The risks associated with electricity are very large in terms of loss of life and property. The biggest accidents are caused by electric current and the most electric shock accidents are experienced. Factors effective in these accidents are:
- Alternating current or direct current
- Magnitude of electric current (ie voltage)
- Direction of current intensity and its path
- Frequency in case of alternating current
- Time of current effect
- Dry and wet soil if there is a grounding problem
- Presence of uninsulated parts in the power line
- Finding substances that prevent the passage of the current between the source of the current and the problem point
The same risks apply to medical devices and equipment as they are electrically powered devices. There are three basic regulations governing the safety and marketing of medical devices:
- Regulation on implantable active medical devices
- Regulation on medical devices
- Regulation on in-vitro medical diagnostic equipment
These regulations issued by the Ministry of Health comply with the European Union directives. European Union countries and our country are responsible for the safety, marketing and supervision of medical devices in accordance with these legal regulations. In this way, individuals and organizations using these devices ensure that they comply with the general standards for performance and safety. These devices are manufactured in accordance with the relevant legal regulations and are CE marked.
These devices, which are used for diagnosis and treatment in human health, are covered by the Regulation on Electrical Equipment Designed for Specific Voltage Limits (2014 / 35 / EU) issued by the Ministry of Science, Industry and Technology. In this context, LVD low voltage tests must be performed by the manufacturers of all medical devices covered by the relevant regulations.
There are many published standards on medical devices. A few standards considered for LVD testing are:
· TS EN 60601-1 Electrical medical equipment - Part 1: General rules for basic safety and required performance
· TS EN 60601-2-2 ... Specific features for the safety of high-frequency surgical instruments
· TS EN 60601-2-3 ... Specific features for basic safety and required performance of short-wave therapy equipment