Safety of PEMF devices
Here follows some really important things you should know about the safety of your PEMF device.
When choosing a PEMF therapy device it is important to know if the device meets the international standards for safety according to Good Manufacturing Practice and the ISO standards of the International Organization for Standaridization for manufacturing of
ISO 13485 specifies requirements for a quality management system that the manufacturer must proof on yearly basis that their PEMF devices are manufactured according to the regulatory requirements applicable for medical devices.
These manufacturing facilities are each and every year audited by an independent organization to verify compliance. These organizations are called Notified Bodies and they in turn are accredited in Europe.
Some PEMF devices on the market make use of a separate power supply to connect to the mains. This not only makes the PEMF device less reliable but just a short in the cable between the power supply and the device will burn out this power supply. What happens next: a non-medical standard replacement power supply is used with all the dangers of electrocution!
Here are some important points for your consideration:
The coils inside the therapy pad must be double isolated.
Hermetically sealed and waterproof, to protect against any electrical contact between the user and electrical currents inside the coils.
The electrical output connected to the coils must float = electrically isolated.
Even if someone by mistake touches a coil directly no electrical current should be able to flow between the device and the person.
If the electrical output of the device, connected to the coils, will short circuit, neither the device nor the coils should be damaged.
Automatically detecting if an applicator is disconnected while disabling any possible output current.
Check out the safety of the PEMF device before you buy!
Ask for proof of certification according to medical standards and not just according to electrical safety! Your life is on the line!