CEI UNI EN ISO 20387
2021
Biotechnology – Biobanking – General requirements for biobanking
- Format:
- Language(s) :
- Published :
- English
- 07/01/2021
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 | |
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STANDARD INFO: | |
Standard Name | CEI UNI EN ISO 20387 |
Scope | Biotechnology - Biobanking - General requirements for biobanking |
Publisher | CEI - Comitato Elettrotecnico Italiano |
Languages | English |
State | [ Active ] |
Publication Year | 2021 |
Most recent Version | MOST RECENT |
Whether to be replaced | |
Addendum | |
FILE INFO: | |
Edition | 21# |
File Size | 1 file , 2.6 MB |
Number of Pages | 50 |
Published | 07/01/2021 |
CEI UNI EN ISO 20387 | ||
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History | Publisher Year | |
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