a device os system is an MEE or not, and the patient environment stands only to the reach of the MEE or ME system, so unless your PACS is to be used besides the patient, having the possibility of being contacted by MEEs, there?s no point in using 60601-1 or 60601-1-2.

Would the FDA expect to be included in 510(k) submission?

No.