Safety of Devices

iso 13485 for pemf devices

What is really important to know about the safety of your PEMF device?

When choosing a pulsed electromagnetic field therapy device it is very important to know if the device meets all international specifications for safety according to GMP (Good Manufacturing Practice) and ISO standards (International Organization for Standaridization) for design and manufacturing of medical devices.

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The actual plant of the manufacturer is audited by an independent organization to verify compliance once a year.

Some devices on the market employ a separate power supply to connect to the mains, which makes the device not only less reliable, but in addition, a short circuit in the cable between the power supply and the device will heat up the power supply and destroy it after a couple of minutes.

Just to give a few additional safety examples for the devices we manufacture:

  • The coils inside the therapy pad and mattress are double isolated and in addition hermetically sealed and waterproof, to protect against any electrical contact between you and electrical currents inside the coils.
  • The electrical output connected to the coils "floats", so even in case someone would cut through a pad with a knife and touch the coils, no electrical current can flow between the device and yourself.
  • Even in case the electrical output of the device, connected to the coils, will short circuit, neither the device nor the coils will be damaged.
  • The professional models automatically detect if the pad is disconnected and will show a warning signal, switching off the output.
  • When a Curatron device is controlled by a personal computer the controls on the device are automatically disabled avoiding any possibility for mistakes.

I would advise to check out the safety of the device you intend to purchase very carefully and buy only from a manufacturer complying with the set out standards for manufacturing of medical devices and not just general electrical safety!

Copyright - Ben Philipson Curatronic Ltd.
safety of pemf devices