<p>ISO/TR 10993-22:2017 describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (e.g. <i>in situ</i> grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials.</p>
<p>ISO/TR 10993-22:2017 includes considerations on the:</p>
<p>- characterization of nanomaterials;</p>
<p>- sample preparation for testing of nanomaterials;</p>
<p>- release of nano-objects from medical devices;</p>
<p>- toxicokinetics of nano-objects;</p>
<p>- biological evaluation of nanomaterials;</p>
<p>- presentation of results;</p>
<p>- risk assessment of nanomaterials in the context of medical device evaluation;</p>
<p>- biological evaluation report;</p>
<p>- nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.</p>
<p>The following are excluded from this document:</p>
<p>- natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;</p>
<p>- intrinsic nanostructures in a bulk material;</p>
<p>- nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.</p>
<p>NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks.</p>
<p>ISO/TR 10993-22:2017 is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.</p>
Registration number (WIID)
65918
Scope
<p>ISO/TR 10993-22:2017 describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (e.g. <i>in situ</i> grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials.</p>
<p>ISO/TR 10993-22:2017 includes considerations on the:</p>
<p>- characterization of nanomaterials;</p>
<p>- sample preparation for testing of nanomaterials;</p>
<p>- release of nano-objects from medical devices;</p>
<p>- toxicokinetics of nano-objects;</p>
<p>- biological evaluation of nanomaterials;</p>
<p>- presentation of results;</p>
<p>- risk assessment of nanomaterials in the context of medical device evaluation;</p>
<p>- biological evaluation report;</p>
<p>- nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.</p>
<p>The following are excluded from this document:</p>
<p>- natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;</p>
<p>- intrinsic nanostructures in a bulk material;</p>
<p>- nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.</p>
<p>NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks.</p>
<p>ISO/TR 10993-22:2017 is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.</p>
