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<p>This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.</p>
<p>This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.</p>
<p>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.</p>
<p>This document does not apply to biological material intended for therapeutic use.</p>
<p>NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.</p>
<p>NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.</p>
Reģistrācijas numurs (WIID)
88703
Darbības sfēra
<p>This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.</p>
<p>This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.</p>
<p>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.</p>
<p>This document does not apply to biological material intended for therapeutic use.</p>
<p>NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.</p>
<p>NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.</p>
