ISO/TC 276

Projekta Nr.ISO/DIS 20387
Nosaukums<p class="MsoBodyText" style="tab-stops: 19.85pt 28.1pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure that collections of biological material and associated data are of appropriate quality.</span></p> <p class="MsoBodyText" style="tab-stops: 19.85pt 28.1pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">This document is applicable to all organizations performing biobanking. This can include biobanking of biological material and associated data:</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">a)<span style="mso-tab-count: 1;">    </span>from multicellular organisms (e.g. human, animal, fungus and plant);</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">b)<span style="mso-tab-count: 1;">    </span>from microorganisms;</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">c)<span style="mso-tab-count: 1;">    </span>derived from sources such as environmental samples (e.g. soil, sediment, water, air).</span></p> <p class="MsoBodyText" style="tab-stops: 19.85pt 28.1pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.</span></p> <p class="MsoBodyText" style="tab-stops: 19.85pt 28.1pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">This document does not apply to biological material intended for therapeutic use.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">NOTE 1<span style="mso-tab-count: 1;">   </span>International, national or regional regulations or requirements can also apply to specific topics covered in this document.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">NOTE 2<span style="mso-tab-count: 1;">   </span>For entities handling human materials procured and used for diagnostic and treatment purposes, </span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">ISO</span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;"> <span class="stddocNumber">15189</span> and other clinical standards are intended to apply first and foremost. </span></p>
Reģistrācijas numurs (WIID)88703
Darbības sfēra<p class="MsoBodyText" style="tab-stops: 19.85pt 28.1pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure that collections of biological material and associated data are of appropriate quality.</span></p> <p class="MsoBodyText" style="tab-stops: 19.85pt 28.1pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">This document is applicable to all organizations performing biobanking. This can include biobanking of biological material and associated data:</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">a)<span style="mso-tab-count: 1;">    </span>from multicellular organisms (e.g. human, animal, fungus and plant);</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">b)<span style="mso-tab-count: 1;">    </span>from microorganisms;</span></p> <p class="ListNumber1" style="tab-stops: 19.85pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">c)<span style="mso-tab-count: 1;">    </span>derived from sources such as environmental samples (e.g. soil, sediment, water, air).</span></p> <p class="MsoBodyText" style="tab-stops: 19.85pt 28.1pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.</span></p> <p class="MsoBodyText" style="tab-stops: 19.85pt 28.1pt 39.7pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">This document does not apply to biological material intended for therapeutic use.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">NOTE 1<span style="mso-tab-count: 1;">   </span>International, national or regional regulations or requirements can also apply to specific topics covered in this document.</span></p> <p class="Note" style="tab-stops: 19.85pt 39.7pt 48.25pt 59.55pt 79.4pt 99.25pt 119.05pt 138.9pt 158.75pt 178.6pt 7.0cm; mso-layout-grid-align: none; text-autospace: none;"><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;">NOTE 2<span style="mso-tab-count: 1;">   </span>For entities handling human materials procured and used for diagnostic and treatment purposes, </span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt;">ISO</span><span lang="EN-GB" style="mso-bidi-font-size: 12.0pt; mso-fareast-font-family: Batang;"> <span class="stddocNumber">15189</span> and other clinical standards are intended to apply first and foremost. </span></p>
StatussIzstrādē
ICS grupa07.080