Network isolator: Difference between revisions

Revision as of 21:46, 17 October 2009

Revision as of 06:54, 6 September 2010

Line 27:

==Technical requirements==

The international standard [[List of IEC standards|IEC 60601-1]] Medical Electrical Equipment (3rd edition) specifies stringent criteria on the safety and isolation of medical devices. These requirements are of course much more stringent than those of a typical consumer product standard (i.e. IEC 60950 Safety of Information Technology Equipment), as the patient may be unconscious, anaesthetised, or otherwise unable to move, and the need for patient protection is therefore paramount.

The IEC 60601-1 standard requires that two independent precautionary measures (Means of Patient Protection, or MOPPs) are set in place, to protect the patient from electrical shock in the medical system. A network isolator can be constructed to provide one or both required MOPPs. In the case where only a single MOPP is present in a system, a second measure of protection for the medical device must be made. This can be achieved, for example, by installing a fixed, low-resistance earthing cable, bar, or strap, referred to as a potential equalisation conductor. Conformation to the requirements of applicable standards and guidelines, in particular the IEC 60601-1 standard, involves manufacturers themselves declaring [[CE mark|CE]] compliance and/or gaining certification from an approved independent testing laboratory.