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Norm

ISO 20387:2018

Ausgabedatum: 2018 08 03

Biotechnology — Biobanking — General requirements for biobanking

This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biolog...
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Herausgeber:
International Organization for Standardization
Format:
Digital | 36 Seiten
Sprache:
Englisch

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.

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.

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.

This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.

NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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.

final draft ISO Standard
ISO/FDIS 20387
Ausgabedatum : 2018 04 26
Biotechnology — Biobanking — General requirements for biobanking
Draft International Standard (ISO Entwurf)
ISO/DIS 20387
Ausgabedatum : 2017 07 20
Biotechnology — Biobanking — General requirements for biobanking