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The 3rd edition of IEC 60601-1 extended the patient focus to require an overall means of protection (MOP) that combined one or more “means of operator protection” (MOOP) and “means of patient protection” (MOPP), recognizing the potential hazards seen by each user are different. For instance, an operator has access to a control panel, while the patient may be connected via probes. An ISO 14971 Risk Analysis/Management process is then used to define one of four possible “means of protection” classifications noted above.
PTM Published on: 2018-06-06