Standard Swedish standard · SS-ISO 20387:2019

Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018, IDT)

Status: Valid

Scope
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.

Subjects

Biology, botany, zoology


Product information

Language: English

Written by: SIS

International title: Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018, IDT)

Article no: STD-80009585

Edition: 1

Approved: 2/7/2019

No of pages: 48

Also available in: SS-ISO 20387:2019