Note 1 to entry: An effect is a deviation from the expected. Control 4ĥ Introduction ISO IEC Directives, HLS (Annex L) ISO31000:2018 & ISO 9000:2015 Not intended for managing product related risk Effect of uncertainty on objectives. Monitor Identify Estimate & Evaluate For any particular medical device, other International Standards could require the application of specific methods for managing risk. ISO specifies a process through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control. 4 Introduction As one of the stakeholders, the manufacturer makes judgments relating to safety of a medical device, including the acceptability of risks, taking into account the generally aknowledged state of the art, in order to determine the suitability of a medical device to be placed on the market for its intended use.
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