<p>This document specifies:</p>
<p>— the general principles governing the biological evaluation of medical devices within a risk management process;</p>
<p>— the general categorization of medical devices based on the nature and duration of their contact with the body;</p>
<p>— the evaluation of existing relevant data from all sources;</p>
<p>— the identification of gaps in the available data set on the basis of a risk analysis;</p>
<p>— the identification of additional data sets necessary to analyse the biological safety of the medical device;</p>
<p>— the assessment of the biological safety of the medical device.</p>
<p>This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: </p>
<p>— the patient's body during intended use;</p>
<p>— the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). </p>
<p>This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.</p>
<p>This document also gives guidelines for the assessment of biological hazards arising from:</p>
<p>— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;</p>
<p>— breakage of a medical device or medical device component which exposes body tissue to new or novel materials. </p>
<p>Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.</p>
<p>This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.</p>
Registration number (WIID)
68936
Scope
<p>This document specifies:</p>
<p>— the general principles governing the biological evaluation of medical devices within a risk management process;</p>
<p>— the general categorization of medical devices based on the nature and duration of their contact with the body;</p>
<p>— the evaluation of existing relevant data from all sources;</p>
<p>— the identification of gaps in the available data set on the basis of a risk analysis;</p>
<p>— the identification of additional data sets necessary to analyse the biological safety of the medical device;</p>
<p>— the assessment of the biological safety of the medical device.</p>
<p>This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: </p>
<p>— the patient's body during intended use;</p>
<p>— the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). </p>
<p>This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.</p>
<p>This document also gives guidelines for the assessment of biological hazards arising from:</p>
<p>— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;</p>
<p>— breakage of a medical device or medical device component which exposes body tissue to new or novel materials. </p>
<p>Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.</p>
<p>This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.</p>
