CEI UNI EN ISO 20387

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CEI UNI EN ISO 20387

2021

Most Recent

Biotechnology – Biobanking – General requirements for biobanking

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ENGLISH

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.

CEI UNI EN ISO 20387
STANDARD INFO:
Standard NameCEI UNI EN ISO 20387
ScopeBiotechnology - Biobanking - General requirements for biobanking
PublisherCEI - Comitato Elettrotecnico Italiano
LanguagesEnglish
State[ Active ]
Publication Year2021
Most recent VersionMOST RECENT
Whether to be replaced
Addendum
FILE INFO:
Edition21#
File Size1 file , 2.6 MB
Number of Pages50
Published07/01/2021
This document does not provide a preview.
CEI UNI EN ISO 20387
HistoryPublisher Year

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