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<p class="MsoBodyText"><span lang="EN-GB">This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).</span></p>
<p class="MsoBodyText"><span lang="EN-GB">While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not apply to the design, development and industrial production of commercially used IVD medical devices.</span></p>
Reģistrācijas numurs (WIID)
81506
Darbības sfēra
<p class="MsoBodyText"><span lang="EN-GB">This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).</span></p>
<p class="MsoBodyText"><span lang="EN-GB">While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document does not apply to the design, development and industrial production of commercially used IVD medical devices.</span></p>
