<p>This document specifies terminology, principles and a <i>process</i> for <i>risk management</i> of <i>medical devices</i>, including software as a <i>medical device</i> and <i>in vitro diagnostic</i> <i>medical devices</i>. The <i>process</i> described in this document intends to assist <i>manufacturers</i> of <i>medical devices</i> to identify the <i>hazards</i> associated with the <i>medical device</i>, to estimate and evaluate the associated <i>risks</i>, to control these <i>risks</i>, and to monitor the effectiveness of the controls.</p>
<p>The requirements of this document are applicable to all phases of the <i>life cycle</i> of a <i>medical device</i>. The <i>process</i> described in this document applies to <i>risks</i> associated with a <i>medical device</i>, such as <i>risks</i> related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.</p>
<p>The <i>process</i> described in this document can also be applied to products that are not necessarily <i>medical devices</i> in some jurisdictions and can also be used by others involved in the <i>medical device</i> <i>life cycle</i>.</p>
<p>This document does not apply to:</p>
<p>— decisions on the use of a <i>medical device</i> in the context of any particular clinical <i>procedure</i>; or</p>
<p>— business <i>risk management</i>.</p>
<p>This document requires <i>manufacturers</i> to establish objective criteria for <i>risk</i> acceptability but does not specify acceptable <i>risk</i> levels.</p>
<p><i>Risk management</i> can be an integral part of a quality management system. However, this document does not require the <i>manufacturer</i> to have a quality management system in place.</p>
<p>NOTE Guidance on the application of this document can be found in ISO/TR 24971<sup>[</sup><sup>9</sup><sup>]</sup>.</p>
Registration number (WIID)
72704
Scope
<p>This document specifies terminology, principles and a <i>process</i> for <i>risk management</i> of <i>medical devices</i>, including software as a <i>medical device</i> and <i>in vitro diagnostic</i> <i>medical devices</i>. The <i>process</i> described in this document intends to assist <i>manufacturers</i> of <i>medical devices</i> to identify the <i>hazards</i> associated with the <i>medical device</i>, to estimate and evaluate the associated <i>risks</i>, to control these <i>risks</i>, and to monitor the effectiveness of the controls.</p>
<p>The requirements of this document are applicable to all phases of the <i>life cycle</i> of a <i>medical device</i>. The <i>process</i> described in this document applies to <i>risks</i> associated with a <i>medical device</i>, such as <i>risks</i> related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.</p>
<p>The <i>process</i> described in this document can also be applied to products that are not necessarily <i>medical devices</i> in some jurisdictions and can also be used by others involved in the <i>medical device</i> <i>life cycle</i>.</p>
<p>This document does not apply to:</p>
<p>— decisions on the use of a <i>medical device</i> in the context of any particular clinical <i>procedure</i>; or</p>
<p>— business <i>risk management</i>.</p>
<p>This document requires <i>manufacturers</i> to establish objective criteria for <i>risk</i> acceptability but does not specify acceptable <i>risk</i> levels.</p>
<p><i>Risk management</i> can be an integral part of a quality management system. However, this document does not require the <i>manufacturer</i> to have a quality management system in place.</p>
<p>NOTE Guidance on the application of this document can be found in ISO/TR 24971<sup>[</sup><sup>9</sup><sup>]</sup>.</p>
