Difference between Medical Electrical Equipment and Medical Equipment System

karthika subramaniam

Starting to get Involved
#1
Hello Everyone!

What is the difference between ME Equipment and ME system?

IEC 60601-1, 3.1 edition – Terms and Definitions
* MEDICAL ELECTRICAL SYSTEM
ME SYSTEM
combination, as specified by its MANUFACTURER, of items of equipment, at least one of which is ME EQUIPMENT to be inter-connected by FUNCTIONAL CONNECTION or by use of a MULTIPLE SOCKET-OUTLET

3.33
* FUNCTIONAL CONNECTION
connection, electrical or otherwise, including those intended to transfer signals, data, power or substances


Examples for ME equipment’s
- High Frequency Surgical Equipment.
- Cardiac Defibrillators.
- Patient Monitors.
- Therapeutic and Diagnostic Ultrasound Equipment.
- Medical Lasers.
- Patient Ventilators.
- Infant Incubators and Warmers

Particular standard takes priority over the general standard IEC 60601-1. In that regard wrt IEC 60601-2-1, states that the requirements of clause 16 of the general standard do not apply.
Requirements of clause 16 of 60601-1 are not applicable to electron accelerators in the scope of 60601-2-1?
Medical LINAC does not falls under ME System?

Can anyone help in understand the difference between ME Equipment and ME System
 
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swathi.sp

Starting to get Involved
#2
Within the standards you mentioned you are correct that Clause 16 of the General Standard does not apply.
This was due to
1) the restrictive nature of the Equipment definition vs the System definition and
2) the electrical requirements placed on Systems within Clause 16.


1) All electron and light ion accelerators consists of several pieces of “Equipment” when examined with electrical and signal connectivity in mind. While this would make the equipment a System in the general sense, both have been defined as Equipment within their respective Particular standards.
2) Some of the requirements in Clause 16 would conflict with requirements already in the Particular Standard and in some cases make it difficult to determine what is part of the Equipment and what is the System. For this reason, it was decided at the time that it was better to just exclude Clause 16 of the General Standard from the Particular Standard.


After these Standards were published, the Working Group started referencing IEC 60601-1 Ed. 3.1 for the newer work to be published. This version made it easier to include Clause 16 in our Particular Standards. The first to do this will be version 4.0 of IEC 60601-2-1.

In IEC 60601-2-1 edition 4.0, Clause 16 is now stated as applying and those subclauses that need to be excluded or modified are now called out in this standard.
 

mehrnaz

Starting to get Involved
#3
regarding this question. also i am not sure a dental unit with patient chair and operating light is a ME system or ME equipment?
can any body help me in this regard?
 
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