K
karthika subramaniam
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
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